Lilly offers AI discovery models to biotech partners

 Eli Lilly is offering AI-powered drug discovery models developed at a cost of around $1 billion to biotech companies for free, as long as they provide 'training data' to refine them.

The new launch – called Lilly TuneLab – is a machine learning (ML) platform that the company says has been "trained on years of…research data" and represents "one of the industry's most valuable datasets used to train an AI system available."

It is an addition to the Catalyze360 suite of offerings that Lilly makes available to its early-stage biotech partners to help them bring innovative new projects through development more quickly, along with access to lab facilities and scientific mentorship, R&D software, and financial investments.

AI has emerged as a transformative force in the life sciences industry thanks to its ability to process large-scale datasets, uncover patterns, and generate predictions, and it is already being used to find drug targets, design new drugs, and repurpose existing therapies, among other applications.

"Lilly has spent decades building comprehensive datasets for drug discovery. Today, we're sharing the intelligence gained from that investment to help lift the tide of biotechnology research," said Daniel Skovronsky, Lilly's chief scientific officer.

"Lilly TuneLab was created to be an equaliser so that smaller companies can access some of the same AI capabilities used every day by Lilly scientists," he added. "By opening up access, we hope to accelerate the creation of new medicines for patients who need them."

Some companies have already said they are partnering with Lilly for TuneLab, including two South San Francisco biotechs.

Circle Pharma will use it to develop new macrocycle therapeutics for hard-to-treat cancers, while Insitro – a specialist in AI-powered drug discovery itself – will work with Lilly on advanced ML models that can accurately predict key pharmacological properties of small molecules.

"The rapid design of safe and effective small molecules has long been a holy grail in drug discovery, but has been stymied by the unpredictability of key pharmacological properties, such as a molecule's behaviour in vivo," said Insitro founder and CEO Daphne Koller.

"AI can address this challenge, but only with robust, coherent, and consistently collected data on advanced molecules, data that are very rarely found," she added.

"That is why we are especially excited to again partner with Lilly in bringing our ML capabilities to their unique dataset, so we can build best-in-class predictive models for small molecule properties, and bring the benefits of delivering better drugs faster to the patients who are waiting."

https://pharmaphorum.com/news/lilly-offers-ai-discovery-models-biotech-partners

Lundbeck retreats from dozens of markets

 Lundbeck has announced a major change to its commercial strategy, withdrawing from 27 markets and handing day-to-day operations to partner companies.

The move – described as a "sharpening" of commercial strategy – will affect more than 600 workers in the affected countries who will lose their jobs but, according to Lundbeck, "are expected to have the opportunity to get a new job with the local partners." That figure is equivalent to more than 10% of Lundbeck's current workforce.

The partners are Swixx Group, Zuellig Pharma, and NewBridge Pharmaceuticals, who will be tasked with making sure that Lundbeck's medicines continue to be available in the 27 markets, which accounted for 12% of group revenues last year.

The handover – which will see the partners take responsibility for the sales, marketing, access, and distribution of Lundbeck's medicines – is due to be completed by the start of December. The company expects the transition to result in around DKK 390 million ($61 million) in costs this year with no impact on its 2025 guidance.

Swixx is taking control of 22 countries across the Americas, central and eastern Europe, as well as Russia and Turkiye, while Zuellig will handle Indonesia, Malaysia, Philippines, and Singapore, and NewBridge will take Saudi Arabia and United Arab Emirates.

That means Lundbeck is maintaining its presence in western Europe and the Nordics, plus Australia, Brazil, Canada, China and Hong Kong, Japan, Korea, and the US.

"This step is essential to building the commercial infrastructure that will sustain our long-term strategy and deepen our commitment to serving patients," commented Lundbeck's president and chief executive Charl van Zyl.

"By reducing complexity and shifting resources to the markets and brands with the greatest growth potential, we are focusing capital to accelerate progress on our strategic priorities – most notably our growing late-stage pipeline in neuro-rare and neuro-specialty diseases," he added.

The move comes less than 12 months after van Zyl applauded his company's efforts to build a pipeline poised to four new molecular entities (NMEs) in phase 3 trials in 2026, fuelled by sales growth for on-market brands Rexulti (brexpiprazole) for agitation in Alzheimer's patients and Vyepti migraine therapy (eptinezumab).

