Recently, a phase II, non-randomized study of brain radiotherapy combined with pyrrolitinib and capecitabine for the treatment of brain metastasis in HER2-positive breast cancer (BROPTIMA study) was published online in JAMA Oncology, an authoritative international oncology journal (IF: 28.4). Prof. Guo Xiaomao and Prof. Yu Xiaoli of the Affiliated Cancer Hospital of Fudan University are the co-corresponding authors of this article, and Prof. Yang Zhaozhi and Prof. Meng Jin are the co-authors. The results of this study showed that the one-year central nervous system-progression-free survival (CNS-PFS) rate for combination therapy reached 74.9%, with a median CNS-PFS of up to 18 months and a central nervous system-objective remission rate (CNS-ORR) of 85%. In terms of safety, with a median follow-up of 17.3 months, the neurological status of most patients remained stable. This is the first prospective clinical study exploring pyrrolitinib in combination with brain radiotherapy for the treatment of patients with ...
CG Oncology’s main asset is cretostimogene, an oncolytic virus in late-stage development as a treatment for advanced bladder cancer. The IPO filing follow the report of interim efficacy data showing a 75% complete response rate. By FRANK VINLUAN When bladder cancer does not respond to the current standard of care therapy, the next treatment option is surgery to completely remove the bladder. CG Oncology aims to give patients another choice. The biotech has reached late-stage development with an oncolytic virus and it’s now looking to the public markets to finance clinical testing. Irvine, California-based CG has not yet set financial terms for the planned offering, outlined in paperwork filed with the Securities and Exchange Commission this past week. IPO research firm Renaissance Capital estimates the stock offering could raise up to $100 million. CG has applied for a Nasdaq listing under the stock symbol “CGON.” CG is developing treatments for ...
BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditional “hard-to-drug” targets, announced a strategic collaboration and licensing agreement with Galapagos NV. Under the collaboration, BridGene will use its chemoproteomics platform, IMTAC, to discover novel small molecule drug candidates against the collaboration targets. The parties will collaborate to advance the molecules to clinical candidates, which Galapagos has the exclusive rights to develop and commercialize. The preclinical research collaboration will focus on oncology targets named by Galapagos. Galapagos will pay BridGene up to $27 million in upfront and preclinical research milestone payments and more than $700 million in clinical and commercial milestones, assuming success of the programs. BridGene is also eligible to receive tiered royalties on net sales of each product resulting from the collaboration. “BridGene’s proven expertise in discovering small molecule drugs for challenging targets positions them as an ideal partner in pioneering new avenues in ...
The companies will aim to select targets, discover and develop new therapeutics Owkin and Evotec have entered into an artificial intelligence (AI)-powered strategic partnership in oncology, immunology and inflammation (I&I). Both companies will collaborate to accurately select targets, discover and develop new therapeutics. As part of the agreement, the French-American techbio company, Owkin, will identify indication-relevant targets and subgroups using AI applied to multimodel patient data with its cutting-edge target discovery engine. Evotec will utilise its shared research and development (R&D) platform to accelerate and de-risk the validation of targets, the identification of drug candidates and the successful completion of pre-clinical development activities up to an investigational new drug application (IND). In addition, an Owkin-Evotec joint research strategy team will steer the collaboration to design fully tailored strategic programme plans from target selection to IND, as well as ensuring the delivery of the programmes. Evotec will receive R&D funding from ...
Pharmaceutical Executive Editorial Staff Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations to CG Oncology Inc’s cretostimogene grenadenorepvec (CG0070) for the treatment of patients with high-risk Bacillus Calmette-Guérin (BCG)–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without Ta or T1 tumors.1 The novel, intravesically delivered oncolytic immunotherapy is currently being evaluated in the Phase III BOND-003 and the Phase II CORE-001 clinical trial in combination with pembrolizumab (Keytruda) in the same indication. An investigator-sponsored clinical trial is evaluating cretostimogene grenadenorepvec in combination with nivolumab (Opdivo) for the treatment of muscle invasive bladder cancer. The regulatory action was based on data from an ongoing clinical trial program, including the Phase III BOND-003 trial (NCT04452591), which ...
