Monthly Archives: December 2020

VistaGen Announces Publication in CNS Spectrums Detailing Proposed Mechanism of Action of Its Investigational Neuroactive Nasal Sprays for Anxiety and…

Dr. Louis Monti, VistaGen’s Newly-Appointed Vice President, Translational Medicine, and Dr. Michael Liebowitz, VistaGen CNS Clinical and Regulatory Advisory Board Member, Collaborate on Review Dr. Louis Monti, VistaGen’s Newly-Appointed Vice President, Translational Medicine, and Dr. Michael Liebowitz, VistaGen CNS Clinical and Regulatory Advisory Board Member, Collaborate on Review

The rest is here:
VistaGen Announces Publication in CNS Spectrums Detailing Proposed Mechanism of Action of Its Investigational Neuroactive Nasal Sprays for Anxiety and...

Sorrento Announces the Submission of a Marketing Authorization Application to COFEPRIS (Mexico) for COVI-STIX™ Rapid Detection Test of SARS-CoV-2…

SAN DIEGO, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that a Marketing Authorization Application has been submitted by its agents in Mexico to Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the health regulatory authority for Mexico, for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients, "Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2".

Read the original post:
Sorrento Announces the Submission of a Marketing Authorization Application to COFEPRIS (Mexico) for COVI-STIX™ Rapid Detection Test of SARS-CoV-2...

Ascendis Pharma A/S Announces Filing of Investigational New Drug Application to Initiate TransCon™ TLR7/8 Agonist Clinical Program

- TransCon TLR7/8 Agonist is designed for intratumoral, sustained release of resiquimod with minimal systemic exposure, while inducing a potent anti-tumor response -

See the original post here:
Ascendis Pharma A/S Announces Filing of Investigational New Drug Application to Initiate TransCon™ TLR7/8 Agonist Clinical Program

Adaptive Biotechnologies to Present at the 39th Annual J.P. Morgan Healthcare Conference

SEATTLE, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (“Adaptive Biotechnologies”) (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced it will be participating in the upcoming 39th Annual J.P. Morgan Healthcare Conference.

Read the original post:
Adaptive Biotechnologies to Present at the 39th Annual J.P. Morgan Healthcare Conference

Medicenna Establishes At-the-Market Sales Facility

TORONTO and HOUSTON, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (NASDAQ: MDNA, TSX: MDNA), a clinical stage immuno-oncology company, announced today that it has entered into a sales agreement with SVB Leerink acting as sales agent (the “Sales Agreement”), pursuant to which the Company may, from time to time sell, through “at-the-market” offerings on the Nasdaq Capital Market (the “Nasdaq”) such number of common shares as would have an aggregate offering price of up to US$25 million (the “ATM Offering”) under the ATM Prospectus Supplement (as defined below).

See the rest here:
Medicenna Establishes At-the-Market Sales Facility

MedMira Announces Product Update

HALIFAX, Nova Scotia, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Today, MedMira Inc. (MedMira) (TSXV: MIR), is pleased to announce its validated REVEALCOVID-19TM PLUS Total Antibody Test for the detection of total antibodies against both the Nucleocapsid and Spike regions of the SARS-CoV-2. REVEALCOVID-19TM PLUS Total Antibody Test is an update to MedMira’s REVEALCOVID-19TM Total Antibody Test that addresses the total antibody testing demands arising from recent developments in COVID-19 vaccines across global markets.

Read the original here:
MedMira Announces Product Update

Histogen Announces Pricing of $14.0 Million Upsized Public Offering

SAN DIEGO, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today announced that it has it has priced a public offering of an aggregate of 14,000,000 shares of common stock (or common stock equivalents offered through the issuance of pre-funded warrants), together with accompanying warrants to purchase up to an aggregate of 14,000,000 shares of common stock, at an effective public offering price of $1.00 per share and accompanying warrant. Each share of common stock (or common stock equivalent offered through the issuance of a pre-funded warrant) will be sold in the offering with one warrant to purchase one share of common stock. The warrants have an exercise price of $1.00 per share, are immediately exercisable, and expire five years following the date of issuance.

