On July 12, 2022 -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 initiation of its first clinical trial with a SADA construct (Press release, Y-mAbs Therapeutics, JUL 12, 2022, View Source [SID1234616613]). This Phase 1 multicenter basket trial targets malignant melanoma, sarcoma and small cell lung cancer. The trial will have three parts: Part A with 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 59 patients at 6-10 U.S. sites to be included in the trial.

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The GD2-SADA construct was created using our SADA technology, which was licensed by the Company from Memorial Sloan Kettering Cancer Center ("MSK") and Massachusetts Institute of Technology ("MIT") in April 2020. The SADA technology utilizes a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target. Unbound constructs predictably disassemble into smaller antibody fragments and are excreted through the kidneys within hours after administration. In a second infusion, a radioactive payload binds to the antibody constructs attached to the tumor target in order to radiate the tumor. This provides the possibility of targeting tumors with precision while minimizing radiation of normal tissues. We believe that the SADA technology platform can deliver a variety of payloads and could potentially be developed against multiple tumor targets, as well as for theragnostic purposes.

"The FDA acceptance of the IND for GD2-SADA marks an important milestone towards our mission of developing novel SADA treatments as we continue to execute our clinical development strategy for our pipeline of SADA constructs for the treatment of cancers with unmet medical need," said Thomas Gad, founder, President and Interim CEO. "We are seeing significant partnership interest for the SADA technology and we believe we are well-positioned to leverage the SADA platform as we move forward. We are truly excited about the potential of the SADA technology, which has already shown great promise, and we believe that it can further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents."

Researchers at MSK, including Dr. 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, MSK has institutional financial interests in the technology and in Y-mAbs.

On July 12, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that management will host a virtual research forum in which it will unveil the next product candidate, discuss immunostimulatory ADCs (iADCs) as a novel modality, and highlight recent enhancement to its cell-free manufacturing platform (Press release, Sutro Biopharma, JUL 12, 2022, View Source [SID1234616612]).

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Webcast details:

Wednesday, July 20, 2022 at 4:30 pm ET, or 1:30 pm PT
To access and register for the live webcast, please go to View Source
The webcast information will also be available through the News & Events section of the Investor Relations portion of the Company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.

On July 12, 2022 Locust Walk reported that deal team members compile key statistics and trends on strategic transactions and financings (Press release, Locust Walk Partners, JUL 12, 2022, View Source;utm_medium=rss&utm_campaign=2022-q2-report-global-trends-in-biopharma-transactions [SID1234616610]). Our 2022 Second Quarter Report applies the latest data to analyze current activities in the life sciences deal landscape.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The steady deterioration of the life science public market has had far reaching ripple effects to other parts of the ecosystem, from a deep decline in public and private financings to the rise in high value partnering and M&A transactions. In this quarter’s market conditions report, Locust Walk reviews the factors driving current negative sentiment and provides our advice for navigating the road ahead.

We believe the industry has further to go before conditions reset and a steady recovery can begin. With the public market quiet and the private markets more selective, companies of all sizes are showing increased interest in strategic partnerships as a source of non-dilutive financing. Big Pharma has remained on the M&A sidelines, until recently with the announcement of a flurry of large transactions. Ultimately, this deal activity, combined with reset valuations and positive news flow, may be our path to recovery.

Despite the near-term challenges, Locust Walk remains optimistic about our industry’s long-term fundamentals. While the sector is now experiencing overhang from its status as a previously hot area, Biopharma’s fundamental societal role and advancements in our understanding of disease and how to address them have not changed. We invite you to read our report and would welcome the opportunity to discuss its contents with you.

On July 12, 2022 Fresenius reported that Romidepsin Injection, a drug used to treat cutaneous T-cell lymphoma (CTCL) in adults, is now available from Fresenius Kabi in the United States (Press release, Fresenius, JUL 12, 2022, View Source [SID1234616609]). This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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On July 12, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported it has reached a key milestone on the path to commercialization of Rhenium-186 NanoLiposome (186RNL) as the Company completed the technology transfer and initiation of cGMP manufacturing of the 186RNL drug intermediate with Piramal Pharma Solutions (PPS) (Press release, Cytori Therapeutics, JUL 12, 2022, View Source [SID1234616607]). Additionally, the intermediate drug product is in stability testing and compliant with U.S. Food and Drug Administration (FDA) guidance for manufacture of liposomal products for use in late-stage clinical trials and commercialization.

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In early 2021, Plus Therapeutics entered into a master services agreement with PPS for the development, manufacture and supply of the Company’s 186RNL drug intermediate product and has now completed the associated technology transfer of analytical test methods and development activities with PPS.

"The Company has met another significant CMC milestone by having fully compliant 186RNL intermediate, and is on time and on budget to have GMP drug availability in the second half of 2022 for ongoing and planned clinical trials in adults with recurrent glioblastoma, leptomeningeal metastases and future disease targets," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Furthermore, in the third quarter of 2022, we plan to issue specific guidance on feedback obtained from two FDA meetings, one based on potential acceptability of Plus Therapeutics’ CMC package and one for feedback on our future plans for clinical development of 186RNL for recurrent glioblastoma."