This Week in Biotech #36
Catch up on the latest biotech breakthroughs and upcoming trends (Jan 17-23).
Welcome to This Week in Biotech by Biotech Blueprint!
THIS WEEK’S KEY TAKEAWAYS 🔑
This week in biotech was marked by several notable updates, particularly in the areas of AI-driven drug development and new clinical trial results. Moderna is finally trading in the green this week, as its stock surged following Oracle Chairman Larry Ellison’s comments on the potential of artificial intelligence in mRNA-based cancer vaccines. Ellison’s comments at the launch of the $500B Stargate Project highlighted the transformative power of AI in accelerating personalized cancer vaccine development, a space where Moderna is already advancing with its mRNA-4157 vaccine. Meanwhile, AbbVie and Neomorph announced a collaboration to develop molecular glue degraders for oncology, a cutting-edge therapeutic approach that targets proteins responsible for cancer growth.
Molecular glue degraders are an emerging class of small molecules that work by selectively binding to and promoting the degradation of target proteins inside cells, which may otherwise be undruggable. Unlike traditional small molecules that simply inhibit protein function, molecular glue degraders recruit the cell’s own degradation machinery to break down specific proteins linked to diseases like cancer or immune system disorders. This innovative approach is generating significant interest, particularly for oncology and immunology.
In clinical trials, ALX Oncology presented positive data from its ASPEN-06 trial at the ASCO Gastrointestinal Cancers Symposium, showing that its CD47 blocker, evorpacept, significantly improved tumor response in HER2-positive gastric cancer. The addition of evorpacept to standard treatments demonstrated a strong overall response rate and durable clinical benefit. On the regulatory side, the FDA approved Amgen’s Lumakras for metastatic colorectal cancer, marking a significant milestone for KRAS-targeted therapies.
In political news, the inauguration of Donald Trump this week further stirred up discussions in the biotech sector, particularly with the revelation that Robert F. Kennedy Jr. owns shares in CRISPR Therapeutics. Kennedy, nominated to lead the U.S. Department of Health and Human Services, holds investments in several biotech companies, which has raised questions about potential conflicts of interest. Despite his stance against pharmaceutical industries, his ongoing investments in biotech could influence policy decisions within the sector, with his Senate confirmation hearing set for later this month.
🎙️ PODCAST
MARKET UPDATES
🔹 Moderna’s (MRNA) stock surged after Oracle Chairman Larry Ellison highlighted the potential of artificial intelligence in the development of mRNA-based cancer vaccines at the launch of the Stargate Project, a $500B AI initiative. Moderna is already using AI to accelerate drug development, and its personalized cancer vaccine mRNA-4157 is currently in late-stage development. Ellison explained that AI could be used to develop personalized cancer vaccines in about two days by analyzing tiny tumor fragments in blood tests. This could lead to early cancer detection and the development of individualized vaccines. Other AI-focused drug developers also saw gains in response to the announcement.
BIOTECH NEWS
🔹 AbbVie and Neomorph announced a collaboration to develop molecular glue degraders for oncology and immunology. Molecular glue degraders are a new class of small molecules that can selectively target and trigger degradation of proteins that drive cancer growth or immune system dysregulation. The collaboration will leverage AbbVie's expertise in oncology and immunology drug development and Neomorph's leading molecular glue discovery platform. Neomorph will receive an upfront payment and is eligible to receive up to $1.64 billion in aggregate option fees and milestones, as well as tiered royalties on net sales.
🔹 Former U.S. Treasury Secretary Larry Summers shared at the World Economic Forum in Davos his prediction that the rapid pace of innovation in “miracle drugs” like Wegovy and Zepbound will continue, with similar breakthroughs happening every few years. He believes new technologies are driving this progress, particularly in the life sciences. However, Novartis CEO Vas Narasimhan cautions that while these drugs are important, they may not fully solve underlying health issues and require lifelong use, emphasizing the need for a broader approach to tackling conditions like obesity.
🔹 Exicure announced the acquisition of GPCR USA, a subsidiary of GPCR Therapeutics. The acquisition includes GPCR’s Opdivo, an autoimmune disease treatment, and Yervoy, a cancer treatment. GPCR USA is currently conducting a phase 2 clinical trial for a new blood cancer drug, daratumumab. The company is also exploring the potential of GPC-100 for the treatment of various diseases, including obesity.
🔹 The FDA has approved Johnson & Johnson’s Spravato (esketamine) nasal spray as a standalone treatment for adults with major depressive disorder who haven’t responded to at least two other antidepressants. This marks the first time a treatment for this condition can be used without an accompanying oral antidepressant.
🔹 Robert F. Kennedy Jr.’s investment in CRISPR Therapeutics caused the company’s stock price to surge by 10% after it was revealed in a disclosure form. Kennedy, nominated to lead the Department of Health and Human Services under Trump, holds between $1,001 and $15,000 in CRISPR shares, along with investments in other companies like Apple, Amazon, and Bitcoin. He has pledged to divest from these assets if confirmed. Despite his criticism of the pharmaceutical industry, Kennedy still holds investments in biotech firms he would oversee if appointed. His Senate finance committee hearing is scheduled for later this month.
