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Gilead To Acquire All Remaining Rights To Potential First-In-Class Immunotherapy GS-1811 From Jounce Therapeutics

On December 27, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and Jounce Therapeutics, Inc. (Nasdaq: JNCE) reported to have amended their existing license agreement for GS-1811 (formerly JTX-1811), enabling Gilead to buyout remaining contingent payments potentially due under the license agreement executed in August 2020 (Press release, Jounce Therapeutics, DEC 27, 2022, View Source [SID1234625610]). As part of the transaction, certain operational obligations of the parties related to GS-1811, an anti-CCR8 antibody, set forth in the license agreement have also been terminated. Gilead will acquire certain related intellectual property, including all outstanding rights of Jounce to GS-1811, pursuant to the transaction agreement. GS-1811, a potentially first-in-class immunotherapy, is designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells in the tumor microenvironment and is currently in Phase 1 clinical development as a possible treatment for patients with solid tumors.

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"We are pleased to announce the signing of this transaction with Gilead who have a strong track record of developing and successfully commercializing leading brands in biotechnology," said Richard Murray, Ph.D., chief executive officer and president of Jounce. "This transaction allows us to extend our runway and remain focused on delivering meaningful and long-lasting benefits to cancer patients. It was important for Jounce at this time to bolster our cash resources given challenges in capital markets for biotech companies."

Jounce will receive proceeds of $67 million for this transaction and Gilead will be solely responsible for all further research, development, and commercialization of GS-1811 globally.

"Today’s news about GS-1811 further demonstrates our commitment to our rapidly evolving oncology franchise and mission of pioneering next-generation medicines for people with cancer," said Bill Grossman, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Gilead Oncology. "GS-1811, with its potential new pathway of activating the immune system, gives us the opportunity to potentially change the standard of care with a treatment that works from inside cancerous cells to shrink solid tumors."

Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with Jounce to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.04.

Jounce will no longer be entitled to receive the remaining contingent payments of up to $645 million in milestones and high single digit to mid-teens royalties based upon worldwide sales under the original license agreement. Additional details of the transaction, including related agreements and matters, will be contained in a Current Report on Form 8-K to be filed by Jounce.

Ablaze Pharmaceuticals and Yonghe Pharma Initiate Development and Manufacturing Services Agreement for Targeted Radiopharmaceutical Therapies

On December 26, 2022 Ablaze Pharmaceuticals ("Ablaze") reported the initiation of a development and manufacturing services agreement with Yonghe Pharmaceutical Technology Co., Ltd. ("Yonghe") to develop series of targeted radiopharmaceutical therapy ("TRT") products (Press release, Ablaze Pharmaceuticals, DEC 26, 2022, View Source [SID1234625603]). Under the agreement Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze from pharmaceutical research and preclinical activities to clinical studies.

"This agreement with Yonghe represents a significant step for Ablaze in our efforts to optimize our preclinical and clinical development program for target radiopharmaceutical therapy" said Dr. Tiecheng Qiao, President and Chief Executive Officer of Ablaze. "Target radiopharmaceutical therapy is a proven approach to treating many cancers. We are excited about this opportunity to bring this novel class of TRT products to benefit patients in China."

"We are glad to support Ablaze and its targeted radiopharmaceutical therapy programs. TRT offers the potential to play an important role in the fight against cancer, we seek to provide a robust and efficient radiopharmaceutical manufacture, testing, and supply process for our partners from early-stage development through commercialization" said Mr. Bo Lin, Chairman of Yonghe.

Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-037 (CD73 Inhibitor) in Combination with KEYTRUDA® (pembrolizumab)

On December 26, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported that it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) on a multicenter, open-label, Phase I dose-finding study of ATG-037 as a monotherapy and in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with locally advanced or metastatic solid tumors (the STAMINA-001 study) (Press release, Antengene, DEC 26, 2022, View Source [SID1234625602]).

The primary objective of the STAMINA-001 study is to evaluate the safety and tolerability of ATG-037 as monotherapy and in combination with KEYTRUDA, to determine the appropriate dose for Phase II studies. Secondary objectives of the study include the characterization of the pharmacology and evaluation of preliminary efficacy of ATG-037. Under the terms of the Agreement, the study will be conducted by Antengene, and MSD will provide KEYTRUDA for the combination portions of the trial.

