On April 5, 2023 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 United States Adopted Names (USAN) Council has approved the use of the nonproprietary name of "hypericin sodium" for the novel active ingredient in both HyBryte (research name SGX301) for the treatment of cutaneous T-cell lymphoma (CTCL) and SGX302 for the treatment of mild-to-moderate psoriasis (Press release, Soligenix, APR 5, 2023, View Source [SID1234629840]).

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"We are pleased that USAN has approved the proposed name," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to continuing to work with the World Health Organization (WHO) to advance the International Nonproprietary Name (INN) hypericin from a proposed INN to a recommended INN, which is expected to occur later this year."

Information on hypericin sodium will be posted on the USAN website (www.ama-assn.org/go/usan) before the end of 2023 and will be submitted to the U.S. Pharmacopeial Convention for publication in the U.S. Pharmacopeia Dictionary of USAN and International Drug Names.

On April 5 2023 Proxygen, a leader in the discovery and development of molecular glue degraders, reported a multi-year research collaboration and license agreement with Merck & Co Inc., Rahway, N.J., USA, known as MSD outside the U.S. and Canada, to jointly identify and develop molecular glue degraders against multiple therapeutic targets (Press release, Proxygen, APR 5, 2023, View Source [SID1234629837]).

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"We are very excited to announce this collaboration with MSD and look forward to combining our innovative platform technology and unique expertise in identifying novel molecular glue degraders with MSD’s world class research and development capabilities. This partnership provides us with the framework and resources to further leverage our platform for the discovery of new drugs against challenging targets," says Bernd Boidol, Ph.D., chief executive officer of Proxygen.

Under the terms of the agreement, Proxygen will receive an upfront payment from MSD and be eligible for future payments of up to $2.55 billion based on the achievement of specified research, development, and commercial milestones across all programs. Additionally, Proxygen is eligible to receive royalties on net sales of any such products.

"Advances in our understanding of molecular glue degraders are opening exciting new avenues in the pursuit of novel therapeutic mechanisms," said Robert M. Garbaccio Ph.D., vice president and head of Discovery Chemistry at MSD. "We look forward to working with the Proxygen team to advance this promising area of research and evaluate new opportunities to treat disease.

On April 3, 2023, Precigen, Inc., (the "Company"), reported to have entered into an amended and restated exclusive license agreement (the "License Agreement"), with Alaunos Therapeutics ("Alaunos") (Filing, 8-K, Precigen, APR 5, 2023, View Source [SID1234629836]). The License Agreement amends and replaces the terms of that certain Exclusive License Agreement by and between the Company and Alaunos, dated October 5, 2018.

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Pursuant to the terms of the License Agreement, the Company has granted Alaunos an exclusive, worldwide, royalty-free, sub-licensable license to research, develop and commercialize T-cell receptor products, designed for neoantigens for the treatment of cancer or the treatment and prevention of human papilloma virus, or HPV, to the extent that the primary reason for such treatment or prevention is to prevent cancer, which is referred to as the HPV Field. The Company has also granted Alaunos an exclusive, worldwide, royalty-free, sub-licensable license for certain patents relating to the Sleeping Beauty technology to research, develop and commercialize TCR Products for both neoantigens and shared antigens for the treatment of cancer and in the HPV Field. The Company also granted Alaunos certain non-exclusive rights with respect to shared antigens, NK cells and gamma delta T-cells.

Alaunos will be solely responsible for all aspects of the research, development and commercialization of the exclusively licensed products for the treatment of cancer and will not be subject to an diligence obligation with respect to such efforts.

Pursuant to the License Agreement, Alaunos no longer has any rights to the Company’s technology with respect to (i) products utilizing the Company’s RheoSwitch gene switch, or RTS to express IL-12, or the IL-12 Products, for the treatment of cancer, (ii) chimeric antigen receptor, or CAR, products including CD-19 and BCMA, or (iii) products utilizing an additional construct that expresses RTS IL-12, or Gorilla IL-12 Products, for the treatment of cancer and in the HPV Field. In addition, the Company may research, develop and commercialize products for the treatment of cancer, outside of the products exclusively licensed to Alaunos. Alaunos will provide the Company with certain access to information and materials related to Alaunos’s prior use of the Company’s technologies that is no longer within the scope of the License Agreement.

In consideration of the licenses and other rights granted by the Company, Alaunos will pay the Company an annual license fee of $75,000. Neither Alaunos nor the Company will have any other obligations with respect to the payment of milestones or royalties on products developed in connection with the License Agreement.

The Company has agreed that, during the term of the License Agreement, it will not use the licensed intellectual property to research, develop or commercialize any exclusive product for the treatment of cancer.

The License Agreement will terminate on a product-by-product and/or country-by-country basis upon the expiration of the last to expire patent claim for a licensed product. In addition, Alaunos may terminate the License Agreement on a country-by-country or program-by-program basis following written notice to the Company, and either party may terminate the License Agreement following notice of a material breach.

The License Agreement also contains customary representations, warranties and covenants from Alaunos and the Company, as well as customary provisions related to indemnity, confidentiality and other matters.

