On October 11, 2023 Scholar Rock Holding Corporation (Nasdaq: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported the pricing of an upsized underwritten public offering of 12,408,760 shares of its common stock at a public offering price of $6.85 per share (Press release, Scholar Rock, OCT 11, 2023, View Source [SID1234635868]). The aggregate gross proceeds to Scholar Rock from this offering are expected to be approximately $85.0 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares are being offered by Scholar Rock. The offering is expected to close on October 16, 2023, subject to the satisfaction of customary closing conditions. In addition, Scholar Rock has granted the underwriters a 30-day option to purchase up to an additional 1,861,314 shares of common stock at the public offering price, less the underwriting discounts and commissions.

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Scholar Rock intends to use the net proceeds from the offering to advance apitegromab, develop its clinical and preclinical pipeline, as well as for working capital and other general corporate purposes.

J.P. Morgan Securities LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. BMO Capital Markets Corp. and Wedbush Securities Inc. are acting as co-managers for the offering.

The securities described above are being offered by Scholar Rock pursuant to a shelf registration statement on Form S-3 (No. 333-268329) that was declared effective by the Securities and Exchange Commission (SEC) on November 25, 2022. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering were filed with the SEC on October 11, 2023, and are available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204 or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On October 11, 2023 ImmPACT Bio USA, Inc. ("ImmPACT BIO"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the BIO Investor Forum, to be held from October 17-18, 2023 in San Francisco, CA (Press release, ImmPACT-Bio, OCT 11, 2023, View Source [SID1234635867]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s president and chief executive officer, will participate in a panel discussion entitled "Opportunities in Bispecific Therapy Development," on Tuesday, October 17, 2023 at 11:00 AM PT.

On October 11, 2023 Allorion Therapeutics (Allorion), a clinical-stage biotechnology company dedicated to the discovery and development of next-generation targeted drugs for cancer and autoimmune diseases, reported the dosing of its first patient in the Phase 1/2 trial of ARTS-021 (NCT05867251) (Press release, Allorion Therapeutics, OCT 11, 2023, View Source [SID1234635865]). This open-label, first-in-human study is currently ongoing in the US and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ARTS-021 in adult patients with advanced or metastatic solid tumors.

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ARTS-021 is a potent and highly selective CDK2 inhibitor formulated specifically for targeting HR+/HER2- breast cancers and CCNE1-amplified cancers. The objective is to enhance therapeutic efficacy and overcome resistance in these hard-to-treat cancer types. "Dosing the first patient with ARTS-021 marks a pivotal milestone given there remains an unmet need for highly selective CDK2 inhibitors," commented Greg Berk, MD, Chief Medical Officer of Allorion Therapeutics. "In 2023, nearly 300,000 new cases of HR-positive breast cancer were diagnosed and there remains very few treatment options. In addition, CCNE1 amplification, a frequently observed genetic alteration in human cancer, is present in 10 to 20% of ovarian cancer with no approved targeted therapies. With the advancement of the ARTS-021 program, there is potential for a transformative treatment that could notably enhance the lives of HR-positive breast cancer patients and those with CCNE1-amplified tumors."

On October 11, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that it has expanded its exclusive license agreement with the University of Pittsburgh to include the SNAP-CAR technology platform in natural killer (NK) cells (Press release, University of Pittsburgh, OCT 11, 2023, View Source [SID1234635864]). This amended agreement builds upon the original exclusive license agreement with the University of Pittsburgh for SNAP-CAR T-Cell, a "universal" CAR T technology platform designed to target multiple antigens simultaneously and potentially address a range of hematologic and solid tumors, including HER2-expressing cancer.

