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AstraZeneca Enters Strategic Drug Discovery Agreement with insitro
AstraZeneca announced that it has entered into a new strategic drug discovery collaboration and licensing agreement with insitro, a leading artificial intelligence therapeutics company. Using advanced AI systems, the collaboration will identify novel drug targets and advance the design of new therapeutics for patients for metabolic dysfunction-associated steatohepatitis, MASH, and cardiomyopathies. insitro will apply its Virtual Human AI platform to identify causal disease biology across both indications and advance AstraZeneca-nominated targets from discovery through to development candidate. Under the terms of the agreement, insitro will receive an upfront payment of $40M, and is also eligible for up to approximately $1.46B in potential development and commercial milestones, plus potential single digit royalties based on global commercial sales.
EU Sets 350,000 Annual Import Limit on Chinese Hybrid Vehicles
Catch up on the weekend's top five stories with this list compiled by The Fly: 1) The European Union will instill a 350,000-car limit per year for imports of Chinese hybrid vehicles, with the measure taking effect as soon as December 1, Alberto Nardelli and Jorge Valero of Bloomberg reports, citing a document outlining the plan seen by the journal. The cap will increase annually by 6% starting the second year of application. The cap will apply to all imports of hybrids. Publicly traded companies in the space include BYD (BYDDY), Geely (GELYF), Honda (HMC), Mercedes-Benz (MBGYY), Nissan (NSANY), Stellantis (STLA), Toyota (TM) and Volkswagen (VWAGY). 2) Amazon (AMZN) is in discussions to acquire Decart, an AI startup, in a deal that may be valued around $7B, Kate Clark and Lauren Thomas of The Wall Street Journal reports, citing people familiar with the matter. A deal could come soon if talks don't fall apart or another suitor doesn't emerge, the sources added. 3) Pennsylvania Governor Josh Shapiro and Department of Community and Economic Development, DCED, Secretary Rick Siger announced the Commonwealth has secured an over $800M investment from global biopharma company GSK (GSK) to expand its operations in Montgomery County. The expansion will create more than 300 new jobs over the next five years, retain approximately 4,500 existing full-time jobs across the Commonwealth, and continue growing Pennsylvania's life sciences industry. GSK is expanding its facilities in Upper Merion Township, with construction planned to begin in 2027. 4) Nvidia (NVDA) is in discussions to either acquire or increase its investment in Reflection AI, a US start-up, George Hammond, Michael Acton, George Steer, and Arash Massoudi of The Financial Times reports, citing people with direct knowledge of the matter. Discussions are currently in the early stages, and a deal could take different forms, the sources added. 5) AstraZeneca (AZN) announced results from the HICKORY Phase III trial showed that efzimfotase alfa, ALXN1850, did not achieve statistical significance but demonstrated a numerical improvement in the primary endpoint of Six-Minute Walk Test in adolescents and adults with hypophosphatasia, HPP, who had not been previously treated with Strensiq at week 25, compared to placebo. In the overall population, at week 25, efzimfotase alfa achieved a least squares mean difference of 17.05 metres change from baseline in the primary endpoint of 6MWT, compared to placebo.
efzimfotase alfa Shows Improvement in HPP Trial
Results from the HICKORY Phase III trial showed that efzimfotase alfa, ALXN1850, did not achieve statistical significance but demonstrated a numerical improvement in the primary endpoint of Six-Minute Walk Test in adolescents and adults with hypophosphatasia, HPP, who had not been previously treated with Strensiq at week 25, compared to placebo. In the overall population, at week 25, efzimfotase alfa achieved a least squares mean difference of 17.05 metres change from baseline in the primary endpoint of 6MWT, compared to placebo. The lack of statistical significance was largely due to better-than-expected results observed in the adult-onset HPP placebo group. In a post hoc analysis, at week 25, 45.2% of patients treated with efzimfotase alfa achieved the minimum clinically important difference, MCID, from baseline in 6MWT, compared to 30.0% in the placebo group, indicating a 2.5-fold higher odds of achieving a clinically meaningful 6MWT response. In the overall population, at week 25, efzimfotase alfa demonstrated nominally significant improvement in the key secondary endpoint of FACIT-Fatigue, achieving an LS mean difference of 5.74 vs placebo. Other key secondary endpoints numerically favoured efzimfotase alfa, including 30-second Sit-to-Stand, Lower Extremity Functional Scale and BPI-SF Pain Severity.
Guardant Health's Guardant360 CDx Receives CE Mark in Europe
Guardant Health (GH) announced that Guardant360 CDx has received CE-marking under Europe's in Vitro Diagnostic Medical Devices Regulation as a companion diagnostic to identify patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer who may benefit from treatment with ETCAMAH, AstraZeneca's (AZN) next-generation oral selective estrogen receptor degrader and complete ER antagonist. Approval in Europe reinforces Guardant Health's commitment to enabling practice-changing ongoing monitoring across the world's largest healthcare markets. With Guardant 360 CDx, clinicians can test for ESR1 mutations in tumors through a simple blood draw, ahead of disease progression. This approach reinforces the transformative role of liquid biopsy in guiding therapy decisions earlier in a breast cancer patient's journey. The European approval follows prior regulatory approvals of Guardant360 CDx as a companion diagnostic for ETCAMAH in the United States and Japan. "Guardant360 CDx offers molecular insights that can support informed treatment decisions for patients with advanced breast cancer, addressing the disease before it gets out of control," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "What is even more exciting is that we see tremendous potential for this type of testing protocol to transform the treatment of other cancer types to change the future of oncology."
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