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Induced Pluripotent Stem Cells: Reprogramming Platforms …

Induced Pluripotent Stem Cells. The depth of Yamanaka's perception through the discoveries in somatic cell nuclear transfer, 10 cellular fusion, 11 ESC research, 1,12 and understanding of pluripotency related transcription factors 13,14 has led to the landmark discovery in stem cell research.This major breakthrough was the demonstration that ectopic expression of cellular transcription factors ...

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Induced Pluripotent Stem Cells: Reprogramming Platforms ...

Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth – StreetInsider.com

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US government considers ethics of aborted tissue research – Angelus News

A new federal ethics advisory board for fetal tissue research has convened to consider future federally-funded research proposals that involve tissue from aborted babies.

The Human Fetal Tissue Research Ethics Advisory Board of the National Institutes of Health (NIH) met for the first time on July 31, to advise the Health Secretary on the ethics of research proposals involving fetal tissue of aborted babies.

The board was first announced in June of 2019, when the Trump administration decided to halt new research with aborted fetal tissue at NIH facilities, and limited funding of such research conducted outside the NIH.

For the research conducted outside the NIH, or extramural research, the administration announced that an ethics advisory board would be appointed to consider such funding and advise the secretary of Health and Human Services (HHS) on the proposals.

Some researchers have called for the administration to end its moratorium, saying that research with aborted fetal tissue could be vital to developing treatments and a cure for the new coronavirus (SARS-CoV-2).

In February, the HHS announced that it would begin accepting nominations to the board, and during that time period, some researchers at an NIH research laboratory told theWashington Postthat the administrations moratorium on fetal tissue research was hindering possible advances in research on treatments for the coronavirus.

Dr. David Prentice, now a member of the NIH Human Fetal Tissue Research Ethics Advisory Board, told CNA in March that the timing of the comments was peculiar as it could have been related to the consideration of appointments to the board.

Several leading coronavirus vaccine candidates are using cell lines from aborted babies, including some funded by the U.S.; other candidates have been determined to be ethically uncontroversial by the pro-life Charlotte Lozier Institute.

One candidate in particularbeing developed by Moderna and the National Institute of Allergy and Infectious Diseasesis not using fetal cell lines directly in production, but is based on research that involved aborted fetal cell lines. As Moderna was not involved in that research, CLI said that the vaccine candidate is ethically uncontroversial.

The NIH ethics board members are appointed for a duration that lasts as long as the board is convened; the boards charter says that [t]he estimated annual person-years of staff support required is 0.7. Appointments to the board are made by the HHS secretary.

Heading the advisory board is Paige Cunningham, interim president of Taylor University, an evangelical Christian university in Indiana.

Several Catholic bioethicists are on the board, including Fr. Tadeusz Pacholczyk, director of education at the National Catholic Bioethics Center. The co-chair of the Catholic Medical Association (CMA) ethics committee, Greg Burke, is a member, along with CMA member Dr. Ashley Fernandes of the Ohio State University medical school.

The pro-life Charlotte Lozier Institute (CLI) is also represented on the board, with CLI vice president Dr. David Prentice and associate scholars Ingrid Skop and Maureen Condic as members.

Some board members, such as Dr. Lawrence Goldstein of the University of California San Diego, support fetal tissue research; hecalledcell lines from fetal tissue critical in vaccine development, along with stem cell research and the use of humanized mice to develop immune cell-forming tissues.

Two members testified in 2016 before the House select investigative panel of the Energy and Commerce Committee, in a hearing on bioethics and fetal tissue.

Cunningham said at the hearing that [t]he fetus is a human subject entitled to the protections that both traditional and modern codes of medical ethics provide to human subjects.

Kevin Donovan, MD, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, also testified, noting the current moral ambiguity in the nations discourse on abortion.

We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed, he said. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home.

If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction, he said.

During the public portion of the July 31 meeting, board members were introduced and then heard from several researchers who were either in support of or in opposition to research using fetal tissue from elective abortions.

The 2008 Vatican documentDignitatis Personaeaddressed the topic of aborted fetal tissue research, saying that there is a duty to refuse to use such biological material even when there is no close connection between the researcher and the actions of those who performed the artificial fertilization or the abortion, or when there was no prior agreement with the centers in which the artificial fertilization took place.

This duty springs from the necessity to remove oneself, within the area of ones own research, from a gravely unjust legal situation and to affirm with clarity the value of human life, the Congregation for the Doctrine of the Faith document stated.

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US government considers ethics of aborted tissue research - Angelus News

Mesa Discusses Treating Myelofibrosis and Other MPNs – Targeted Oncology

Ruben Mesa, MD, director, Mays Cancer Center at The University of Texas Health San Antonio, MD Anderson Cancer Center San Antonio, TX, reviewed a case of a 68-year-old woman with a myeloproliferative neoplasm, during a virtual Case Based Peer Perspectives event.

Targeted Oncology: What type of testing would you perform on this patient? Are there certain mutations in particular that you are looking for?

MESA: The NGS [next-generation sequencing] panels are helpful. In myelofibrosis, theyre the most necessary in the potential transplant candidate [who is] of intermediate risk [and for whom] youre uncertain of the [prognosis]. In patients who are high risk, its also useful information. If someone hasoverwhelmingly high-risk disease, theyre not going to be at higher risk [based on these results], but I think its helpful information that we continue to learn about in terms of clonal evolution. Or, if they go to transplant, we know what the clones look like at the onset prior to undertaking [the trans- plant]. Our medical therapies have not resolved these muta- tions, but of course that could change. Its helpful information for us to know.

There are bad actors like ASXL1, EZH1/2, [and] the IDH1 muta- tions. The absence of a bunch of these somatic mutations is somewhat reassuring. Its helpful in combination with the clini- cal data. How are they feeling as far as their spleen, cytopenias, etcetera? There are [many] of these models that have been created, and some of which now have genetic data only. Thats probably incomplete. I can put the stained clone in 2 different patients, but if one is 45 years old and healthy and the other is 70 years old with comorbidities, theres no way those patients are doing the same. I think the clone is important, but the clone always has to live in a person.

Which risk-assessment tool do you use most often?