ATG-037, is an innovative asset in-licensed from Calithera with global rights and developed in-house by Antengene, has been approved to enter clinical studies in Australia and China, thus becoming the first oral small molecule CD73 inhibitor entering the clinical-stage in China and the wider Asia Pacific region. The patient enrollment for the Phase I study of ATG-037 is currently underway in Australia.

"Antengene believes that cancer treatments involving the rational combination of immuno-oncology drugs and targeted therapies may offer the greatest opportunity for substantial advances in treatment outcomes for patients with cancer," said Dr. Amily Zhang, Antengene’s Chief Medical Officer. "The mechanism of action of ATG-037 in inhibiting adenosine-generating CD73 is expected to reverse an immunosuppressed tumor microenvironment, thereby creating potential additive benefit with multiple immuno-oncological approaches. We are very excited to assess the impact of ATG-037 as a monotherapy and in combination with MSD’s KEYTRUDA, and have already begun recruiting patients for the STAMINA-001 study in Australia. We hope this collaboration will generate data that allows us to proceed to later phase studies in patients with a variety of cancers, with potential for significant positive impact on treatment outcomes." continued Dr. Zhang.

"Exploring novel combinations between compounds from our portfolio with immunotherapeutic drugs or drugs with highly targeted mechanisms of action has always been Antengene’s top priority towards delivering transformational cancer therapies. We are enthusiastic about the collaboration with MSD because it marks another milestone for us to fulfill our vision of ‘Treating Patients Beyond Borders’," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-037

ATG-037 is an orally available, small molecule CD73 inhibitor. CD73 generates adenosine, which leads to immunosuppression in the tumor microenvironment. ATG-037 has demonstrated promising preclinical efficacy as a monotherapy and in combination with immune checkpoint inhibitors (ICIs) and chemotherapy agents. In preclinical studies, the compound has demonstrated the ability to overcome the "hook effect" that has been observed in some anti-CD73 antibodies. In addition, GLP toxicology studies indicate the compound potentially has a wide therapeutic window.

Coherus and Junshi Biosciences Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

On December 24, 2022 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) reported that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) by the Prescription Drug User Fee Action (PDUFA) date of December 23, 2022 (Press release, Coherus Biosciences, DEC 24, 2022, View Source [SID1234625599]).

The FDA previously communicated that an on-site inspection of Junshi Biosciences’ manufacturing facility for toripalimab is required before the Agency can approve the application; however, they were unable to conduct the inspection during the current review cycle due to the ongoing impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and Coherus are engaged in ongoing discussions with the Agency about the pre-approval inspection plans.

"There is a significant unmet need for those living with NPC, and toripalimab has demonstrated significant and clinically meaningful improvement as recognized by the FDA’s Breakthrough Therapy Designation. Both Coherus and the FDA are highly committed to bringing toripalimab to NPC patients in the U.S. as quickly as possible," said Theresa LaVallee, Ph.D., Coherus’ Chief Development Officer. "We are working closely and collaboratively with the FDA to schedule inspections of the manufacturing facility quickly and understand the need to ensure the safety of their inspectors. We continue to support the FDA as needed to allow for their assessment of toripalimab to be finalized."

"Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary," said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. "Together with our partner Coherus, we are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in order to provide NPC patients with a treatment that has been demonstrated to be safe and effective. Our production operations are well prepared for the inspection."

The FDA has granted priority review for the toripalimab BLA for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system and decreases PD-1’s expression on the T-cell as a second method of restoring the body’s immune response.

The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer ("SCLC").

CiMaas to present at Biotech Showcase 2023

On December 24, 2022 CiMaas BV, a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary NK cell expansion platform, reported the date for a presentation of the company at the Biotech Showcase 2023, the investor conference as follows: Monday, January 09, 2023, at 3:00PM at the Hilton San Francisco – Union Square, 333 O’Farrell Street, Ballroom Level San Francisco, CA 94102, USA (Press release, CiMaas, DEC 24, 2022, View Source [SID1234625598]).