Sparks Fly in Biotech — This Week in Biotech #59
Bispecifics, macrocycles, and in vivo CAR-T show targeted power in a volatile regulatory climate (June 27 – July 2, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 59, covering biotech & pharma news from June 27th to July 2nd, 2025.
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THIS WEEK IN BIOTECH VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Regeneron scores a major win with FDA accelerated approval of Lynozyfic, a BCMAxCD3 bispecific for late-line multiple myeloma. A 70% response rate, biweekly/monthly dosing options, and long durability position it as a potential best-in-class contender.
Argenx bets on macrocyclic peptides, striking a $1.5B deal with Unnatural Products to go after previously “undruggable” targets. The AI-driven platform could redefine how oral therapeutics engage intracellular proteins.
RFK Jr. moves to overhaul vaccine injury compensation, aiming to broaden Covid-19-related claims. The initiative may carry reputational and legal implications for all major vaccine developers.
AbbVie enters the in vivo CAR-T race, acquiring Capstan Therapeutics for up to $2.1B. Its lipid nanoparticle platform reprograms CD8+ T cells in situ, a scalable alternative to ex vivo cell therapies.
China’s obesity drug landscape heats up as Innovent wins approval for mazdutide, the first dual GLP-1/GCG agonist on the market. It may offer a local, cost-competitive rival to Wegovy and Zepbound ahead of semaglutide’s 2026 patent expiry.
Moderna’s flu vaccine delivers strong phase 3 data, outperforming standard shots by 26.6% in adults 50+, reinforcing mRNA’s potential in seasonal respiratory immunization and paving the way for combination flu/COVID vaccines.
The CDC expands RSV vaccine guidance to include at-risk adults aged 50–59 and backs GSK’s broad meningococcal shot for young adults. Moderna, still awaiting FDA approval for its RSV candidate in 18–59-year-olds, saw its stock climb 5% yesterday and 11.5% over five days.
The Supreme Court upholds ACA preventive care coverage, preserving zero-cost access to HIV PrEP and cancer screenings for over 150M Americans. Gilead and diagnostics firms rallied on the news.
WHO reiterates that thimerosal is safe, countering rising U.S. concerns after RFK Jr.’s revamped vaccine panel suggested thimerosal-free flu shots. No new evidence of harm was presented.
BIOTECH/PHARMA NEWS 🧬
🔹 The FDA has granted accelerated approval to Regeneron’s Lynozyfic, a BCMAxCD3 bispecific antibody, for adults with multiple myeloma who have failed at least four prior treatments. In the phase 1/2 trial, it showed a 70% response rate, including 45% complete responses, rapid and long-lasting effects with 89% duration at nine months. It is the first bispecific offering adjustable dosing (biweekly or monthly) for responders. Safety warnings include risks of cytokine release syndrome and neurological effects. A confirmatory trial is underway.
🔹 Argenx has entered a multi-target agreement worth up to $1.5 billion with Unnatural Products (UNP) to develop oral macrocyclic peptides targeting challenging “undruggable” proteins. UNP will lead early-stage discovery and preclinical work, leveraging its AI-driven macrocycle platform, while Argenx retains the option to advance candidates into clinical development. Macrocyclic peptides combine the binding precision of antibodies with the oral delivery advantages of small molecules, thanks to their stability and ability to penetrate cells, making them ideal for previously unreachable targets.
🔹 In a recent interview, RFK Jr. stated that his team at HHS is launching efforts to overhaul how the U.S. compensates individuals who report vaccine-related injuries, with a specific focus on expanding coverage to include Covid-19 vaccines. Kennedy criticized the existing Vaccine Injury Compensation Program as overly legalistic and narrow in scope, pointing to a need for broader access and a longer timeframe to file claims. While he didn’t name specific manufacturers, the initiative could have implications for companies like Pfizer, Moderna, J&J, AstraZeneca, and Novavax, all of which developed COVID-19 shots. The proposed changes, though still early, signal a potentially significant shift in how the U.S. handles post-vaccine adverse event reporting and compensation.
🔹 IGM Biosciences has agreed to be acquired by Concentra Biosciences for $1.247 per share in cash, plus a contingent value right (CVR) tied to the company’s remaining net cash and potential asset sales. The biotech firm, known for its engineered IgM antibody platform, faced significant challenges in recent years and is now being absorbed by a private buyer aiming to extract value from its assets. The deal is expected to close by Aug. 2025, pending a successful tender offer.
🔹 Unicycive Therapeutics received a Complete Response Letter from the FDA for its drug candidate oxylanthanum carbonate (OLC), intended to treat hyperphosphatemia in chronic kidney disease patients on dialysis. The rejection stemmed from manufacturing deficiencies at a third-party vendor, with no concerns raised about OLC’s clinical, safety, or preclinical data. Despite noting that the company has a backup manufacturer, already experienced with OLC production, the stock dropped nearly 25%. The company maintains a cash runway into the second half of 2026 and remains optimistic about moving forward with FDA approval.
🔹 AbbVie has announced plans to acquire Capstan Therapeutics for up to $2.1B, gaining access to CPTX2309, a first-in-class in vivo CAR-T therapy currently in phase 1 for B cell-mediated autoimmune diseases. Unlike traditional ex vivo CAR-T treatments, CPTX2309 uses Capstan’s targeted lipid nanoparticle (tLNP) platform to deliver mRNA directly to CD8+ T cells in vivo, reprogramming them to attack disease-driving B cells without complex manufacturing or preconditioning. Capstan’s broader tLNP technology may enable future applications across a range of autoimmune conditions.
