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Reimagining Biotech with Jake Becraft of Strand Therapeutics — Tim’s Founder Kitchen
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Key Moments
Strand Therapeutics' mRNA platform can reprogram cancer cells to signal the immune system, leading to complete tumor regression in advanced melanoma, but widespread adoption hinges on regulatory and delivery infrastructure reforms.
Key Insights
Strand Therapeutics' experimental drug demonstrated complete regression of advanced melanoma, including visceral metastasis, in a patient who had exhausted all standard treatment options, with no detectable lesions 18 months later.
China is significantly outpacing the US in clinical trial speed and efficiency, creating a 'flywheel structure' that attracts capital and leads to Chinese companies bringing drugs to the US market first.
The cost to manufacture certain cell therapies, like CAR-T, can reach $750,000, making them 'bad products' from a business perspective due to accessibility issues, even if they are 'good drugs' therapeutically.
A key hurdle in genetic medicine for 30 years has been 'step two' – moving beyond liver-targeted therapies to delivery across the entire body via intravenous administration, which Strand aims to solve.
The US regulatory process for initiating first-in-human trials is excessively burdensome, costing millions of dollars and taking 18 months for an IND application, unlike streamlined systems in Australia and China.
Policy makers and government incentives play a critical role in shaping the future of medicine, with a 50% likelihood in the next two years for significant FDA reform to accelerate clinical trials, especially if policy makers adopt an 'opportunistic tone' of problem-solving.
Transforming cancer treatment with a novel immune-activating RNA therapy
Strand Therapeutics is developing next-generation genetic medicines that instruct cells to produce therapeutic proteins. Their approach focuses on delivering RNA messages to specific cells to correct or remove disease-causing proteins. In oncology, this translates to reprogramming cancer cells to signal the immune system to attack them. This strategy has shown remarkable results in advanced melanoma patients who have failed all other treatments. In one striking case, a patient with stage 4 melanoma, including aggressive visceral metastasis to the lungs, bone, and muscle, experienced complete tumor regression after treatment with Strand's therapy. The patient, who had been through multiple lines of therapy including checkpoint inhibitors like Keytruda, has remained cancer-free with no detectable lesions 18 months later. This outcome highlights the potential of Strand's approach to not only extend lives but to potentially achieve long-term remission where other therapies fail.
The global race for clinical trial speed and China's growing dominance
A significant concern discussed is the United States' lagging position in clinical trial infrastructure, particularly for first-in-human (FIH) trials. China has industrialized its FIH trial process, making it highly efficient and cost-effective. This has created a 'flywheel structure' where American companies initially went to China for data, but now Chinese companies are conducting their trials faster and bringing their drugs to the US market. This efficiency attracts risk capital, further incentivizing investment in China. The implications are substantial, potentially shifting the global landscape of drug discovery and development away from the US if the trend continues.
Distinguishing between a 'good drug' and a 'good product' in medicine
Jake Becraft emphasizes a crucial distinction between a 'good drug' and a 'good product.' A good drug effectively treats a patient, even if the administration is complex or its manufacturing is costly. Conversely, a good product is accessible, scalable, and integrates with existing healthcare infrastructure. For example, in vivo cell therapies, while therapeutically powerful, can cost $750,000 to manufacture and take three months, making them 'bad products.' The ideal scenario is an outpatient procedure, deliverable via a simple IV infusion, which represents a 'good product.' This distinction underscores the importance of manufacturing, cost, and delivery logistics in determining a therapy's ultimate impact.
Overcoming the 30-year challenge of non-liver genetic medicine delivery
For decades, genetic medicine has largely been confined to treating diseases within the liver, as the liver naturally filters blood and readily absorbs delivered genetic materials. Moving beyond the liver to target other organs or the entire body via intravenous (IV) administration has been the 'holy grail' of genetic medicine for 30 years, representing the elusive 'step two' in the classic biotech development model (Step 1: Prove it works in the liver; Step 2: Question Mark; Step 3: Profit). Strand Therapeutics' core mission is to solve this 'step two' delivery problem, which they view as encompassing potency, specificity, and delivery, rather than being solely a 'delivery problem.' Their goal is to enable genetic medicines to reach any cell in the body safely and effectively.