Those four hopefuls are anti-alpha-synuclein antibody amlenetug for multiple system atrophy (MSA) – although midstage data was a bit mixed – as well as anti-PACAP drug Lu AG09222 for migraine prevention, ACTH blocker Lu AG13909 for Cushing's disease and congenital adrenal hyperplasia, and 5-HT 2C receptor super-agonist bexicaserin for seizures associated with rare forms of epilepsy. Lundbeck acquired the latter when it bought Longboard Pharma last year for $2.6 billion.

https://pharmaphorum.com/news/lundbeck-retreats-dozens-markets-slashing-staff

'Lilly lines up Julianne Moore to front brain health campaign'

 Lilly has launched a new awareness campaign in the US, focusing on dementia, and named A-list actress Julianne Moore to front it.

Called Brain Health Matters, the global campaign is encouraging people to take charge of their brain health and lower their risk of dementia from conditions like Alzheimer's disease, running on US television, digital, and audio platforms starting this month and backed up by a supporting website.

More than a decade ago, Moore won critical acclaim for her sensitive portrayal of Alice Howland, a linguistics professor at Columbia University who is diagnosed with familial Alzheimer's disease at age 50 in the movie Still Alice.

Now, she is drawing on her experience in that role as well as advocacy across a range of issues, including gun violence prevention and support of survivors of sexual assault, to encourage people to be aware of the early signs of failing brain function.

While she had no personal experience of dementia among family or friends, Moore carried out extensive research into Alzheimer's in preparation for Still Alice, which won her an Oscar for Best Actress as well as a BAFTA in the UK.

"One of the things that has stayed with me from my conversations with people living with Alzheimer's disease is that taking responsibility for one's brain health is essential for protecting our freedom to do the things that make life meaningful," said Moore, who aims to empower individuals to talk with their doctors about dementia risk and encourage annual cognitive assessments and lifelong brain health habits.

"I've seen how much proactive care matters in helping us keep doing what we love," she added. "That's why I'm encouraging everyone to prioritise their brain health through regular conversations with their doctors."

According to Lilly, nearly four in five Americans say they would want to know if they have Alzheimer's disease before symptoms interfere with daily activities, while research indicates that earlier detection and accurate diagnosis contribute to better care for patients.

Meanwhile, with a new generation of drugs for Alzheimer's disease reaching the market that can slow down cognitive decline – including Lilly's anti-amyloid therapy Kisunla (donanemab) and Eisai/Biogen's rival Leqembi (lecanemab) – there is added impetus for people at risk of developing Alzheimer's to get a diagnosis as early as possible.

The number of people aged 65 and older with Alzheimer's dementia is projected to reach 13.8 million by 2060, according to the Alzheimer's Association.

"As our population ages and we see the positive impact of earlier intervention in symptomatic Alzheimer's disease, it is becoming critical that we assess brain health regularly," said Anne White, president of Lilly Neuroscience.

"This campaign is about getting more people to talk about brain health and prioritise it along with other aspects of routine healthcare."

https://pharmaphorum.com/news/lilly-lines-julianne-moore-front-brain-health-campaign

Bristol, BioNTech Post Geographically Consistent Mid-Stage PD-L1/VEGF Data in SCLC

 

Truist Securities called pumitamig’s data on Monday “very reassuring,” given the consistency between its performance in Chinese and global patient populations.

Bristol Myers Squibb and BioNTech’s investigational bispecific BNT327, also known as pumitamig, achieved high response and disease control rates in a Phase II study of small cell lung cancer, marking the first-ever global data for the anti-PD-L1/VEGF therapy.

Pumitamig elicited a confirmed overall response rate (ORR) of 76.3% at the Aug. 7 data cutoff. The results, presented Monday at the 2025 World Conference on Lung Cancer, come from 38 evaluable patients who had extensive-stage small cell lung cancer. The bispecific antibody was administered alongside standard-of-care chemotherapy, achieving a 100% disease control rate.

BioNTech was up 2% before the opening bell on Tuesday, while BMS was trading largely flat.

In a note to investors on Monday, Truist Securities said they found this readout “very reassuring” given that it “confirmed the treatment effect seen in China” in a global patient population. BMS and BioNTech did not present geographically disaggregated figures on Monday, but a China readout in March at the 2025 European Lung Cancer Congress touted a confirmed ORR rate of 85.4% and a disease control rate of 97.9%.

On Monday, BioNTech and BMS additionally reported 56.7% tumor shrinkage, with nearly 90% of participants seeing early shrinkage. Median progression-free survival was 6.8 months, while overall survival data were not yet mature at the time of the readout.

In February, BioNTech launched a global Phase III study for pumitamig, dubbed ROSETTA-LUNG01, designed to evaluate the bispecific antibody plus chemotherapy as a first-line option for extensive-stage small lung cancer. That trial is expected to complete in September 2029.

