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.

On July 16, 2024 CatalYm reported the completion of a $150 million Series D financing (Press release, Catalym, JUL 16, 2024, View Source [SID1234644888]). The oversubscribed round was led by new investors, Canaan Partners and Bioqube Ventures, and joined by Forbion’s Growth Opportunities Fund ("Forbion Growth"), Omega Funds and Gilde Healthcare. Existing investors Jeito Capital, Brandon Capital Partners, Novartis Venture Fund and Vesalius Biocapital III also participated in the round. The proceeds will fund the expansion of the company’s broad Phase 2b development of visugromab into randomized Phase 2b studies in select checkpoint naïve frontline and second-line treatment settings. Visugromab has already demonstrated outstanding anti-tumor activity in combination with checkpoint inhibitor treatment.

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Visugromab is a humanized monoclonal antibody engineered to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15), which acts as a key regulator of immune resistance to cancer therapies. CatalYm recently reported impressive follow-up results from its ongoing "GDFATHER" Phase 1/2a trial (GDF-15 Antibody-mediaTed Human Effector Cell Relocation Phase 1/2a) (NCT04725474) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024 in Chicago. The data showed that treatment with visugromab combined with the anti-PD-1 antibody, nivolumab achieves deep and durable anti-tumoral activity, including several complete responses in anti-PD-1/PD-L1 relapsed/refractory patients with non-small cell lung cancer (NSCLC), urothelial cancer (UC) or hepatocellular carcinoma (HCC).

"This substantial raise and strong syndicate recognize our achievements as a company and emphasize the excellent results of visugromab and our broad Phase 2b clinical program. We continue to demonstrate visugromab’s potential to induce cancer remission depth and durability across multiple solid tumor indications emphasizing the substantial role visugromab could play in a novel anti-cancer therapy regimen," said Phil L’Huillier, Managing Director and Chief Executive Officer at CatalYm. "We are building significant momentum for CatalYm’s development strategy and look forward to the support of these high-profile new and existing international investors, who share our vision of breaking immunosuppressive barriers to improve therapeutic outcomes."

In conjunction with the close of the financing, Colleen Cuffaro, Partner at Canaan, Jon Edwards, Managing Partner at Bioqube Ventures and Otello Stampacchia, Managing Director and Founder at Omega Funds, will join the CatalYm Board of Directors. Stefan Luzi, Partner at Gilde Healthcare will join as Board Observer.

"The recent data presented at ASCO (Free ASCO Whitepaper) highlight visugromab’s highly differentiated therapeutic profile and validate the ability of Phil and his team to expeditiously execute on the company’s clinical plan," commented Colleen Cuffaro, Partner at Canaan Partners. "As the company advances into expanded Phase 2b development, we are excited to provide our strategic guidance on the company’s trajectory toward changing the current treatment regimens for hard-to-treat solid tumor indications."

Jon Edwards, Managing Partner at Bioqube Ventures added: "We were initially drawn to the exciting biology around GDF-15 and found CatalYm to be at the forefront of the field. We believe this approach has the potential to significantly increase durability and deepen responses, unlocking the full potential of I/O treatments. We are excited to support this fantastic team, and syndicate, in running robust clinical studies in a variety of promising indications."

Founded in 2016 with support from Forbion Ventures Fund III and BGV, CatalYm is a leader in the development of a new class of cancer treatments aiming to prevent or reverse cancer resistance to checkpoint inhibition, chemotherapy and other targeted treatments. The approach neutralizes GDF-15, a critical immunosuppressant used by tumor cells to survive. With its broad Phase 2b development plan, the company targets high-need solid tumor indications including NSCLC, UC, HCC and bladder cancer where existing and acquired resistance are a major problem. CatalYm is now in preparations to launch further randomized, controlled studies in several major cancer indications in combination with checkpoint inhibitors and standard-of-care in first- and second-line treatment in the first half of 2025.