Principia Biopharma, Inc.

Sanofi is turning back on the anti-ITL2 monoclonal antibody after bringing it into phase 2 development.\n Four years after Sanofi shelled out $125 million for global rights to Biond Biologics’ novel immune checkpoint inhibitor, the French pharma is handing the prospect back to Biond.The move is due to an ongoing R&D prioritization at Sanofi, with the pharma attributing the transfer to broader efforts to “focus on programs that support the company’s strategy,” according to a March 3 press release.Sanofi’s original $125 million bet in 2021 was rooted in the potential the anti-ITL2 monoclonal antibody held to turn the innate and adaptive immune systems against tumors and featured more than $1 billion in potential milestones, plus a chance to lead the ILT2 field. The companies already wrapped up a phase 1 dose-escalation study weighing BND-22 as a monotherapy and in combination with Keytruda, plus Eli Lilly and Merck KGaA’s Erbitux (cetuximab). The partners said the therapy was well-tolerated and reported “several confirmed clinical responses” in heavily pre-treated patients. Biond had been responsible for the phase 1a assessment of the drug, while Sanofi was in charge of further development. Based on the early-stage results, Sanofi initiated enrollment for a phase 2 dose-optimization and expansion study of solo BND-22 in patients with rare bile duct cancer cholangiocarcinoma and in combination with Erbitux for non-small cell lung cancer or colorectal cancer.While Sanofi was an “outstanding partner,” Biond remains “committed to the continued development” of the program, whether “independently or in partnership with strategic collaborators,” CEO and co-founder Tehila Ben Moshe, Ph.D., said in a statement. The biotech plans to \"continue treating patients who are benefiting from BND-22 treatment\" in the Sanofi-started trial, she said.Through the transfer, Israel-based Biond will retain access to the clinical data already generated by Sanofi. The biotech also plans to launch a phase 2 biomarker study of the med in combination with anti-PD-1 therapy. Sanofi’s pipeline shakeup has resulted in the removals of a clutch of programs tied to its multibillion-dollar takeovers of Ablynx, Principia Biopharma and Synthorx. In January, it was revealed that the company dropped three phase 1 assets, including an IL-2 candidate from its $2.5 billion Synthrox acquisition and two based on a platform technology picked up from its $4.1 billion Ablynx buy. The drugmaker also scratched a late-stage multiple sclerosis program using Principia’s BTK inhibitor tolebrutinib.

Sanofi disclosed removals from its pipeline alongside the progress of other molecules. \n Sanofi has removed (PDF) a clutch of programs from its clinical pipeline, scratching out entries for its late-phase BTK inhibitor and phase 1 prospects linked to the multibillion-dollar takeovers of Ablynx, Principia Biopharma and Synthorx.The French drugmaker added the BTK inhibitor tolebrutinib to its pipeline by acquiring Principia for $3.7 billion. Facing down skepticism, Sanofi guided the asset to mixed phase 3 data last year, with the win in one form of multiple sclerosis offset by failures in another form of the disease. The company removed the relapsing multiple sclerosis program from its pipeline but plans to file for approval in another setting.Sanofi removed three assets from its phase 1 pipeline. Pegenzileukin, the IL-2 candidate Sanofi picked up through its $2.5 billion takeover of Synthorx, was one of the assets affected by the clearout. The molecule suffered a setback in 2022, triggering a 1.6 billion euro ($1.7 billion) impairment, but Sanofi kept going.The drugmaker began a phase 1/2 program in 2023 to optimize the dose schedule for the treatment of solid tumors. Sanofi listed the study of the candidate, which is also called SAR444245 and THOR-707, in “cancer, in combination” among the programs removed from phase 1 in the fourth quarter. The other two early-phase removals affected nanobodies, the platform technology Sanofi acquired in its 3.9 billion euro ($4.1 billion) takeover of Ablynx. One of the removed drug candidates, SAR445611, is an anti-CX3CR1 nanobody that Sanofi was developing in an inflammatory indication. The second jettisoned molecule is SAR444200, a GPC3-based nanobody T-cell engager that Sanofi was testing in solid tumors.\"Sanofi continues to prioritize our pipeline to focus on medicines and vaccines that deliver the greatest value for patients,\" a company spokesperson told Fierce Biotech in an emailed statement. \"That\'s why we\'ve made the decision to discontinue these select programs where we believe we cannot deliver meaningful value to patients.\"Sanofi disclosed the removals alongside the progress of other molecules. SP0202 advanced into phase 3, furthering Sanofi’s push to bring the SK bioscience-partnered 21-valent pneumococcal conjugate vaccine candidate to market. Sanofi recently agreed to pay 50 million euros ($52 million) upfront to expand its pneumococcal vaccine collaboration with SK.When it comes to dealmaking this year, Sanofi\'s CFO François Roger said the French pharma would be looking out for companies in the value range of 2 billion euros to 5 billion euros. “We will continue to explore external growth opportunities to strengthen our four existing therapeutic areas and potentially cover white spaces,” Roger said on an earnings call with analysts this morning. “We don\'t feel any pressure to go crazy on M&A and BD, so we will remain very disciplined while having the opportunity to compliment whatever we have in our pipeline.”Editor\'s note: This article has been updated with a statement from Sanofi.