Excerpt from:
Histogen Announces Pricing of $14.0 Million Upsized Public Offering

Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -…

December 30, 2020 04:38 ET | Source: Research and Markets

Dublin, Dec. 30, 2020 (GLOBE NEWSWIRE) -- The "CAR-T - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

The "CAR-T - Pipeline Insight, 2020," report provides comprehensive insights about 250+ companies and 250+ pipeline drugs in CAR-T pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

CAR-T: Overview

CAR-T is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. CAR T-cell therapy is used to treat certain blood cancers, and it is being studied in the treatment of other types of cancer. Also called chimeric antigen receptor T-cell therapy.

Potential Mechanisms of CAR-T Cell-Mediated Toxicity

Significant progress has been made in the field of cancer immunotherapy, and CAR-T cells have shown outstanding efficacy in clinical trials. As with all technologies, CAR-T technologies also need to go through a long process of development, and CAR-T cell therapy has related acute and chronic toxicities that have become a roadblock on the developmental path. If these setbacks are not overcome, it will be difficult to make a more significant breakthrough.

Cytokine Release Syndrome

Cytokine release syndrome (CRS) is the most common toxic side effect in CAR-T cell therapy. CRS is a systemic inflammatory response caused by the significant increase in cytokines accompanied by the rapid in vivo activation and proliferation of CAR-T cells, usually occurring within a few days after the first infusion. CRS is a clinical condition with mild symptoms of fever, fatigue, headache, rash, joint pain, and myalgia. Severe CRS cases are characterized by tachycardia, hypotension, and high fever. Mild to moderate CRS is usually self-limiting and can be managed through close observation and supportive care. Severe CRS must be treated with tocilizumab or steroids alone for intensive treatment.

Advances in Research of CAR-T Cell Therapy for Solid Tumors

Although early CAR-T cell trials of solid tumors did not show the same success as observed in leukemia trials, a better understanding of the multiple barriers seen in solid tumors could promote the design of clinical trials for CAR-T cells. In this early stage of clinical development, CAR-T cells offer much hope. The ability of genetic manipulation techniques to modify CAR-T cells provides almost unlimited opportunities for other changes and improvements, thus providing a strong desire for future success.

Global Landscape of CAR-T Cell Therapy

At present, CAR-T cells are widely used in cellular immunotherapy for various tumors. According to statistics, more than 300 clinical trials of CAR-T cell therapies have been approved by many national drug regulatory agencies, including the FDA of the United States. Statistical data from these clinical trials show that although the effects of various clinical trials vary due to the use of different sources and the preparation techniques of CARs and T cells, as well as differences in pretreatment and combinations of drugs, overall, CAR-T cells are effective in treating tumors with an effective rate of 30% to 70% or even more than 90%. For example, the complete remission rate for r/r ALL treated with the Novartis drug CTL0l9, which the FDA has approved, is 93%. Perhaps CAR-T cell therapy will ultimately remedy the fate of human cancer.

CAR-T Emerging Drugs Chapters

This segment of the CAR-T report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

CAR-T: Therapeutic Assessment

This segment of the report provides insights about the different CAR-T drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in CAR-T

There are approx. 250+ key companies which are developing the therapies for CAR-T. The companies which have their CAR-T drug candidates in the most advanced stage, i.e. phase III include, Janssen Research & Development, ViiV Healthcare, Sorrento Therapeutics, Celgene, Novartis, Abbott etc.

Report Highlights

Current Treatment Scenario and Emerging Therapies:

Key Players

Key Products

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/c6ze76

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Go here to see the original:
Global CAR-T Pipeline Insight Report 2020: Overview, Landscape, Therapeutic Assessment, Current Treatment Scenario and Emerging Therapies -...