Astellas subsidiary Xyphos Biosciences has entered a research partnership and licence agreement with Kelonia Therapeutics aimed at developing new immuno-oncology therapeutics in an $875m deal. The alliance will merge Xyphos’ ACCEL technology with Kelonia’s in vivo gene placement system to develop universal, off-the-shelf in vivo chimeric antigen receptor (CAR) T-cell therapies for up to two programmes. Kelonia focuses on genetic medicine innovation and utilises its in vivo gene placement system to precisely deliver genetic material to the target cells within the patient’s body. This system employs lentiviral particles for efficient delivery. Xyphos’ ACCEL technology platform features the convertible CAR used on immune cells. Xyphos will oversee the development and marketing of the products resulting from the joint research. Kelonia is entitled to an upfront payment of $40m for the first programme. If Xyphos opts for the second programme, an additional $35m will be paid to Kelonia. The deal also includes ...
Recently, the FUTURE series of studies has brought good news again. The results of the FUTURE-SUPER clinical trial led by the team of Prof. Zhimin Shao and Prof. Zhonghua Wang from the Affiliated Cancer Hospital of Fudan University have been announced, which fully confirmed the effectiveness and safety of the first-line precision treatment based on the “Fudan typing”, and is about to change the clinical practice of the treatment of TNBC. The results of the study will be announced in 2023. The results of the study were first announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, which attracted the attention of scholars around the world, and on January 9, 2024, the study was published in The Lancet Oncology, the top international oncology journal, with an impact factor as high as 51.1 under a fast-track system. The clinical study is also another landmark achievement of the ...
Pharmaceutical Executive Editorial Staff SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with breast and ovarian cancers. The NDA was given a Prescription Drug User Fee Act action date of June 29, 2024. “This innovative drug will offer hospital pharmacists and patients access to a differentiated, ready to administer, injectable product with unique characteristics that’s expected to facilitate rapid adoption once approved,” said Orlaith Ryan, Shorla Oncology chief technical officer and cofounder, in a press release. The novel therapy is a formulation of a well-established freeze-dried powder medication that has been in use dating back to the 1950s. The ready-to-dilute liquid formulation eliminates the need for powder reconstitution, which Shorla stated will bolster the product’s efficiency and lower the ...
Though GSK divested much of its oncology assets to Novartis in 2015, the company has built it back through a internal R&D and business development deals. GSK Senior Vice President, Global Head of Oncology, R&D Hesham Abdullah explained the company’s evolving cancer strategy in an interview during the J.P. Morgan Healthcare Conference in San Francisco. By FRANK VINLUAN GSK committed $270 million up front in recent months to gain access to early-stage assets in the class of cancer therapies known as antibody drug conjugates, or ADCs. The deals are part of a broad industry to acquire assets in this therapeutic modality, GSK’s top cancer executive Hesham Abdullah acknowledges. But for GSK, the deals are just one part of an evolving oncology strategy. The strategy has been years in the making. In 2015, GSK divested its oncology business, which Novartis acquired for $16 billion. Abdullah, who is GSK’s senior vice president, ...
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”. ...
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