On November 5, 2021 The Jaime Leandro Foundation for Therapeutic Cancer Vaccines (JLF) and partners reorted the treatment of the first cancer patient with a personalized neoantigen vaccine through a self-pay compassionate use program (Press release, xCures, NOV 5, 2021, View Source [SID1234594659]).
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JLF is a 501(c)3 non-profit organization whose mission is to make personalized anticancer vaccines available to patients with limited or no treatment options. Although neoantigen vaccines are not currently FDA approved, preliminary data is supportive of their use via compassionate access.
Personalized neoantigen vaccines are directed at tumor-specific mutation targets called neoantigens and leverage vaccine technology approaches to boost immune responses to a patient’s tumor. Although personalized neoantigen vaccines are very promising and have shown a favorable safety profile, their development and administration are hampered by regulatory, intellectual property, and clinical science obstacles. JLF has therefore partnered with multiple companies and institutions to bring these promising neoantigen vaccines directly to patients and their physicians.
By accelerating progress, informing patients, and enabling treatment, JLF and partners have worked diligently to help cancer patients and their clinicians overcome limited access to cancer vaccines through traditional trials. JLF has partnered with Washington University School of Medicine in St. Louis to use their pVAC-Seq algorithm, an important technology for the selection of neoantigens in the design of the vaccines. Of the many instrumental partners, key steps of vaccine design, manufacture, and patient treatment are provided by ennov1, CSBio, and xCures.
"We are delighted that xCures’ backend technology, regulatory know-how, and partnerships, enable cancer patients to access novel treatments while providing important real-world data," said Mika Newton, CEO of xCures. "By partnering with JLF we enabled the use of a personalized neoantigen vaccine under compassionate use/expanded access."
"We are thrilled to collaborate with JLF, and partners to ensure efficient analysis, optimal vaccine design and secure storage through our cloud-based platform and genomic technology," said James Inglis-Jones, Chairperson of ennov1.
"It’s exciting to contribute with CSBio’s peptide and instrumentation manufacturing technology towards manufacturing a fully personalized anticancer peptide vaccine," stated the CEO of CSBio, Jason Chang.
After a long process starting in fall 2020, the FDA approved treatment for the first two patients in the Spring of 2021. "We are very pleased to announce the initiation of treatment of the first cancer patient at Providence Saint John’s Health Center in Santa Monica, CA under the care of Dr. Santosh Kesari," stated JLF President, William Hoos.
The patient’s husband praised this new pathway to treatment. "JLF and partners allowed us the option to pursue a treatment we wanted, a cancer therapy based on current research, trials, and science." said Brad C. Through cancer vaccines, we now have hope for more time, better chance for survival, and hopefully a roadmap for others to follow as well."