MIPSS [Mutation-Enhanced International Prognostic Score System] is the most popular, and it has a couple of advantages. One is that it has its own website; you can Google it and book- mark it on your computer. I always tell my trainees, dont bother to memorize any prognostic score in terms of how to calculate it because we have [a] calculator. But have a sense of what...the biological [characteristics are] that make a difference in terms of the prognosis for patients that give you some insight into the behavior of the disease. Have a sense of where and when that [is] useful.

There have been multiple models that have been validated. They help to stratify patients in terms of their outcomes in a range of ways. They are largely surrogates [of transformation to acute myeloid leukemia] as well, although its a different issue. The outcome for the patient with myelofibrosis if they pass away from the diseasewhich is still the majority of patientsis [that] they either die of progressive features of myelofibrosis, which can include progressive debilitation, cytopenias, and a range of complications related to that, or they progress to acute leuke- mia and can pass away from those sets of difficulty.

Why are prognostic models referenced in the National Comprehensive Cancer Network (NCCN) guidelines?

I was involved with the original NCCN guidelines for MPNs [myeloproliferative neoplasms].1 Originally, we had the prog- nostic score, or at that point the DIPSS [Dynamic International Prognostic Scoring System] or the DIPSS-Plus...to help stratify whos lower risk or whos higher risk in terms of therapy to get rid of some of the granularity.

Would you consider transplant in this case?

I have had patients who have done well with transplant. Transplant can be curative, but we can also wait too long, partic- ularly in the setting of myelofibrosis. I think when its being used as salvage therapy in myelofibrosis, the outcomes are less [successful] than we would like. In my estimation, the best time to have a transplant is probably before either the patient or physician really feels the patient needs one. Its during their optimal JAK inhibitor response that they probably do the best. Now, on the flip side, thats the time that they have the most to lose in that their quality of life is good and theyre stable. Its a difficult decision.

Which systemic therapies might you consider in this patient?

In terms of medical therapy, we now have 2 approved ther- apies in the front line, both ruxolitinib [Jakafi] and fedratinib [Inrebic], and many others in development that were discussed at the ASCO [American Society of Clinical Oncology] Annual Meeting and at the 25th Annual Congress of EHA [European Hematology Association].

Ruxolitinib has now been approved for a long time with data from the randomized studiesnow almost historical in nature with the COMFORT studies, both COMFORT-I [NCT00952289] and COMFORT-II [NCT00934544]. It showed for the first time in randomized settings a drug that was effective in myelofibrosis. Ruxolitinib was clearly better than placebo [and best alternative therapy] in the COMFORT-I study that Srdan Verstovsek, MD, PhD, and I led, and which was a European study.2

That was relevant because at the time the standard of care was Hydrea [hydroxyurea]. We recognized in retrospect that hydroxyurea is not as great a therapy for myelofibrosis. Its good therapy for ET [essential thrombocytopenia]. It helps to control platelets reasonably well in many, but its not a perfect drug. In polycythemia vera, its a reasonable frontline therapy, although interferon may have advantages. In myelofibrosis, it might help with leukocytosis but doesnt do much for splenomegaly symp- toms, anemia, fibrosis, or progression toward acute leukemia.

Would you send her for transplant, start ruxolitinib or fedratinib, observation, or something else?

Ill remind [you that] this patient is 68 years old, has a big spleen, has a JAK2 mutation, and leukoerythroblastosis...most physicians would start her on ruxolitinib. That would surely be consistent with our NCCN guidelines.1 Some would refer [her] for stem cell transplant. That would not be incorrect. She has some higher- risk features. She has anemia, 2% [peripheral blood] blasts, and mild thrombocytopenia. In all honesty, some of these things we do in parallel.

I dont typically [rely on transplant], but I do send patients who are potentially eligible to visit with a transplant physician so that that process can start. The patient can learn more about the process. We could see what a potential donor solution would be. We could see what sort of initial response to therapy that they have. Patients who go to transplant would likely start JAK inhibi- tion before they would go [for their transplant]. Even if they found a good sibling match, and the patient wants to go through with that, its probably going to take 3 to 4 months and they can be on JAK inhibition before that. They might have a better outcome with the spleen being smaller and going to transplant better. [Its] a bit of an artificial question in that you might choose to do more than one of these things in parallel.

What are the advantages of JAK inhibition with ruxolitinib?

There are patients from the phase 1 study of ruxolitinib at our centers that are still on the therapy. These are individuals that had expected survival [times] of under 3 years. I think that patients that are having a great response to JAK inhibition have their natural history improved. Splenomegaly symptoms were both clinically meaningful [and measurable according to early ruxolitinib activity].

Every time weve looked at it, there is an indication that ruxoli- tinib improves survival for patients. Now, the studies were not survival studies in their design, and that was for a variety of reasons. It would have been largely unethical and unrealistic to expect patients to stay on placebo forever so that they could do worse on a control arm [to prove] survival advantage. Having been involved with caring for patients with myelofibrosis before JAK inhibitors and after, theres no question that these drugs improve survival. Id say that the rate by which patients passed away...has decreased significantly over the past decade as opposed to my first 15 years of treating myelofibrosis. [Ruxolitinib] does not cure the disease, and its not [successful] in every patient. I dont think we yet truly know why we see that difference.

Why is the spleen response with ruxolitinib so important?

I do not believe...that shrinking the spleen because of its mechan- ical effect leads to an improvement in survival. However, the spleen is a good barometer of the quality of JAK inhibitor response, and responding to JAK inhibitors improves survival. I think tracking this thing is important, not just because it shrinks but because it means that whatever benefit were getting from JAK inhibition is present.

What is the optimal dose of ruxolitinib in this patient population?

Weve learned several things over time, including the issue of dosing, as it relates to efficacy and survival. Patients probably need to be on 10 mg twice a day or more to be getting the optimal benefit. Ideally, [we should be] getting them to 15 mg twice a day, or, if reasonable, 20 mg twice a day. There is contro- versy. My colleague...strongly believes we should start everyone at the higher dose. I think its OK to start lower, but you must accelerate the dose. There are likely too many patients out there on a suboptimal dose of ruxolitinib. Starting with those doses is fine, but rapidly increasing the dose where you truly see a signif- icant reduction in the size of the spleen and improvement in the symptoms [is necessary]. If youre not achieving that, then that is when its important to think about second-line therapy, dose adjustments, or a clinical trial.

