Strike Pharma and FyoniBio conclude successful cell line development of Strike’s bi-specific antibody and clinical lead candidate
Uppsala, Sweden and Berlin, Germany – Strike Pharma, whose proprietary Adaptable Drug Affinity Conjugate (ADAC) technology enables development of individualized immunotherapeutic treatments and FyoniBio, the selected CDO expert, specialized in tailored cell line and process development, are pleased to announce a successful conclusion to the cell line development phase of Strike Pharma`s innovative therapeutic recombinant bi-specific mAb candidate with results exceeding expectations.
FyoniBio has employed its versatile CHOnamite® cell line development platform for high-yield expression. A multi-parameter transfection approach ensured selection of a final production clone with an excellent titer of 5.8 g/L and the desired product quality of the complex bi-specific antibody. The clone shows highly stable expression, sufficient for future work at commercial scale and excellent upstream process performance. Overall, the selected clone is characterized by excellent manufacturability parameters, keeping production costs down.
“Strike Pharma is delighted to see the collaboration with FyoniBio leading to such great results. Our focus is to combine a bi-specific antibody, targeting CD40, with a plethora of antigenic cargoes to facilitate personalized immunotherapy approaches. Strike Pharma is currently focusing its cargo development on the well-recognized K-Ras antigenic peptides. This development is highly dependent upon a reliable cell line which has now been achieved. This fundamental milestone for completion of our pre-clinical package takes us closer to first-in-human trials.” commented Mårten Winge, CEO of Strike Pharma.
“We are pleased to be able to contribute to bringing this promising molecule quickly into human trials. The success of this project underscores that our CHOnamite® cell line development platform, including the integrated analytical platform, is ideally suited to generate highly productive cell lines for complex molecules such as Strike Pharma’s bi-specific mAb. Underlying this success is the very cooperative and enthusiastic project team formed from both parties, who enjoy working together,” said Dr. Lars Stöckl, Managing Director at FyoniBio.
About Strike Pharma (www.strikepharma.com)
Headquartered in Uppsala, Sweden, Strike Pharma is using the company’s proprietary Adaptable Drug Affinity Conjugate (ADAC™) technology to take precision medicine to a new level, enabling development of truly individualized immunotherapeutic treatments based on the genetic profile of each patient’s tumor. Such highly targeted treatment offers the potential to not only increase therapeutic efficacy, but also to reduce dosage levels thereby minimizing the risk of side effects.
Today, Strike Pharma’s key development program is focused on selection of novel, clinically-relevant candidates for use in cancer immunotherapy, generating pre-clinical in vitro and in vivo data for a selected lead asset intended for treatment of patients with shared antigens. ADAC technology is used to combine a bi-specific antibody, targeting CD40, with well-recognized K-Ras antigenic peptides.
The company is confident that the ADAC technology platform has the potential to facilitate development of many other antibody-based therapeutics and that this novel approach will have a significant impact across a wide variety of disease indications within the rapidly developing field of personalized medicine.
Strike Pharma was founded in 2020 with the aim of commercializing ADAC technology. Investors include Eir Ventures, Flerie Invest, Uppsala University Invest, Almi Invest, SLU Invest and Monesi Förvaltnings.
Mårten Winge CEO
+46 (0) 70 657 59 27
About FyoniBio (www.fyonibio.com)
FyoniBio’s ISO-9001 certified service portfolio covers the development chain from cell line development, process development and in-depth analytical characterization, including bioassays and clinical sample monitoring under GCLP. FyoniBio’s expertise builds on the long-standing experience of our scientists who have developed various cell lines and processes which entered late-stage clinical trials. Our customized approaches enable rapid, high-titer cell line development in various mammalian host cell lines specialized in meeting individual product requirements. Besides our CHOnamite® platform, that includes our CHOFlow cell line for ADCC enhanced antibodies, we provide the human GEX® platform, which is particularly suited for recombinant proteins with complex glycan structures. Furthermore FyoniBio is highly skilled in mass spectrometry based in-depth analytical characterization of biopharmaceuticals and offers the whole package of clinical sample analysis from assay establishment, validation and measurement of clinical samples under GCLP.
All services are established according to our internal quality management system to assure compliance with international ISO standard and meeting international GMP standards.
Dr. Ulrike Scheffler; Senior Director Business Development
Phone: +49 (0) 17619489825