With ROSETTA-LUNG-01, BMS and BioNTech “are leading the race among the PD-(L)1 x VEGF bispecifics in SCLC,” Truist wrote on Monday. The analyst firm anticipates a launch in 2028, potentially unlocking a $1.4-billion revenue opportunities for the partners.

By blocking both PD-L1 and VEGF, pumitamig addresses two fundamental cancer pathways: It prevents cancer cells from evading the immune response, blocking checkpoint inhibition via PD-L1, while also suppressing the formation of new blood vessels through VEGF-directed growth, that would otherwise sustain the tumor. The investigational bispecific was originally developed by Biotheus, which BioNTech acquired in November 2024 for $800 million upfront and up to $150 million in milestones. Then, in June this year, BMS put $11 billion on the line to jointly develop the asset.

Monday’s readout follows a similar PD-L1/VEGF presentation by Summit Therapeutics, which on Sunday reported overall survival data for its own bispecific ivonescimab, in non-small cell lung cancer, pointing to better outcomes in Asian patients versus those in Western countries. This geographic discrepancy, as well as missing significance in overall survival outcomes, makes ivonescimab’s regulatory prospects “uncertain,” Truist wrote in a separate note on Monday.

https://www.biospace.com/drug-development/bms-biontech-post-geographically-consistent-mid-stage-pd-l1-vegf-data-in-sclc

As Ori Wins Designation, FDA’s Advanced Manufacturing Program Nears Proof Point

 

Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.

Last week, Ori Biotech announced that it has joined the short list of companies to receive advanced manufacturing technology designation from the FDA. Seeking to support uptake of new manufacturing technologies, the agency has said AMT will involve early, priority interactions with drug developers using designated technologies. The scheme has attracted industry interest, and nine months after finalizing the initiative, the FDA is on the cusp of showing whether the designation can deliver on its objectives.

Absent an AMT designation, each sponsor that uses a technology needs to submit comprehensive manufacturing information as part of their investigational new drug (IND) and drug approval applications despite making products in a similar way to every other user of the platform. According to the FDA, the agency established the AMT designation to streamline this process, encouraging early adoption of technologies that improve the reliability and robustness of manufacturing processes, enhance product quality, reduce drug development time or increase or maintain the supply of certain critical drugs.

To date, Ori is one of three companies that have announced publicly that they’ve received AMT designation. Cellares received AMT designation in April for technology for automating cell therapy production. Cellino secured a designation for its induced pluripotent stem cell manufacturing platform in May. Ori’s designation is for its IRO system for automating, digitizing and standardizing parts of the cell and gene therapy manufacturing process.

Ori CEO Jason Foster told BioSpace the company collated data from 10 to 12 customers to show the FDA that its system is robust and can improve consistency while increasing throughput. Foster said the agency submitted two rounds of questions seeking specifics on the broader use of the platform, and that the designation process would be very familiar to companies that have had other interactions with the agency.

“Now the fun work starts,” Foster said. “The crucial piece is how do we leverage AMT to help our partners get products into the clinic more quickly and get them to patients more quickly?”

How AMT Could Accelerate R&D

Foster said the stated benefits of the designation, such as priority interactions with the FDA, should help Ori’s clients accelerate IND submissions and reach the clinic faster. The Ori CEO also expects clients to have “an easier time” when discussing chemistry, manufacturing and controls (CMC) with the agency.

“We’re submitting a master file that will have a lot of this [CMC] data in it so that they can reference that and reference the IRO technology as the AMT-designated technology, so that those boxes are ticked,” Foster said. “A lot of the regulatory conversations about cell therapies are around manufacturing, so the ability to streamline that discussion would be well accepted by our partners and by the agency.”

Michael Paglia, chief technology officer at ElevateBio BaseCamp, told BioSpace the validation that comes from AMT designation could help technology providers overcome a barrier to the use of their products. At ElevateBio, Paglia and his colleagues use proprietary and partnered technologies to develop and make cell and gene therapies for clients. ElevateBio is part of Ori’s preferred partner network.

Paglia joined ElevateBio before its official launch in 2019 and now evaluates new manufacturing technologies from other companies. The experience has shown him what evidence companies want to see when deciding whether to work with a new service provider or adopt a novel technology, he said.