Sanofi is likely to increase its M&A this year since it has more cash in its pockets, as the French pharma also monitors China as a possible source of new drug innovation, CFO François Roger said during a media call Thursday morning. “We have always been very active in the M&A space. We may be a bit more in the near future due to the fact that we have a strong balance sheet,” Roger said. In a separate media call, CEO Paul Hudson said Sanofi would likely target preclinical and Phase 1 assets because it already has a robust late-stage pipeline. Roger added Sanofi would prefer to focus on assets worth between €2 billion and €5 billion. It’s been more than a year since Hudson announced Sanofi’s strategic shift to become a pure-play biopharma company. Now, Roger said that it is going to receive a significant amount of cash following its plans to relinquish the controlling stake in its consumer health unit Opella. This deal could close in the second quarter at the earliest. That transaction is estimated to be worth in the high single-digits in billions of euros, which means Sanofi can move “relatively quickly” on potential new deals, Roger said. Further, Sanofi’s debt position is “relatively low,” which would allow it to make such deals, he said. Because Sanofi is established in autoimmune disease, it could add more dermatology, respiratory, gastroenterology or rheumatology candidates into its pipeline, Hudson said: “That allows us to bring breakthrough science at a low marginal cost once it’s launched, because we have the people in place to do the job properly, and we have an incredible reputation.” The rare disease space is also attractive. In retrospect, Hudson said he would’ve liked to add more such assets to its portfolio in the past few years since the company has the capability, and this would offer the unit more breakthroughs on top of what’s being done internally. Sanofi is also interested in vaccines and neurology, he added. Sanofi will remain open-minded about other disease areas but it won’t be as efficient. “It takes a lot to push yourself in an area where you have no expertise,” Hudson said. Nonetheless, Roger said the company “doesn’t feel any pressure to go crazy on M&A” and would be “very disciplined.” He said it would “reward its shareholders first” with plans announced Thursday for a share buyback program this year worth €5 billion. As for China, Sanofi views the country as not only a source of revenue (it is the company’s second largest market), but also as a key source of innovation. Roger pointed out that more than 20% of new molecular entities come from China, so “this is not something that we can neglect.” One key decision Sanofi will have to make if it is to invest in China is whether such deals would be focused on the Chinese market alone or have utility outside the country as well, Roger said. In December, the company announced it is spending about €1 billion for a new insulin facility in Beijing for the Chinese market and neighboring countries. Elsewhere, Sanofi said that Beyfortus has reached blockbuster status, with €1.7 billion in sales in its first year in the market. The infant RSV antibody, which it co-developed with AstraZeneca, had steady growth in the past quarters after having to address supply issues early last year. While there is more growth to be had in 2025 by entering new geographies and increasing uptake rates, Roger said the rise in Beyfortus revenue this year might “not be to the same extent” as last year. Merck’s own antibody challenger in RSV could enter the market in 2025. Roger noted that Sanofi “welcomes competition,” but also pointed to the key differences between the two assets. The drugmaker also said Thursday that it axed four programs, including a Phase 3 study of its BTK inhibitor tolebrutinib in relapsing multiple sclerosis. Sanofi obtained the drug in 2020 as part of its $3.7 billion acquisition of Principia Biopharma and it’s still being advanced for other forms of MS . Other assets on the chopping block included a Phase 1 candidate called pegenzileukin that targets IL-2 for cancer and a T cell engager dubbed SAR444200 in early development for solid tumors. Sanofi also discontinued SAR445611, a monoclonal antibody that was in Phase 1 development for inflammation. Additional reporting by Ayisha Sharma.