On July 16, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported that its self-developed novel B7-H3-targeting ADC (R&D code: 7MW3711) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of small cell lung cancer (Press release, Mabwell Biotech, JUL 16, 2024, View Source [SID1234644897]).

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The FDA grants Orphan Drug Designation to treatments for rare diseases in the United States that affect fewer than 200,000 patients. Orphan Drug Designation offers policy benefits to drug developers, including as aid with medication development, tax credits for a part of clinical trial expenditures, and seven years of market exclusivity upon approval.

7MW3711 is a novel B7-H3-targeting ADC developed by Mabwell’s IDDC platform. It is composed of innovative antibody molecule, novel linker, and novel payload Mtoxin (TOP1i). When 7MW3711 enters human body, it specifically binds to antigens on the tumor cell membrane surface, be internalized and trafficked to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells.

7MW3711 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs in the same class at home and abroad, 7MW3711 has shown better tumor killing effects in multiple animal tumor models. In the safety evaluation model of animals including cynomolgus monkeys, the on-target and off-target toxicities of 7MW3711 are effectively controlled, showing its good safety profile and pharmacokinetic properties. The above research results indicate that 7MW3711 has clinical differentiation characteristics and a promising future of clinical development.

About the next generation ADC platform – IDDC

IDDC is a next generation ADC site-specific conjugation technology platform independently developed by Mabwell, consisting of multiple systematic core patented technologies including the site-specific conjugation process DARfinity, the site-specific linker IDconnect, the novel payload Mtoxin, and the conditional release structure LysOnly. The next generation ADCs developed based on the above systematic patented technologies have better structural uniformity, quality stability, efficacy, and tolerability. The novel payload Mtoxin (MF6) demonstrates good pharmacodynamics, bystander killing efficacy, and anti-multidrug resistance.

The IDDC platform has been validated in multiple drug candidates under development. Mabwell currently has several ADCs in clinical development stages. Among them, the novel Nectin-4-targeting ADC, 9MW2821, is in Phase III clinical trial for the indication of urothelial carcinoma. The novel B7-H3-targeting ADC, 7MW3711, and Trop-2-targeting ADC, 9MW2921, are both in clinical trial stages.

On July 16, 2024 Full-Life Technologies ("Full-Life"), a fully integrated global radiotherapeutics company, reported that it has entered into a license agreement with SK Biopharmaceuticals, a global biotech company, for exclusive worldwide clinical research, development, manufacturing, and commercialization rights to Full-Life’s "FL-091" radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) positive cancers (Press release, Full-Life Technologies, JUL 16, 2024, View Source [SID1234644896]).

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This licensing deal worth $571.5 million includes an upfront payment, and development and commercial milestones, separate from royalties. Under the terms of the agreement, SK Biopharmaceuticals will in-license the NTSR1-targeting Radionuclide Drug Conjugate (RDC) program FL-091 – as well as its back-up compounds – aimed at developing and commercializing it as an innovative anti-cancer drug.

FL-091 is a small-molecule radioligand vector designed to deliver targeted radiation therapy to cancer cells by binding specifically to NTSR1, a receptor protein, which is selectively overexpressed in various types of solid tumors, including colorectal cancer, prostate cancer, and pancreatic cancer.

SK Biopharmaceuticals also has a right of first negotiation to license other pre-selected RDC programs of Full-Life.

Lanny Sun, Chief Executive Officer of Full-Life, said, "This agreement with SK Biopharmaceuticals highlights the potential of FL-091 in advancing cancer treatment and demonstrates SK Biopharmaceuticals’ unwavering commitment to building an oncology business around medical innovation. We look forward to future collaborations with SK Biopharmaceuticals, and to leveraging its expertise and resources to advance radiopharmaceutical therapy. The agreement is aligned with our strategic vision of fostering global partnerships and making a meaningful impact on patients worldwide."

Donghoon Lee, Chief Executive Officer and President of SK Biopharmaceuticals, said, "The licensing agreement with Full-Life not only brings the two companies closer together for future collaborations in the fastest rising biotech sector, but also most importantly, pushes SK Biopharmaceuticals forward to become a ‘Big Biotech’. Since the introduction of the company’s strategy roadmap to venture into radiopharmaceuticals last year, we have been on track toward our envisioned goal. We expect to further unveil and implement business plans for RPT (radiopharmaceutical therapy) this year, and actively pursue clinical development and commercialization in the near future to provide treatment options and create new value worldwide."

