On April 5, 2023 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (Press release, Intas Pharmaceuticals, APR 5, 2023, View Source [SID1234629845]).

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"The promise of HLX02’s reference product—Herceptin1—is well documented, and we’re thrilled to announce this regulatory milestone as we work to provide patients increased options and access for treatment of serious conditions in oncology, immunology, and critical care," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "Biosimilars are key to making healthcare more affordable and accessible. We’re working to develop the deepest portfolio of biosimilars to enhance the patient experience and improve the cost of care across the continuum."

HLX02 was originally developed by Accord’s business partner Shanghai Henlius Biotech, Inc. headquartered in Shanghai, China. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

Approved in more than 30 countries, HLX02 was approved for commercialization by the European Commission (EC) and China’s National Medical Products Administration (NMPA) in July 2020 and August 2020, respectively, for the same indications as the innovator product.

The BLA submission is based on robust structural and functional analytical comparison data using multiple orthogonal techniques and head-to-head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab. The clinical results demonstrated that HLX02 and reference trastuzumab are highly similar in terms of quality, safety, and efficacy.

Accord BioPharma has already received BLA approval on two other biosimilars, and the company plans to introduce several additional biosimilars to the U.S. market in the next five years.

On April 5, 2023 Deka Biosciences ("Deka"), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, reported that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia (Press release, Deka Biosciences, APR 5, 2023, View Source [SID1234629844]). The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

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"We are beyond thrilled to begin the clinical trial of DK210 (EGFR), marking our first program to enter clinical development," said John Mumm, Ph.D., President and CEO of Deka. "Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first DiakineTM, establishing a solid foundation for the expanded use of this treatment in cancer patients."

"This novel agent holds significant potential for patients and we are excited to be at the forefront of this groundbreaking platform that places great emphasis on patient comfort and convenience via a self-administered treatment," shared Dr. Spira, CEO and Clinical Director at NEXT Oncology in Virginia.

DK210 (EGFR) is the first of several experimental therapeutics developed as part of Deka’s platform of molecules, which combines the cytokines full strength IL-2 and a high affinity IL-10. While IL-2 is known to be toxic, when coupled with IL-10, toxicity is not only reduced but its potency is increased, thereby creating a more tolerable and effective treatment for patients. It is the first of several experimental therapeutics in Deka’s platform of molecules which are being developed to treat both cancer and inflammatory diseases. These therapeutics, known as DiakinesTM, involve coupling two cytokines together onto a single chain variable fragment (scFv) targeting system to enhance their precision in targeting specific tissues. Furthermore, the scFv scaffold used in the DiakineTM platform also improves efficacy, safety and manufacturability of each treatment.

On April 5, 2023 Blueprint Medicines Corporation (Nasdaq: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that, effective April 1, 2023, the Compensation Committee of Blueprint Medicines’ Board of Directors granted non-qualified stock options to purchase an aggregate of 5,933 shares of its common stock and an aggregate of 2,965 restricted stock units (RSUs) to 5 new employees under Blueprint Medicines’ 2020 Inducement Plan (Press release, Blueprint Medicines, APR 5, 2023, View Source [SID1234629843]).

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The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Blueprint Medicines, as an inducement material to such individual’s entering into employment with Blueprint Medicines, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

The options have an exercise price of $44.99 per share, which is equal to the closing price of Blueprint Medicines’ common stock on March 31, 2023. Each option will vest as to 25% of the shares underlying such option on the first anniversary of the grant date and as to an additional 1/48th of the shares underlying the option monthly thereafter, in each case, subject to each such employee’s continued employment on each vesting date. Each RSU will vest as to 25% of the shares underlying the RSU award on the first anniversary of the grant date and as to an additional 25% of the shares underlying the RSU award annually thereafter, subject to each such employee’s continued employment on each vesting date. The options and RSUs are subject to the terms and conditions of Blueprint Medicines’ 2020 Inducement Plan, and the terms and conditions of the stock option and RSU agreement covering the grant.

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.