BioSpace Global Roundup, Sept. 12
BIRAC – India’s biotech economy may see a significant boom over the next few years. According to a recent report from BIRAC, India’s Biotechnology Industry Research Assistance Council, the country’s bio-based economy could grow to $100 billion by 2025, a significant jump from its $50 billion size in 2018. According to Financial Express, BIRAC has supported 516 startups in India and is eying more. According to the report, BIRAC has launched an incubator program called Bio-Nest. So far, more than 40 of these incubators have been established.
Adaptimmune – The FDA granted Orphan Drug Designation to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas. There are approximately 50 types of soft tissue sarcomas. Adaptimmune is currently investigating its ADP-A2M4 SPEAR T-cells in two types of sarcoma: synovial sarcoma and MRCLS. Synovial sarcoma is a cancer of the connective tissue around joints. Synovial sarcoma accounts for approximately 6% to 10% of all soft tissue sarcomas.
Kitov Pharmaceuticals – Israel-based Kitov presented newly released proof-of-concept data showing evidence of NT-219 mechanism of action in reversing cancer drug resistance in PDX models. The data was presented in a poster at the American Association for Cancer Research's Pancreatic Cancer: Advances in Science and Clinical Care conference. NT-219 is a first-in-class small molecule bi-specific inhibitor of two key cancer resistance pathways STAT3 and IRS1/2. The preclinical study initially evaluated the efficacy of NT-219 in combination with the approved chemotherapy agent gemcitabine on four PDX models of mutated KRAS pancreatic cancer. Data demonstrated reversal of gemcitabine-resistant tumors in all PDX models following treatment with NT-219 and gemcitabine. One of these models demonstrated complete response in about half of the animal group upon addition of NT-219 to gemcitabine. The study was then extended to define an optimal dose regimen and future clinical protocol. Kitov plans to submit an Investigational New Drug Application to the U.S Food and Drug Authority for a clinical study on NT-219 in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma.
Gyros Protein Technologies – Based in Sweden, Gyros Protein Technologies AB, a company focused on nanoliter-scale immunoassays and peptide synthesizers and reagents, announced the introduction of Gyrolab p24 Kit, for lentivirus titer determination in lentivirus vector manufacturing. The new Gyrolab p24 Kit adds to the company’s wide range of ready-to-use kits and Gyrolab Bioaffy CDs which are used by scientists and bioengineers in the rapidly growing cell and gene therapy market, where lentivirus vectors are commonly used to transport therapeutic genes.
Noscendo GmbH – Germany-based Noscendo announced the successful completion of the development of its proprietary diagnostic platform DISQVER combined with corresponding CE certification as the first key milestone since the seed financing in October 2018. Noscendo’s platform detects bacteria, fungi, DNA viruses and parasites in the patient’s bloodstream on the basis of next-generation sequencing and uses proprietary algorithms to assess the corresponding pathogen relevance. Following the successful product development and CE certification, pilot testing with eight maximum care hospitals throughout Germany confirmed the benefits of Noscendo’s platform with regards to the identification of primary pathogens across multiple pathogen classes.
ProBioGen AG – Germany-based ProBioGen closed a licensing agreement with Bayer AG for the GlymaxX Technology. Bayer will use GlymaxX to further increase the potency of an undisclosed antibody candidate for oncological indications. ProBioGen’s proven antibody-dependent cellular cytotoxicity (ADCC) enhancing technology GlymaxX will be applied during cell line development. Terms of the licensing agreement were not disclosed.
MeiraGTx – London-based MeiraGTx announced that clinical data updates from the company’s Phase I/II trial of AAV-RPE65 will be presented at two upcoming medical meetings. The Phase I/II open-label, multi-center, dose-finding trial evaluated AAV-RPE65 in patients with retinal dystrophy associated with disease-causing variants in the RPE65 gene, a condition that causes severe sight impairment beginning at birth. AAV-RPE65 is a second-generation gene therapy candidate developed specifically to treat RPE65-deficiency, and optimized for transduction efficiency, potency and stability. MeiraGTx previously reported positive topline data from this trial demonstrating safety and tolerability, as well as statistically significant improvement across several endpoints assessing clinical activity.
Xenon Pharmaceuticals – British Columbia-based Xenon entered into an agreement with Flexion Therapeutics to provide the Massachusetts-based company with the global rights to develop and commercialize XEN402, a NaV1.7 inhibitor, for the management of post-operative pain. Flexion’s new preclinical program, known as FX301, will consist of XEN402 formulated for extended-release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of postoperative pain. Flexion paid Xenon an upfront payment of $3 million. In addition, Xenon will also be eligible for milestone payments of up to $9 million through initiation of a Phase II proof of concept trial. Following successful results, Xenon may be entitled to future clinical development and global regulatory approval milestone payments of up to $40.75 million, commercialization milestone payments of up to $75 million, as well as future sales royalties ranging from mid-single to low-double-digit percentages.
Inventiva – France-based Inventiva announced the positive recommendation of the fourth and last Data Safety Monitoring Board of the NATIVE Phase IIb clinical study evaluating lanifibranor in NASH. No safety issues were reported and, as for the first three DSMB meetings, the DSMB recommended to continue the study without changing the protocol. Following the positive conclusions of the last DSMB and the successful completion of patient recruitment in the study announced earlier this month, Inventiva confirms the publication of the study results in the first part of 2020.
Celyad -- Belgium-based Celyad is developing autologous and allogeneic CAR-Ts that use natural killer cell receptor NKG2D, targeting both hematologic cancers and much more challenging solid tumor targets. Celyad is also advancing cell therapy manufacturing techniques due to experience gained at its 11-year-old in-house manufacturing facility. Last week, Celyad started treating clinical trial patients with the new OptimAb production process which uses a shortened eight-day cell culture and incorporates a selective PI3K inhibitor to promote memory T-cell production over shorter-lived effector T-cells. The company is presenting data from this study, as well as two others at the CAR-TCR Summit in Boston this week.