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]).

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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.

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]).

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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").

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]).

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On December 23, 2022, Novavax, Inc. (the "Company") reported to have completed the issuance and sale of $25.25 million aggregate principal amount of the Company’s 5.00% Convertible Senior Notes due 2027 (the "Additional Notes") to J.P. Morgan Securities LLC, Jefferies LLC and Cowen and Company, LLC, as representatives (the "Representatives") of the several initial purchasers (the "Initial Purchasers"), pursuant to their election to purchase Additional Notes, which was exercised in full, pursuant to the purchase agreement, dated as of December 15, 2022, by and among the Company and the Initial Purchasers (the "Purchase Agreement") (Filing, 8-K, Novavax, DEC 28, 2022, View Source [SID1234625663]). The Additional Notes have the same terms and were issued pursuant to the same indenture with the Bank of New York Mellon Trust Company, N.A., as trustee, as the Company’s 5.00% Convertible Senior Notes due 2027 issued on December 20, 2022, as described in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21, 2022 (the "Notes Form 8-K"). The information set forth in Item 1.01 of the Notes Form 8-K is incorporated herein by reference.

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The Company’s net proceeds from this offering (including the previously-announced net proceeds of approximately $142.2 million from the initial closing on December 20, 2022, as described in the Notes Form 8-K) were approximately $166.3 million, after deducting the Initial Purchasers’ discounts and commissions and the estimated offering expenses payable by the Company. As previously announced, the Company may use the net proceeds from the offering of the Notes for general corporate purposes, including but not limited to the continued global commercial launch of Nuvaxovid, repayment or repurchase of a portion of the $325.0 million in outstanding principal amount of its 3.75% convertible senior unsecured notes due February 1, 2023, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, repayments under its supply agreements, as well as acquisitions and other strategic purposes.

On December 23, 2022, Vor Biopharma Inc. (the "Company") entered into an At-the-Market Equity Offering Sales Agreement (the "Agreement") with Stifel, Nicolaus & Company, Incorporated ("Stifel") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $125.0 million after the date of the Agreement through Stifel as its sales agent (Filing, 8-K, Vor BioPharma, DEC 23, 2022, View Source [SID1234625601]). Also on December 23, 2022, the Company filed a prospectus supplement offering up to $125.0 million of shares of its Common Stock in accordance with the Agreement, on the Company’s Registration Statement on Form S-3 (No. 333-263541). The Agreement replaces the Open Market Sale AgreementSM between the Company and Jefferies LLC, dated March 14, 2022, which was terminated effective as of December 22, 2022.

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Stifel may sell the Common Stock under the Agreement (A) in negotiated transactions with the consent of the Company or (B) by any other method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including block transaction, sales made directly on the Nasdaq Global Select Market or sales made into any other existing trading market for the shares of Common Stock. Stifel will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Stifel a commission of up to three percent (3.0%) of the gross sales proceeds of any Common Stock sold through Stifel under the Agreement, and also has provided Stifel with customary indemnification rights. In addition, the Company has agreed to reimburse certain legal expenses and fees by Stifel in connection with the offering.

The Company is not obligated to make any sales of Common Stock under the Agreement. The offering of shares of Common Stock pursuant to the Agreement will terminate upon the earlier of (i) the sale of all Common Stock subject to the Agreement or (ii) termination of the Agreement in accordance with its terms.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.