AI
Monday, June 19, 2023 5:56:58 PM
I have been doing some more research on the FDA’s Tissue Agnostic drug and biologic development and approvals.
On April 26, 2019, the FDA along with the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (FOCR), convened a workshop at the FDA’s headquarters in Silver Springs, Maryland. By the way, according to Google Maps, the FDA headquarters is less than 10 miles away from NWBio’s headquarters in Bethesda, Maryland.
The target audiences for this workshop were new drugs and biologics Sponsors who were interested in obtaining Tissue Agnostic approval for their new treatments.
There were several presenters and speakers that day, primarily from the FDA, FOCR, and ASCO. There were also other speakers and presenters, including: representatives from the EMA, academic and research institutions, patient advocacy groups, and industry. Here is the agenda for that workshop:
https://www.fda.gov/media/128264/download
Industry reps and speakers also included Sponsors who had been successful in obtaining Tissue Agnostic approvals for their treatment.
This included Merck, who obtained accelerated conditional Tissue Agnostic approval for pembrolizumab (Keytruda) on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic micro satellite instability-high solid tumors. Merck was required by the FDA to conduct some post-approval studies to confirm clinical benefit of pembrolizumab. Merck did those post-approval confirmatory studies and received full Tissue Agnostic approval from the FDA on March 29, 2023:
https://www.merck.com/news/fda-converts-to-full-approval-indication-for-keytruda-pembrolizumab-for-certain-adult-and-pediatric-patients-with-advanced-microsatellite-instability-high-msi-h-or-mismatch-repair-deficient/
I was particularly interested in one of the speakers and presenters from the FDA. His name is Dr. Adnan Jaigirdar. He is a medical officer in Oncology in the Office of Tissues and Advance Therapies (OTAT), in the Center for Biologics Evaluation and Review (CBER) at FDA.
I highlighted some words in Dr. Jaigirdar’s bio that I found very interesting and compelling:
This suggest to me that not only will DCVax-L (along with poly-ICLC) eventually be approved on a Tissue Agnostic basis, the combinations of DCVax-L + Pembrolizumab + CSF-1R inhibitor will also eventually be approved on a Tissue Agnostic basis.
Also, I noticed that on May 4, 2019, about 8 days after the Tissue Agnostic workshop at the FDA, Dr. Jaigirdar appeared at the New York Academy of Science (NYAS) Frontiers in Cancer Immunotherapy conference and co-led a discussion about “Innovative Approaches to Clinical Trial Design”. Our good friend George Zavoico (who now works for NWBio) was one of the Chairpersons for this NYAS conference:
https://www.nyas.org/events/2019/frontiers-in-cancer-immunotherapy-1/?tab=agenda
I know that some will say that these are all random, isolated and unrelated events. But, I see it differently. I also put together a list of all of the major events and milestones that have occurred from 2019 to today:
On April 26, 2019, the FDA along with the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (FOCR), convened a workshop at the FDA’s headquarters in Silver Springs, Maryland. By the way, according to Google Maps, the FDA headquarters is less than 10 miles away from NWBio’s headquarters in Bethesda, Maryland.
The target audiences for this workshop were new drugs and biologics Sponsors who were interested in obtaining Tissue Agnostic approval for their new treatments.
There were several presenters and speakers that day, primarily from the FDA, FOCR, and ASCO. There were also other speakers and presenters, including: representatives from the EMA, academic and research institutions, patient advocacy groups, and industry. Here is the agenda for that workshop:
https://www.fda.gov/media/128264/download
Industry reps and speakers also included Sponsors who had been successful in obtaining Tissue Agnostic approvals for their treatment.
This included Merck, who obtained accelerated conditional Tissue Agnostic approval for pembrolizumab (Keytruda) on May 23, 2017, for the treatment of adult and pediatric patients with unresectable or metastatic micro satellite instability-high solid tumors. Merck was required by the FDA to conduct some post-approval studies to confirm clinical benefit of pembrolizumab. Merck did those post-approval confirmatory studies and received full Tissue Agnostic approval from the FDA on March 29, 2023:
https://www.merck.com/news/fda-converts-to-full-approval-indication-for-keytruda-pembrolizumab-for-certain-adult-and-pediatric-patients-with-advanced-microsatellite-instability-high-msi-h-or-mismatch-repair-deficient/
I was particularly interested in one of the speakers and presenters from the FDA. His name is Dr. Adnan Jaigirdar. He is a medical officer in Oncology in the Office of Tissues and Advance Therapies (OTAT), in the Center for Biologics Evaluation and Review (CBER) at FDA.
I highlighted some words in Dr. Jaigirdar’s bio that I found very interesting and compelling:
This suggest to me that not only will DCVax-L (along with poly-ICLC) eventually be approved on a Tissue Agnostic basis, the combinations of DCVax-L + Pembrolizumab + CSF-1R inhibitor will also eventually be approved on a Tissue Agnostic basis.
Also, I noticed that on May 4, 2019, about 8 days after the Tissue Agnostic workshop at the FDA, Dr. Jaigirdar appeared at the New York Academy of Science (NYAS) Frontiers in Cancer Immunotherapy conference and co-led a discussion about “Innovative Approaches to Clinical Trial Design”. Our good friend George Zavoico (who now works for NWBio) was one of the Chairpersons for this NYAS conference:
https://www.nyas.org/events/2019/frontiers-in-cancer-immunotherapy-1/?tab=agenda
I know that some will say that these are all random, isolated and unrelated events. But, I see it differently. I also put together a list of all of the major events and milestones that have occurred from 2019 to today:
Bullish
