#20 - No tricks – just frighteningly fast approvals
The coffee break biotech roundup, by SomX.
Good evening fellow night owls,
This week, we've stirred up a cauldron of biotech delights: a world-first trial is set to haunt brain cancer into retreat; Lilly and J&J unveil eerily effective data for Crohn's treatments; Massachusetts conjure tax incentives for life sciences; AbbVie unlock the gates of the blood-brain barrier; and Sangamo perform a time-bending feat for its Fabry gene therapy.
And in the spirit of the season, we're thrilled to announce we've reached 500 subscribers! A heartfelt thank you to you all for joining our coven.
Yours ghoulishly,
Count Dodracula
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🧠 World-first trial could revolutionise brain cancer treatment (The Independent): Glioblastomas are notoriously aggressive and enigmatic cancers, adept at slipping past traditional therapies. But a new trial is taking a dynamic approach: by personalising the therapies participants receive, guided by their genomic makeup, researchers can test multiple drugs over a shorter period. With £3.36M from Cancer Research UK and Minderoo Foundation, this trial could pave the way for an agile and targeted approach to treating brain cancer.
Our take: After two decades and over a thousand brain cancer trials yielding little to no breakthrough, this study takes a whole new approach to clinical trials. Instead of inching through single-drug studies, researchers are testing multiple treatments side-by-side, including drugs developed for other cancers. Using whole genome sequencing to match therapies to each patient’s unique tumour profile could not only unlock a bespoke approach to brain cancer, but could help speed up the development of new treatments too.
✅ Awaiting expanded approvals, Lilly and J&J release late-stage data for Crohn's treatments (Endpoints): Well isn’t this quite the treat… J&J's Tremfya (guselkumab) has achieved significant clinical remission in 66% of patients during a Phase 3 study for moderate-to-severe Crohn's disease – outshining the placebo (17% remission) and potentially becoming the only IL-23 inhibitor offering both subcutaneous and intravenous options. Not to be outdone, Lilly's Omvoh (mirikizumab) showcased that 81% of ulcerative colitis patients maintained long-term remission in their Phase 3 trial.
Our take: It looks like targeting the IL-23 pathway might just be the golden ticket for Lilly and J&J. Traditionally, treatments for Crohn's have been rather like using a sledgehammer to crack a nut: effective but with a litany of side effects and fleeting relief. With Tremfya and Omvoh demonstrating sustained remission, we could see a significant leap forward in patient care, improving quality of life and potentially reducing healthcare costs from hospitalisations and complications.
💼 Massachusetts tax incentives for Moderna, Vertex and more creating 1,155 jobs (BioSpace): In a thrillingly bold move, the Massachusetts Life Sciences Center is awarding $21.4 million in tax incentives to 19 life science companies across drug discovery, medical devices, diagnostics, and manufacturing – creating over 1,155 new jobs – in a bid to make the state “the best place in the world to launch and scale life sciences solutions.”
Our take: Massachusetts has long been a cornerstone of the global biotechnology landscape and with 17 of the companies investing in job creation – not just in the usual Boston and Cambridge haunts – the new tax breaks will nurture emerging biotech clusters and diversify the talent pool across the state. Amidst stiff competition and funding challenges in the biotech sector, this decentralisation is a smart play to bolster local economies whilst ensuring long-term stability.
🤝 AbbVie to acquire a J&J-backed brain drugmaker for $1.4B (BioPharma Dive): It’s a happy halloween indeed for Aliada Therapeutics – a young biotech boasting Johnson & Johnson's clever drug delivery technology – who is being acquired by AbbVie, for the tidy sum of $1.4 billion in cash. Aliada specialises in ferrying therapeutics across the notoriously selective blood-brain barrier, a formidable obstacle in treating neurological diseases like Alzheimer's. The deal, expected to close by year's end, aims to bolster AbbVie's neuroscience endeavours, which it has marked as a "key growth area."
Our take: The blood-brain barrier has long thwarted neurological treatments by acting as the brain's steadfast gatekeeper. By utilising innovative delivery mechanisms to transport complex therapeutics into the central nervous system, there's potential to address neurological conditions that have long eluded effective treatment such as Alzheimer's, Parkinson's, and other CNS disorders! Ooooooo 👻.
And finally…
⏱️ Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package (Fierce Biotech): Sangamo’s Fabry gene therapy, ST-920, just got a major boost as the FDA granted it an accelerated approval pathway, slicing an estimated three years off its journey to market. The FDA has graciously agreed to accept data from the ongoing Phase 1/2 trial for accelerated approval, using the eGFR slope at 52 weeks – a reliable measure of kidney health – as an intermediate clinical endpoint. ST-920 could enable patients to produce their own enzyme and reduce their reliance on regular treatments like Sanofi's Fabrazym.
Our take: A stroke of good fortune for Sangamo! The company had previously pressed pause on their ST-920 efforts while seeking additional funding and a suitable partner. This new route to approval will sidestep a lengthy Phase 3 trial, not only saving time but also a fair bit of capital. And with shares in Sangamo jumping 33% in the wake of the news, they could now be looking a little more attractive to potential investors and partners…
Tune in
Reinventing your China strategy
McKinsey’s Franck Le Deu and Wendy Pan, of BayHelix and Goodwin, join BioCentury to discuss the trends and dynamics affecting biotech innovation and partnerships within China.
The pulse of the medtech industry
John Babbitt, Partner in life sciences at Ernst & Young, discusses medtech M&As, venture capital funding and recent IPOs, as well as how the record number of AI approvals from the FDA is addressing healthcare demands.
Steady but slow: future outlook for investment
Konstantina Katcheves from Teva Pharmaceuticals and TOWER Capital’s Sanskriti Thakur discuss 2024’s economic shake-ups and share what might be on the cards for biotech in 2025.
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