Modra Pharmaceuticals BV is planning to move its oral formulation of docetaxel into a pivotal trial, hoping to offer advanced prostate cancer patients a safer treatment option than intravenous chemotherapy. The Amsterdam, the Netherlands-based company has just announced phase IIb results in metastatic castration-resistant prostate cancer from ModraDoc-006/r, a tablet containing docetaxel and co-administered with ritonavir to enhance bioavailability.
Before taking on the role of CEO at Bluesphere Bio Inc., David Apelian would have said the most exciting work he’d done in immuno-oncology had been at Globeimmune Inc., where he’d served as chief medical officer for more than a decade, working in the field of cancer immunotherapy “back when no one believed the immune system would be something we could leverage against cancer.”
LONDON – Curve Therapeutics Ltd. has gone straight from £4.5 million (US$6.1 million) in startup funding to signing a $1.7 billion drug discovery agreement with Merck & Co. Inc. The deal will see Curve apply its mammalian cell discovery technology to five oncology and neuroscience targets nominated by Merck.
New and updated preclinical and clinical data presented by biopharma firms at the ASCO Genitourinary
Cancers Symposium, including: Arvinas, Astellas, Astrazeneca, Aura. Aveo, Bioxcel, Janssen, Merck, Mustang, Propella, Seagen.
Immunogen Inc. and Eli Lilly and Co., having already seen a collaboration collapse in 2018, will try it again. Immunogen granted the exclusive rights to research, develop and commercialize antibody-drug conjugates (ADCs) that are directed toward targets Lilly will select. Waltham, Mass.-based Immunogen will receive $13 million up front from Lilly and is eligible to receive another $32.5 million in exercise fees if Lilly licenses all the targets. Down the road, Immunogen could receive as much as $1.7 billion in exercise fees and milestones payments.
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.”
In the bad old days of cancer treatment, it was the nasty side effects of chemotherapy that often ended up limiting treatment – and while checkpoint inhibitors have raised the bar in terms of efficacy and safety, they can have dangerous and unpleasant off-target consequences, too. Finding ways to focus the immune system on cancer and limiting any off-target effects will not only make checkpoint inhibitor therapy more tolerable but could also improve survival rates – and Sweden’s Ilya Pharma AB aims to do this with a novel approach combining synthetic biology with cell therapy.
South Africa’s Competition Commission sent a warning this week to the biopharma industry when it announced that it is prosecuting Roche Holding AG for what it called excessive pricing of the company’s breast cancer drug, Herceptin, which is also marketed as Herclon in South Africa.
Cstone Pharmaceuticals Co. Ltd.’s orally administered Tibsovo (ivosidenib tablets) received the green light from China’s NMPA for use in adult patients with relapsed/refractory acute myeloid leukemia (r/r AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation. It is the first IDH1 inhibitor to reach market in China.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.