预约演示

JPM24: Roche's pharma BD chief explains renewed ADC interest but is spoilt for choice

2024-01-12

交易

并购上市批准

Roche recently penned three pacts in close succession, but the company's head of pharma partnering James Sabry said it isn't swinging into dealmaking mode.

Rochee of the first Big Pharmas to embrace antibody-drug conjugates (ADCs), Roche plans to make further bets on the popular cancer modality, according to the company's global head of pharma partnering, James Sabry, Ph.D. But biotechs looking for an alliance must first meet an invisible bar.

“We plan to do more deals, and we plan to do internal work in ADCs,” Sabry sRochen an interview with Fierce Biotech on the scanceres of the 2024 annual J.P. Morgan Healthcare Conference.

Sabry’s comments—and a recent licensing deal—marked a change of public tone at Roche toward ADCs. Back in mid-2022, chairman and then-CEO Severin Schwan told reporters that Roche had “rather limited interest” in ADCs despite other companies’ growing investments in the field.

Still, getting on Roche’s good side won’t be an easy task for prospective ADC pRochers—Sabry’s team reviews around 6,000 opportunities across all disease areas each year.Roche

“For Roche, what tRocheotech companies are competing with is our internal ADCk,” he said. But that internal work isn’t necessarily visible to outsiders. When asked what internal capabilities Roche has built around ADCs, Sabry said, “You’ll see when the products come.”

RocheRocheently has two commercial ADCs, both built with other companies’ technologies. HER2-targeted Kadcyla was made with ImmunoGen’s platform, and large B-cell lymphoma drug Polivy has SeaRocheo thank. But since forming those partnerships over a decade ago, the Swiss company had stayed quiet on the ADC deal-making scene, while the likes of Merck & Co., AstraZeneca, Eli Lilly and AbbVie recently bought into the field.

Rochee not a fashion company,” Sabry said. “We don’t just jump on a bandwagon because everyone else isKadcylait. We do thingImmunoGen we really beand large B-cell lymphomaproduct will brinSeagenual value to patients.”Merck & Co.AstraZeneca Eli Lilly AbbVie

Roche broke the silence at the beginning of 2024 by in-licensing a c-MET ADC from China’s MediLink Therapeutics. The deal came more than two years since AstraZeneca and Daiichi Sankyo’s Enhertu trounced Kadcyla in a head-to-head breast cancer trial.

Rochertu broke every rule that we thought about ADCs,” Sabry said. c-MET once thought certMediLink Therapeuticsround the target’s overexpression level onAstraZenecasue, Daiichi Sankyotibody ratio, and thKadcylality of the linker.breast cancerof the head-to-head fail against AstraZeneca's drug, Roche went back to the drawing board to renew its understanding of the modality.

“There’s a lot of internal research we were doing in order to suppoRocheals like the MediLink deal,” Sabry said.cancer AstraZeneca Roche

It doesn’t mean Roche has fully understood the new rules of ADCs, Sabry said. “When you don’t know the rules, then you look for clinical data.”

“The nice thing Roche ADCs is that you know clinically usually within phase 1 whether the drug is safe, and whether it has some effect,” he said. “So that’s what we’re looking for. It can be very early-stage clinical data.”

Cautious approach to platform deals

As to whether Roche would buy out an ADC specialist similar to Pfizer’s acquisition of Seagen, AbbVie’s proposed purchase of ImmunoGen and Johnson & Johnson’s Ambrx takeover, Sabry said only when the external technology is “so different that we don’t have it on the inside” will Roche make platform deals. And even with platforms, Roche would typically form collaborations to generate multiple products.

Case in point:Roche week Roche put doADC$66 million upfront to Pfizer Moma TherapeuticsSeagenfoAbbVieidentify and develop “a ImmunoGenumberJohnson & JohnsonargAmbrxnvolved in cancer cell growth and survival. In a separate deal, Roche tapped Remix Therapeutics’ drug discovery engRocheo develop small molecules that target RNA proceRoche.

In the few cases where RoRocheas bought a company outright in the pastMoma Therapeuticsch and Spark Therapeutics, the business would often be kept as a separate unit, Sabry obcancer.Roche Remix Therapeutics

But Roche’s $4.3 billioRocheeover of Spark in 2019 hasn’t produced many results,Genentechto 74Spark Therapeuticsancs ($870 million) worth of impairment charges for 2022.