“The challenge is, ‘Okay, you built this beautiful facility, you have great, talented people, but how many batches have you made clinically? How many INDs have you supported? Has your lentiviral vector been in a clinical or a commercial product? Do you have an approved product that you’ve manufactured for? Have you been part of a BLA?’” Paglia said, recounting the types of questions he often hears from drug developers.

Paglia said the technology developers that he evaluates do a great job on tasks such as toxicology studies and putting together device master files. However, the critical question for ElevateBio’s clients is whether a technology has been used to make a therapy for a patient. Paglia said AMT designations could give companies developing new technologies “a seal of approval, so to speak, from the FDA.”

Proving the Program Works

Foster expects the first Ori partners using the AMT designation to support filings to have candidates in clinical trials in the next six months. The filings will begin to show whether the IRO platform and AMT designation can significantly shorten R&D programs that often take 10 years or more.

“We think we can shave about three years off the development timeline with a combination of faster tech transfer, faster optimization, but also hopefully this prioritization of review through the FDA,” Foster said, adding that that would save “a huge amount of money, a huge amount of time.”

Foster sees these savings as critical to the viability of cell and gene therapies, some of which have improved clinical outcomes but underwhelmed commercially. Reducing the cost of developing and making cell and gene therapies, including by lowering the rate of manufacturing failures, could address one barrier to uptake by driving down the price of the treatments, he said.

If the AMT designation is to contribute to those improvements, the FDA will need to remain committed to the idea amid changes at the agency. The designation emerged during Peter Marks’ time as director of the Center for Biologics Evaluation and Research. Marks left the agency in March. But Foster cited the views voiced by members of the new regime at an event in June as evidence of FDA’s ongoing support for advanced therapies.

“Every indication we have,” the Ori CEO said, “is that the administration continues to greatly support advanced therapies and wants to open up access for patients, which would mean further supporting the AMT designation.”

https://www.biospace.com/policy/as-ori-wins-designation-fdas-advanced-manufacturing-program-nears-proof-point

Regeneron’s Antibodies Block Cat and Birch Allergies With ‘Robust Activity’

 

Regeneron’s antibody duos significantly lowered eye itching and redness, as well as pin prick reactivity, in people with cat and birch allergies. Still, BMO Capital Markets expressed uncertainty about the assets’ “commercial potential in a highly generic market.”

Regeneron’s investigational allergen-blocking antibodies have successfully eased symptoms in two separate late-stage studies of cat and birch pollen allergies.

Writing to investors on Monday, analysts at BMO Capital Markets said Regeneron’s “antibody cocktails” resulted in “robust reductions” in various allergy symptoms, including eye itchiness and redness. BMO is “broadly impressed by the strength” of Regeneron’s findings, though the firm remains uncertain about the assets’ “commercial potential in a highly generic market.”

In the cat study, Regeneron tested a combination of two antibodies—REGN1908 and REGN1909—designed to target the most dominant cat allergen, a molecule called FeID1. Results showed that ocular itch was cut by 52% versus placebo, assessed one week after treatment.

REGN1908 and REGN1909 likewise significantly eased conjunctival redness and skin prick reactivity, with respective effect sizes of 39% and 44%. The antibody combo had stronger efficacy in study participants whose allergies were first confirmed to have been driven by FeID1, resulting in a 65% drop in ocular itching.

Similarly, Regeneron tested two other antibodies, REGN5713 and REGN5715, designed to target BetV1, the dominant allergenic birch pollen protein. Results likewise demonstrated “impressive” symptom reduction, according to BMO, with a 51% decrease in eye itching. Conjunctival redness and skin prick reactivity dropped by 46% and 44%, respectively.

In both studies, Regeneron’s antibody cocktails were safe and well-tolerated, with no dropouts linked to serious treatment-related adverse events. The pharma expects to launch additional late-stage trials later this year for birch allergy and in the first half of 2026 for cat allergy.

Despite these two late-stage wins, BMO raised questions regarding the market prospects of Regeneron’s antibodies. “Commercialization story remains uncertain,” the analysts wrote. “While we do not discount the number of sufferers of allergies, we need to hear more about a potential commercial strategy for Regeneron to penetrate this market, which is heavily dominated by generics like antihistamines.”

Elsewhere in the allergy space, ARS Pharmaceuticals in March won the FDA’s go-ahead for the nasal-spray version of its epinephrine drug neffy, indicated for type I allergic reactions, including anaphylaxis, in children. The approval opened up the use of neffy 1-mg to kids 4 years and older who weigh from 15 kg to less than 30 kg.

https://www.biospace.com/drug-development/regenerons-antibodies-block-cat-and-birch-allergies-with-robust-activity

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