Introduction
After 14 years on the board of Moderna, Robert Langer, Sc.D., a co-founder of the biotech company known for its groundbreaking mRNA vaccine for COVID-19, is stepping down. Langer will continue to contribute as an advisor, marking the end of an era and the beginning of a new chapter for both Langer and Moderna.
Robert Langer’s Impact on Moderna and Beyond
Robert Langer is a titan in the field of chemical engineering and biotechnology. As one of the nine Institute Professors at MIT, the highest rank achievable by a faculty member, Langer’s contributions to science and technology are immense. His prolific career includes over 1,600 academic articles and more than 1,495 issued and pending patents, making him the most cited engineer in history. His extensive research lab has been the cradle for numerous companies, some of which have been acquired by major pharmaceutical giants like Johnson & Johnson and Pfizer.
A Pioneering Journey with Moderna
Langer’s association with Moderna began long before the company became a household name. Moderna was incubated within Flagship Labs, the innovation branch of Flagship Pioneering, before officially launching in 2010. Langer’s vision and expertise have been integral to the company’s success, particularly in the development of its mRNA technology.
In a press release announcing his retirement from the board, Langer expressed his pride in the company’s achievements and his continued commitment to its future: “I have decided that now is the right time for me to step down. It has been an honor to contribute to the groundbreaking work and incredible progress the company has achieved.” His advisory role will allow him to continue influencing the company’s strategic direction.
Leadership Changes at Moderna
Alongside Langer’s departure, Stephen Berenson, managing partner at Flagship Pioneering, will also step down from Moderna’s board. David Rubenstein, co-founder and co-chairman of The Carlyle Group, will join the board effective August 5, bringing a new perspective to the company. These changes signify a strategic shift as Moderna continues to evolve and expand its influence in the biotech industry.
Langer’s Legacy and Future Endeavors
Langer’s influence extends beyond Moderna. He served on the FDA’s Science Board from 1995 to 2002, including a term as chairman from 1999 to 2002. In 2015, he received the Queen Elizabeth Prize for Engineering, one of the highest honors in the field, for his pioneering advances at the intersection of engineering, chemistry, and medicine.
Langer’s legacy is not just limited to his scientific achievements. His son, Michael Langer, acknowledged his father’s contributions in a LinkedIn post, expressing excitement about working alongside him to build the next generation of biotech companies. This sentiment highlights Langer’s enduring commitment to innovation and mentorship in the biotech community.
The Next Frontier: Gene Therapy and Beyond
While Moderna focuses on its future, the biotech industry is abuzz with advancements in gene therapy. Pfizer, another major player, has recently made significant strides with its gene therapy candidates for hemophilia. Pfizer’s giroctocogene fitelparvovec, a gene therapy for hemophilia A, has shown promising results in phase 3 trials, potentially offering a one-time treatment alternative to regular infusions.
Pfizer’s Gene Therapy Breakthrough
Hemophilia A, characterized by insufficient levels of the blood protein factor VIII, traditionally requires regular infusions. Pfizer’s gene therapy aims to enable patients to produce factor VIII themselves after a single infusion. Data from 50 patients in the phase 3 AFFINE study showed a “statistically significant” reduction in annualized bleed rate, from 4.73 to 1.24, and maintained factor VIII activity above pre-dosed levels in 84% of participants.
Despite these promising results, questions remain about the long-term durability of the treatment. Pfizer noted that while the therapy was generally well-tolerated, some patients experienced transient elevated factor VIII levels, which did not impact efficacy or safety outcomes. The therapy has received fast-track and regenerative medicine designations from the FDA, with further discussions with regulators planned in the coming months.
Challenges and Competitions in Gene Therapy
The competitive landscape in gene therapy is intense. BioMarin, which received approval for its gene therapy Roctavian in 2023, has struggled with market uptake, treating only a handful of patients across Europe and the U.S. Pfizer aims to surpass these challenges with its own offerings. The company’s hemophilia B gene therapy, Beqvez, was the first FDA-approved gene therapy for Pfizer and the second-ever for the condition.
Looking ahead, Pfizer plans to seek FDA approval for another therapy, marstacimab, to treat both hemophilia A and B. The approval process and subsequent market performance will be crucial in determining the long-term success of Pfizer’s gene therapy portfolio.
Conclusion
Robert Langer’s departure from Moderna’s board marks a significant milestone in the biotech industry. His contributions to science, engineering, and the development of mRNA technology have left an indelible mark on Moderna and the broader scientific community. As Langer transitions to an advisory role, Moderna and the biotech industry at large continue to push the boundaries of innovation, with gene therapy emerging as a promising frontier. The ongoing advancements by companies like Pfizer signal a new era of treatment possibilities, offering hope for patients with conditions like hemophilia and beyond.