BeiGene to Host Investor Research and Development Day in Person and via Webcast on July 18, 2023

On July 7, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will host an investor Research and Development Day in New York City and via webcast on July 18, 2023 (Press release, BeiGene, JUL 7, 2023, View Source [SID1234633108]). John V. Oyler, BeiGene’s Co-Founder, Chairman and CEO, along with the Company’s leadership team, will provide an update on BeiGene’s deep and broad global innovation pipeline and platforms, and share insights on the Company’s vision, differentiated capabilities, and value creation drivers.

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Live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source , View Source or View Source Archived replays will be available for 90 days following the event.

Atara Biotherapeutics, Inc. Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On July 7, 2023 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the grant of 116,550 restricted stock units of Atara’s common stock to five newly hired employee (Press release, Atara Biotherapeutics, JUL 7, 2023, View Source [SID1234633107]). These awards were approved by the Compensation Committee of Atara’s Board of Directors and granted under the Atara Biotherapeutics, Inc. 2018 Inducement Plan, with a grant date of July 3, 2023, as an inducement material to the new employee entering into employment with Atara, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25 percent vesting on the first quarterly vesting date after the first anniversary of the vesting commencement date and the remainder vesting in 12 approximately equal quarterly installments over the following three years, subject to the employee being continuously employed by Atara as of such vesting dates.

Atara is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

Asgard Therapeutics announces publication on direct reprogramming of cancer cells to force antigen presentation, in collaboration with Lund University

On July 7, 2023 Asgard Therapeutics ("Asgard"), a private biotech company pioneering in-vivo direct reprogramming approaches for cancer immunotherapy, reported the publication in Science Immunology demonstrating reprogramming of over 60 mouse and human tumors cells across a broad spectrum of tumor types into functional antigen-presenting cells (Press release, Asgard Therapeutics, JUL 7, 2023, View Source [SID1234633106]). This study[1] represents a significant milestone for Asgard’s reprogramming technologies, providing the foundation for the ongoing development of its in-vivo engineering programs.

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To access the publication: DOI: 10.1126/sciimmunol.add4817

Fabio Rosa, PhD, Co-Founder and Head of Research at Asgard Therapeutics, said: "This study represents a major output of our long-lasting collaboration with the Pereira Lab at Lund University focusing on the unique anti-tumor properties of conventional type 1 dendritic cells (cDC1s). We showed for the first time that reprogrammed cDC1s kick start in-vivo anti-tumor immunity, leading to complete regression of tumors! In addition, reprogramming induced loss of tumorigenic properties in cancer cells, supporting the feasibility of moving towards an in-vivo engineering approach. At Asgard, we have recently selected our lead candidate AT-108, an off-the-shelf gene delivery vector encoding our proprietary combination of reprogramming factors. AT-108 is delivered directly in-vivo to recreate cDC1s’ functional properties in tumor cells and kick-start personalized anti-tumor immunity, bypassing limitations of ex-vivo cell therapies and complex tumor neoantigen identification. AT-108 is now moving into advanced pre-clinical development with IND planned for 2026."

Filipe Pereira, PhD, Co-founder and Head of Innovation at Asgard Therapeutics, Professor and Group leader at Lund University said: "Cancer cells downregulate antigen presentation to evade immune surveillance. Reversal of this mechanism has been attempted with definite mediators and downstream pathways, but we wanted to take it a step forward. By applying our knowledge of cell fate reprogramming, we have now demonstrated that the minimal transcription factor network of cDC1s[2] can be applied to engineer cancer cells’ identity. We observed that a common cDC1 and antigen presenting signature (of more than 600 genes) was commonly upregulated across mouse and human cancer cells, including patient-derived samples from 7 indications, broadly activating downstream pathways critical for efficient anti-tumor immunity (i.e. class I and II MHC molecules, co-stimulatory signaling, IL-12, CXCL10, among others). Our findings support the platform potential of our reprogramming approach which armed cancer cells with the ability to present their own endogenous tumor antigens and activate in-vivo cytotoxic CD8+ T cell responses, leading to increased survival of tumor-bearing mice".