What adverse effects (AEs) of ruxolitinib are there that treating physicians should be concerned with?

In terms of toxicities, there are issues of cytopenias. In the phase 1 studies, it was thrombocytopenia that was the dose-limiting toxicity. Anemia is the most functional difficulty in that the throm- bocytopenia is present, but it usually is not the driver in terms of limiting your dose.

When would you choose to use fedratinib?

Since last September, we have the approval of fedratinib as well for these patients.3 It was supported by the phase 3 JAKARTA study [NCT01437787], a randomization between fedratinib at 2 different dose levels versus placebo in patients that had intermediate- or high-risk myelofibrosis. The timing of the trial overlapped with the period before ruxolitinib was approved.

There was a nice response in terms of splenomegaly compared with placebo. There was a 500-mg arm that performed reasonably well in terms of efficacy but had more toxicity, so the approved dose is 400 mg.

In terms of toxicity, there are gastrointestinal toxicities. Typically, patients are [given] prophylaxis with antidiarrheals and antinausea drugs. Id have to say most patients dont tend to have a lot of difficulties with that. They can have cytopenias; there [are] no direct head-to-head data between fedratinib and ruxolitinib in terms of rates of cytopenias, but its not clear that there is necessarily a clear advantage between one or the other.

What does the black box warning say for encephalopathy in patients who receive fedratinib?

It was recognized that there were several cases of individuals who had had some degree of CNS [central nervous system] toxicity in 8 cases out of about the 900 patients that were treated. It was suspected that it was Wernicke encephalopathy. The drug was put on a clinical hold. Those cases were subsequently looked at in great detail by neurologists and others, and what was seen was that there was a rare CNS-confusion episode that did occur. It was only clear that 1 of the patients met the criteria of having Wernicke encephalopathy, but they likely had [that] when they were enrolled in the study. In addition, the Wernickes may have been worsened because this patient, at the 500-mg dose, did have a lot of nausea and vomiting.4

With an abundance of caution the drug was approved, but with a black box warning [cautioning physicians to] measure thiamine, replace thiamine if need be, and monitor for Wernicke [enceph- alopathy]. Having prescribed it after its approval, [I have found that] its not a major limiting factor, but just something to be mindful of and exercise every caution.

References

1. NCCN. Clinical Practice Guidelines in Oncology. Myeloproliferative neoplasms, version 1.2020. Accessed June 29, 2020. https://www.nccn.org/professionals/ physician_gls/pdf/mpn.pdf

2. Mesa RA, Kiladjian JJ, Verstovsek S, et al. Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies. Haematologica. 2014;99(2):292-298. doi:10.3324/haematol.2013.087650

3. FDA approves fedratinib for myelofibrosis. FDA. August 16, 2019. Accessed June 29, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/ fda-approves-fedratinib-myelofibrosis

4. Mullally A, Hood J, Harrison C, Mesa R. Fedratinib in myelofibrosis. Blood Adv. 2020;4(8):1792-1800. doi:10.1182/bloodadvances.2019000954

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Mesa Discusses Treating Myelofibrosis and Other MPNs - Targeted Oncology

Edited Transcript of CLDX.OQ earnings conference call or presentation 6-Aug-20 8:30pm GMT – Yahoo Finance

NEEDHAM Aug 7, 2020 (Thomson StreetEvents) -- Edited Transcript of Celldex Therapeutics Inc earnings conference call or presentation Thursday, August 6, 2020 at 8:30:00pm GMT

* Anthony S. Marucci

Celldex Therapeutics, Inc. - Founder, President, CEO & Director

Celldex Therapeutics, Inc. - SVP of Regulatory Affairs

Celldex Therapeutics, Inc. - Senior VP, CFO, Secretary & Treasurer

Celldex Therapeutics, Inc. - SVP of Corporate Affairs & Administration

Welcome to the Celldex Therapeutics Mid-Year 2020 Conference Call. My name is James and I'll be your operator for today's call. (Operator Instructions).

And then I'd like to turn the call over to Sarah Cavanaugh. Sarah, you may begin.

Sarah Cavanaugh, Celldex Therapeutics, Inc. - SVP of Corporate Affairs & Administration [2]

Thank you very much. Good afternoon and thank you all for joining us.

With me on the call today are Anthony Marucci, co-founder, President and CEO of Celldex, Dr. Tibor Keler, co-founder Executive Vice President and Chief Scientific Officer, Dr Diane Young, Senior Vice President and Chief Medical Officer. Sam Martin, Senior Vice President and Chief Financial Officer, Dr Margo Heath-Chiozzi, Senior Vice President of Regulatory and Dr Diego Alvarado, Senior Director of Research.

Before we begin our discussion, I'd like to mention that today's speakers will be making forward-looking statements. Such statements reflect on current views with respect to future events and are based on assumptions and subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Certain of the factors that might cause Celldex's actual results to differ materially from those in the forward-looking statements, include those set forth under the headings Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operation in Celldex's annual report on Form 10-K, quarterly reports on Form 10-Q and its current reports on Form 8-K as well as those described in Celldex's other filings with the SEC and its press releases.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should carefully review all of these factors and be aware that there may be other factors that could cause these differences. These forward-looking statements are based on information, plans and estimates as of this call, and Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.

Please be advised that the question and answer period will be held at the close of the call. I'd also like to mention that because of the current COVID-19 situation and also two of our offices are located in the areas of the hurricane, we do have folks dialing in from a number of different remote locations and I ask that you may be bear with us phone lines are a little scratchy because we're dealing with multiple issues on that end.

So with that, I'd like to turn the call over to Anthony. Anthony?

Anthony S. Marucci, Celldex Therapeutics, Inc. - Founder, President, CEO & Director [3]

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Thank you, Sarah. Good afternoon everyone and thank you for joining us. We hope you are all safe and healthy and appreciate you're taking the time to connect with us today. We are looking forward to updating all of you on our progress and providing more detail on our plans for the future. I want to take a few minutes to review the recent events and then I will ask Diane to update you on our clinical programs and Sam to review the financials. We will close the call with your questions.