🔹 Innovent Biologics has received Chinese regulatory approval for mazdutide, the first approved dual GCG/GLP-1 receptor agonist for chronic weight management. Originally developed by Eli Lilly, the drug demonstrated up to 14.8% weight loss at 48 weeks in the GLORY-1 trial, with notable benefits in waist circumference and liver fat reduction, an important factor in a country where fatty liver disease affects nearly a third of the population. While heavyweight competitors Wegovy and Zepbound are already approved in China, adoption has lagged, due in part to pricing and distribution. With semaglutide’s patent set to expire in China in 2026, mazdutide could capture market share as a locally produced, potentially more accessible option. Analysts project strong upside, with global sales estimates ranging from $566M by 2029 to $1.3B by 2030, signaling that Innovent may emerge as a significant force in China’s rapidly evolving obesity drug market.
CLINICAL TRIAL UPDATES 📊
🔹 Organon released results from its phase 2 proof-of-concept study, showing that OG-6219 did not significantly reduce endometriosis-related pain compared to placebo. The trial assessed the efficacy, safety, and tolerability of OG-6219 in premenopausal women aged 18–49 with surgically confirmed endometriosis. Organon, a women’s health-focused spin-out from Merck, acquired OG-6219 in 2019 from Forendo Pharma and had been developing the drug as its lead candidate for endometriosis. Following these results, Organon will discontinue development of OG-6219 and shift focus to other pipeline programs.
🔹 Moderna announced positive phase 3 results for its seasonal flu vaccine candidate mRNA-1010, which showed 26.6% greater efficacy than a standard dose flu vaccine in adults 50+. The vaccine performed well across all included influenza strains and age groups, with similar safety and tolerability to existing options. The trial enrolled over 40k participants across 11 countries. Given the strong data, especially following one of the worst flu seasons in 15 years, Moderna plans to engage regulators and pursue approvals. The company also highlighted the potential for mRNA-based flu vaccines to support faster strain matching and combination products with COVID-19.
🔹 INmune Bio experimental Alzheimer’s drug XPro delivered a mixed bag in its phase 2 trial. While the study failed to meet its primary cognitive endpoint across the full patient group, a defined subgroup, those with amyloid positivity and elevated inflammation, showed encouraging improvements in cognition, behavior, and disease biomarkers. Notably, levels of pTau217, a hallmark of Alzheimer’s pathology, were reduced. Despite the safety profile being clean, including no ARIA events in high-risk patients, Wall Street’s reaction was swift, with shares plunging over 60% premarket.
PUBLIC HEALTH SPOTLIGHT 🦠
🔹 The CDC has approved expanded use of RSV and meningococcal vaccines based on an April panel recommendation, even after Health Secretary RFK Jr. disbanded the Advisory Committee on Immunization Practices. RSV shots are now recommended for adults aged 50–59 who are at higher risk, and GSK’s pentavalent meningococcal vaccine is endorsed for healthy 16–23-year-olds and at-risk individuals aged 10+. Meanwhile, Moderna (MRNA), whose RSV vaccine mRESVIA hasn’t yet received FDA approval for the 18–59 age group, saw its stock climb over 5% yesterday and is up approximately 11.5% over the past five days, a reaction to the CDC’s broader support for RSV immunization.
🔹 The U.S. Supreme Court’s 6-3 decision to uphold a key Affordable Care Act provision requiring insurers to cover preventive services at no cost has major public health and market implications. The ruling preserves access to screenings and HIV prevention for over 150M Americans, affirming the constitutionality of the U.S. Preventive Services Task Force’s appointments. Public health experts welcomed the move. The decision also lifted healthcare stocks tied to preventive care. Cancer screening companies like Exact Sciences (EXAS), Guardant Health (GH), and Labcorp (LH) saw gains, as did Gilead (GILD), whose newly approved twice-yearly injectable HIV PrEP, Yeztugo, now stands on firmer reimbursement ground.
🔹 A new WHO report reaffirms that COVID-19 likely originated through zoonotic spillover, transmission from wild animals, likely bats, to humans in China. While the leading theory remains animal to human transfer, WHO Director General Tedros Ghebreyesus emphasized that a lab-related origin, such as a leak from the Wuhan Institute of Virology, cannot be ruled out due to insufficient data. The WHO criticized the Chinese government for withholding key information, including early genetic sequences and lab biosafety details. Ultimately, the panel concluded it still cannot determine when, where, or how SARS-CoV-2 first entered the human population.
🔹 The WHO reaffirmed on Friday that thimerosal, a mercury-based preservative used in some vaccines, poses no known harm, countering renewed concerns after the CDC’s vaccine advisory panel recommended thimerosal-free flu shots in the U.S. Dr. Katherine O’Brien of the WHO emphasized that the compound has been thoroughly reviewed by multiple global health agencies, with no evidence of harm found.
AI SUMMARY 🎙️
Listen to an AI-generated summary of this episode below.
ON THE HORIZON 🔭
🔹 July 2025 FDA PDUFAs:
July 10: Regeneron’s Lynozyfic ✅ APPROVED
July 22: Replimune Group Inc.’s Vusolimogene oderparepvec for advanced melanoma.
July 23: GSK’s Blenrep for the treatment of relapsed/refractory multiple myeloma.
July 27: Royalty Pharma’s aficamten for the treatment of obstructive hypertrophic cardiomyopathy.
July 28: Apellis Pharmaceuticals’ Pegcetacoplan for kidney disease.
July 29: PTC Therapeutics’ Sepiapterin for phenylketonuria.
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