The abscopal effect: localized treatment triggering systemic anti-cancer immunity
Strand's approach leverages the 'abscopal effect,' where localized treatment of a tumor triggers a systemic immune response that targets other hidden tumors throughout the body. In their injectable therapy, the genetic medicine is delivered directly into a tumor site. This activates the immune system to attack the injected tumor, and crucially, educates it to recognize and eliminate other tumor deposits, even those in deep visceral organs like the lungs. While the abscopal effect is not a new concept, Strand claims to be one of the first companies to demonstrate this effect extensively and consistently across multiple patients, particularly in visceral metastases, moving it from a rare phenomenon to a more broadly applicable therapeutic strategy.
Streamlining regulatory pathways for faster clinical trials
The current US regulatory process for initiating clinical trials is a major impediment. Submitting an Investigational New Drug (IND) application to the FDA is a lengthy and expensive process, with one application reportedly costing millions and requiring extensive documentation (e.g., 22,000 pages). This contrasts with systems in Australia and China, which utilize Clinical Trial Notification (CTN) systems or hospital Institutional Review Boards (IRBs) for initial safety assessments, significantly reducing time and cost. Becraft advocates for moving away from the FDA's direct permission-based oversight for early-stage trials towards a notification system, allowing hospitals and IRBs to manage initial safety reviews, thereby freeing up the FDA to focus on efficacy and final drug approval. This reform is seen as crucial for maintaining US competitiveness in biomedical innovation.
The rise of platform therapeutics and the need for new business models
Becraft frames Strand's technology as a 'therapeutic platform' – a common technological infrastructure that can be used to build multiple different medicines. This contrasts with traditional drug development, where each new drug starts from 'square one.' He draws parallels to Moderna's mRNA vaccine platform, which took years to develop but enabled rapid COVID-19 vaccine creation. He also likens it to SpaceX's development of reusable rocket technology, enabling various payloads. To realize the full potential of these platforms for diverse diseases, new business models are needed to navigate resource constraints and attract capital for long-term, ambitious projects, moving beyond the typical venture capital model focused on shorter-term exits.
Policy reform: incentivizing innovation and securing US biomedical leadership
The conversation highlights the critical need for policy reform to foster innovation in biotechnology. Becraft argues that by streamlining clinical trial processes and reducing regulatory burdens, the US can create a more attractive environment for investment and innovation. This includes rethinking the FDA's role, incentivizing bolder research, and adapting regulatory and payment systems for niche, personalized medicines. The urgency is driven by global competition, particularly from China, and the risk of the US falling behind. Becraft's op-ed in the Washington Post and subsequent engagement with policymakers, including reaching the President's legislative priorities, underscore his commitment to advocating for these changes. The ultimate goal is to ensure the US remains a leader in developing life-saving medicines by enabling faster, cheaper, and more ambitious scientific advancements.
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Common Questions
Strand Therapeutics aims to design next-generation genetic medicines that deliver RNA messages to specific cells in the body to correct protein deficiencies or combat diseases like cancer by returning cells to homeostasis.
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Mentioned in this video
Discussed as a country where clinical trial infrastructure for first-in-human trials is highly efficient and quick, leading to the US losing ground in drug development.
Described as falling behind China in clinical trial efficiency due to burdensome regulatory environments, despite being a major player in drug development.
Noted as a country that is making aggressive bets and taking big swings to attract innovation, demonstrating impressive speed and ambition, making it potentially attractive for companies like Strand.
Mentioned as a country where scientific research, particularly in areas like psychedelics, is funded due to much less red tape and faster processes compared to the US.
Mentioned as a location where psychedelic research is occurring, but with the caveat that its data might not hold the same credibility or attention in the US context.
Cited as a country with a more efficient clinical trial notification (CTN) system for first-in-human trials, making it faster and cheaper than the US.
The US Food and Drug Administration, discussed as a regulatory body whose current processes for approving first-in-human trials are slow, costly, and hinder innovation.
An academic research laboratory at the Massachusetts Institute of Technology, where Jaime, a polymath professor and healthcare entrepreneur, works.
A clinical oncology conference where Strand Therapeutics presented a striking photo of a patient who responded to their melanoma treatment.
Mentioned in the context of their AI report, with Jake suggesting a similar comprehensive report is needed for biotechnology due to rapid advancements and policy gaps.
Newspaper that published the story of baby KJ, a key example of personalized CRISPR therapy.
A company focused on designing next-generation genetic medicines, specifically using RNA to correct protein problems and activate the immune system against cancer within the body itself.
Phil Strandwitz's company, in which the host is an investor.
A pioneering biotechnology company, whose origin story book was highly recommended by Jake for its insights into contracts, negotiations, and the serendipitous nature of early biotech.
