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Ncardia inks $60M funding deal to expand discovery and commercial production services for stem cells – FierceBiotech

Ncardia is the result of the 2017 merger of Pluriomics and Axiogenesis. (Getty/designer491)

Ncardia, a human-induced pluripotent stem cell developer,picked up $60 million via a strategic partnership with Kiniciti.

The Belgian iPSC contract research, development and manufacturing company is partnering with the U.S. investment firm to boost discovery, clinical and commercial production capabilities, the companiessaid Tuesday.

Ncardia manufactures iPSC derived cells and provides assay development, disease modeling and cell-based screening. The company is the result of a 2017 combination ofPluriomics and Axiogenesis. Within months of the merger,Ncardiasigned disease modeling licensing pacts with Roche and Evotec.

Now, through its Kiniciti deal, Ncardia can expand globally and invest in good manufacturing practice capabilities for cell therapies, the company said. Ncardia's discovery services will benefit from the financing, said Kiniciti CEO Geoff Glass in a statement.

RELATED:On back of Roche pact, newly formed Ncardia wins iPSC deal with Evotec

That includes building more human cellular models that can predict whether drugs are safe and effective earlier in the development stage, said Stefan Braam, Ph.D., CEO and co-founder of Ncardia, in a statement. The manufacturing technology will go toward iPSC-based allogenic platforms for immuno-oncology.

Kiniciti is a platform company from private equity firm Welsh, Carson, Anderson & Stowe that launched in February with$250 million to invest in non-therapeutic cell and gene therapy startups.Biospring Partners joinedas an investor earlier this month for an undisclosed amount.

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Ncardia inks $60M funding deal to expand discovery and commercial production services for stem cells - FierceBiotech

Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed…

TOKYO & MUNICH & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced positive topline results from the global pivotal QuANTUM-First phase 3 trial evaluating quizartinib, a highly potent and selective FLT3 inhibitor, in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).1

QuANTUM-First met its primary endpoint, demonstrating that patients who received quizartinib in combination with standard induction and consolidation chemotherapy and then continued with single agent quizartinib had a statistically significant and clinically meaningful improvement in overall survival (OS) compared to those who received standard treatment alone. The safety of quizartinib was shown to be manageable and consistent with the known safety profile.

AML is one of the most common forms of leukemia in adults, representing about one-third of all cases.2 The five-year survival rate of AML is about 29%, and patients with FLT3-ITD positive AML have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1,3 There remains a high unmet need to improve survival for the majority of patients with AML.4

The results of the phase 3 QuANTUM-First trial showed that adding quizartinib, a potent and selective FLT3 inhibitor, to chemotherapy significantly prolonged overall survival in patients with newly diagnosed FLT3-ITD positive AML, said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. We look forward to sharing the QuANTUM-First data with the hematology community and will initiate discussions with global regulatory authorities.

Data from QuANTUM-First will be presented at an upcoming medical meeting and shared with regulatory authorities globally.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, multi-center global phase 3 study evaluating quizartinib in combination with standard induction and consolidation chemotherapy and then as continued single agent therapy in adult patients (age 18 75) with newly diagnosed FLT3-ITD positive AML.

Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo in combination with standard anthracycline and cytarabine-based induction and consolidation regimens. Eligible patients, including those who underwent allogenic hematopoietic stem cell transplant (HSCT), continued with single agent quizartinib or placebo for up to 36 cycles.

The primary study endpoint is OS. Secondary endpoints include event-free survival (EFS), post-induction rates of complete remission (CR) and composite complete remission (CRc), and the percentage of patients who achieve CR or CRc with FLT3-ITD minimal residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints, were also evaluated.

QuANTUM-First enrolled 539 patients at approximately 200 study sites worldwide including in Asia, Europe, North America, Oceania and South America. For more information, visit ClinicalTrials.gov.

About Acute Myeloid Leukemia (AML)

More than 474,500 new cases of leukemia were reported globally in 2020 with more than 311,500 deaths.5 AML is one of the most common types of leukemia in adults, representing about one-third of all cases.2 A heterogenous blood cancer, AML is characterized by a five-year survival rate of about 29%, the lowest by far among the major leukemia subtypes.6,7

Treatment guidelines for patients with newly diagnosed AML recommend a cytarabine-based chemotherapy regimen with or without a targeted therapy as determined by the presence of genetic mutations, age and other factors.8 Patients with newly diagnosed FLT3 mutated AML may receive a FLT3 inhibitor as part of their initial treatment regimen and/or subsequent regimens.8 While intensive chemotherapy and/or HSCT can improve chances for sustained remission in eligible patients, a substantial proportion of patients are not suitable for either intervention, and cure rates are particularly low for older patients.1,6 In recent years, new targeted treatments have increased options and improved outcomes for some patients with molecularly defined AML subtypes.6

About FLT3-ITD

FLT3 (FMS-like tyrosine kinase 3) is a transmembrane receptor tyrosine kinase protein normally expressed by hematopoietic stem cells; FLT3 plays an important role in cell development by promoting cell survival, growth and differentiation through various signaling pathways.1 Mutations of the FLT3 gene, which occur in approximately 30% of patients with AML, can drive oncogenic signaling.1 The most common type of FLT3 mutation is the FLT3-ITD (internal tandem duplication), which is present in about 25% of all AML patients and contributes to cancer cell proliferation.1 Patients with FLT3-ITD mutations have a particularly unfavorable prognosis, including an increased risk of relapse and shorter overall survival.1

About Quizartinib

Quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, is in phase 1/2 clinical development in pediatric and young adult patients with relapsed/refractory FLT3-ITD AML in Europe and North America.1 Several phase 1/2 combination studies with quizartinib are also underway at The University of Texas MD Anderson Cancer Center as part of a strategic research collaboration focused on accelerating development of Daiichi Sankyo pipeline therapies for AML.

