CH24H

The oral version of OV329—a GABA-aminotransferase inhibitor for the chronic treatment of epilepsies—will remain one of Ovid Therapeutics' top priorities. Ovid Therapeutics already revealed last month that it was trimming back its headcount as the company navigates an unexpected setback for the Takeda-partnered epilepsy med soticlestat. Now, the biotech has confirmed that it’s halting work on its preclinical programs, including an intravenous (IV) formulation of its seizure drug in order to save cash.The company already made clear in a regulatory filing at the time that laying off 17 people—equivalent to 43% of Ovid’s workforce—in July was spurred by a need to “prioritize its programs and extend its cash runway.”In its second-quarter earnings report this morning, the biotech spelt out what pipeline changes it had in mind. The company is halting its preclinical work—although the only high-profile casualty will be the IV formulation of OV329.While Ovid also referred to “other preclinical programs” as facing the axe, it didn’t go into further details.Instead, the oral version of OV329—a GABA-aminotransferase inhibitor for the chronic treatment of epilepsies—will remain one of the company’s top priorities. A phase 1 multiple ascending dose study is expected to wrap up this year. The other key priority for Ovid is OV888/GV101, a Graviton Bioscience-partnered ROCK2 inhibitor capsule that is being lined up for a phase 2 study in cerebral cavernous malformations. With $77 million to hand in cash and equivalents, the company expects to pave a cash runway into 2026.Ovid CEO Jeremy Levin put the pipeline changes in the context of the failure of soticlestat to reduce seizure frequency in patients with refractory Lennox-Gastaut syndrome, a severe form of epilepsy, in a phase 3 trial in June. Ovid sold its rights to the cholesterol 24 hydroxylase inhibitor to Takeda for $196 million back in 2021 but is still in line for commercial milestones and low double-digit royalties up to 20% on global net sales.“Following Takeda's unexpected phase 3 results for soticlestat, we moved rapidly to focus our resources to preserve capital,” Levin said in today’s release. “This approach included restructuring the organization and initiating ongoing program prioritization efforts to support the achievement of meaningful clinical and regulatory milestones within our financial plan.”Takeda was also taken aback by soticlestat’s failure. The Japanese pharma notched a $140 million impairment charge as a result of the phase 3 miss. Still, Takeda said recently that it still holds some hope that the “totality of the data” could one day earn an FDA nod anyway. 

In its quarterly results presentation Wednesday, Takeda disclosed a JPY 21.5 billion ($143 million) impairment charge on its rare epilepsy drug soticlestat. The company shelled out nearly $200 million upfront back in 2021 to regain full rights to the CH24H enzyme inhibitor from Ovid Therapeutics.The financial hit comes in the wake of disappointing Phase III results reported a few weeks ago. The pivotal SKYLINE and SKYWAY trials targeting Dravet syndrome and Lennox-Gastaut syndrome (LGS), respectively, failed to meet their primary endpoints. Although the LGS programme has been dropped, Takeda said SKYLINE only "narrowly" fell short of its objective and it remains cautiously optimistic about soticlestat's potential in the Dravet indication.The company said the "totality" of data for Dravet syndrome patients "suggests clinically meaningful benefit" despite the primary endpoint miss.In other pipeline updates, the company said it has also ended its Phase III programme for pabinafusp alfa (TAK-141/ JR141) in Hunter syndrome for EU markets, following a strategic review of its alliance with JCR Pharmaceuticals. JCR remains the drug's study sponsor and plans to continue the Phase III trial for participating patients.In addition, an early-stage trial for ponatinib in paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia was "closed due to dose-limiting toxicities."Meanwhile, Takeda reported a "strong" overall performance for the first fiscal quarter. Revenue grew by 14.1% to JPY 1.2 trillion ($8 billion), driven by its growth and launch products portfolio, which saw a 17.8% gain at constant currencies. The segment now represents nearly half of total revenue, according to the company.Its ulcerative colitis and Crohn's disease treatment Entyvio saw sales surge by 22.1% to JPY 234.4 billion. The company's rare diseases portfolio grew by 16.8% to JPY 199.5 billion, buoyed by Takhzyro's 35.6% growth to JPY 56 billion. Plasma-derived therapies climbed by 29.7% to JPY 271.4 billion.Milano Furuta, the company's chief financial officer, maintained a cautious outlook for the remainder of the fiscal year, which is unchanged from May, saying "we expect the impact of generic erosion to accelerate in coming quarters and the phasing of our R&D investment will focus on the second half of the year due to the planned initiation of multiple Phase III programmes."The Japanese pharma unveiled a $900-million restructuring plan earlier this year that will affect 641 employees at two sites in the Boston area.

