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Bristol Myers pays $100M for a different kind of ADC | BioPharma Dive

Dive Brief: - Bristol Myers Squibb is acquiring an antibody-drug conjugate to treat bone and blood cancers from multinational biotechnology startup Orum Therapeutics, the companies announced Monday. - Under the terms of the deal, Bristol Myers will pay Orum $1

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Dive Brief:

  • Bristol Myers Squibb is acquiring an antibody-drug conjugate to treat bone and blood cancers from multinational biotechnology startup Orum Therapeutics, the companies announced Monday.
  • Under the terms of the deal, Bristol Myers will pay Orum $100 million for the program and commit to paying as much as $80 million more if certain milestones are met.
  • Orum describes its therapy, dubbed ORM-6151, as an antibody-enabled protein degrader, merging the concept of an antibody-drug conjugate with the field of protein degradation. Orum said it has received Food and Drug Administration clearance to enter Phase 1 testing in acute myeloid leukemia and myelodysplastic syndromes.

Dive Insight:

Orum, which operates in Boston and Daejeon, South Korea, is developing a twist on antibody-drug conjugates, or ADCs. This class of medicines commonly link a targeting antibody to a tumor-killing toxin, guiding the potent drug to tumors while sparing healthy tissue. Rather than a toxin, Orum is using a small molecule designed to degrade target proteins.

The company announced plans to develop ORM-6151 in late 2022 as the second experimental drug of this type in its pipeline. It debuted preclinical data at the American Society of Hematology conference showing how the tumor-targeting medicine could be used to treat acute myeloid leukemia.

ORM-6151 is also being developed for high-risk myelodysplastic syndromes, in which immature blood cells in the bone marrow don’t mature into healthy blood cells.

Orum’s lead drug, called ORM-5029, is in a Phase 1 clinical trial and targets HER2-expressing solid tumors in patients with breast cancer. The company expects to complete the study in 2025, according to a federal database of clinical trials.

When the company started working on their approach, few startups were trying to combine protein degraders with ADCs, said Sung Joo Lee, Orum’s CEO.

“When we started this effort, people didn't really recognize that value,” Lee said. “But now, everybody's excited. Everybody wants to enter the space. So we're very proud that this deal has validated our approach.”

Orum's financial advisers at Perella Weinberg Partners connected Lee with Bristol Myers, paving the way for the deal. “They're obviously the leader in the oncology and degrader space,” Lee said.

Bristol Myers is one of several large drugmakers now investing ADCs in a major way. The commercial success of drugs such as AstraZeneca’s Enhertu and Seagen’s Adcetris has prompted a recent flurry of ADC-related dealmaking, including one last month between Merck and Co. and Daiichi Sankyo.

Analytics company Global Data estimates that pharma companies signed roughly $16 billion worth of antibody-drug conjugate licensing deals in 2022.

Targeted protein degradation is also an up-and-coming field, putting Orum at the center of two fast-moving areas of research. ADC pioneer Seagen is working with the biotech Nurix on a similar kind of hybrid therapy.

Editor's note: This story has been updated to clarify comments from Sung Joo Lee.

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Related questions

01What about safety and efficacy?

Twenty years have passed since the first PROTAC was reported, and many companies have brought protein degraders to preclinical and clinical development. This leads to the crucial question of whether new generations of targeted protein degraders are safe and effective. Shen points out that no major safety-related issues have been observed with PROTAC drugs in clinical programs. He does not anticipate any major safety issues with ATAC degraders, even though clinical data on PROTAC safety is still limited, especially with respect to long-term outcomes. Shen’s optimism is shared by Tozzo. “By leveraging ASGPR,” Tozzo says, “we are engaging the natural machinery that the body is already using for protein degradation.” Another key question involves whether the efficacy of various protein degraders may diminish over time. In the case of PROTACs, Shen notes that there is no evidence from clinical trials that they are more prone to resistance development than standard inhibitors. However, preclinical studies suggest that defects in the E3-ubiquitination system could become a source of resistance to PROTACs. As Shen explains, “Time will tell whether any of the resistance mechanisms observed in preclinical studies may emerge in the clinical setting.” Despite the many unknowns, the companies we interviewed were optimistic about the prospect of clinical trials for their targeted protein degraders. Nasveschuk notes that C4 Therapeutics has three projects that are in Phase I trials, and multiple other drugs in the preclinical stage. Hansen also emphasizes the success of Nurix’s therapies that degrade a protein called Bruton’s tyrosine kinase (BTK). She notes that the company’s lead BTK degrader, NX-2127, has already demonstrated proof of efficacy in ongoing Phase I trials: “Thus far, we have demonstrated rapid, robust, and sustained BTK degradation independent of BTK mutations.” Tozzo likewise suspects that ATAC inhibitors will perform well in clinical trials. She states, “Based on the robust degradation we have observed in our nonhuman primate studies with our proof-of-concept ATAC degraders, we anticipate good translation of ATAC degradation activity in the clinic.”

Source: www.genengnews.com ↗
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