AstraZeneca (AZ) and Absci have entered into a collaboration agreement worth up to $247m to develop an artificial intelligence (AI)-designed antibody drug for a specified oncology target. The partnership will combine AZ’s capabilities in oncology research and development with Absci’s Integrated Drug Creation platform, which the generative AI company says “unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimising multiple drug characteristics important to both development and therapeutic benefit”. The agreement includes an upfront commitment from AZ as well as research and development funding, milestone payments and royalties on product sales. Puja Sapra, senior vice president of biologics engineering and oncology targeted delivery at AZ, said: “This collaboration is an exciting opportunity to utilise Absci’s de novo AI antibody creation platform to design a potential new antibody therapy in oncology.” Absci outlines that its approach “overcomes the limits of traditional drug discovery”. ...
In a bid to expand its oncology pipeline AbbVie has announced it will acquire ImmunoGen under a definitive agreement. The proposed $10.1bn acquisition will see AbbVie purchase ImmunoGen’s outstanding shares at $31.26 per share. The acquisition is expected to be completed in mid-2024. On an investor call following the announcement this morning (30 November), AbbVie’s executive vice president and chief financial officer Scott Reents, said the funding of the transaction will be driven by a combination of cash and debt. The exact split of cash and debt has not been indicated, but Reents anticipates that AbbVie will spend at least $2bn in cash in the acquisition. Through the transaction, AbbVie will gain an asset in Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s lead antibody-drug candidate (ADC), which received an accelerated approval to treat folate receptor alpha (FRα)-positive, platinum resistant ovarian, fallopian tube, or primary peritoneal cancer, in November 2022. As per AbbVie’s executive ...
Pictured: Cancer cell surrounded by cytokines/iStock, Marcin Klapczynski Alkermes on Wednesday announced that it has completed the spinoff of its oncology business to become a pure-play neuroscience company. Mural Oncology will begin trading on the Nasdaq starting Thursday, with Alkermes shareholders receiving a share of Mural for every 10 shares of Alkermes. Mural is launching with $275 million, which is expected to fund it through the fourth quarter of 2025, and an interleukin-2 cytokine as its most advanced asset. Nemvaleukin alfa is being studied as a monotherapy for advanced mucosal or cutaneous melanoma in Phase II and is in a Phase III study in combination with Keytruda for platinum-resistant epithelial ovarian cancer. The therapeutic is designed to avoid the hallmark toxicities of IL-2 immunotherapies. The studies are potentially registrational with readouts expected in early 2025. Additional assets include therapies targeting IL-18 and IL-12. Mural will nominate a development candidate for each program in ...
Merck KGaA has signed a licensing agreement worth over €1.4bn with Jiangsu Hengrui Pharmaceuticals for the rights to its next-generation PARP1 inhibitor HRS-1167 outside of China. The deal also includes an option for an exclusive licence for its Claudin-18.2 antibody drug conjugate (ADC), SHR-A1904. Compared to first-generation PARP inhibitors, HRS-1167 has higher selectivity and affinity for PARP1 and induces DNA trapping, Merck said, adding that the candidate is currently in phase 1 clinical development and “has the potential to be used as a monotherapy and as part of a combination therapy for treating a wider range of patients”. Danny Bar-Zohar, global head of research and development and chief medical officer for the Healthcare business of Merck KGaA, said: “This partnership with Hengrui fully aligns with both our external innovation ambition and our oncology research and development strategy by diversifying our robust internal pipeline in our focus areas of DNA damage ...
Dive Brief Siemens Healthineers has acquired Aspekt Solutions to strengthen the service offering at its Varian cancer therapy unit. Neither party disclosed the value of the deal. Aspekt supports radiation oncology sites — the type of health centers that use Varian devices — with services such as dosimetry consulting, clinic management, technology evaluation and staffing. Varian sees the acquisition as complementary to its Advanced Oncology Solutions unit, which provides professional and clinical services to improve the implementation of its technologies. Dive Insight Varian, a provider of radiation oncology equipment and software, pitches its AOS unit as enabling sites to adopt technologies, improve quality and expand capacity. The unit collaborates with radiation oncology sites to simplify data entry, optimize databases, reduce variation between dosimetrists and train staff on safety. In doing so, Varian aims to address challenges such as the rising cost of care and staff shortages. “Through our AOS offerings, ...
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