A partial clinical hold on BioNTech's ADC candidate, Takeda's option deal with Ascentage, and a senior leadership meeting between Chinese and U.S. drug regulators made our news this week. BioNTech and MediLink's HER3 ADC has been put on a partial clinical hold by the FDA. Takeda has identified a potential challenger to Novartis' Scemblix. Senior officials from China and U.S. drug authorities met at the FDA's headquarters for the first time since 2017. And more. 1. FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness' The FDA has put a partial hold on a phase 1 trial of MediLink Therapeutics’ BioNTech-partnered HER3-targeted antibody-drug conjugate. A BioNTech presentation recently showed that as of Feb. 4, two patients from the fifth dose cohort and one in the seventh dose group had died in the study. In the slides, BioNTech said it will focus further clinical development on lower dose levels. 2. Takeda circles leukemia rival to Novartis' Scemblix in up to $1.3B deal with Ascentage Takeda is paying $100 million for an option to license a third-generation BCR-ABL tyrosine kinase inhibitor from China’s Ascentage Pharma. The drug, called olverembatinib and already approved in China, is a competitor to Novartis’ Scemblix in chronic myeloid leukemia. Takeda is also making a $75 million investment in Ascentage, which is in line for up to about $1.2 billion in milestones if everything plays out positively. 3. China’s NMPA visits US in first senior-level meeting at FDA HQ since 2017 (tweets) Deputy Commissioner Zhao Junning of China’s National Medical Products Administration met with FDA Deputy Commissioner Kim Trzeciak Tuesday in the first senior-level meeting between the two agencies at FDA’s headquarters since 2017. The two agencies discussed the 2007 FDA-SFDA China Agreement on the Safety of Drugs and Medical Devices, including their 2024 work plan, according to the FDA. 4. Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADC Day One Biopharmaceuticals paid $55 million up front to get its hands on ex-China rights to MabCare Therapeutics’ antibody-drug conjugate targeting PTK7, which is overexpressed in esophageal, ovarian, lung and endometrial cancers among adults, as well as in neuroblastoma, rhabdomyosarcoma and osteosarcoma in children. The Chinese biotech may get up to $1.15 billion in potential milestones. 5. Takeda flunks pivotal epilepsy tests but mulls path to market for Ovid-partnered prospect Takeda’s soticlestat, for which it paid Ovid Therapeutics $196 million to partner on, missed the primary endpoints in two phase 3 trials in two forms of epilepsy, refractory Lennox-Gastaut syndrome and Dravet syndrome, respectively. Still, arguing that the cholesterol 24 hydroxylase inhibitor showed some treatment effects, Takeda said it will discuss the totality of the data with the FDA. 6. India's Lupin announces CEO pick for new subsidiary as it moves into the CDMO arena Lupin is venturing into the CDMO space with its new subsidiary Lupin Manufacturing Solutions, which will work on the development, production and sale of active pharmaceutical ingredients. The unit will be led by Abdelaziz Toumi, who previously worked at Bayer, Catalent, Lonza and other companies. Lupin has in the past dealt with drug recalls and FDA citations.   7. Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M Emergent BioSolutions has agreed to sell its fill-finish drug product facility in Baltimore-Camden to Taiwanese CDMO Bora Pharmaceuticals for $30 million. Bora intends to keep about 350 Emergent employees currently stationed at the 87,000-square-foot facility. The deal follows Bora’s $210 million acquisition of Minnesota generic manufacturer Upsher-Smith Laboratories earlier this year. Other News of Note:  8. Innovent braves bruising cytokine space, linking fusion protein to tumor responses in small study 9. Samsung Biologics upgrades another production pact, this time with Baxter for $223M 10. Mission Based Media unveils ad-free model for health podcasts, including Eisai-backed Alzheimer’s series 11. Biocon looks for partner to trial generic to Novo’s Wegovy, Ozempic in China