“WheRochedid the Spark deal, it was bSparkon an enthusiasm around gene therapy,” Sabry said. “As you can imagine, that enthusiasm is still there, we still believe gene therapy will become a major type of therapy in the future. What we mean is that it’s going to take time for that to evolve.”

In October, RocheSparked a deal potentially worth $216 million with SpliceBio for a gene therapy against an inherited retinal disease, which is Spark’s sweet spot thanks to FDA-approved Luxturna.

The gene theRocheworld just celebrated a major breakthrough with theSpliceBio of Vertex and CRISPR Therapeutinherited retinal diseaseene-editing therapy based on CRISPR technology. StillLuxturnaargued that the main limitation for gene therapy is the lack of ability to target specific cells effectively.

“We would consider CRISPR, like, eventually,” Sabry said.Vertex CRISPR Therapeutics

How the MediLink, Moma and Remix announcements appeared in close succession raises the question of whether Roche has shifted into deal-making mode. But Sabry assured Fierce that “that was just the way they lined up.” The number of deals Roche negotiated last year, including the flurry of pacts announced in the last few days, was similar to the number in previous years, he said.

Roche did appear to have spent more on later-stage candidates in 2023, including purchasing Roivant and PfiRoche Televant for over $7 billion to get its hands on a phase 3-ready anti-TL1A antibody in bowel disease. Roche also splashed $3Rochellion upfront to in-license Alnylam’s RNA interference hypertension candidate zilebesiran, which in September reported positive blood pressure data from a phase 2 trial.

Roche trial failures have left some room in Roche’s late-stage pipeline and created an urgency to fill iPfizerry acknowledged. Besides, the biotech winter also opened projects up for the Swiss conglombowel disease.Roche Alnylam Alnylam zilebesiran

But Roche didn’t start the year by setting aRochea to balance drug discovery pacts and late-stage buys, Sabry said. The decisions are based on science.

“We Rocheve that the most interesting companies are the ones that dramatically change the way we think about what a medicine is,” Sabry said. He noted how Alnylam’s zilebesiran is the first to go further upstream of a signaling cascade than other existing hypertension meds.

Roche’s pharma division currently doesn’t have any commercial presence in cardiovascular or metabolic diseases—although that looks set to change. When asked if the Azilebesiran indicates a new push into that area, Sabry said: “Yes, absolutely, we’re gonna hypertensioninto new medicines in metabolic disease [and] in cardiovascular disease, for sure.”

Rocheyes on Chinacardiovascular or metabolic diseases Alnylam metabolic disease cardiovascular disease

Another thing that Roche seems to be doing differently is that it’s recently started to partner with biotechs from China. In addition to MediLink, Roche’s Genentech paid $60 million upfront in August 2022 and committed $590 million in biobucks to in-license an androgen receptor degrader from Jemincare. By May 2023, the Swiss drugmaker was laying out $70 million in upfront and near-term payments to obtain a brain-penetrating HER2 molecule from Zion Pharma.

Sabry called those Rochedates “world-class drugs” that can compete with others from Western companies. Roche has also set up a business dMediLinkntRoche baGenentechanghai led by Harm-Jan Borgeld, head of Asia partnering.androgen receptor Jemincare HER2 Zion Pharma

China has become a hotbed for partnering, especially in ADCs. MediLink has also out-licensed its ADC caRochete to BioNTech, for example, while Hansoh holds two ADC deals with GSK. Merck also has a multi-program ADC collab with Kelun Biotech, and in December Bristol Myers Squibb shelled out $800 million upfront in a deal worth up to $8.4 billion for an EGFRxHER3 bispecific ADC from SystImmune, a subsidiary of China’s Biokin Pharmaceutical.

“I believe China will become as powerful as America and EuropeMediLinks of invention,” Sabry saidADC BioNTech Hansoh ADC GSK Merck ADC Kelun Biotech Bristol Myers Squibb ADC SystImmune Biokin Pharmaceutical

The biotech winter was also one of reasons behind the torrent of deals in China as local firms partner up to survive. “China has not matured fully into the late stages of development yet, but it will,” Sabry predicted.

“The issue in China is that they don’t have mature management teams for these biotech companies, because they are still a young industry,” he said. Once Chinese biotechs and their management develop, they will find other resources to take them forward because “the capital flows where the innovation is,” Sabry observed.

As for the potential risk of heightened geopolitical tensions, Sabry said: “When we go to China, we hope that the Chinese look at us and [think of us as] a Swiss company, not an American company.”