Quizartinib is currently approved for use in Japan under the brand name VANFLYTA for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test. Quizartinib is an investigational medicine in all countries outside of Japan.

About Daiichi Sankyo Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

About Daiichi Sankyo

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose to contribute to the enrichment of quality of life around the world. In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an Innovative Global Healthcare Company Contributing to the Sustainable Development of Society. For more information, please visit http://www.daiichisankyo.com.

References

1 Daver N et al. Leukemia. (2019) 33:299312. 2 American Cancer Society. Key Statistics for Acute Myeloid Leukemia. Updated January 2020. 3 Leukemia and Lymphoma Society. Facts and Statistics. Leukemia: Survival (SEER Data for 2009-2015). 4 Daver N et al. Blood Cancer Journal. (2020) 10:107. 5 Global Cancer Observatory. Population Fact Sheet: World. Updated November 2020. 6 Short et al. Cancer Discov. (2020);10:50625. 7 Leukemia and Lymphoma Society. Facts and Statistics. Leukemia: Survival (SEER Data for 2009-2015). 8 NCCN Practice Guidelines for Oncology. Acute Myeloid Leukemia. Version 3.2021 (March 2, 2021).

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Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed...

T2 Biosystems Announces Continued International Expansion into Taiwan with Exclusive Distribution Agreement

LEXINGTON, Mass., Nov. 19, 2021 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced the execution of a territory exclusive distribution agreement in Taiwan.

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T2 Biosystems Announces Continued International Expansion into Taiwan with Exclusive Distribution Agreement

Context Therapeutics® to Present Clinical Data on ONA-XR in Breast Cancer at 2021 San Antonio Breast Cancer Symposium

Primary results from ONAWA (SOLTI-1802) trial of ONA-XR in early breast cancer to be presented in addition to updates from ongoing clinical trials of ONA-XR in metastatic breast cancer Primary results from ONAWA (SOLTI-1802) trial of ONA-XR in early breast cancer to be presented in addition to updates from ongoing clinical trials of ONA-XR in metastatic breast cancer

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Context Therapeutics® to Present Clinical Data on ONA-XR in Breast Cancer at 2021 San Antonio Breast Cancer Symposium

European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

Basel, 19 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has granted conditional marketing authorisation for Gavreto® (pralsetinib) as a monotherapy for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of people with RET fusion-positive advanced NSCLC.1

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European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

Explosive Growth Launches Kraspharma Into REMEDIUM TOP-5

Nicosia, Cyprus, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Rafarma Pharmaceuticals, Inc. OTC:(RAFA) reports that PJSC Kraspharma at the end of 2020 entered the TOP-5 of the most dynamic and largest pharmaceutical companies in Russia for 2020, showing incredible growth rates with a net profit increase of 220.9% compared to 2019. Specifically, Kraspharma went from $5,563,056 (USD) at the end of 2019 to $17,853,905 at the end of 2020. The growth was featured in the ratings by the authoritative Russian industry publication "Remedium", published in Q3 of 2021.

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Explosive Growth Launches Kraspharma Into REMEDIUM TOP-5

Arvinas and Pfizer Announce Updated Phase 1 Dose Escalation Data for ARV-471 to be Presented in Spotlight Poster Session at 2021 San Antonio Breast…

NEW HAVEN, Conn. and NEW YORK, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) announced today that updated safety and efficacy data from the Phase 1 dose escalation trial of ARV-471, a novel oral estrogen receptor (ER)-targeting PROteolysis TArgeting Chimera (PROTAC®) protein degrader, will be presented in a spotlight poster-discussion session at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-10, 2021. ARV-471 is being jointly developed by Arvinas and Pfizer for the treatment of patients with locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.

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Arvinas and Pfizer Announce Updated Phase 1 Dose Escalation Data for ARV-471 to be Presented in Spotlight Poster Session at 2021 San Antonio Breast...

EyePoint Pharmaceuticals Announces Closing of $115.4 Million Public Offering

WATERTOWN, Mass., Nov. 19, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced the closing of the previously announced underwritten public offering of 5,122,273 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,095,000 shares of common stock, and pre-funded warrants to purchase up to an aggregate of 3,272,727 shares of its common stock. The shares of common stock were sold at a public offering price of $13.75 per share, and the pre-funded warrants were sold at a purchase price of $13.74 per pre-funded warrant, for aggregate gross proceeds of approximately $115.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by EyePoint. All of the securities were sold by EyePoint.

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EyePoint Pharmaceuticals Announces Closing of $115.4 Million Public Offering

Adamis Pharmaceuticals Schedules Financial Results Conference Call and Business Update

SAN DIEGO, Nov. 19, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, today announced that it will host an investor conference call on Monday, November 22, 2021 at 2 p.m. Pacific Time to discuss its financial and operating results for the first nine months of 2021, as well as provide a business update. The Company’s press release concerning its financial results will be available after 1 p.m. Pacific Time on November 22, 2021 and on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly reports on Form 10-Q for the quarters ended March 31, 2021, June 30, 2021 and September 30, 2021 on that date.

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Adamis Pharmaceuticals Schedules Financial Results Conference Call and Business Update

Vor to Participate in Piper Sandler 33rd Virtual Annual Healthcare Conference

CAMBRIDGE, Mass., Nov. 19, 2021 (GLOBE NEWSWIRE) -- Vor Biopharma (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced that Dr. Robert Ang, Vor’s President and Chief Executive Officer, will be participating at the Piper Sandler 33rd Virtual Annual Healthcare Conference.

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Vor to Participate in Piper Sandler 33rd Virtual Annual Healthcare Conference