On October 28, 2019 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported their participation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) occurring November 6th-10th in National Harbor, Maryland (Press release, Applied BioMath, OCT 28, 2019, View Source [SID1234549946]). They will present two posters at the conference Friday, November 8th.

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Katie Williams, PhD, Associate Director, Business Development, Applied BioMath will present the poster titled "A semi-mechanistic platform model to capture individual animal responses to checkpoint inhibitors in a syngeneic mouse model." In this work, we describe the generation of a model platform that captures essential aspects of the pharmacokinetics, cellular and tumor growth effects of murine surrogates of two checkpoint therapeutic antibodies, anti-PD1 and anti-CTLA4, in the CT26 syngeneic tumor model. The model describes individual animal responses regarding drug exposure, key intra-tumoral cell kinetics and tumor volume changes and provides biologically plausible explanations for the observed differences between good and poor responders to treatment with anti-PD1 or anti-CTLA4.

Jennifer Park, PhD, Director, Business Development, Applied BioMath will present the poster titled "Semi-mechanistic PK and target-occupancy modeling to support dose justification for anti-PD-L1 clinical candidate CK-301 (TG-1501) in oncology patients." In this work, a semi-mechanistic pharmacokinetic/target-occupancy (PKTO) model was developed with in vitro, preclinical and clinical data to facilitate dose selection of CK-301 (also known as TG-1501, cosibelimab), an anti-PD-L1 monoclonal antibody (mAb), for ongoing and future clinical trials in oncology patients. The model was used to compare the PK and tumor target occupancy (TO) at steady state under various dosing regimens with cosibelimab to those with three marketed anti-PD-L1 mAbs (i.e. atezolizumab, durvalumab and avelumab).

"We are excited to participate at SITC (Free SITC Whitepaper) for the first time this year!" said John Burke, PhD, Co-founder, President and CEO, Applied BioMath. "We hope to introduce the benefits of systems modeling and simulation to SITC (Free SITC Whitepaper) attendees, and how this analysis can be applied to cancer immunotherapy research and development from very early development through clinical trials."

For more information about all of Applied BioMath’s events, visit View Source

On October 28, 2019 SFA Therapeutics, Inc. reported that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company’s novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC) (Press release, SFA Therapeutics, OCT 28, 2019, View Source [SID1234549943]).

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"By granting an Orphan Drug Designation to SFA001, FDA has given a special status to treatment of the most prevalent form of liver cancer. This ODD designation will provide SFA Therapeutics with significant drug development and tax advantages as well as an expanded period of market exclusivity," stated Ira Spector, PhD, SFA Therapeutics’ CEO. "These advantages undoubtedly will speed the drug’s availability for a disease that kills hundreds of thousands of patients annually world-wide."

While hepatocellular carcinoma afflicts 54,000 patients a year in the US (Cancer.net), the World Health Organization estimates the disease causes as many as 880,000 deaths per year globally –especially in China and other parts of Asia. SFA Therapeutics has already been granted two patents recognizing the uniqueness of SFA001 treatment. In validated transgenic HBX animal models, SFA001 blocked the progression of hepatitis B to hepatocellular carcinoma and demonstrated a non-chemotoxic mechanism of action in two different animal models of HCC.

On October 28, 2019 CARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company reported that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy (Press release, Carsgen Therapeutics, OCT 28, 2019, View Source [SID1234549942]). CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).

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RMAT designation was based on clinical data from an ongoing CT053 phase 1 study in heavily pre-treated multiple myeloma patients in China. Updated data from CT053 will be presented at the 61th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando on December 9.

"RMAT eligibility is an important regulatory milestone for CARsgen in the continued development and commercialization of CT053 anti-BCMA CAR T cell therapy," said Zonghai Li, M.D., Ph.D., the chief executive officer of CARsgen. "The RMAT designation indicates that CT053 has demonstrated potential to address unmet medical needs for patients with rrMM. The designation is a remarkable achievement towards expediting the product development and review of our planned biologics license application (BLA) and will be invaluable to bringing this cutting-edge advance to patients as quickly as possible. RMAT as well as the PRIority MEdicines (PRIME) eligibility received from the European Medicines Agency (EMA) empower us to collaborate closely with the U.S. FDA and EMA to rapidly advance the CT053 development program toward global regulatory approvals." The CT053 anti-BCMA CAR-T program has also received Investigational New Drug (IND) clearance and Orphan Drug designation from the U.S. FDA and authorization of its Clinical Trial Application (CTA) from Health Canada.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicines and advanced therapies, including CAR T cell therapies. The designation includes all the benefits of the FDA’s Fast Track and Breakthrough Therapy designations, providing the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA senior management to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the BLA and other opportunities to expedite development and review. Between December 13, 2016 and September 30, 2019, the FDA received and assessed a total of 115 requests for eligibility. Of these, only 44 have been granted RMAT designation.

On October 28, 2019 Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (NASDAQ: NEPT) (TSX: NEPT), reported that it will be holding a conference call on November 11, 2019 at 8:30 AM (EST) to discuss its second quarter results ended September 30, 2019 (Press release, Neptune Technologies et Bioressources inc, OCT 28, 2019, View Source [SID1234549941]).

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The Second quarter results press release will be issued on November 11, 2019 before the conference call.

Conference Call Details:

Date:

Monday, November 11, 2019

Time:

8:30 AM Eastern Standard Time

Call:

1 (888) 231-8191 (Canada and U.S.)

1 (647) 427-7450 (International)

Conference ID: 8390812

Webcast:

A live audio webcast and presentation of the results can be accessed at: View Source

A replay of the call will be available shortly after the call’s completion and until December 11, 2019. The replay can be accessed online in the Investors section of Neptune’s website under Investor Events and Presentations. It is also under this section that you will find the archive of the webcast, along with its accompanying presentation.

On October 28, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the Company will release its third quarter 2019 financial results on Monday, November 11, 2019 before the U.S. financial markets open (Press release, Compugen, OCT 28, 2019, View Source [SID1234549940]). Management will host a conference call and webcast on at 8:30 am ET to provide a quarterly corporate update and review the Company’s poster presentations from the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) to be held November 6-10, 2019.

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To access the live conference call by telephone, please dial 1-888-668-9141 from the United States, or +972-3-918-0609 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.