On June 4, 2025 Oncovita, a biotechnology company developing innovative virus-based immunotherapies for cancer treatment, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead investigational therapy, MVdeltaC, for the treatment of pleural mesothelioma—a rare and aggressive cancer with high unmet medical need and limited therapeutic options (Press release, Oncovita, JUN 4, 2025, View Source [SID1234653714]).

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MVdeltaC is a novel immunotherapy based on a genetically modified attenuated Schwarz strain measles virus, engineered to selectively replicate in tumour cells and stimulate a potent anti-cancer immune response. This approach combines direct tumor cell lysis and immune system activation, with the goal of improving outcomes for patients with advanced solid tumors, including pleural mesothelioma.

"Receiving Orphan Drug Designation from the FDA for MVdeltaC marks a major milestone for Oncovita and validates our approach of harnessing the potential of measles vaccine viruses to treat solid tumors, particularly rare and devastating cancers such as pleural mesothelioma," said Stéphane Altaba, CEO of Oncovita. "This regulatory support strengthens our strategy to advance innovative immunotherapies as we prepare to enter clinical development with MVdeltaC by 2026."

"With this designation, Oncovita is now well-positioned to enter the U.S. market with its modified attenuated measles virus for the treatment of pleural mesothelioma. This recognition highlights the promise of this novel approach against one of the most aggressive cancers in medicine," added Dr. Stéphane Champiat, MD, PhD, Head of Medical Affairs at Oncovita.

The FDA’s Office of Orphan Products Development grants Orphan Drug Designation to support the development of therapies for rare diseases affecting fewer than 200,000 people per year in the United States. This designation provides several benefits for the development of such therapies, including tax credits for eligible clinical trials, waiver of FDA application fees, and up to seven years of market exclusivity following product approval.

On June 4, 2025 Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, reported that it has completed dose escalation in IAM1363-01, its Phase 1/1b clinical trial evaluating IAM1363, a selective and brain-penetrant small molecule inhibitor of wild-type and oncogenic mutant HER2 (Press release, Iambic Therapeutics, JUN 4, 2025, View Source [SID1234653730]).

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With completion of dose escalation, Iambic is advancing two well-tolerated doses into the dose optimization phase of the study. Patients enrolling into dose optimization include those with HER2-altered cancers and brain metastases, any advanced cancer harboring a HER2 TKD (tyrosine kinase domain) mutation, and advanced HER2-amplified non-small cell lung cancer.

"We are very encouraged by the progress of the study and the pace at which we arrived at what we believe are potentially efficacious dose levels," said Neil Josephson, M.D, Iambic’s Chief Medical Officer. "IAM1363 provides us considerable flexibility to evaluate the treatment as a monotherapy and in combination with other targeted therapies as we look to address a broad range of HER2-altered cancers."

The Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 in patients with advanced HER2 cancers. The study, which has multiple sites in the US, will expand to the EU, UK and APAC.

"Patients entering this study, particularly those with brain metastases, have few available treatment options," said Andrae Vandross, M.D., who leads the Phase 1 clinical trial group at NEXT Oncology in Austin, TX, a IAM1363 study site. "Our focus is on identifying important potential advances for these individuals and to look at novel approaches that may provide a therapeutic benefit."

In preclinical studies, IAM1363 has demonstrated over 1000-fold selectivity for HER2 compared to EGFR, a promising pharmacokinetic and safety profile, preferential tumor enrichment, and penetrance of the central nervous system. In HER2 tumor models, including intracranial tumor models, IAM1363 has demonstrated favorable efficacy and tolerability compared to benchmark tyrosine kinase inhibitors and HER2-targeted antibodies, and antibody-drug conjugates.

Iambic intends to present data from the study at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) in October 2025.

About Iambic’s AI-Driven Discovery Platform

The Iambic AI-driven platform was created to address the most challenging design problems in drug discovery, leveraging technology innovations such as Enchant (multimodal transformer model that predicts clinical and preclinical endpoints) and NeuralPLexer (best-in-class predictor of protein and protein-ligand structures). The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform enables identification of novel chemical modalities for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and multiparameter optimization for highly differentiated development candidates. Through close integration of AI-generated molecular designs with automated chemical synthesis and experimental execution, Iambic completes design-make-test cycles on a weekly cadence.

On June 4, 2025 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients living with inflammatory and immunological diseases, reported that members of the RAPT management team will participate in the following investor conferences in June (Press release, RAPT Therapeutics, JUN 4, 2025, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-participate-upcoming-investor-conferences-1 [SID1234653715]):

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Goldman Sachs 46th Annual Global Healthcare Conference – Fireside chat on Tuesday, June 10, 2025 at 9:20 a.m. ET
UBS Spring Biotech Conference – Investor one-on-one meetings on Tuesday, June 24, 2025
To access the live webcast or subsequent archived recording of the Goldman Sachs fireside chat, please visit the RAPT Therapeutics website at https://investors.rapt.com/events-and-presentations.