The study was led by Filipe Pereira in a collaborative effort between his team in the Cell Reprogramming in Hematopoiesis and Immunity Group at Lund University Stem Cell Center (LSCC), Asgard Therapeutics, a member of SmiLe Incubator, and its collaborators, Inge Marie Svane from the National Center of Cancer Immune Therapy in Denmark, Lennart Greiff and Malin Lindstedt from Lund University, among many others. The research at Asgard has been carried out with support from the Eurostars-2 Joint Program with co-funding from the European Union’s Horizon 2020 research and innovation program, and Sweden’s Innovation Agency, E!115376 REPRINT Grant 2021-03371, and the Strategic innovation programs Swelife and Medtech4Health, a joint venture by Vinnova, Formas and the Swedish Energy Agency, Grant 2020-04744.

The illustration depicts a novel Trojan horse approach to cancer immunotherapy by reprogramming cancer cells to become traitors to their kind. Using the minimal regulatory network of type 1 conventional dendritic cells (connections and cells inside the horse), Zimmermannova & Ferreira et al. reprogrammed human and mouse cancer cells into dendritic cells. This strategy bypassed tumor evasion mechanisms and endowed tumor cells with professional antigen presentation leading to activation of specific CD8+ T cells (soldiers), and anti-tumor immunity in vivo. This study paves the way for a new class of cancer immunotherapies based on cell fate reprogramming.

Unleashing the Anti-CTLA-4 therapy by enhancing the Therapeutic index

On July 7, 2023 Adagene presented its corporate presentation (Presentation, Adagene, JUL 7, 2023, View Source [SID1234633105]).

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Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On July 7, 2023 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported the closing of its previously announced registered direct offering for total gross proceeds of $25 million, before deducting the placement agents’ fees and other offering expenses (Press release, Abeona Therapeutics, JUL 7, 2023, View Source [SID1234633104]).

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"Our existing institutional investors have shown their confidence in Abeona by participating in this registered direct offering without discounts or warrant coverage," said Vish Seshadri, Chief Executive Officer of Abeona. "We have been very encouraged by the favorable feedback and insights from healthcare professionals, patient communities, payors and hospital administrators based on the results of EB-101 in clinical trials, and we are positioned to launch EB-101 in the U.S. without depending on a partner. The $25 million offering allows us to now start preparing for the commercialization of EB-101 and aim for a timely launch upon potential BLA approval in the first half of 2024, while also extending our cash runway well into the fourth quarter of 2024."

Abeona will use the net proceeds from the offering primarily to fund preparations for commercialization of its product candidate EB-101, as well as for working capital and general corporate purposes. Based on EB-101’s Rare Pediatric Disease designation, Abeona expects to qualify to receive a priority review voucher (PRV) upon Biologics License Application (BLA) approval and subject to final determination by the FDA. The PRV can be used to receive an expedited review process of a subsequent marketing application for a different product or sold to another company to create additional capital.

The Company sold 3,284,407 shares of its common stock (and, in lieu of common stock for certain investors, pre-funded warrants to purchase 2,919,140 shares of its common stock) at an offering price of $4.03 per share (or $4.0299 per pre-funded warrant, which represents the per share offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant). The pre-funded warrants are immediately exercisable at a nominal exercise price of $0.0001 per share and may be exercised at any time until the pre-funded warrants are exercised in full.

The offering was led by Nantahala Capital Management, LLC and included participation by Adage Capital Partners LP and two other existing investors.

Cantor Fitzgerald & Co. acted as the sole lead-placement agent for the offering. A.G.P./Alliance Global Partners acted as the co-placement agent for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. The prospectus supplement and the accompanying prospectus that form a part of the registration statement have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by e-mail at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security 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 any such state or jurisdiction.