On August 17, 2020 Bristol Myers Squibb (NYSE: BMY) and Dragonfly Therapeutics, Inc. ("Dragonfly"), reported that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly’s interleukin-12 (IL-12) investigational immunotherapy program, including its extended half-life cytokine DF6002 (Press release, Dragonfly Therapeutics, AUG 17, 2020, View Source [SID1234563717]). DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

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Under the agreement, Bristol Myers Squibb will become responsible for the development and any subsequent commercialization of DF6002 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding, and manufacturing. Dragonfly will receive $475 million in near-term upfronts, and is eligible to receive performance-based development, regulatory and commercial milestone payments. In addition, Dragonfly will receive up to 24% royalties on worldwide net sales. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Dragonfly received U.S. Food and Drug Administration clearance in May 2020 for its investigational new drug application to develop DF6002. In addition, Dragonfly has an ongoing Phase 1/2 clinical trial for patients with advanced solid tumors, which began in July 2020. Bristol Myers Squibb intends to advance the research and development of DF6002 in oncology and hematology.

"As we continue to expand our focus in oncology, we are pleased to be adding an IL-12 Fc-fusion protein to our oncology pipeline in the form of DF6002," said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President & President, Research & Early Development, Bristol Myers Squibb. "We look forward to our continued work with Dragonfly to further guide the program’s clinical data at this pivotal point in its development, as we continue to deliver on our commitment to serve more patients with cancer."

"We are excited to be collaborating once again with Bristol Myers Squibb, whose broad range of oncology agents makes it a fantastic partner to accelerate the development of DF6002, the most advanced cytokine in Dragonfly’s pipeline," said Bill Haney, Co-founder and CEO of Dragonfly Therapeutics. "We are confident that the talent, experience and commitment to science-driven innovation of the Bristol Myers Squibb team will enable DF6002 to discover novel, lifesaving solutions for patients."

About DF6002

DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated in adult patients for the treatment of advanced solid tumors. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.

On August 17, 2020 Seneca Therapeutics, Inc. ("Seneca Therapeutics") reported the appointment of James M. Hussey as Chief Executive Officer and member of the Board of Directors (Press release, Seneca Therapeutics, AUG 17, 2020, View Source [SID1234563716]). Jim has been a CEO or President for nearly 20 years and a C-Suite member at several successful biotech/pharmaceutical companies.

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"We are pleased to have a veteran CEO from the biotech/pharmaceutical industry like Jim join our team," said Dr. Paul Hallenbeck, President, Chief Scientific Officer and Founder of Seneca Therapeutics. "We will be working together to advance Seneca Valley Virus ("SVV-001") into clinical trials later in 2021".

"I am excited to join the Seneca Therapeutics team to develop SVV-001. Based on the data generated to date, I am extremely optimistic about the clinical trials planned for next year," said James M Hussey, CEO of Seneca Therapeutics. "I’m convinced that oncolytic viruses are key to the future of immunotherapy and that SVV-001 is the best-in-class oncolytic virus. SVV-001 potentially addresses over 60% of solid tumors—including some of the most refractory cancers– with safe, effective immuno-oncology products that harness the body’s own immune system to defeat cancer."

Jim joins the Seneca Therapeutics team at a pivotal moment. The company plans on entering Phase I-II clinical studies with SVV-001 in combination with a checkpoint inhibitor in neuroendocrine cancers in 2021. Seneca Therapeutics recently received FDA guidance on its clinical protocol and IND. Further, the company also recently secured important intellectual property rights including enabling technology that will allow Seneca Therapeutics to develop a companion diagnostic to identify patients likeliest to respond to SVV-001 using TEM8 and potentially other molecules. TEM8, the receptor of SVV-001, is expressed on the surface of the majority of solid tumor cells but minimally expressed on normal cells and supports SVV-001’s extensive safety profile as determined in numerous animal models and multiple clinical trials. TEM8 is expressed in many solid tumors including breast, lung, pancreatic, skin, and neuroendocrine cancers.

On August 17, 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 clearance of the pivotal ENVASARC protocol after filing the protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application on July 15 (Press release, Tracon Pharmaceuticals, AUG 17, 2020, View Source [SID1234563715]). The application cross referenced the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology. TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the fourth quarter of 2020.

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"We are pleased to receive clearance from the FDA to initiate the pivotal ENVASARC trial of envafolimab in sarcoma and look forward to dosing the first patient in the fourth quarter of this year," said James Freddo, M.D., Chief Medical Officer of TRACON. "Immunotherapy has radically changed the treatment paradigm for a number of cancers and our hope is envafolimab will do the same for sarcoma patients who have few treatment options."

ENVASARC Study Design

Key elements for the ENVASARC pivotal trial include:

Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States.
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 partners 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 August 17, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in the two-day Fortress Biotech ("Fortress") Virtual Summit taking place on Tuesday, August 18 and Wednesday, August 19 (Press release, Mustang Bio, AUG 17, 2020, View Source [SID1234563714]). The Summit will be hosted by the B. Riley FBR, Inc., Research team and feature multiple programs from Fortress’ diversified pipeline.

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On Tuesday, August 18, Dr. Litchman will present Mustang’s gene therapy programs and participate in a panel with Harry L. Malech, M.D., Chief of the Genetic Immunotherapy Section for the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The panel will take place at 2:50 p.m. ET and registration for the event is available here.

Dr. Litchman will also present Mustang’s cancer cell therapy programs and participate in a panel with Stephen J. Forman, M.D., Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of City of Hope’s T Cell Therapeutics Research Laboratory on Wednesday, August 19, 2020. The panel will take place at 1:20 p.m. ET and registration for the event is available here.
Following each event, the webcasts will be available on the Events page, located within the Investor Relations section of Mustang’s website, View Source, for approximately 30 days.

On August 17, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James F. Oliviero, President and Chief Executive Officer, will present a company overview and participate in a panel discussion at the Fortress Biotech Virtual Summit hosted by Mayank Mamtani, of B. Riley FBR, Inc., on Wednesday, August 19, 2020 at 1:50 p.m. ET (Press release, Checkpoint Therapeutics, AUG 17, 2020, View Source [SID1234563713]). A registration link and webcast information can be found below.

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The panel discussion will focus on cosibelimab, Checkpoint’s potentially best-in-class anti-PD-L1 antibody. Mr. Oliviero will be joined on the panel by David M. Miller, M.D., Ph.D., who will provide his insight on the use of immunotherapy in cutaneous squamous cell carcinoma ("cSCC") and the issues patients face when accessing available treatments. Dr. Miller is an Instructor in Dermatology and Medicine at Harvard Medical School and member of the Department of Dermatology and the Department of Medicine at Massachusetts General Hospital, where he is Director of the Center for Merkel Cell Carcinoma and Co-Director of the MGH-MEEI Non-Melanoma Skin Cancer Multi-Disciplinary Clinic.

Checkpoint will present updated interim safety and efficacy data from its ongoing registration-enabling clinical trial of cosibelimab in patients with metastatic cSCC at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020, to be held September 19-21, 2020. Checkpoint recently announced that the trial is over half enrolled, with full enrollment anticipated around year-end.

Registration link and webcast information:

Please click here to register for the event on Wednesday, August 19, 2020.
Following the event, the webcast will be available on the Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days.