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The addition of SNAP-CAR NK adds a third NK-focused technology to Coeptis’ development portfolio. Recently Coeptis completed an exclusive license agreement with Deverra Therapeutics, which included rights to a proprietary allogeneic stem cell expansion and differentiation platform for the generation of NK cells from pooled donor cord blood CD34+ cells that are being used without HLA matching in first-in-human clinical trials. This highly scalable and cost-effective cell generation platform combined with the universal SNAP-CAR technology has the potential to generate a first-in-class fully universal (no HLA matching and antigen agnostic) targeted cell therapy. Coeptis has also obtained exclusive rights from VyGen Bio to negotiate towards the acquisition of the GEAR cell therapy and companion diagnostic platforms, including CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers with an initial focus on multiple myeloma.

"The original exclusive license agreement with the University of Pittsburgh was a watershed moment for Coeptis, and with the growing recognition of the potential of NK cells, we believe this amendment is another extremely important step for this partnership and for Coeptis," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Expanding this agreement to include engineering of NK cells to generate SNAP-CAR NK therapies highlights our commitment to being on the leading edge of this important technology with a team that is fully capable of expanding upon the existing technology to incorporate and synergize with complementary technologies that we have brought inhouse to Coeptis, including assets recently in-licensed from Deverra Therapeutics."

"We are pleased to expand our partnership with Coeptis as we work to advance our efforts in developing a universal CAR-T system and believe NK cells have the potential to be an important cell type for developing better treatments for a range of cancers," said Jason Lohmueller, Ph.D., Assistant Professor of Surgery and Immunology in the Division of Surgical Oncology Research, University of Pittsburgh. "Expanding this agreement to include allogeneic NK cells enables our teams to develop cell therapies that can be developed with off-the-shelf convenience and greater access to patients. We continue to strive for therapies that can target multiple antigens simultaneously while also offering greater control over toxicity."

On October 11, 2023 Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific antibodies for oncology, reported that the company has entered into an exclusive worldwide licensing agreement for its OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics, a biopharmaceutical company developing therapies for rare allergic and immunological diseases (Press release, Ichnos Sciences, OCT 11, 2023, View Source [SID1234635863]). With the execution of this agreement, Ichnos has successfully licensed its two assets for inflammatory and immunological diseases, a key milestone in the company’s prioritization of its pipeline of oncology drug candidates.

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Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications. In exchange, Ichnos will receive up to $320 million in upfront, development, regulatory and sales milestone payments in addition to up to low double-digit royalties. Ichnos has also agreed to allow Astria to draw down on its existing investigational drug substance and drug product stocks at normalized costs to facilitate development.

Telazorlimab is a novel, humanized IgG1 monoclonal antibody that targets OX40 on T cells responsible for inflammation and immunity diseases. Excessive OX40 signaling, expressed on activated T cells, is the feature of several inflammatory diseases, including atopic dermatitis (AD). Astria plans to develop an affinity-matured version of telazorlimab and apply YTE half-life extension technology to create a product that aims to address the need for a safe, effective, and infrequently administered AD treatment.

"As Ichnos continues to grow as a biotechnology company, this agreement enables our team to focus on advancing our robust pipeline of clinical-stage multispecific antibodies in oncology generated by our proprietary BEAT platform1, as well as continue the discovery and development of our NK-cell engaging programs for solid tumors," said Cyril Konto, M.D., President and CEO of Ichnos. "I am proud of the work achieved by the Ichnos team in successfully completing the Phase 2b with telazorlimab in atopic dermatitis and potentially opening up a new therapeutic class for this disease. Ichnos is confident in Astria Therapeutics’ capabilities and vision for pursuing the development of its OX40 program and delivering a potentially life-changing treatment to patients with inflammatory and immune diseases."

"We are looking forward to building on the foundational work that Ichnos has done with their OX40 portfolio," said Jill Milne, Ph.D., co-founder and CEO of Astria Therapeutics. "We believe that by using Ichnos’ affinity-matured next generation monoclonal antibody OX40 antagonist and applying YTE half-life extension technology, we have the potential to deliver a best-in-class profile for atopic dermatitis patients; one that we think can be safe, effective, and long-acting. In addition to OX40 antagonism already being a clinically validated mechanism in atopic dermatitis, we also are excited about the opportunity for potential expansion into additional indications."