#08 - Lunar lab breakthroughs

The one minute biotech roundup, by SomX.

Greeting terrestrials 🦤,

Keep your telescopes high and your lab coats handy, as this week’s biotech news is shooting for the stars!

This week, we bring you T-cell therapy approvals, AI-driven drug discoveries, a controversial MDMA therapy trial, and whispers of a universal flu vaccine. And if that’s not enough to pique your curiosity, how about a lunar Ark for Earth’s biodiversity? I bet even Noah couldn’t have predicted that one…

Bon voyage,

Dodo Armstrong

If there’s anything you’d like to see in future editions of Biotech Dodo, send us a message.

Discover 🔍

🧫 FDA clears Adaptimmune T-cell therapy for soft tissue cancer (pharmaphorum) – The FDA has finally given the nod to Adaptimmune's Tecelra, a rather clever T-cell therapy for synovial sarcoma. It's been a jolly long wait – over a decade, in fact – since we've seen any new treatments for this type of cancer. Designed for adults with unresectable or metastatic cases where chemotherapy's fallen short, the therapy could be quite the lifeline.

Our take: What a milestone! Tecelra is the first FDA-approved engineered T-cell therapy for solid tumours, which are notoriously tricky to treat. The therapy, which targets the MAGE-A4 antigen, shows remarkable improvements in response rates and overall survival for patients with this rare cancer. Not to be slowed down, Adaptimmune is fuelling up with a second therapy in the pipeline.

🧠 It took more than two decades for MDMA to reach the FDA. In two months, its prospects cracked. What happens next? (Endpoints) – After 20+ years of research, Lykos Therapeutics’s MDMA therapy for treating PTSD faces potential FDA rejection. Despite positive Phase 3 results, concerns about trial design and data collection are under scrutiny, with patient safety and abuse potential at the forefront of the FDA advisory committee’s worries. Lykos is preparing for all outcomes, including another trial or additional data requests.

Our take: Clearly challenges remain with bringing psychedelics to market. While a fascinating intersection of neuroscience, psychiatry and pharmacology, Lykos’ approval is looking unlikely due to a litany of concerns expressed by the committee – and an overwhelming number of votes against the FDA recommendation. Whatever the outcome, hopefully we won’t have to wait another 20 years for a new PTSD treatment.

🤖 Healx, an AI-enabled drug discovery platform for rare diseases, raises $47M (Tech Crunch) –  Well, I say! Cambridge's own Healx has secured $47 million in a Series C round co-led by Europe’s Atomico and Silicon Valley’s R42. Healx’s AI drug discovery pipeline matches complex biological disease signatures with small molecules and drugs to advance rare disease treatment. With regulatory clearance in hand, they're also set to begin Phase 2 clinical trials with a daily oral tablet for NF1 in the US this year.

Our take: The sky’s the limit for Healx! Their AI wizardry looks at all manner of existing drugs in development, including ones that have been shelved, helping give the traditionally slow and expensive drug discovery process a head start. In fact Healx’s lead NF1 candidate, HLX-1502, reformulates an existing drug – leveraging prior safety data to potentially reduce side effects. The potential payoff? The market size for NF1 alone is a cool $16 billion.

💉 Is a universal influenza vaccine on the horizon? (BioTechniques) – Researchers at Oregon Health & Science University have successfully repurposed an HIV and TB vaccine platform to tackle the H5N1 influenza variant, a deadly flu virus pegged to be the next pandemic front-runner. The unusual vaccine design involves inserting fragments of target pathogens into cytomegalovirus (common herpes), using the 1918 influenza virus flu variant as template.

Our take: Interestingly the 1918-based vaccine protects against the H5N1 variant – opening up the possibility of a “universal” flu vaccine that not only protects us from current flu strains, but also ones that have yet to be identified. Such adaptability is essential for rocketing past new emerging viral threats and could change the infectious disease landscape of the future. A 'one and done' flu jab? Count Dodo in!

And finally…

🌙 Scientists propose lunar biorepository as ‘backup’ for life on Earth (The Guardian) – Watch out Noah, scientists have proposed a lunar Ark to protect Earth's endangered creatures!  A lunar biorepository could be the perfect place for important DNA samples to shelter from a climate breakdown and other Earth-based disasters. The moon's consistent -196°C temperature provides ideal conditions for long-term cell preservation, potentially enabling future cloning or genetic diversity enhancement.

Our take: Well, who'd have thought the barren moon ideal for life?! The naturally cryogenic environment of the moon eliminates the need for active cooling systems – reducing those pesky electric and liquid nitrogen bills – and is protected from the effects of global warming. While still largely theoretical, this concept emphasises the need for radical, international approaches to biodiversity conservation. Do they do Dodo shaped spacesuits?

Tune in 🎧

The Long Run
Luke Timmerman is joined by Sean McClain, founder and CEO of Absci, to discuss using AI to speed up biologic drug discovery. 

Data in Biotech
Ross Katz chats to Jonathan Eads, VP of Engineering at genomics intelligence company Genomeno, about his work on extracting genomic evidence to make it usable.

The Emerging Biotech Leader
Kim Kushner and Dr. Chantal van Gils, an SSI Strategy expert, talk about evidence requirements for medical devices, patient-focused drug development, and investing in real-world evidence generation.

Apply ✍️

🇺🇸 Center Director, Center for Devices and Radiological Health, FDA – Stickler for the rules? The FDA is looking for a dynamic leader to head up its Center for Devices and Radiological Health. Applicants must have 15+ years of experience in public health or medical product regulation and a deep understanding of FDA policies and programs.

🧪 Chemistry Lead, Siftr Bio – Ready to be a pioneer? Newly founded Siftr Bio is on the lookout for a brilliant organic/medicinal chemist to lead chemistry programs targeting small molecules and biologics. With a PhD in organic chemistry, you'll drive projects, tackle synthetic challenges, and shape Siftr’s scientific direction.

⚙️ Senior Engineer, MSAT, CARGO Therapeutics – Obsessed with cell therapy manufacturing? CARGO is seeking a Senior Engineer to lead tech transfers and optimise manufacturing processes. With 8+ years in biotech, especially cell therapy, you’ll play a key role in advancing CARGO’s clinical-stage portfolio.

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