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Vicebio, next-generation vaccine biotech, to be acquired by Sanofi for US$1.6 billion

On July 21, 2025 Vicebio Ltd ("Vicebio" or the "Company"), a biopharmaceutical company developing novel vaccines against life-threatening respiratory viral infections, reported to have entered an exclusive, definitive agreement to be acquired by Sanofi (Press release, Sanofi, JUL 21, 2025, View Source [SID1234654462]). Under the terms of the agreement, subject to customary conditions, Vicebio shareholders will receive up to a total of US$1.6 billion, including an upfront payment of US$1.15 billion as well as development and regulatory milestones payments of US$450 million.

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Vicebio was created by Medicxi to develop next-generation vaccines for respiratory viruses utilising its proprietary Molecular Clamp technology, discovered at The University of Queensland. This technology uniquely stabilises viral glycoproteins to elicit strong protective immune responses and enables high-yield production for ready-to-use liquid multivalent formulations. The Molecular Clamp technology is applicable to a wide range of viruses including Respiratory Syncytial Virus (RSV), Human Metapneumovirus (hMPV), Parainfluenza viruses, Influenza and Coronaviruses. In September 2024 Vicebio announced a Series B financing, led by TCGX with investment from Life Sciences at Goldman Sachs Alternatives, Avoro Ventures, venBio Partners, and with participation from UniQuest and founding investor Medicxi, which enabled Vicebio to accelerate clinical development of VXB-241 and next generation products.

Vicebio is currently running an exploratory Phase 1 clinical trial with lead asset VXB-241, a bivalent vaccine targeting both RSV and hMPV viruses, pathogens that are a significant burden in the elderly and those with a weakened immune system. Interim analysis of the exploratory Phase 1 study showed a favourable safety and tolerability profile in adults aged 60 and above.

Dr. Giovanni Mariggi, Chairman of Vicebio and Partner at Medicxi, said: "Our aim in creating Vicebio was to back a clear product vision to develop a best-in-class vaccine against respiratory viruses. We are extremely proud of what we have accomplished in the last few years thanks to a team effort by the Company, University of Queensland, our investors and the Board. We are excited to partner with Sanofi which will further accelerate VXB-241’s development to ensure it ultimately benefits those in need."

Cariad Chester, Managing Partner at TCGX said: "Vicebio has successfully developed best-in-class multivalent vaccines targeting leading causes of respiratory disease. These vaccines have the potential to protect millions of patients from life-threatening viral infections and we are thrilled to partner with Sanofi to accelerate their development. We look forward to working with Sanofi and combining our innovative technology with Sanofi’s global clinical development capability."

Dr. Emmanuel Hanon, Chief Executive Officer of Vicebio, added: "Vicebio and its incredibly passionate team have been driven by the ambition to develop next-generation vaccines aimed at targeting multiple life-threatening respiratory viruses simultaneously. This acquisition validates our ability to combine innovation and deep scientific expertise towards a common goal of advancing public health prevention, and we’re excited to enter the next chapter to accelerate the global impact of our work."

IDEAYA Biosciences to Participate in Upcoming July 2025 Investor Relations Event

On July 21, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the upcoming investor relations event (Press release, Ideaya Biosciences, JUL 21, 2025, View Source [SID1234654461]).

2025 BTIG Virtual Biotechnology Conference
Tuesday, July 29th, 2025 at 4:40 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Justin Zelin, Director, Biotechnology Research Analyst
A live audio webcast of the conference event, as permitted by the conference host, will be available at the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of available webcasts will be accessible for 30 days following the live event.

DualityBio’s Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation

On July 21, 2025 DualityBio (HKEX Stock Code: 9606.HK) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310 (Press release, DualityBio, JUL 21, 2025, View Source [SID1234654460]). This designation is for the treatment of adult patients with advanced, unresectable or metastatic nonsquamous non-small cell lung cancer (nsqNSCLC) with an EGFR exon 19 deletion or L858R mutation with disease progression on or after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles (UCLA) presented the first-in-human Phase I/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "DB-1310 demonstrated encouraging clinical efficacy and manageable safety in patients with EGFRm nsqNSCLC and multiple solid tumors. It is noteworthy that preclinical investigations of DB-1310 in combination with EGFR TKIs and other anticancer agents have also demonstrated robust synergistic tumor suppression activity. We will spare no effort to accelerate the clinical development of DB-1310 and look forward to its potential, as a next-generation HER3 ADC, to become a novel therapeutic option for a broad population of cancer patients."

