On April 5, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the compensation committee of the Company’s Board of Directors granted stock option awards to purchase an aggregate of 258,000 shares of its common stock to four employees outside Fusion’s 2020 Stock Option and Incentive Plan (Press release, Fusion Pharma, APR 5, 2023, View Source [SID1234629842]). The stock options were granted as an inducement material to the individual becoming an employee of Fusion in accordance with Nasdaq Listing Rule 5635(c)(4).

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The options have an exercise price of $3.80 per share, which is equal to the closing price of Fusion’s common stock on April 3, 2023. Each option has a ten-year term and vests over four years, with 25% of the original number of shares vesting on the one-year anniversary of the grant date and then in equal installments for 36 months thereafter, subject to the employee’s continued service with Fusion through the applicable vesting dates.

On April 5, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the first patient has been dosed with both the protein dose and the 177Lu-DOTA imaging dose in its Phase 1 clinical trial, evaluating the Company’s pre-targeted radioimmunotherapy Self-Assembly and Disassembly-Bispecific ("SADA") technology platform for the treatment of certain GD2-positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma (Press release, Y-mAbs Therapeutics, APR 5, 2023, View Source [SID1234629841]). The two-step approach separating the administration of SADA protein ("pre-targeting") from the administration of radioactive ligand is believed to differentiate SADA constructs from most other radioimmunotherapy approaches.

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"We are excited to advance our SADA platform into the clinic for the first time with the initiation of patient dosing in this trial. This is a significant milestone for Y-mAbs in our efforts to potentially build a global franchise of radiotherapeutic assets" said Thomas Gad, Founder, President, and Interim CEO. "SADA can potentially generate the clinical data to further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses. Further, during the first part of the study, Part A, we plan to collect imaging data to assess tumor targeting and assess the PK profile of GD2-SADA, as this could potentially allow for early evaluation of the program and more informed development decisions."

The Phase 1 dose-escalation, single-arm, open-label, non-randomized, multicenter trial (NCT05130255) targets malignant melanoma, sarcoma and small cell lung cancer. The trial will have three parts: Part A will explore dose-finding for the SADA molecule and testing of dosing intervals between the protein and the 177Lu-DOTA payload; Part B will determine the optimal dose of 177Lu-DOTA; and Part C will be evaluating safety and initial signals of efficacy using repeated dosing. The Company expects a total of approximately 60 patients to be enrolled in the trial across 6-10 U.S. sites.

The GD2-SADA construct was created using the Company’s SADA platform, which was licensed by the Company from Memorial Sloan Kettering Cancer Center ("MSK") and Massachusetts Institute of Technology ("MIT"). SADA utilizes a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target. In prior nonclinical studies unbound constructs predictably disassembled into smaller antibody fragments and were taken up by the liver or excreted through the kidneys within a few days after administration. In a second infusion, a radioactive payload designed specifically to target the SADA molecules attached to the tumor target. We believe this approach provides the possibility of targeting tumors with precision while minimizing radiation of normal tissues. We believe the SADA platform has the potential to deliver a variety of payloads and be developed against multiple tumor targets, as well as for theragnostic purposes.

Researchers at MSK, including Dr. Nai-Kong Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, and MSK has institutional financial interests in the technology.

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.