Confo Therapeutics NV is banking an up-front payment of $40 million from a licensing deal with Eli Lilly and Co. involving its lead asset, CFTX-1554, an oral inhibitor of the angiotensin II type 2 receptor (AT2R), which is in phase I development for neuropathic pain. The deal includes up to $590 million more in potential milestones and tiered sales royalties. Confo could also secure a further $590 million in additional milestones should Lilly elect to take forward an antibody-based inhibitor directed against the same target.
New phase III data from Inovio present mixed picture for VGX-3100 in cervical lesions
Inovio Pharmaceuticals Inc. offered ambiguous results with the DNA-based immunotherapy VGX-3100 as a treatment for cervical high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV)-16 or HPV-18. Data from the phase III study called Reveal2 showed a miss on the primary endpoint (lesion regression and viral clearance) in the biomarker-selected population, but hit statistical significance in the all-comers group. The latest results are inconsistent with an earlier study, Reveal1, which did achieve statistical significance in biomarker patients. HPV types 16 and 18 are responsible of 70% of cervical cancers and precancerous cervical lesions, according to the U.S. NIH. Inovio’s stock (NASDAQ:INO) didn’t react much, trading midday at $1.29, up 5 cents.
US regulatory landscape not getting better for ultra-rare disease therapies
The development path for rare disease treatments is strewn with numerous challenges, not least of which are the regulatory hurdles. For companies developing promising candidates to treat ultra-rare diseases such as Barth syndrome and the patients with those diseases who are running out of time, the regulatory obstacles in the U.S. may seem almost insurmountable. Yet all that may be needed to knock the hurdles down to size are education, consistency and communication across the FDA. However, new concerns about drug development in general could be building the barriers even higher.
Biocom 2023: Pharma’s wants and needs in the new market environment
During two different panels at Biocom California’s Global Life Science Partnering & Investor Conference, executives from a variety of pharmaceutical companies laid out their wants and needs in the current market environment. Multiple companies noted that they are now or expect to be generating 50% or more of their revenue from drugs discovered outside their walls. While the desire to bring in compounds is good news for biotechs looking to partner or be acquired, smaller companies may need to temper their expectations for payouts.
Pharmas search for strong, early innovation as top products near patent cliffs
As several key revenue-driving products fall off patent in coming years, pharmaceutical companies are increasingly focused on mechanisms by which they can draw innovation to them. What launched as the Partner of Choice organization, for example, has now become the newly named Pfizer Ignite model – an end-to-end engine designed to bring innovation to the pharmaceutical company in return for services. And other pharma companies have similar efforts designed to support innovation ahead of potential partnerships.