About FL-091

FL-091 is a novel small-molecule radioligand vector targeting NTSR1 positive solid tumors. Overexpression of NTSR1 has been associated with disease progression of multiple types of cancers, including colorectal, breast, pancreatic, and head and neck cancers. FL-091 radioligands have demonstrated favorable biodistribution profiles and enhanced binding affinity to NTSR1, as well as encouraging anti-tumor activities in preclinical studies. The development of the alpha-emitter therapy candidate 225Ac-FL-091 targeting NTSR1-positive tumors is currently in progress.

On July 16, 2024 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company") a commercial stage medical device and biopharmaceutical company focused on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. ("Beyond Cancer")), reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will participate in one-on-one meetings at the BTIG Virtual Biotechnology Conference being held August 5-6, 2024 (Press release, Beyond Air, JUL 16, 2024, View Source [SID1234644895]).

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If you are interested in meeting with the Beyond Air team during the conference, please contact your BTIG representative.

On July 16, 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 the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, JUL 16, 2024, View Source [SID1234644894]). The FDA previously granted Orphan Drug and Fast Track Designations to SLS009 for the treatment of AML.

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"Receiving our second Rare Pediatric Disease Designation, following pediatric acute lymphoblastic leukemia last month, is another acknowledgment of SLS009’s novel transformational treatment potential to improve the lives of patients, including children with AML," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "This designation reinforces our dedication to addressing the urgent needs of children with AML, including those with treatment-resistant mutations, highlighting the promise of SLS009 to offer the specialized care and support they require, especially considering the limited treatment options for rare pediatric diseases. We look forward to continued SLS009 development and enrolling pediatric AML patients in our Phase 2 clinical trial."

AML prognosis with currently available treatments in the refractory and/or relapsed pediatric patient population remains poor. In a representative study, the 5-year overall survival (OS) rate in relapsed pediatric AML was 33% for all patients, and in patients whose remission lasted less than 12 months only 15.7%. In patients who did not achieve complete remission after one course of chemotherapy 5-year overall survival was 0%. About 50% of children with pediatric AML relapse. Generally, the only therapy considered curative in relapsed and refractory patients is a bone marrow transplant and the primary goal of chemotherapy is to achieve remission so that pediatric patients can be transplanted.

Rare Pediatric Disease (RPD) Designation is granted by the FDA for serious or life-threatening diseases that affect fewer than 200,000 people in the United States and in which the serious or life-threatening manifestations primarily affect individuals less than 18 years of age. If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS might be eligible to receive a Priority Review Voucher (PRV) that could be redeemed to receive a priority review for any subsequent marketing application. PRVs may be used by the sponsor or sold to another sponsor for their use and have recently sold for approximately $100 million.

On July 16, 2024 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported it initiated dosing of ORIC-944, a potent and selective allosteric inhibitor of PRC2, in combination with darolutamide as well as in combination with apalutamide, in the first half of 2024 as part of the ongoing Phase 1b trial in patients with metastatic prostate cancer (Press release, ORIC Pharmaceuticals, JUL 16, 2024, View Source [SID1234644891]). Each combination cohort includes a dose escalation and expansion portion, evaluating the combination of ORIC-944 and NUBEQA (darolutamide) or ORIC-944 and ERLEADA (apalutamide).

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The company also announced that it has entered into clinical trial collaboration and supply agreements with Bayer and Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-944 in combination with NUBEQA, Bayer’s androgen receptor (AR) inhibitor, and ERLEADA, Johnson & Johnson’s AR inhibitor.

Under the terms of the collaborations, ORIC will continue to conduct and sponsor the ongoing Phase 1b trial, and Bayer and Johnson & Johnson will provide darolutamide and apalutamide, respectively, for the study. ORIC maintains full global development and commercial rights to ORIC-944.

"We are pleased to enter into these clinical collaborations to investigate the broader potential of ORIC-944 in combination with AR inhibitors, a combination approach that we believe is particularly promising based on our preclinical findings as well as emerging clinical data," said Jacob M. Chacko, M.D., president and chief executive officer. "As reported at the AACR (Free AACR Whitepaper) Annual Meeting earlier this year, the combination of ORIC-944 and AR inhibitors demonstrated synergy in multiple prostate cancer models with a unique mechanism of reprogramming prostate cancer to revert to an AR-dependent state. Together with the emerging clinical profile of ORIC-944, which has already demonstrated superior clinical half-life, robust target engagement and favorable safety as a monotherapy, the combination of ORIC-944 with an AR inhibitor has the potential to become a novel treatment paradigm for patients with prostate cancer."

About ORIC-944
ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile.