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.

On July 16, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported improved performance of its key building block, EvaxMHC, within its AI-Immunology platform, at the 32nd Intelligent Systems for Molecular Biology (ISMB) conference taking place in Montreal, Canada, from July 12-16, 2024 (Press release, Evaxion Biotech, JUL 16, 2024, View Source [SID1234644889]).

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A key feature in developing effective AI-designed personalized and precision vaccines is the ability to accurately predict which small fragments, known as peptides, of pathogens or cancer cells are displayed on the surface of cells by Major Histocompatibility Complex (MHC) molecules. This display allows the immune system to recognize and eliminate the threat. Evaxion’s EvaxMHC building block predicts which peptides are more likely to be presented by MHC molecules, thereby aiding vaccine target discovery and facilitating the development of effective vaccines.

Christian Kanstrup, Evaxion’s CEO, comments: "Our results demonstrate significant improvements in the prediction of peptide-MHC interactions, particularly for MHC class II molecules, which have historically been difficult to predict accurately. With this advancement on AI-Immunology we now have a more reliable and effective tool for designing personalized and precision vaccines for cancer and infectious diseases. The improved EvaxMHC building block is used in the ongoing Phase 2 trial with Evaxion’s lead vaccine candidate, the personal cancer vaccine EVX-01."

Key highlights showcased at the presentation:

A state-of-the-art deep-learning framework was utilized, enhancing the accuracy of peptide-MHC predictions

Our approach includes three new strategies: Creating a unified representation for both MHC class I and -II molecules, utilizing a deep transformer encoder-decoder architecture, and adopting a generative adversarial network (GAN) pretraining mechanism

The updated EvaxMHC building block led to improved vaccine designs demonstrated in preclinical studies
About AI-Immunology
AI-Immunology is a scalable and adaptable artificial intelligence technology platform at the forefront of vaccine discovery for infectious diseases and cancers. By integrating the collective power of proprietary AI models PIONEER, EDEN, RAVEN, and ObsERV, the platform can model the complexity of the patient’s immune system. AI-Immunology advanced computational modeling swiftly and uniquely identifies, predicts, and designs vaccine candidates, revolutionizing the landscape of immunotherapy by offering a holistic and personalized approach to combat fast-evolving pathogens and malignant cells.