As you may likely know in early June of this year, Dr Marcus Maurer a leading medical expert in Urticaria, whose research focuses on mast cells presented data from our KIT inhibitor, CDX-0159 and a late breaking session at the EAACI Annual Congress. These data provided an important proof of concept for the program and suggested significant potential which will dramatically impact mast cell driven disorders. These data also help support the $150 million public offering driven by high quality healthcare investors. Importantly, these proceeds will fund the company through 2023 and a number of very important milestones. We are on track to initiate two studies of CDX-0159 and chronic urticaria this fall and I have completed considerable work that Diane will discuss the support expanded development in 2021 and beyond.

As we have always done, we believe is important to focus our resources of people and financial on the programs that hold the most promise for patients and shareholders. Based on the current data we have in-house, we have prioritized the development of our KIT inhibitor CDX-0159, our CDX agonist, CDX-1140 and the first candidate from our bispecific program CDX-527 which combines our proprietary CD-27 agonist with the PD-1 blockade. In turn, we have made a decision not to advance our ErbB3 inhibitor, CDX-3379, which has been in an exploratory study with cetuximab to assess the utility of biomarkers for patient selection and cetuximab resistant head and neck cancer. Despite prophylactic treatment which Diane will discuss in more detail, patients continue to have difficulty tolerating therapy and we believe our resources are best utilized to expand the development of CDX- 0159 and our other pipeline programs.

For our CDX-0159 program, we intend to start two urticaria studies, one in inducible urticaria and the other in spontaneous urticaria this fall and to initiate both the Phase 1 study of CDX- 527 and refractory advanced cancers as well as the combination cohort of CDX-1140 with chemotherapy and treatment of naive metastatic pancreatic cancer later this year. This program is all support multiple data readouts later this year and next year including results from the CDX-0159 study and inducible urticaria in the first quarter of 2021 and the results from the study in spontaneous urticaria in the second half of next year.

We are also in the midst of a thorough assessment of additional opportunities for CDX-0159 and as we now of this list, we plan to initiate our third study and another mast cell driven disease next summer.

With this introduction, I would like Diane to cover activities in more detail. Diane?

--------------------------------------------------------------------------------

Diane C. Young, [4]

--------------------------------------------------------------------------------

Thank you, Anthony. Let me start with CDX-0159. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds to the KIT receptor with high specificity and potently inhibits it's activity. The KIT receptor tyrosine kinase is expressed in mast cells which mediate inflammatory responses such as hypersensitivity an allergic reaction. Ultimately, KIT signaling controls the differentiation, tissue recoupment, survival and activity of mast cells and we believe targeting KIT represents a unique strategy in diseases involving mast cells.

At the EAACI meetings, results from our recently completed Phase 1A study in healthy volunteers were presented. CDX -0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, a protease made almost exclusively by mast cells. The phase 1A study was a randomized double blind, placebo-controlled single-ascending dose escalation study of CDX-0159 in 32 healthy subjects.

Subjects received a single intravenous infusion of CDX-0159 at 0.31319 milligrams per kilogram or placebo. As Dr. Maurer presented a single dose of CDX-0159 supress plasma tryptase levels in a dose-dependent manner indicative of systemic mast cell suppression or ablation, tryptase reduction was evident at 24 hours after infusions and minimal levels were typically observed within one week. Tryptase suppression below the level of detection was observed after a single one milligram per kilogram dose and was maintained for more than two months at single doses of both 3 and 9 milligrams per kilogram.

A subset of subjects from the 3 milligram per kilogram and 9 milligrams per kilogram cohorts agreed to continued follow-up For tryptase analysis which was ongoing at the time of the EAACI meeting. This follow-up and analysis was completed in July and tryptase levels remain below the level of detection for 14 weeks in the 3 milligram per kilogram cohorts for 50% of the returning subjects and 18 weeks in the 9 milligrams per kilogram cohort for all returning subjects. In this study, dose-dependent increases in plasma stem cell factor also mere decreases in tryptase consistent with allosteric blockade of stem cell factor to KIT and further demonstrating complete target engagement in vivo.

Importantly, CDX-0159 also demonstrated a favorable safety profile. The most common adverse events were mild infusion related reactions which spontaneously resolved without intervention. Asymptomatic decreases in neutrophil and white blood cell counts were also observed in laboratory testings but we returning towards normal at the end of the study. We also observed long serum half-life and lack of anti-drug antibodies which provide support to explore less frequent dosing in future studies. Based on these results, we plan to initiate 2 Phase 1B studies of CDX-0159 this fall, one in chronic inducible urticaria and one in chronic spontaneous urticaria, both of which are mast cell driven diseases specifically selected to provide clinical proof of concept for CDX-0159. I'll start with the study in the inducible urticaria as this indication will read out first with data expected in the first quarter of next year.

There were multiple forms of inducible urticaria and 0.5% of the total population suffer from them. We have selected two of the most common forms: symptomatic dermagraftism and cold-induced urticaria. Symptomatic dermagraftism is characterized by the development of a wheel and flare reaction in response to a stroking, scratching or rubbing of the skin usually occurring within minutes of the inciting stimulus. People afflicted with cold-induced urticaria experienced symptoms like itching, burning wheels and angioedema where their skin comes in contact with temperatures below skin temperature. For both of these diseases mast cell activation, leading to release of soluble mediators is thought to be the driving mechanism leading to the wheels and other symptom.

As you can tell based on their name, what's unique about these indications Is that they are induced by certain triggers and importantly investigators can induce these same reactions in the clinic. Dr Maurer will lead this study in his specialty clinic for urticaria in Berlin. We expect to enroll 20 patients, ten with symptomatic dermagraftism and ten with cold-induced urticaria who are resistant to antihistamine treatment. Their symptoms will be introduced in the clinic and a single dose of CDX-0159 at 3 milligram per kilogram will be administered. Patients will be followed for 12 weeks to evaluate safety and tolerability, clinical activity and pharmacokinetics and pharmacodynamics. Importantly, we intend to perform serial skin biopsies on patients so we can explore the impact of CDX-0159 on mast cells in the skin. This will help address whether CDX-0159 is inactivating the mast cells or leading to their deaths in elimination from skin.