On June 4, 2025 TriSalus Life Sciences, Inc. ("TriSalus" or the "Company") (Nasdaq: TLSI), which seeks to transform outcomes for patients with solid tumors by integrating our innovative delivery technology with standard-of-care therapies and our investigational immunotherapy, reported the launch of the TriNav FLX Infusion System, the latest addition to the TriNav Portfolio (Press release, TriSalus Life Sciences, JUN 4, 2025, View Source [SID1234653731]). TriNav FLX, with enhanced trackability, significantly expands our existing portfolio of TriNav products, offering Interventional Radiologists enhanced trackability and more options to select the right product for the right patient1.

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The TriNav FLX Infusion System retains the same trusted Pressure-Enabled Drug DeliveryTM (PEDDTM) benefits as existing products but introduces an important advancement in design – The new system features twice the length of more flexible material at the distal end, allowing for easier navigation through more tortuous vessels. This enhancement is particularly beneficial for procedures where precise control and flexibility are required due to challenging peripheral vascular anatomy.

Key features of the TriNav FLX Infusion System include:

Enhanced Trackability: The more flexible distal end provides improved navigation through challenging pathways.
Reduction in Force: In benchtop models, the TriNav FLX demonstrated a 28% reduction in force during navigation compared to the standard TriNav design.1
"We’re excited to further expand our TriNav portfolio with the introduction of the TriNav FLX Infusion System," said Mary Szela, CEO of TriSalus Life Sciences. "With TriNav FLX, we now offer a comprehensive suite of advanced technologies designed to support Interventional Radiologists in navigating a wide range of peripheral vessel sizes and complexities. Our continued investment in portfolio innovation underscores our commitment to making Pressure-Enabled Drug Delivery accessible to more patients. Importantly, TriNav FLX is also eligible for reimbursement under HCPCS Code C8004 for simulation—or mapping—as well as C9797 for treatment procedures. This dual coverage allows clinicians to use TriNav FLX for both planning and delivery in radioembolization, supporting greater precision and continuity of care."

For more information about the TriNav Infusion System portfolio, including indications, contraindications, and instructions for use, visit View Source

On June 4, 2025 TOLREMO therapeutics AG (TOLREMO)), a clinical stage biotechnology company pioneering non-oncogene addiction in cancer, reported data from its ongoing Phase I study of TT125-802, a novel, orally administered bromodomain inhibitor of CBP/p300, for patients with advanced solid tumors who have relapsed or are refractory to standard-of-care therapies, including an abstract published at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, TOLREMO, JUN 4, 2025, View Source [SID1234653717]). Updated data from the study was discussed at TOLREMO’s SAB meeting during ASCO (Free ASCO Whitepaper) and recorded in a virtual ASCO (Free ASCO Whitepaper) data update.

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To date TT125-802 shows impressive anti-tumor activity in advanced solid tumors, including deep and durable responses in non-small cell lung cancer (NSCLC). In addition, TT125-802 demonstrates a best-in-class safety profile without thrombocytopenia, the primary toxicity associated with its class of inhibitors.

"Five out of seven NSCLC patients on this study experienced tumor shrinkage following progression on their prior therapy. The two patients with KRAS-G12C- or EGFR-mutant NSCLC – the two tumor types we had preclinically selected as target indications – each showed deep and durable responses to single agent TT125-802. There remains a large and urgent need for more effective and tolerable therapies, and TT125-802 has the potential to offer an improved therapeutic option through resistance-targeted combinations," said Florian Vogl, M.D., PhD, Chief Medical Officer at TOLREMO.

"EGFR- and KRAS-targeted therapies have historically been limited by intrinsic and acquired resistance. Inhibiting transcriptional mechanisms of resistance via CBP/p300 represents an exciting and much needed opportunity for more effective and tolerable therapies. TT125-802 has shown impressive activity in NSCLC even as a monotherapy, and I look forward to combining the drug with EGFR and KRAS-G12C inhibitors to provide better treatment options to my patients," added Pasi Jänne, M.D., PhD, Scientific Advisory Board member at TOLREMO and Senior Vice President for Translational Medicine and the Director of the Belfer Center for Applied Cancer Science at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School.

"The best-in-class safety and activity in solid tumors is particularly notable because we didn’t set out to develop a CBP/p300 inhibitor – initially, TT125-802 was developed phenotypically to inhibit non-oncogene addiction in cancer," said Stefanie Flückiger-Mangual, PhD, CEO and co-founder of TOLREMO. "By starting with the biology around transcriptional addiction, it led us to CBP/p300 as a novel target in this space and yielded best-in-class chemistry, enabling a wider therapeutic window and broadening the clinical potential of our asset both in hematological malignancies as well as in solid tumors."

Dr. Jänne and Dr. Omar Saveedra Santa Gadea, a medical oncologist at NEXT Oncology Hospital Quirónsalud in Barcelona, Spain also shared their perspective on the importance of these results, including specific review of clinical case studies as part of an ASCO (Free ASCO Whitepaper) video update at View Source