On July 16, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported that further progress in its long-standing immuno-oncology collaboration with Merck KGaA, Darmstadt, Germany (Press release, F-star, JUL 16, 2020, View Source [SID1234561978]).

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Merck KGaA, Darmstadt, Germany has chosen to exercise early its option to license a preclinical program in the ongoing collaboration with F-star. Merck KGaA, Darmstadt, Germany will take over responsibility for future development and commercialization. This is the second license option exercised by Merck KGaA, Darmstadt, Germany who, in May 2019, brought the first program from the collaboration into its pipeline. An undisclosed option exercise payment has been made to F-star and Merck KGaA, Darmstadt, Germany will pay future success-based milestones and royalties on net sales resulting from the transaction.

The companies have also agreed to the licensing terms for the inclusion of two additional preclinical programs under the existing partnership. No financial terms related to the revised agreement are being disclosed.

Eliot Forster, CEO of F-star, said: "The continued success of our long-term collaboration with Merck KGaA, Darmstadt, Germany demonstrates the ability of our proprietary mAb2 antibody platform technology to produce multiple programs to overcome the current limitations of existing immuno-oncology therapies. We are thrilled that Merck KGaA, Darmstadt, Germany will take these new programs into its portfolio, while we continue to develop our pipeline of three clinical stage molecules that we believe have the potential to be best-in-class."

On July 16, 2020 MaaT Pharma reported the appointment of Claude Bertrand, PharmD, PhD, as an independent member to the company’s Board of Directors and welcomes John Weinberg, MD, as new Chief Medical Officer (Press release, MaaT Pharma, JUL 16, 2020, View Source [SID1234561975]). As an experienced executive in leading research and development efforts in senior positions at major international pharmaceutical companies such as Servier, Ipsen and AstraZeneca, Dr. Bertrand will provide his broad expertise in advancing novel therapeutics from discovery towards commercialization. Dr. Weinberg has over 25 years of experience in the pharmaceutical industry and will use his expertise in microbiome-based therapeutic development and immune-modulation to oversee MaaT Pharma’s clinical activities and direct clinical development strategies.

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"We are honored to add Dr. Bertrand to our Board, who brings with him decades of high-level leadership in pharmaceutical R&D, as we move towards late-stage development for our microbiome restoration therapeutics," said Hervé Affagard, co-founder and CEO of MaaT Pharma. "We also welcome John Weinberg to our leadership team. John has a proven track record of guiding and managing clinical development programs for microbiome therapeutics which will be critical as we accelerate the development of MaaT013 and expand our portfolio with our capsule formulation, MaaT033."

Dr. Bertrand commented on his appointment: "MaaT Pharma is pioneering an important approach to improving clinical outcomes in oncology through safe and effective microbiome-based biotherapeutics and has taken a leadership position in the rapidly evolving regulation and manufacturing of microbiome products. I look forward to working alongside my fellow board members to guide and support the development of the company and its exciting pipeline."

Dr. Weinberg stated: "I am convinced of the therapeutic potential of MaaT Pharma’s approach to restore the balance between the patient and their microbiome, especially in diseases in which immune modulation plays a key role; therefore, I am very excited to join as the company is poised to expand its therapeutic focus beyond hematological cancer indications. My goal is to define an innovative clinical development program and contribute to the continued growth of the pipeline."

Since 2017, Dr. Claude Betrand holds the position of Executive Vice President of R&D and Chief Scientific Officer at Servier, France’s largest independent pharmaceutical company, with a product portfolio addressing cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes. Prior to this, he served as Executive Vice-President of R&D at Ipsen Pharma for over seven years and as Global Senior Vice President for Respiratory & Inflammation Research Area at AstraZeneca for more than five years. His career also includes senior positions at Novartis, Roche, and Pfizer. Dr. Bertrand studied pharmacy and obtained his PharmD and PhD from Strasbourg University in immuno-pharmacology and neurogenic inflammation.

Prior to joining MaaT Pharma, Dr. John Weinberg held the position of Chief Medical Officer at the microbiome-focused company 4D Pharma PLC, where he was responsible for building and managing the clinical development program and initiating multiple Phase I/II studies. With more than 25 years in the pharmaceutical industry, he has held various senior positions at Veloxis Pharmaceuticals, Novartis Pharmaceuticals and Enzon Pharmaceuticals, gaining a breadth of international experience in clinical development of various oncology, hematology and transplantation therapeutics. Dr. Weinberg holds an MD from University of the Witwatersrand School of Medicine in Johannesburg, South Africa and an MBA from INSEAD in Fontainebleau, France.

On July 21, 2020 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its second-quarter 2020 financial results on Thursday, July 30, 2020 after the financial markets close (Press release, Vertex Pharmaceuticals, JUL 16, 2020, View Source [SID1234561970]). The company will host a conference call and webcast at 5:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On July 16, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported the filing of the pivotal ENVASARC protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application (Press release, Tracon Pharmaceuticals, JUL 16, 2020, http://ir.traconpharma.com/news-releases/news-release-details/tracon-pharmaceuticals-announces-filing-protocol-envasarc [SID1234561969]). The application cross references the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology.

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TRACON previously reported results of a May 8 teleconference with the FDA whereby the agency agreed with TRACON’s proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS). TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the second half of 2020.

ENVASARC Study Design

Key elements for the ENVASARC pivotal trial include:

Multi-center, open-label, randomized, non-comparative, parallel cohort study.
Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
Open-label format with blinded independent central review of efficacy endpoint data.
About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China. 3D Medicines and Alphamab Oncology, TRACON’s corporate partner for this program, plan to submit a BLA to NMPA in China for envafolimab in 2020 based on the ORR in MSI-H/dMMR advanced solid tumor patients. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at ASCO (Free ASCO Whitepaper) 2020 was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

On July 16, 2020 Shanghai Junshi Biosciences reported that it has completed a $692 million IPO on the Shanghai STAR Board, becoming the first biopharma to have a dual listing on the Hong Kong and STAR Exchanges (Press release, Shanghai Junshi Bioscience, JUL 16, 2020, View Source [SID1234561961]). Junshi staged a $394 million Hong Kong IPO in late 2018, about the same time the company’s Tuoyi became the first China-developed anti-PD-1 approved for China use. Benefiting from strong demand, Junshi significantly increased the size of its STAR debut offering from an original $400 million.

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