B₊labs

If you’d told Jim Wilson three years ago he’d be stepping down as director of Penn's storied Gene Therapy Program, he wouldn’t have believed you. And yet he’s now doing exactly that. My latest for STATon Wilson's new ventures. https://lnkd.in/gxD-aRaa

I have started, built, and exited several biotech companies (over $6B in exit value). Unusually, my companies are started as university spin-outs. I bootstrapped each of them using creative financing techniques and only taking institutional money once the valuation was high enough to ensure control by the founder group through exit. In starting up the companies, there was a general formula I applied (used by many of us serial entrepreneurs). 1. Obtain the in vivo technical proof of concept as cheaply and as quickly as possible. If the technology is going to fail, you want it to do so quickly. 2. Scale up the technology. Lots of technologies that look great in the lab can’t be scaled for commercial production. Scale-up should be done before commencement of clinical trials (else you may have to do them over). With biologics, the process is the product. 3. Determine the regulatory path. If a platform technology, pick a first indication where the FDA hurdles will be lower (like devastating rare disease with unmet need). 4. Hire the start-up team. This is a scrappy bunch that can do multiple functions and is used to a start up environment. This team will likely be replaced as the company grows and becomes more systematized. 5. Determine the manufacturing plan. Out-source if good, affordable alternatives exist. 6. Compile the budget and financing plan. Keep cash burn as low as possible (use options where possible). Determine the valuation inflection points and the amount of cash to get to each. This sets your financing strategy. I’ve never wanted to go public so I usually determine what’s necessary to exit after human POC is achieved. 7. Raise money initially from friends and family and non-dilutive means, followed by institutional investors. Find investors who want to be helpful in building the business and can provide value through connections and advice. Chemistry is key. An investor-founder relationship is like a marriage. It can be great or very harmful. 8. Find items to monetize. Are there services, data, or IP that can be sold or licensed? 9. Pursue collaborations to share risk and benefit from others expertise or technology. 10. Get a strong IP position. Think outside of patents to biologics market exclusivity and rare disease exclusivity. #biotech #startup #entrepreneurship

The Gene Therapy Program at the University of Pennsylvania will be transitioning effective October 1, 2024, into two new companies in order to continue our groundbreaking research.    GEMMA Biotherapeutics (GEMMABio) is the new therapeutics company, and it will comprise the research and innovation arm to speed the research of and global access to life-changing advanced therapies for those living with rare diseases (www.gemmabiotx.com). Franklin Biolabs is the new genetic medicines contract research organization (CRO), and it will be the services and production arm, providing comprehensive solutions from discovery to development and distribution for the global genetic medicines industry (www.franklinbio.com).    For more information on the two new companies, please see this press release that was issued on July 31, 2024 (https://lnkd.in/e9A8Dz6S). The news was covered by a variety of media outlets, including the Philadelphia Inquirer (https://lnkd.in/eGwtEaUc) and Biocentury (https://lnkd.in/eez-g964).   For clients of the vector core and immunology core: we look forward to working with you these next several weeks as part of the University of Pennsylvania, and then going forward in our new capacity. These services will continue this fall as part of Franklin Biolabs. The transition has just started, and you will be receiving more information from us in the coming weeks. In the meantime, please continue to correspond with us and place orders according to the current processes. Please feel free to reach out to your contacts at GTP with any immediate questions.

Researchers at the University of Pennsylvania have uncovered important biological mechanisms underlying T cell exhaustion in chronic diseases and cancer, published recently in Cell by Cell Press. The work was led by E. John Wherry, PhD, Co-Director of the PICI Center at Penn, and included PICI Investigator Alexander Huang, MD, and 2023 Parker Scholar Divij Mathew, PhD. Key findings: → LAG-3: The Immune System's Hidden Conductor – LAG-3 orchestrates how T cells respond during prolonged battles with cancer. LAG-3 maintains levels of TOX, an important protein that influences T cell behavior, and directs how T cells interact with other molecules. This insight could lead to new strategies for keeping immune cells effective against tumors. → PD-1 and LAG-3: A Two-Pronged Approach – PD-1 and LAG-3 work differently to regulate immune responses. PD-1 mainly stops T cells from multiplying, while LAG-3 reduces their ability to kill cancer cells. Understanding this difference explains why blocking both proteins in cancer treatment works so well, and could help create better combination therapies. → New Cancer Detection Pathway: Researchers uncovered a novel mechanism where LAG-3 helps T cells recognize Qa-1b, a stress signal on cancer cells. This newly identified pathway represents a potential target for augmenting anti-tumor immunity, possibly expanding the range of cancers that could respond to immunotherapy. Congratulations to the team for advancing our understanding of T cell exhaustion and receptor biology! Read more in Cell: https://lnkd.in/e5UbzkNg #CancerResearch #Immunotherapy