Eyes on BioPharma Headlines

This month, we've had Eyes on investment trends, strategic restructuring, and FDA decisions. Fall seems to be gearing up, and we can't wait to see what's next.

Biopharma venture capital reached its highest quarterly level since 2022, although obstacles remain in the exit market.

In the second quarter of this year, venture capital investing in the biopharmaceutical industry reached a record high of $9.2 billion across 215 agreements, the most since the same quarter in 2022. This contrasts with the $7.4 billion from 196 agreements recorded in the previous quarter.

According to some analysts, the industry’s adjustment to current federal interest rates plus restored trust in the sector may account for the funding increase. Nonetheless, a portion of the high amount is due to the success of large venture capital companies (VCs) in AI and obesity-related mega-rounds, like Xaira's $1 billion fundraising or Metsera’s $290 million launch capital.

Exits were reduced, however, from $10 billion across 24 firms in the first quarter of 2024 to $4.5 billion across 15 companies in the second. The overall M&A cycle has slowed, though there were several significant ones, such as Profound Bio / Genmab and Escient Pharma / Incyte. IPOs were mixed, with a smaller number of high-quality companies going public.

For more details check out the links below:

• JPM Outlook

• Pitchbook

• BioPharmaDive

Eli Lilly's external innovation and cooperation arm, Lilly Catalyze360, is accepting new members as it continues to leverage its Mounjaro and Zepbound cash flow for significant outside acquisitions.

FierceBiotech notes that Lilly has significantly increased its presence in fields like neurodegeneration, pain, diabetes, obesity, and oncology in recent years, both domestically and abroad. However, the company appears open to exploring additional areas outside of those domains.

Eli Lilly CEO David Ricks formally introduced Lilly Catalyze360 at the J.P. Morgan Healthcare Conference in January of this year. Three major pillars support the program: Lilly Ventures, Lilly Gateway Labs, and Lilly ExploR&D. Lilly Ventures seeks to be a global partner and investor for biotech companies, whereas Gateway Labs offers researchers co-working spaces that double as accelerators. ExploR&D's goal is to provide drug developers with Lilly's clinical development and investigational novel drug-enabling capabilities.

According to a spokeswoman, as of May, about 20 businesses had used Lilly's Gateway Labs concept, and a comparable number of biotechs had registered for ExploR&D. Many of Catalyze360's early collaborative agreements, meanwhile, have not yet been made public.

For more details, check out the links below:

• FierceBiotech

• PharmaTell Studio

• PharmaTell Studio

Eli Lilly has recently entered into a drug discovery partnership with Genetic Leap, an RNA specialist, in an AI-enabled arrangement valued up to $409 million in upfront and milestone payments.

Genetic Leap, a New York-based company, is based on AI models intended to aid in identifying medications that target RNA. The stack includes tools for identifying fresh targets and figuring out how to interact with verified but unhackable targets. In 2022, Astellas and the biotech company collaborated to employ the platform to identify small compounds with an RNA target against an unknown oncology target.

Lilly has now become a partner in Genetic Leap. Under a research agreement with Big Pharma, Genetic Leap will create genetic therapeutic candidates against specific targets by utilizing its RNA-targeted AI platform. Lilly will select targets in high-priority areas, and Genetic Leap will develop oligonucleotide medications to combat the targets.

Because of this, Genetic Leap is now a member of a group of biotech companies trying to change the way people think about RNA drugs. RNA technology was thought to fit poorly with small molecules because they are inherently polarised molecules with short binding spaces. But biotech companies like Arrakis Therapeutics, which have emerged in the last ten years, are starting to make progress.

For more details, check out the links below:

• Reuters

• PharmaTell Studio

• PharmaTell Studio

Regeneron's intentions to take on Johnson & Johnson and Pfizer in the blood cancer market have been slowed by the FDA.

Regeneron has received a CRL (comprehensive response letter) regarding problems at a third-party manufacturer for Linvoseltamab, a bispecific antibody that targets BCMAxCD3. Linvo was submitted for approval by Regeneron based on phase 1/2 data in patients with relapsed or refractory multiple myeloma. After accepting the application for priority review, the FDA scheduled a decision date of August 22. Regeneron disclosed at the beginning of August that a manufacturing issue would probably cause the decision to be postponed past the PDUFA deadline. 

Regeneron reports that the FDA sent the CRL on the results of a preapproval inspection conducted at a third-party fill/finish manufacturer for a product candidate from another business. The third-party manufacturer informed Regeneron that it expects a reinspection that might conclude the matter and believes the FDA's findings have been addressed. Similar remarks were made by Regeneron on its earnings call at the beginning of August, implying that the manufacturer has been working on the improvements for at least a few weeks. The business anticipates a re-inspection in the "coming months."

Findings from an inspection at a Catalent facility denied Regeneron's application for approval of Eylea HD last year. Seven weeks after revealing the denial, the business received approval for Eylea HD.

Despite losing its competitive advantage to competing treatments, the bispecific, presently undergoing evaluation by the European Medicines Agency, has produced data indicating it could potentially have an advantage compared to Tecvayli from J&J and Elrexfio from Pfizer. The trial's overall response rate (ORR) was 71%, and its complete response rate (CRR) was 46%.

Beyond efficacy, Regeneron states that linvoseltamab may be more advantageous depending on the rate of cytokine release syndrome and the speed at which this adverse event manifests, the possibility of fewer hospital days for patients compared to those on competing medications, and the possibility of lower dosing frequency.

For more details, check out the links below:

• PharmaTell Studio

• PharmaTell Studio

• PharmaTell Studio

Ira Mellman, a prominent cell biologist and unit leader at Genentech who has spent 17 years with the company, will leave in the coming months. Genentech will also terminate its cancer immunology research department.

To create a single cancer research body inside Genentech Research and Early Development, the company's cancer immunology research function and its molecular oncology research—now headed by Frederic de Sauvage—will merge.

In addition to the oncology shakeup, the departments of immunology and neuroscience in research biology will merge with the discovery functions from Genentech's human pathobiology and OMNI reverse translation group.

Management says that the reorganization will impact few employees. The decision was made in response to Genentech's clinical work in cancer immunotherapy, which, in certain cases, has not produced good enough results. Most notably, tiragolumab, the company's closely monitored anti-TIGIT program, is barely surviving after multiple setbacks, the most recent of which occurred in first-line nonsquamous non-small cell lung cancer in conjunction with the PD-L1 inhibitor Tecentriq. The business also ended its Adaptimmune collaboration on allogenic cell therapy in April.

More generally, the business announced in April that Roche has been closely examining its pipeline lately, which has resulted in the termination of 20% of its total number of new molecular entities since the third quarter of 2023. Genentech is one of the primary drug R&D engines for the parent company of Swiss pharmaceuticals. The April announcement noted that beginning in June, about 43o employees, or around 3% of its workforce, would be let go from various divisions.

For more details, check out the links below:

• PharmaTell Studio

• PharmaTell Studio

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