The second study will be in chronic spontaneous urticaria or CSU, an indication where patients experience urticaria symptoms without identification of a known cause. This is a disease driven by mast cell activation, the release of mediators resulting episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades. It is one of the most frequent dermatologic diseases with the prevalence of 0.5% to 1% of the total population and up to 3.2 million cases annually in the US. The study will be a randomized, double-blind, placebo-controlled Phase 1B dose escalation study that includes patients who are still symptomatic despite antihistamine therapy. We expect to enroll 40 patients across four cohorts, who will receive CDX-0159 or placebo. The dose and dosing schedule will vary by cohort.

Patients dosed at 0.5 and 1.5 milligram per kilogram will receive three doses at 4-week intervals and patients dosed at 3 and 4.5 milligrams per kilogram will receive two doses at an 8-week interval. The 12-week treatment period will be followed by another 12 weeks of follow-up. So 24 weeks total. This design will provide necessary data on the safety of multiple doses and also allow us to evaluate the potential clinical activity of CDX-0159 in this patient population. Again, we will be evaluating safety and tolerability, symptomatic relief as measured through disease activity scores and pharmacokinetics and pharmacodynamics. The study will be conducted at 4 to 5 centers in the USA, beginning in the fall of 2020. We anticipate results from this study in the second half of next year.

For both inducible and spontaneous urticaria, it is clear that these patients can truly suffer. The two top complaints are constant intense itch and poor self image. Their symptoms prevent regular sleep, interfere with daily life and work activities which subsequently promote social withdrawal, isolation and depression. There is truly an unmet need for efficacious therapies that address the root cause of their disease, mast cells.

Beyond urticaria, there are many diseases in which mast cells are the principal driver or a thought to significantly contribute to the pathology. We are digging deeply into the potential opportunity for CDX-0159 in these indications to select additional areas for expansion. Our evaluation includes review of scientific literature, medical guidelines, regulatory documents and market analyzes and discussions with medical experts. We are prioritizing indications in which there is strong evidence that mast cells play an important role in pathophysiology where there are unmet medical needs and where we can envision a clinical development path with clear early decision point.

We have narrowed what began as a list of over 50 indications to 4 major areas of focus. Mast cell activation syndromes including mastocytosis, Asthma including severe forms of asthma, allergic asthma and exercise induced asthma, allergic conditions including food allergies and allergy mediated dermatologic conditions and mast cell driven gastrointestinal disorders.

Our next step is to lay out the clinical development and regulatory path as well as commercial opportunities to help in the final indication selection. We will also be monitoring the field closely to ensure our plans continually reflect all available scientific clinical regulatory and competitive data. Certainly as data begin to emerge from the urticaria studies, this will also inform our final decision. We will continue to update you as we complete our diligent but are confident we will be in a position to initiate a Phase 1B-2 study in a third indication by summer 2021.

Finally, in closing for CDX-0159 I want to point out that we have initiated formulation work for subcutaneous delivery which we believe will be important to the candidates future success. We believe we are well positioned given CDX-0159 and enhanced PK profile and the durable tryptase suppression we observed even at low doses. The preliminary feasibility studies at 150 milligrams per mill look promising.

With that overview on CDX-0159, let me turn now to CDX 1140 and CDX-527. CDX-1140 is a Celldex developed human agonist anti-CD-40 monoclonal antibody that was specifically designed to balance good systemic exposure and safety with potent biological activity a profile, which differentiates CDX-1140 from other CD-40 activating antibodies for systemic therapy. CD-40 expressed on dendritic cells and other antigen presenting cells is an important target for Immunotherapy as it plays a critical role in the activation of innate and adaptive immune responses.

CDX-1140 completed dose escalation as monotherapy and in combination with CDX-301 a dendritic cell growth factor in an ongoing Phase 1 study in patients with recurrent, locally advanced or metastatic solid tumors and B-cell lymphomas. A critical goal of this study was to achieve dosing levels that provide good systemic exposure without dose limiting toxicity. As reported at the SITC meeting last November, CDX-1140 reach this goal with the maximum tolerated dose and recommended Phase 2 dose of 1.5 milligrams per kilogram, one of the highest systemic dose levels in the CD-40 agonist class.

We believe the relatively low doses of other potent CD-40 agonist antibodies tested in the clinic to date may limit their potential and modifying in the tumor micro environment and are hopeful that CDX-1140 at this dose level will better penetrate tumor and be more impactful. Importantly, from a safety perspective at 1.5 milligram per kilogram CDX-1140 is associated with manageable immune related adverse events that are consistent with those observed with approved effective therapies like checkpoint inhibitors.

While CDX-1140 has shown promising signs of single agent activity, it's clear that the combination approaches that target multiple pathways in the immune system likely offer patients the best opportunities for improvement. To that end, we have added multiple combination expansion cohorts including with KEYTRUDA in patients who have progressed on checkpoint therapy and with CDX-301 in patients with head and neck squamous cell carcinoma.

We also expect to initiate a combination with standard of care chemotherapy in first-line metastatic pancreatic cancer later this year. An indication, we are very interested in because both preclinical and clinical data suggests that the CD-40 pathway may have important anti-tumor potential in this disease.

We also expect to report on interim data from CDX-1140 this fall, that would focus on data from the monotherapy expansion cohorts in squamous cell head and neck cancer and renal cell carcinoma, data from the combination with CDX-301 and preliminary data from the combination with KEYTRUDA.

CDX-527, our first bispecific antibody program is also expected to enter the clinic later this year. CDX-527 combines CD-27 mediated T-cell activation with PD-1 blockade. We have developed CDX-527 from our proprietary highly active PDL-1 and CD-27 human antibodies and demonstrated the bispecific to be more potent than the combination of the individual antibodies in preclinical models.

Importantly, our prior clinical experience combining the CD27 agonist antibody varlilumab with PD-1 blockade supports the integration of these two antibodies from a dosing safety and activity perspective. We would expect initial data from this program in the first half of 2021.

Before I turn the call over to Sam to discuss the financials, I want to provide a little more clinical context surrounding the decision on CDX-3379 development.

At ASCO 2019, we presented a retrospective analysis that suggested that the anti-tumor activity with CDX-3379 might be associated with somatic mutations in particular genes associated with tumor suppression.

