Suzhou Ribo Life Science Co., Ltd.

Oncology is “not the largest” therapeutic area for Boehringer Ingelheim, but it's one where the company is “committed” to making a difference, global head of therapeutic areas Ioannis Sapountzis, Ph.D., said in an interview. (Boehringer Ingelheim) With 25 launches planned through 2030, Boehringer Ingelheim is gearing up for a busy few years. As a part of that, the German drugmaker is looking forward to flexing its oncology muscles with two new cancer drug launches in 2025. While the company’s overall pipeline is filled with early-stage assets acquired through recent business development deals, its oncology R&D efforts are largely centered around the late-stage prospects brigimadlin and zongertinib. Brigimadlin, a member of the MDM2-p53 antagonist drug class, recently entered a pivotal trial testing the candidate in patients with the rare cancer dedifferentiated liposarcoma (DDLPS).  DDLPS is an ultra-rare aggressive cancer with “very, very dismal prognosis and a high unmet medical need,” Boehringer’s global head of therapeutic areas, Ioannis Sapountzis, Ph.D., said in an interview at this year’s annual American Society of Clinical Oncology (ASCO) conference in Chicago. The exec pegged the DDLPS patient population at around 3,000 worldwide. The disease space hasn’t seen “any innovation” in 40 years, Sapountzis said. Currently, DDLPS is treated primarily with chemotherapies including doxorubicin, which is nicknamed “red devil chemo” because of its harsh side effects. Brigimadlin is the product of 10 years of research and works by blocking the MDM2 oncoprotein from interacting with the cancer-surpressing p53 gene, helping patients fend off cancer cell growth, according to the company.  Outside of DDLPS, the company aims to expand the drug's use to other sarcoma subtypes. At the ASCO conference, BI presented results from an early study testing the drug in combination with radiotherapy in newly diagnosed glioblastoma patients. The data support “continued investigation” of brigimadlin in the disease, investigators noted. As for zongertinib, the drug is a tyrosine kinase inhibitor being evaluated as a potential treatment for HER2-mutated non-small cell lung cancer (NSCLC).  The company is looking to bring that therapy to market in the first half of 2025. Armed with an existing infrastructure for its marketed EGFR-mutated NSCLC med Giotrif, Boehringer is already busy building out its commercial resources, Sapountiz said. Besides Giotrif, BI's other commercial cancer drug is Vargatef for certain lung cancer patients. Oncology is “not the largest” therapeutic area in the Boehringer’s portfolio, Sapountzis acknowledged, but it’s one where the company has “been committed to really making a difference."   Dealmaking focus   BI has long been active in the M&A space and is “always looking for innovation,” Sapountzis noted. Just last month, the drugmaker shelled out 38.8 million euros ($42 million) to longtime partner OSE Immunotherapeutics in exchange for a preclinical anti-PD1/cytokine med and an expansion of a prior oncology research effort.  So far this year, Boehringer has also signed a T-cell anti-cancer therapy partnership with 3T Biosciences and a collab with Suzhou Ribo Life Science and Ribocure Pharmaceuticals to use RNA to treat metabolic-associated steatohepatitis. “We want to be truly collaborative in everything we do,” Sapountzis said. “We feel that together, we can achieve more; together, we can really advance treatments much better.”  