On April 5, 2023 Nerviano Medical Sciences Srl,a member of NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that two posters will be presented at the upcoming AACR (Free AACR Whitepaper) annual meeting which will be held April 14-19, 2023 at the Orange County Convention Center, Orlando, Florida (Press release, Nerviano Medical Sciences, APR 5, 2023, View Source [SID1234629833]).

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Poster #: 1615. Title: NMS-812, a novel potent PERK inhibitor that also inhibits GCN2, exhibits strong anti-tumor activity as single agent and in combination in preclinical models. Presenter: Claudia Perrera, PhD, Head of Discovery Pharmacology, Nerviano Medical Sciences. Session: PO.ET09.03 – Novel Antitumor Agents 3. When: Monday, April 17 9.00 AM-12.30 PM ET. Where: Section 17 of the Exhibition Hall.

Poster #: 4036. Title: NMS-0963 is a novel potent, selective and orally available Syk inhibitor with promising preclinical activity in diffuse large B-cell lymphoma. Presenter: Grazia Saturno, PhD, Global Asset Leader, Nerviano Medical Sciences. Session: PO.ET09.08 – Tyrosine Kinase and Phosphatase Inhibitors 2. When: Tuesday, April 18 9.00 AM-12.30 PM ET. Where: Section 21 of the Exhibition Hall.

About NMS-812
NMS-812 is a potent and selective inhibitor of PERK and GCN2, two key kinases involved in regulating the "integrated stress response" (ISR), a series of signaling pathways that facilitate cellular adaptation to various types of stress conditions and which, importantly, include those commonly encountered by tumor cells. In this presentation, we elucidate key preclinical data which led to selection of NMS-812 as a clinical candidate. NMS-812 has the potential to be a first-in-class agent targeting the ISR and started patient enrolment in a FIH clinical trial in the setting of relapsed/refractory multiple myeloma in mid-2022 (NCT05027594).

About NMS-0963
NMS-0963 is a novel potent, selective and orally available Syk (Spleen tyrosine kinase) inhibitor. Syk is a non-receptor cytoplasmic tyrosine kinase that plays a fundamental role in BCR (B-Cell Receptor) signaling. Syk represents a therapeutic target for the inhibition of the BCR pathway in B-Cell malignancies, such as Diffuse Large B-Cell Lymphoma (DLBCL), which depend on BCR signaling for aberrant proliferation and growth. In this poster, we present the discovery and characterization of NMS-0963 including in vitro biochemical profile, cell proliferation/mechanism of action and in vivo pharmacodynamic and efficacy data which support the rationale for clinical development of NMS-0963 in DLBCL.

Link:20230404-PERK and SYK posters AACR (Free AACR Whitepaper)2023_PressRelease

On March 31, 2023, Enzo Biochem, Inc. (the "Company") entered into a Revolving Loan and Security Agreement (the "Credit Facility") among Enzo Clinical Labs, Inc. and Enzo Life Sciences, Inc., as borrowers (the "Borrowers"), the Company and certain of its domestic subsidiaries, as guarantors (the "Guarantors"), and Gemino Healthcare Finance, LLC d/b/a SLR Healthcare ABL as lender (Filing, 8-K, Enzo Biochem, APR 5, 2023, View Source [SID1234629834]).

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The Credit Facility provides for a maximum $8 million revolving line of credit. The Borrowers intend to use the borrowing proceeds under the Credit Facility for working capital and general corporate purposes. The commitment under the Credit Facility will expire after one year and all outstanding borrowings under the Credit Facility will become due and payable at that time. Prior to its expiration, the Borrowers will prepay and terminate the Credit Facility upon closing of the Asset Purchase Agreement pertaining to the Clinical Labs business, and a standard termination fee will be payable.

The Credit Facility is secured by a first priority perfected security interest in the collateral. The collateral includes substantially all the U.S. assets of the Borrowers and the Guarantors, including among other assets, cash, receivables, inventory and fixed assets.

Borrowings under the Credit Facility, which are based on eligible receivables of the Borrowers’ Clinical Labs and U.S.-based Life Sciences operating segments, accrue interest at the rate per annum equal to Term SOFR (Secured Overnight Financing Rate) for a three-month tenor plus 5.50%. Other fees, such as an unused line fee and a collateral monitoring fee, also apply. The Borrowers borrowed $5.5 million under the Credit Facility upon the closing thereof.

The Credit Facility includes customary affirmative and negative covenants for revolving credit facilities of this nature, including certain limitations on the incurrence of additional indebtedness and liens. In addition, the Credit Facility requires the Borrowers to maintain certain minimum liquidity levels as of the last day of each calendar month. The levels decline over time, starting at $4 million as of April 30, 2023, then $3 million as of May 31, 2023 and $2 million as of the end of each month thereafter.

The Credit Facility includes customary events of default for revolving credit facilities of this nature, including failure to pay outstanding principal or interest, failure of applicable representations or warranties to be correct in any material respects, failure to perform any other term, covenant or agreement, certain defaults upon obligations under the Employee Retirement Income Security Act, bankruptcy or a change in control. Such events of default would require the repayment of any outstanding borrowings and the termination of the right to borrow additional funds under the Credit Facility.

The description above is only a summary of the material provisions of the Credit Facility and is qualified in its entirety by reference to a copy of the Credit Facility, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.