We decided to examine this hypothesis in an exploratory manner in the ongoing trial to see if there was a path forward that would allow us to utilize biomarkers to identify a targeted population that would respond to CDX-3379. In parallel, we knew that we needed to improve the tolerability of the combination of CDX-3379 and cetuximab specifically diarrhea management. Unfortunately, despite diarrhea prophylaxis measures, this continue to be a side effect which in addition to severe skin rash caused dose reductions and delays in the majority of patients, making it difficult to achieve clinical benefit. When considered together and after talking to our study investigators, we believe the risk benefit profile does not support further development in patients and that the resources allocated to this program would be best focused on expanded development of CDX-0159 CDX-1140 and CDX-527.

We will also continue to advance our preclinical pipeline which is exploring several interesting targets including AXL IoT-4, CD 24 and cyclic-15. Updates on our preclinical programs will be presented at scientific meetings later this year and next.

In summary, we are very pleased with the progress we've made so far this year. We believe CDX-0159 has the potential to be a field changing product across multiple mast cell driven indications and that CDX-1140 is establishing itself as a clearly differentiated CD-40 agonist. We're excited to bring CDX 527 into the clinic and all combined, look forward to a very busy rest of 2020.

We continue to be mindful of COVID-19 and our partnering closely with our clinical trial sites to mitigate any COVID related impact on our studies. So far. we have been very successful in these efforts but like everyone else we are looking cautiously at this fall and winter and contingency planning to help mitigate any risk to our timeline.

With that, I thank you for your time and I will hand the call over to Sam to review the financials. Sam?

--------------------------------------------------------------------------------

Sam Martin, Celldex Therapeutics, Inc. - Senior VP, CFO, Secretary & Treasurer [5]

--------------------------------------------------------------------------------

Thank you, Diane. For the second quarter of 2020 net loss was $11 million or $0.50 per share compared to a net loss of $11.8 million or $0.84 per share for the second quarter of 2019. Net loss for the six months ended June 30, 2020 was $23.7 million or $1.20 per share compared to 29 million or $2.21 per share for the comparable period in 2019.

Research and development expenses were $21.4 million for the six months ended June 30, 2020 compared to $21.2 million for the comparable period in 2019.

General and administrative expenses were $7.2 million for the six months ended June 30, 2020 compared to $8.8 million for the comparable period in 2019.

As of June 30, 2020, we reported cash, cash equivalents and marketable securities of $206.9 million compared to $53.7 million as of March 31, 2020. The increase was primarily driven by net proceeds of $141.4 million from our June 2020 underwritten public offering and net proceeds of $23.7 million from sales of common stock under our controlled equity offering agreement with Cantor completed in the second quarter prior to the public offering in June.

These increases were offset by second quarter cash used in operating activities of $11.2 million. We expect the cash, cash equivalents and marketable securities at June 30, 2020 are sufficient to meet estimated working capital requirements and fund planned operations through 2023. At June 30, 2020 we had 39.1 million shares outstanding.

I will now turn the call over to Anthony to close.

--------------------------------------------------------------------------------

Anthony S. Marucci, Celldex Therapeutics, Inc. - Founder, President, CEO & Director [6]

--------------------------------------------------------------------------------

Thank you, Sam and thank you all for joining us today. To recap, as always, we remain focused on the successful development of our clinical programs.

We look forward to initiating the 2 Phase 1B studies of CDX-0159 this fall and the Phase 1 study of CDX-527 and the CDX-1140 expansion cohort later this year, followed by the third study of CDX-0159 in an additional mast cell indication next summer.

For data readouts, we plan to present data update for the CDX-1140 program later this year. in 2021, we anticipate data from the CDX-0159 study in chronic inducible urticaria in the first quarter, data from CDX-527 in the first half and the data from CDX-0159 study and the chronic spontaneous urticaria study in the second half of the year.

I would also anticipate data from the CDX-1140 combination with KEYTRUDA and other expansion cohorts in 2021. As Sam said, we are well capitalized to complete the studies necessary to reach these milestones and and for that, I'd like to thank the investors that participated in our recent financing. We look forward to keeping you all up to date as we continue our progress on these programs.

With that review, we will open the floor to questions. operator?

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Thank you. We begin our question and answer session. (Operator Instructions) and our first question comes from Kristen Kluska of Cantor Fitzgerald.

.

--------------------------------------------------------------------------------

Kristen Brianne Kluska, Cantor Fitzgerald & Co., Research Division - Analyst [2]

--------------------------------------------------------------------------------

Hi, everyone. Thanks for taking my questions and congrats on the great progress that you've made over this past quarter. So the first question is for the CDS-0159 program, given that some of these patients are likely to have co-morbidities, I'm wondering if you might think these are worth evaluating in the background in either or both the Phase 1B and Phase 2 studies to provide any early proof of effect? Given these indications could also be mast cell driven.

--------------------------------------------------------------------------------

Anthony S. Marucci, Celldex Therapeutics, Inc. - Founder, President, CEO & Director [3]

--------------------------------------------------------------------------------

Sure, Kristen. Thanks. This is Anthony, I'll have Diane answer that question.

--------------------------------------------------------------------------------

Diane C. Young, [4]

--------------------------------------------------------------------------------

Yes. So that's an excellent- very good point Kristen. There is a lot of overlap and other conditions that overlap that there may also be impacted. So that is our intention to -- even in those early studies to try to capture what other co-morbidities the patients have and to try to with that response in some way.

--------------------------------------------------------------------------------

Kristen Brianne Kluska, Cantor Fitzgerald & Co., Research Division - Analyst [5]

--------------------------------------------------------------------------------

Great, thank you. And then as it relates to choosing the third mast cells you have an indicating studies in the summer of next year, I wanted to ask if you think the results from the CINDU trial in the first quarter of next year will in any way help determine which one you ultimately choose as the third indication.

--------------------------------------------------------------------------------

Diane C. Young, [6]

--------------------------------------------------------------------------------

Yes. So I think we'll definitely take the data from the CINDU study that's going to give us information about how we're impacting mast cells and some ideas of dose and duration of clinical effect. So I think that will definitely help to inform what we do next year.

