#10 - Patents, approvals, and a dose of setbacks
The (maybe slightly more than) one minute biotech roundup, by SomX.
Greetings and salutations,
Can you jolly well believe it's the 10th edition of our newsletter already?! A big thank you to everyone who's hopped on board the biotech train so far!
This week’s biotech news brings layoffs, legal showdowns over biosimilars, latest developments in CAR-T therapies, and landmark approvals for cancer therapy
Plus, the mpox global health emergency has led to some interesting surges in the stock market.
Cin cin!
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💥 Following rejection and retractions, Lykos caps off a chaotic week by cutting 75% of staff (Fierce Biotech): What a week… Lykos Therapeutics is downsizing, cutting 75% (around 75 people) of its workforce, following an FDA rejection and the retraction of three MDMA phase 2 trial papers due to protocol violations. Despite these challenges, Lykos plans to push forward with clinical research and focus on ongoing FDA engagement.
Our take: In a bid to salvage their MDMA therapy for PTSD – something we last reported as likely heading for FDA rejection – Lykos has made the tough decision to cut staff, and have also brought in industry veteran David Hough M.D. as senior medical adviser. With his expertise, Hough is well-positioned to lead the charge and help Lykos navigate these challenging waters. If anyone can turn this around, it's him.
⚖️ Amgen sues Samsung biotech unit over bone drug copies (Reuters): Amgen is alleging that Samsung's proposed biosimilars Prolia and Xgeva infringe 34 of their patents. The legal twist is, unlike traditional drugs, these complex biologics are made from living cells and can't be copied exactly. While Samsung has sought FDA approval for these biosimilars – which treat osteoporosis and prevent fractures in bone cancer patients – Amgen aims to halt production and grab some hefty damages along the way.
Our take: With Amgen selling a combined $4.2 billion of Prolia and Xgeva in the US last year alone, it’s no surprise they are trying to defend their turf. Biosimilars promise to make treatments more affordable, but patent battles like this could delay their arrival. Amgen's aggressive defence highlights the tension between protecting innovation and fostering competition...the outcome of this case won’t just shape industry dynamics, it could also impact patients who stand to benefit from lower-cost options.
🎯AstraZeneca’s Imfinzi-Lynparza combo wins landmark EU nod for endometrial cancer (BioSpace): Marking the first ever approval of a combination of an immunotherapy and a PARP inhibitor in endometrial cancer, AZ’s therapeutic duo consists of Imfinzi + chemotherapy as a first-line treatment, followed by Lynparza + Imfinzi as a second-line treatment. Targeting mismatch repair proficient (pMMR) endometrial tumours – 70-80% of endometrial cancer patients – the combo has shown impressive Phase III study results, cutting the risk of disease progression or death by up to 45% vs chemo alone.
Our take: While this on its own is a landmark approval, what makes this news even more impactful is that AZ have also got approval for the use of Imfinzi for patients with mismatch repair deficient (dMMR) disease, a further 20-30% of patients. By targeting both types of tumour, AZ's therapies are now approved for use in 90-100% of endometrial cancer patients. A pretty stonking achievement, if you ask us!
🚨 CAR-T drugs and parkinsonism: a cause for concern? (Labiotech): Galapagos has hit the brakes on its phase 1/2 trial for GLPG5301, targeting relapsed or refractory multiple myeloma, after a patient developed parkinsonism. This follows similar concerns from Johnson & Johnson’s Carvykti, where links to both parkinsonism and Guillain-Barré syndrome have been flagged. While the FDA notes these neurological risks are rare, the trial pause certainly puts safety in the spotlight for CAR-T therapies.
Our take: CAR-T therapies have been a game-changer in cancer treatment, offering hope to patients with few other options, but neurotoxic side effects are throwing a spanner in the works here. These concerns could mean tighter regulations and longer development timelines as companies adjust protocols and ensure patient safety. However, as the number of patients affected by these adverse effects is small, the FDA added that the benefits of the drug outweigh the risks.
And finally…
🦠 Health stocks jump as WHO declares mpox global health emergency (CNBC): Bavarian Nordic, maker of the only approved mpox vaccine, saw shares jump 17% last week, while medical tools supplier Precision System Science soared by 40%. This is due to a surge in mpox cases, attributed to a new variant, which is spreading across Africa, causing WHO to declare it a “public health emergency of international concern”. The U.N. has released $1.45 million in contingency funds to tackle the outbreak, with more coming soon.
Our take: While mpox is usually mild, it can be fatal in rare cases, and WHO and the U.N. are attempting to stop cases reaching 2022 levels, when 1000s of cases were reported worldwide. As encouraging as it is to see developers and suppliers’ stock soaring, the challenge now lies in scaling up vaccine production swiftly to meet global demand, highlighting the pharmaceutical industry's ongoing struggle to adapt to rapidly evolving health threats – a stark reminder of the vulnerabilities in our global health infrastructure…
Tune in 🎧
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🔬 Senior Laboratory Technician, Baseimmune: Fancy yourself a lab maestro? With 5+ years of experience and a keen eye for detail, you’ll manage operations, maintain cell cultures, and support in vivo studies and project workflows whilst in a cutting-edge vaccine R&D environment.
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🧠 11.09 | Intelligent Health | Basel, Switzerland: Featuring conversations on AI in medicine, and highlighting the companies and innovations driving adoption across biotech, pharma and healthtech.
🔬 14.09 | The Power of Bioengineering | London, UK: UCL Bioengineering lecturer Alvena Kureshi will share how leading-edge innovations in bioengineering are revolutionising our approach to wound care.
🏆 26.09 | Endpoints 11 | Boston, US: Join Endpoints at their annual awards event, for an evening of fireside chats and editorial conversations. Plus, network with the most promising biotechs in the industry.
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