CAMBRIDGE, England--(BUSINESS WIRE)--F-star, a clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy, today announces the appointment of Louis Kayitalire, MD, as Chief Medical Officer (CMO), which will be effective on 17 June 2019.
F-star believes this newly created management position will be crucial to F-star’s transition to a wholly-owned portfolio strategy as it expands its clinical operation capabilities and accelerates progression of its proprietary pipeline.
Dr Kayitalire will oversee the clinical development of F-star’s lead product candidate, FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody currently in a Phase 1 clinical trial, recruiting the expansion cohorts of the two highest dose levels. He will also lead the clinical strategy and operations for F-star’s pipeline of potential first- and best-in-class immuno-oncology bispecific antibody therapeutics, including FS120 and FS222, two proprietary product candidates currently in cGMP production and on track for investigational new drug application submissions this year.
Louis Kayitalire said: “This is an exciting time for me to join F-star as the company pivots to a wholly-owned portfolio strategy and accelerates the clinical development of its pipeline. As we saw at the recent ASCO meeting, bispecific antibodies are leading a paradigm shift in cancer care and the potential to improve the outcome for cancer patients has never been greater. I believe F-star is ideally positioned to become the next leader in this field.”
Dr Kayitalire will bring over 20 years’ experience in oncology and immuno-oncology, having previously held positions at major pharmaceutical companies including Bristol-Myers Squibb, Celgene and Eli Lilly. Dr Kayitalire has strong commercial acumen to complement his extensive clinical expertise with a proven track record of developing and delivering clinical research programmes and ensuring alignment with overall medical and commercial strategies. Dr Kayitalire completed his medical training at Butare University, Rwanda and later held a position as Assistant Professor in Oncology at the Paris XI University of France. He is an active member of the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR).
Eliot Forster, CEO of F-star, said: “We are delighted to welcome Louis to the F-star team. His oncology expertise and extensive experience advancing clinical research programmes will be invaluable at this stage in F-star’s evolution as we accelerate development of our lead product candidate, FS118, and work to rapidly progress more assets into the clinic.”
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F-star is a leading clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy. By developing medicines that seek to block tumour immune evasion, the Company’s goal is to offer patients greater and more durable benefits than current immuno-oncology treatments. Through its proprietary tetravalent, bispecific antibody (mAb²™) format, F-star is generating first- and best-in-class drug candidates with monoclonal antibody-like manufacturability. Building on the combined expertise of its world-class management team and scientific leadership, F-star is poised to deliver the next breakthrough immunotherapies for cancer patients.
Currently in a Phase 1 clinical trial at four clinical sites in the United States, FS118 is a potentially first-in-class medicine for the treatment of resistant and refractory cancer. This tetravalent, bispecific antibody is developed to overcome tumour evasion mechanisms promoted by two highly immuno-suppressive molecules: LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1). By simultaneously blocking both inhibitory pathways, FS118 has preclinically demonstrated a potent anti-tumour growth activity(1) as well as a highly differentiated mechanism of action(2) when compared to checkpoint monotherapies alone or in combinations.
In April 2018, a Phase 1 clinical trial started in patients who have relapsed following a prior
PD-(L)1-containing therapy. Information about the trial is available on clinicaltrials.gov NCT03440437. FS118 is manufactured at 2000L scale using standard mAb manufacturing processes.
(1) Dual blockade of PD-L1 and LAG-3 with FS118, a unique bispecific antibody, induces CD8+ T cell activation and modulates the tumour microenvironment to promote anti-tumour immune responses. Kraman et al. (April 2018) - Poster at the annual AACR meeting