Pharmaceutical company that developed Kitruda, a major immunotherapy drug.
A pioneering Boston-based biotech company, mentioned for its aggressive, founder-mode approach to developing drugs for rare diseases, including using "placenta mobiles" for protein purification.
Cited as an example of a company that developed an RNA vaccine platform, enabling rapid development of the COVID-19 vaccine due to years of prior foundational technology work.
A pharmaceutical company mentioned as producing Opdivo, another blockbuster immunotherapy drug.
An example of a company whose economic viability depended on the existence of a delivery platform (smartphones), illustrating how infrastructure enables new business models.
Cited as an example of first-principles thinking, radically decreasing launch costs by reusing rockets; serves as an analogy for developing platform therapeutics in biotech.
Used as an analogy for an 'infrastructure of tech story' in a non-biotech industry, emphasizing how building backend systems can lead to scale and success.
Presented as a fascinating example of disciplining Wall Street to accept long-term unprofitability to build a massive, diversified company, including AWS, which became a significant revenue driver.
Venture capital firm where Josh Kushner is known for successful high-conviction investments.
AI research lab (owned by Alphabet) responsible for AlphaFold, which can design various proteins.
AI safety and research company, mentioned alongside OpenAI as having an internal 'post-conviction moment' prior to widespread public recognition.
Used as an analogy to explain a platform that builds infrastructure for one purpose (delivering food) and then can adapt it for other uses (delivering vaccines), highlighting the concept of derisking for additional 'launches'.
Mentioned as an example of a company that experienced a 'post-conviction moment' internally before wider public consensus and massive market cap growth with products like DALL-E and ChatGPT.
Used as an analogy for a company that built a core platform (the iPhone/smartphone) that solved a delivery problem, enabling other companies to build products on its ecosystem.
Another biotech CEO and a dinner attendee with the host and Jake Becraft.
The first patient to receive a personalized systemic CRISPR-based editing therapy for a fatal liver condition, highlighting the promise and current limitations of personalized medicine primarily focused on the liver.
Praised for his 'first principles based thinking' and its application to SpaceX, serving as an analogy for radical innovation in biotech.
Former CEO of Genentech and Chairman of Apple's board of directors, illustrating the deep connections between biotech and tech innovation.
Mentioned in relation to Art Levinson's board role at Apple and as an example of a leader who returned to a company, cut product offerings, and created a new delivery system with the smartphone.
Mentioned as a great investor at Thrive Capital known for making high-conviction, post-conviction, pre-consensus bets in companies.
Praised as a great capitalist and industrialist, particularly for his long-term vision in building Amazon in the public market and his investor letters.
One of the Nobel Prize-winning scientists credited with the development of CRISPR gene editing, associated with the story of baby KJ.
A blockbuster immunotherapy drug from Merck, which is highly effective for melanoma patients who respond to it, but less so for others due to similar mechanisms of action in existing immunotherapies.
An immunotherapy drug from Bristol Myers Squibb, categorized as a checkpoint blockade.
Mentioned as an example of rapid drug development using Moderna's RNA vaccine platform, although also acknowledged for its political charge.
A protein-based medicine mentioned as an example of a drug developed by applying the platform approach established by early biotech for insulin.
Discussed as an example of early biotechnology using genetic engineering to produce human insulin in bacteria, replacing the previous method of harvesting pig pancreases, and serving as a platform for other protein-based drugs.
Mentioned as another example of a protein-based medicine developed using the platform approach, similar to insulin and Herceptin.
Used as a humorous example of basic human-driven protein design, contrasting it with advanced AI and high-throughput screening.
Mentioned as a tool that can design proteins and antibodies, accelerating drug discovery.
An AI tool from OpenAI, marking a point in the public's awareness of accelerating AI capabilities and the 'consensus moment' for AI.
Described as a $25 billion behemoth that arose as a 'side hustle' within Amazon, exemplifying a successful platform and infrastructure play that contributed to Amazon's massive growth.
An AI program from DeepMind that can design almost any protein, accelerating our knowledge in medicine and highlighting the coming bottleneck in deployment and testing.
An AI tool from OpenAI, marking a point in the public's awareness of accelerating AI capabilities.
A survival graph often used in oncology results to show the percentage of patients surviving over time in clinical trials. Jake emphasizes connecting these statistical lines to individual patient lives.
A gene-editing technology, whose initial euphoric expectations have not been fully met, suggesting challenges in deployment beyond isolated cases like liver conditions.
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