On January 25, 2024 Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), reported the signing of a license agreement with JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Jiangsu Alphamab) and 3D MEDICINES INC. (3D Medicines), (together as the Licensors), for KN035 (Envafolimab) for India, Asia Pacific (except Singapore, Thailand, Malaysia), Middle East and Africa, Russia, CIS, and Latin America (the Territory) (Press release, Glenmark, JAN 25, 2024, View Source [SID1234639485]).

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Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3D Medicines, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory. Jiangsu Alphamab will be the exclusive supplier of the product. 3D Medicines retains the right to develop and commercialize Envafolimab for any purpose outside the Territory. The Licensors will receive a low double digit Million US Dollar amount up to launch, additional triple digit Million US Dollar milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales. The Licensors’ respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between 3D Medicines and Jiangsu Alphamab.

"This is an important milestone for Glenmark, as through this transformational deal, we gain access to the first recombinant humanized single domain antibody against PD-L1 in a subcutaneous formulation for a wide territory globally. We are excited at the opportunity to take this innovative immuno-oncology product to cancer patients across the emerging markets and meaningfully contribute towards improving their access to potentially life-saving treatments," remarked Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd.

Envafolimab, under the brand name ENWEIDA (恩維達) has been approved in China by the National Medical Products Administration (Chinese NMPA) in November 2021 as the global-first subcutaneous injection PD-L1 inhibitor for the treatment of adult patients with previously treated microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) advanced solid tumor. Over 30,000 patients in China have already greatly benefited from this innovative treatment where, in December 2023, it has also been officially included in the ‘List of Breakthrough Therapies’ by the NMPA*.

Overall, dMMR prevalence across 13 tumor types (based on 54 papers and 20,383 patients) was estimated at 16% (11%–22%)**, which makes it quite a widespread genetic signature among cancer patients. Envafolimab has the potential to provide an effective treatment for this population across Emerging Markets and beyond.

Furthermore, Envafolimab is currently being developed in the USA by Tracon Pharma in a pivotal trial in soft tissue sarcoma (STS) subtypes including, Undifferentiated Pleomorphic Sarcoma (UPS) and the genetically related myxofibrosarcoma (MFS). Envafolimab has obtained two orphan drug designation from the U.S. FDA for advanced biliary tract cancer and soft tissue sarcoma (STS), and a Fast Track designation for STS. Additional indications such as biliary tract cancer and non-small cell lung cancer are currently in development.

On January 25, 2024 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that the Company will deliver a corporate presentation at The Microcap Conference (Press release, Soligenix, JAN 25, 2024, View Source [SID1234639484]). The conference will be held January 30 and 31, and February 1, 2024 at Caesars Atlantic City Hotel & Casino in Atlantic City, N.J. For more information about The Microcap Conference, please refer to the conference website at View Source

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Registered conference attendees may schedule one-on-one meetings with Soligenix management via the conference scheduling platform. If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected].

On January 25, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that data from the acute myeloid leukemia cohort of patients in the Phase 1 dose-escalation study of SLS009 (formerly GFH009) will be presented in an oral presentation at the 2024 European School of Haematology Acute Leukaemias (ESH) Conference: 4th How to Diagnose and Treat Acute Leukaemias, taking place March 1-3, 2024, in Stockholm, Sweden (Press release, Sellas Life Sciences, JAN 25, 2024, View Source [SID1234639483]).

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The presentation details are below:

Title: Phase 1 Dose-Escalation Study of GFH009 in Acute Myeloid Leukemia
Session Date and Time: Sunday, March 3, 2024, at 12 pm CET
Session Title: Leukemia Treatment Challenges
Presenter: Dr. Tapan Kadia, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston, Texas
Abstract Number: 6192705

On January 25, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that, under its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib, it has earned a $40 million milestone payment from Roche upon dosing of the first patient with camonsertib (RP-3500 or RG6526) in Roche’s TAPISTRY trial (NCT04589845) (Press release, Repare Therapeutics, JAN 25, 2024, View Source [SID1234639482]). TAPISTRY is a Phase 2, global, multicenter, open-label, multi-cohort clinical trial designed to evaluate the safety and efficacy of targeted therapies or immunotherapy in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations.

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In October, Roche also enrolled the first patient in a camonsertib-based arm in its Phase 1b/2 clinical trial of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698). The TAPISTRY and MORPHEUS trials are actively enrolling patients. In collaboration with Roche, Repare is continuing to conduct tumor specific expansions in the ATTACC trial to support future clinical development for camonsertib + PARP inhibitor combinations.

"This milestone is a key achievement for us, demonstrating Roche’s commitment to the global clinical development of camonsertib and highlighting their exploration of development opportunities for camonsertib across multiple tumor types and genetic alterations to maximize patient impact," said Lloyd M. Segal, President and Chief Executive Officer of Repare.

Under the terms of its collaboration with Roche, Repare received a $125 million upfront payment in July 2022, as well as $13.6 million in additional payments, and is eligible to receive up to $1.2 billion in potential clinical, regulatory, commercial and sales milestone payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its

co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.

About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On January 25, 2024 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into definitive agreements with institutional investors for the purchase and sale of 10,000,000 of the Company’s American Depositary Shares ("ADSs"), each ADS representing four hundred (400) ordinary shares, at a purchase price of $0.80 per ADS, in a registered direct offering (Press release, RedHill Biopharma, JAN 25, 2024, View Source [SID1234639481]). In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 10,000,000 ADSs. The warrants will have an exercise price of $1.00 per ADS, will be immediately exercisable upon issuance and have a term of five years following the issuance date. The closing of the offering is expected to occur on or about January 29, 2024, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be $8 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general working capital, acquisitions, research and development, and general corporate purposes.

The ADSs described above (but not the warrants issued in the private placement or the ADSs underlying the warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form F-3 (File No. 333-258259) previously filed with the Securities and Exchange Commission (the "SEC") on July 29, 2021, and declared effective by the SEC on August 9, 2021. The offering of the ADSs is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the offering of ADSs will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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