🔹 Moderna has announced that they have received ongoing support ($590M) from the U.S. Department of Health and Human Services to accelerate the development of mRNA-based pandemic influenza vaccines. The project will provide additional support for late-stage development and licensure of pre-pandemic mRNA-based vaccines. The agreement will also support the expansion of clinical studies for up to five additional subtypes of pandemic influenza. In 2023, Moderna initiated a phase 1/2 study to generate safety and immunogenicity data of an investigational pandemic influenza vaccine (mRNA-1018) in healthy adults aged 18 years and older. The study included vaccine candidates against H5 and H7 avian influenza viruses. Based on the positive preliminary data from the phase 1/2 study, Moderna is preparing to advance mRNA-1018 into phase 3.
🔹 The FDA has approved Amgen’s Lumakras (sotorasib) in combination with Vectibix (panitumumab) for adults with KRAS G12C-mutated metastatic colorectal cancer. This targeted therapy, the first of its kind for this specific cancer, significantly improved progression-free survival compared to standard treatments in a phase 3 clinical trial. The combination showed positive results in progression-free survival, overall response rate, and overall survival, with a safety profile consistent with previous studies of Lumakras and Vectibix.
🔹 Following the December murder of its CEO Brian Thompson, UnitedHealthcare has appointed company veteran Tim Noel as its new chief executive. Noel previously led the company’s Medicare and retirement division. The healthcare industry is still grappling with the aftermath of Thompson’s death, which sparked outrage over the US healthcare system and led to increased security measures for executives.
CLINICAL TRIAL UPDATES
🔹 Tris Pharma announced positive topline results from its phase 3 ALLEVIATE-1 clinical trial evaluating cebranopadol, a first-in-class dual-NMR agonist (opioid-like painkiller), for the treatment of moderate-to-severe acute pain. The study achieved its primary endpoint of statistically significant reduction in pain intensity compared to placebo following abdominoplasty surgery. Cebranopadol was also well-tolerated, with no serious adverse events related to the drug. These results suggest that cebranopadol could be a safe and effective treatment option for moderate-to-severe acute pain, offering a potential alternative to opioids with a lower risk of addiction and side effects.
🔹 ALX Oncology presented positive updated data from the ASPEN-06 phase 2 trial at the 2025 ASCO Gastrointestinal Cancers Symposium, showing that its investigational CD47 blocker, evorpacept, offers a strong tumor response and durable clinical benefit in patients with HER2-positive gastric cancer. The trial demonstrated that evorpacept, combined with trastuzumab, ramucirumab, and paclitaxel, significantly improved the overall response rate compared to the control group.
🔹 On Jan. 23, Vigil Neuroscience announced positive data from its phase 1 clinical trial evaluating VG-3927 for the potential treatment of Alzheimer’s disease. The data demonstrated a favorable safety and tolerability profile, robust and dose-dependent reduction of sTREM2 in the cerebral spinal fluid, and a favorable pharmacokinetic profile that supports once-daily dosing. Based on these results, the Sanofi-backed biotech plans to advance VG-3927 into a phase 2 clinical trial in Q3 2025. The stock raised by 18% following the announcement.
🔹 On Jan. 22, Lisata Therapeutics announced preliminary Cohort A data from the phase 2 ASCEND trial evaluating their lead asset certepetide in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma. The data showed a positive trend in overall survival, with 4 complete responses observed in the certepetide treatment group compared to none in the placebo group. These results, along with the expectation of even better outcomes in Cohort B, support Lisata’s plans to advance certepetide development to phase 3 in early 2026. The company stock (LSTA) fell nearly 40%.
ON THE HORIZON
🔹 Remaining January FDA PDUFAs:
Jan. 29: Stealth BioTherapeutics is awaiting decision on its New Drug Application for elamipretide, a potential treatment for Barth syndrome. If approved, elamipretide would be the first therapy available for this rare genetic condition, which causes severe heart and muscle problems.
Jan. 29: AstraZeneca and Daiichi Sankyo have submitted a new application for accelerated approval of datopotamab deruxtecan in the U.S. for patients with previously treated advanced EGFR-mutated non-small cell lung cancer. This new application is based on results from the TROPION-Lung05 phase 2 trial and replaces a previous application that has been withdrawn. The companies made this decision based on feedback from the FDA, suggesting a more targeted approach for this specific lung cancer subtype.
Jan. 30: Vertex also awaits an FDA decision on suzetrigine, a potential non-opioid pain medication, by Jan. 30. If approved, suzetrigine would be the first new pain drug in over two decades, offering a non-addictive option for acute pain.
Jan. 31: Axsome Therapeutics expects an FDA decision by Jan. 31 on its resubmitted application for AXS-07, a new oral treatment for acute migraine. The drug offers a potential non-opioid option for migraine relief by inhibiting CGRP release and providing sustained pain freedom. If approved, AXS-07 would be a valuable addition to Axsome’s growing portfolio of neurological treatments.
Have a wonderful rest of your week and thanks for reading Biotech Blueprint!
👩🏻💻 BIOTECH BLUEPRINT CONSULTING
I provide tailored consulting solutions designed to meet the unique challenges of both established companies and startups. My services span a wide range of strategic and technical needs, including:
Research strategy & grant writing
Scientific communication & medical affairs
Data analysis & interpretation
Biotech/pharma innovation & technology assessment
Startup advisory services
I also provide daily Biotech Blueprint newsletters and custom daily analysis (charts & graphs) for individuals and companies.
BOOK A FREE 30-MINUTE CONSULTATION OR A MEET & GREET below.
DISCLAIMER: This content is for informational purposes only. It should not be taken as legal, tax, investment, financial, or other advice. The views expressed here are my own and do not reflect the opinions of any company or institution.
DISCLOSURE: I have no business relationships with any company mentioned in this article.