A platform asset “will further enrich Boehringer Ingelheim’s array of novel potential immune-modulatory cancer treatments,” the company said. Boehringer Ingelheim is handing over a total of 38.8 million euros ($42 million) to long-time partner OSE Immunotherapeutics for a preclinical anti-PD1/cytokine drug as well as to expand their existing solid tumor work into cardio-renal-metabolic diseases. The two companies first began their partnership back in 2018, when Boehringer paid 15 million euros ($18.4 million at the time) for the global rights to develop the preclinical checkpoint OSE-172, a SIRP-alpha antagonist targeting myeloid lineage cells, for solid tumors. The asset is among an emerging class of immuno-oncology drugs that target “don’t eat me” signaling, which is a strategy used by tumors to escape immune destruction. OSE’s original theory was that targeting SIRP-alpha would modulate the CD47 ligand, boosting the ability of the immune system to activate myeloid lineage cells, in turn freeing up the immune system to attack tumors. The immuno-oncology asset—renamed BI 765063—appeared to prove its worth in 2021, when Boehringer unveiled that 45% of evaluable patients with solid tumors who participated in a phase 1 dose-escalation study derived some clinical benefit from the drug. Now, Boehringer wants to see whether BI 765063 can have benefits beyond tumors. The German drugmaker announced this morning that it has amended the deal with OSE so that Boehringer can explore the potential of both BI 765063 and another phase 1 solid tumor drug already licensed from OSE called BI 770371 in cardiovascular-renal-metabolic (CRM) diseases. “The development of the ongoing anti-SIRPα compounds for a new indication adds to the company’s comprehensive CRM pipeline with the initiation of a phase 2 clinical study planned for later this year,” Boehringer explained in the May 22 release. To expand the deal terms, Boehringer is making a one-off payment of 25.3 million euros ($27.4 million). The German pharma also has an option for an “additional buyout” option for the program,, which would trigger another payment. The original 1.1 billion euros ($1.1 billion) in development, regulatory and sales milestones that were set out in 2018 are all still in place. In addition to expanding this existing work, Boehringer is also adding something new into the mix, paying OSE 13.5 million euros ($14.6 million) for a new preclinical program to develop immune-cell activating treatments based on OSE’s cis-targeting anti-PD-1/cytokine platform. The platform asset “will further enrich Boehringer Ingelheim’s array of novel potential immune-modulatory cancer treatments,” the company said in the same release. In addition to the upfront fee, OSE can also expect to receive a near-term milestone payment of 17.5 million euros ($18.9 million). Both amends fit in with Boehringer’s wider dealmaking strategy, which saw a flurry of announcements to kick off the year including a a T-cell anti-cancer therapy partnership with 3T Biosciences and a pact with Suzhou Ribo Life Science and Ribocure Pharmaceuticals to use RNA to treat metabolic-associated steatohepatitis. Boehringer isn’t the only Big Pharma that wants to work with OSE, either. In February, AbbVie paid the biotech $48 million upfront for the global rights to a novel approach to chronic inflammation.

Boehringer Ingelheim has notched some success in the metabolic-associated steatohepatitis space so far this year. Boehringer Ingelheim is making yet another bet that RNA therapies hold the key to treating metabolic-associated steatohepatitis (MASH). The German drugmaker is paying British biotech Ochre Bio $35 million in upfront and near-term research-based milestone payments to investigate “multiple targets” for chronic liver disease. Top of the list of indications will be MASH, previously known as nonalcoholic steatohepatitis (NASH). Should any of the targets in the “multi-year” collaboration prove fruitful, Ochre is also in line for various clinical, regulatory and commercial milestones as well as tiered royalties, which add up to a deal value north of $1 billion. Ochre’s remit is developing RNA therapies that enhance the liver’s regenerative capabilities in order to halt or reverse chronic liver diseases. It’s far from the first time Boehringer has played in this space—the pharma kicked off the year signing a $2 billion biobucks deal with Suzhou Ribo Life Science and Ribocure Pharmaceuticals to see whether their RNAi drug platform that targets disease-causing genes specifically in liver cells could complement Boehringer’s own MASH expertise. Six years earlier, Boehringer penned back-to-back partnerships with Dicerna Pharmaceuticals and MiNA Therapeutics covering the use of siRNA and small activating RNA to treat MASH. Boehringer put this morning’s deal with Oxford, U.K.-based Ochre in the context of its “commitment to improving the lives of people living with interconnected cardiovascular, renal and metabolic diseases, including MASH cirrhosis.” “Our partnership with Ochre Bio is driven by a shared goal to accelerate the development of new treatments for chronic liver diseases including MASH cirrhosis,” Søren Tullin, Ph.D., global head of cardiometabolic diseases research at Boehringer, said in the release. “Ochre Bio brings to the table unique and exciting capabilities in liver disease research,” Tullin added. “We believe their application of advanced genomics and machine learning coupled with human-centric translational models holds the potential to uncover novel regenerative pathways that will make a meaningful difference in the lives of those affected by chronic liver disease.” Boehringer has already notched some success in the MASH space so far this year, with the company’s Zealand Pharma-partnered glucagon/GLP-1 agonist survodutide demonstrating improvements in disease activity and liver scarring in a phase 2 trial in February.