--------------------------------------------------------------------------------

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Edited Transcript of CLDX.OQ earnings conference call or presentation 6-Aug-20 8:30pm GMT - Yahoo Finance

Trending News on Targeted Oncology, Week of August 7, 2020 – Targeted Oncology

This week in oncology news, the FDA granted approval to belantamab mafodotin-blmf (GSK2857916; Blenrep), an immunoconjugate targeted B-cell maturation antigen, for the treatment of relapsed/refractory multiple myeloma and to tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid) as treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

A Biologics License Application was also submitted to the FDA for omburtamab, which is intended for the treatment of pediatric patients with central nervous system (CNS)/leptomeningeal metastasis from neuroblastoma. A Fast Track designation was also granted to BST-236 for the treatment of older adult patients with acute myeloid leukemia. An Orphan Drug designation was also granted to SM-88 for the treatment of patients with pancreatic cancer.

FDA Approves Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma

The FDA granted approval to belantamab mafodotin-blmf for the treatment of patients with relapsed or refractory multiple myeloma who previously received treatment with at least 4 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

FDA Approves Tafasitamab/Lenalidomide for R/R DLBCL

The FDA granted approval to the combination oftafasitamab-cxix plus lenalidomide for the treatment of adultpatients with relapsed or refractory DLBCLnot otherwise specified, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant.

Cellular Therapies Provide Hopeful Outcomes as Treatment of Patients with Myeloma

In an interview with Targeted Oncology, C. Ola Landgren, MD, PhD, discussed the development of CAR T-cell therapy in the treatment landscape of multiple myeloma.

Salvage Blinatumomab Therapy Generates Durable Responses in Relapsed/Refractory DLBCL

Salvage therapy with blinatumomab (Blincyto) may induce durable complete responses and a survival benefit as treatment of patients with relapsed/refractory diffuse large B-cell lymphoma, according to findings from a pooled analysis of 3 clinical trials.

FDA Grants Orphan Drug Designation for SM-88 for Treatment of Pancreatic Cancer

The FDA has granted an Orphan Drug designation to SM-88 for the potential treatment of patients with pancreatic cancer.

Multiple Therapies Show Responses in Lung Cancer With ROS1 Fusions

Ben Levy, MD, discusses the mechanism of resistance such as the G2032R solvent front mutation in patients who received crizotinib (Xalkori) for lung cancer with ROS1 fusions and how to treat them.

Expert Perspective Tumor Board: Hepatocellular Carcinoma

In this series, Ghassan Abou-Alfa, MD, MBA, and a group of experts discuss the treatment landscape of patients with hepatocellular carcinoma in 4 separate case discussions.

Recommendations for Managing Patients With Lung Cancer During COVID-19 Era

In response to the COVID-19 pandemic, the European Society of Medical Oncology has published recommendations for the management of patients with lung cancer to maintain high-quality standards of treatment.

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Trending News on Targeted Oncology, Week of August 7, 2020 - Targeted Oncology

Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth – marketscreener.com

Houston, Texas, Aug. 06, 2020 (GLOBE NEWSWIRE) --

Houston, Texas, August 6, 2020 Immatics N.V. (NASDAQ: IMTX; Immatics), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, today announced the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth), in Houston, Texas. The continued collaboration grants Immatics access to UTHealths state-of-the-art cGMP manufacturing infrastructure at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, enabling continued production and supply of Immatics specialized, cell-based product candidates for testing in multiple clinical trials. Maximum capacity of the facility is anticipated at 48 ACTengine T cell products per month. The new agreement will run until the end of 2024. Under the agreement, UTHealth will provide Immatics with exclusive access to three cGMP suites and support areas for the manufacturing of various Adoptive Cell Therapy (ACT) products. Therapeutic T cell production will be carried out by Immatics manufacturing personnel and will be supported by a UTHealth-Immatics joint quality team.

Steffen Walter, Ph.D., Chief Technology Officer at Immatics, commented: During the last five years, we have established a strong and productive partnership with UTHealth that has enabled the initiation of four ongoing clinical trials. As we remain focused on the development of our clinical pipeline, this extension of our collaboration with UTHealth will fulfill Immatics manufacturing needs for our early-stage ACT clinical programs for the next four years. Being able to rely on a partner with profound cell therapy expertise who is familiar with our technologies and can support cGMP cell therapy production is critical to ensuring the advancement of our clinical trials. We look forward to continuing this fruitful collaboration with the experts at UTHealth.

Fabio Triolo, D.d.R., M.Phil., Ph.D., The Clare A. Glassell Distinguished Chair and Director of the Cellular Therapy Core at UTHealth, added: Signing the extended contract with Immatics fits into our strategy at UTHealth of supporting the development of new treatments for patients in need. We therefore look forward to continuing our collaboration and further leveraging the potential of our manufacturing capabilities.

About Immatics ACT Programs ACTengine is a personalized approach in which the patients own T cells are genetically modified to express a novel proprietary TCR cognate to one of Immatics proprietary cancer targets which are then reinfused back into the patient. Immatics latest proprietary ACTengine manufacturing processes are designed to generate cell product candidates within a short six day manufacturing window and to deliver highly proliferative T cells, with the capability to infiltrate the patients tumor and function in a challenging solid tumor microenvironment. The process is designed to rapidly produce younger, better-persisting T cells capable of serial killing tumor cells in vitro. Immatics is further advancing the ACT concept beyond individualized manufacturing with its product class ACTallo which is being developed to generate off-the-shelf cellular therapies.

More information on the clinical trials can be found at the following links: https://immatics.com/clinical-programs/ and https://clinicaltrials.gov/.

- ENDS - Notes to Editors

About Immatics Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

For regular updates about Immatics, visit http://www.immatics.com. You can also follow us on Twitter and LinkedIn.

About UTHealth Established in 1972 by The University of Texas System Board of Regents, The University of Texas Health Science Center at Houston (UTHealth) is Houstons Health University and Texas resource for health care education, innovation, scientific discovery and excellence in patient care. The most comprehensive academic health center in the UT System and the U.S. Gulf Coast region, UTHealth is home to Jane and Robert Cizik School of Nursing, John P. and Kathrine G. McGovern Medical School and schools of biomedical informatics, biomedical sciences, dentistry and public health. UTHealth includes The University of Texas Harris County Psychiatric Center, as well as the growing clinical practices UT Physicians, UT Dentists and UT Health Services. The universitys primary teaching hospitals are Memorial Hermann-Texas Medical Center, Childrens Memorial Hermann Hospital and Harris Health Lyndon B. Johnson Hospital. For more information, visit http://www.uth.edu.