ImCheck’s Announces EMA Orphan Drug Designation for ICT01 as Treatment for Acute Myeloid Leukemia

On July 21, 2025 ImCheck Therapeutics reported that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its lead program, ICT01, a humanized anti-butyrophilin 3A (BTN3A) monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia (AML) (Press release, ImCheck Therapeutics, JUL 21, 2025, View Source [SID1234654459]). The designation in the EU follows the recently granted U.S. FDA ODD and provides additional validation of the therapeutic potential of ICT01 in AML, a disease with high unmet medical need and limited treatment options for older or unfit patients who are not eligible for intensive chemotherapy.

"Securing orphan drug designation from both the EMA and the FDA in close succession is a major regulatory milestone for ImCheck,"said Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics."It reflects growing international recognition of ICT01’s potential and supports our objective to accelerate clinical development in both the U.S. and Europe. The EMA ODD’s broad market exclusivity for ICT01 once approved provides additional value as we consider our development strategy."

"The EMA’s rapid decision reinforces the highly encouraging clinical data supporting ICT01 and its differentiated mechanism of action," added Stephan Braun, MD, PhD, Chief Medical Officer of ImCheck Therapeutics. "By selectively activating γ9δ2 T cells, a powerful component of the immune system, ICT01 offers a novel therapeutic pathway in AML. This momentum brings us closer to our goal of delivering new therapeutic options to AML patients who currently have limited treatment options."

The EMA’s orphan drug designation is granted to medicines intended for the treatment of life-threatening or chronically debilitating rare conditions affecting fewer than 5 in 10,000 people in the EU. Benefits of the designation include protocol assistance, reduced regulatory fees, and ten years of market exclusivity in Europe following approval.

Autolus Therapeutics’ CAR T Therapy AUCATZYL® (Obecabtagene Autoleucel) Granted European Marketing Authorization for Adult Patients (age 26 and older) with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

On July 21, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported that the European Commission (EC) has granted marketing authorization for AUCATZYL (obecabtagene autoleucel or "obe-cel") for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) (Press release, Autolus, JUL 21, 2025, View Source [SID1234654458]).

The EC approval was based on the results of the FELIX study, an open-label, multi centre, single arm study in adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia. The results were published in the New England Journal of Medicine in November 20241. In the pivotal cohort of patients, (cohort IIA (n=94)), the Complete Response/Complete Response with Incomplete Haematological Recovery (CR/CRi) for patients who received at least one infusion of obecabtagene autoleucel was 76.6%. Median response duration for all infused patients was 21.2 months. Median event-free survival (EFS) was 11.9 months and the estimated 6- and 12-month event-free survival rates were 65.4% and 49.5%, respectively.

The most common non-laboratory Grade 3 or higher adverse reactions were infections-pathogen unspecified (32%), febrile neutropenia (24%) and bacterial infectious disorders (11%). Cytokine release syndrome developed in 87 of the 127 patients (68.5%), with events of grade 3 or higher in three patients (2.4%). Immune effector cell-associated neurotoxicity syndrome developed in 29 of the 127 patients (22.8%), with grade 3 or higher occurring in nine patients (7%).

"We believe AUCATZYL represents an important new treatment option for physicians treating adult r/r B-ALL patients. With the EU marketing authorization, we are now evaluating market entry opportunities in EU countries," said Dr. Christian Itin, Chief Executive Officer of Autolus.

Obe-cel is an autologous CD19 CAR T cell therapy with a proprietary CD19 CAR, invented by a team led by Dr. Martin Pule, at University College London, along with collaborators at Great Ormond Street Hospital and University College London Hospital. The CAR is designed to have a fast "off-rate" which mimics physiological T-cell receptor interactions2.

ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. In Europe, there are approximately 6,0002 new cases of ALL diagnosed every year. In frontline treatment for adult B-ALL, up to 50% of patients will ultimately relapse3. Survival rates remain very poor in adult patients with r/r ALL, with median overall survival of eight months with conventional treatments4, and the standard-of-care treatment can trigger severe toxicities5.

The EC approval applies to all 27 European Union Member States, Iceland, Norway and Liechtenstein. AUCATZYL is currently approved by the U.S. Food and Drug Administration (FDA) and authorized by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).