About the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, which is part of the Cellular Therapy Core at UTHealth, has been Immatics manufacturing partner since 2015. The site is a U.S. Food and Drug Administration (FDA)-registered and inspected cGMP facility that has received accreditation from the Foundation for Accreditation of Cellular Therapy (FACT) as well as certification from the Clinical Laboratory Improvement Amendment (CLIA) and the College of American Pathologists (CAP).

Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as may, should, expect, intend, will, estimate, anticipate, believe, predict, potential or continue, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the Securities and Exchange Commission (SEC). Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.

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Immatics Extends Cell Therapy Manufacturing Collaboration with UTHealth - marketscreener.com

IMAC (IMAC) Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment of…

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IMAC (IMAC) Receives FDA Authorization to Initiate Clinical Study of Its Umbilical Cord-Derived Allogenic Mesenchymal Stem Cells for the Treatment of...

US government considers ethics of aborted tissue research – Pregnancy Help News

(CNA) A new federal ethics advisory board for fetal tissue research has convened to consider future federally-funded research proposals that involve tissue from aborted babies.

The Human Fetal Tissue Research Ethics Advisory Board of the National Institutes of Health (NIH) met for the first time on July 31, to advise the Health Secretary on the ethics of research proposals involving fetal tissue of aborted babies.

The board was first announced in June of 2019, when the Trump administration decided to halt new research with aborted fetal tissue at NIH facilities, and limited funding of such research conducted outside the NIH.

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For the research conducted outside the NIH, or extramural research, the administration announced that an ethics advisory board would be appointed to consider such funding and advise the secretary of Health and Human Services (HHS) on the proposals.

Some researchers have called for the administration to end its moratorium, saying that research with aborted fetal tissue could be vital to developing treatments and a cure for the new coronavirus (SARS-CoV-2).

In February, the HHS announced that it would begin accepting nominations to the board, and during that time period, some researchers at an NIH research laboratory told the Washington Post that the administrations moratorium on fetal tissue research was hindering possible advances in research on treatments for the coronavirus.

Dr. David Prentice, now a member of the NIH Human Fetal Tissue Research Ethics Advisory Board, told CNA in March that the timing of the comments was peculiar as it could have been related to the consideration of appointments to the board.

Several leading coronavirus vaccine candidates are using cell lines from aborted babies, including some funded by the U.S.; other candidates have been determined to be ethically uncontroversial by the pro-life Charlotte Lozier Institute.

One candidate in particularbeing developed by Moderna and the National Institute of Allergy and Infectious Diseasesis not using fetal cell lines directly in production, but is based on research that involved aborted fetal cell lines. As Moderna was not involved in that research, CLI said that the vaccine candidate is ethically uncontroversial.

The NIH ethics board members are appointed for a duration that lasts as long as the board is convened; the boards charter says that [t]he estimated annual person-years of staff support required is 0.7. Appointments to the board are made by the HHS secretary.

Heading the advisory board is Paige Cunningham, interim president of Taylor University, an evangelical Christian university in Indiana.

Several Catholic bioethicists are on the board, including Fr. Tadeusz Pacholczyk, director of education at the National Catholic Bioethics Center. The co-chair of the Catholic Medical Association (CMA) ethics committee, Greg Burke, is a member, along with CMA member Dr. Ashley Fernandes of the Ohio State University medical school.

The pro-life Charlotte Lozier Institute (CLI) is also represented on the board, with CLI vice president Dr. David Prentice and associate scholars Ingrid Skop and Maureen Condic as members.

Some board members, such as Dr. Lawrence Goldstein of the University of California San Diego, support fetal tissue research; he called cell lines from fetal tissue critical in vaccine development, along with stem cell research and the use of humanized mice to develop immune cell-forming tissues.

Two members testified in 2016 before the House select investigative panel of the Energy and Commerce Committee, in a hearing on bioethics and fetal tissue.

Cunningham said at the hearing that [t]he fetus is a human subject entitled to the protections that both traditional and modern codes of medical ethics provide to human subjects.

Kevin Donovan, MD, director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, also testified, noting the current moral ambiguity in the nations discourse on abortion.

We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed, he said. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home.

If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction, he said.

Tweet This: If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction.

During the public portion of the July 31 meeting, board members were introduced and then heard from several researchers who were either in support of or in opposition to research using fetal tissue from elective abortions.

The 2008 Vatican document Dignitatis Personae addressed the topic of aborted fetal tissue research, saying that there is a duty to refuse to use such biological material even when there is no close connection between the researcher and the actions of those who performed the artificial fertilization or the abortion, or when there was no prior agreement with the centers in which the artificial fertilization took place.

This duty springs from the necessity to remove oneself, within the area of ones own research, from a gravely unjust legal situation and to affirm with clarity the value of human life, the Congregation for the Doctrine of the Faith document stated.

Editor's note: This article was published by Catholic News Agency and is reprinted with permission.

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US government considers ethics of aborted tissue research - Pregnancy Help News

Plant Stem Cell Market 2020 Share Growing Rapidly With Latest Trends, Development, Revenue, Demand And Forecast To 2029 – Owned

The research study on Global Plant Stem Cell market 2019 presents an extensive analysis of current Plant Stem Cell market size, drivers, trends, opportunities, challenges, as well as key Plant Stem Cell market segments. Further, it explains various definitions and classification of the Plant Stem Cell industry, applications, and chain structure.In continuation of this data, the Plant Stem Cell report covers various marketing strategies followed by key players and distributors. Also explains Plant Stem Cell marketing channels, potential buyers and development history. The intent of global Plant Stem Cell research report is to depict the information to the user regarding Plant Stem Cell market forecast and dynamics for the upcoming years. The Plant Stem Cell study lists the essential elements which influence the growth of Plant Stem Cell industry. Long-term evaluation of the worldwide Plant Stem Cell market share from diverse countries and regions is roofed within the Plant Stem Cell report. Additionally, includes Plant Stem Cell type wise and application wise consumption figures.

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Plant Stem Cell Market 2020 Share Growing Rapidly With Latest Trends, Development, Revenue, Demand And Forecast To 2029 - Owned