An immunotherapy treatment that effectively kills cancer AND viral infections without toxic side effects. It is affordable and available as an out-patient procedure!
What is the critical gap in cancer treatment that you are addressing?
When it comes to cancer treatment, most of us are familiar with the common first-line medical treatments: chemotherapy, radiation therapy, and various types of surgeries to remove cancer (i.e. mastectomy). Few of us understand the cancer-fighting paradigm of “immunotherapy” that recently entered the clinic. Immunotherapies are designed to help stimulate or restore the ability of the immune system to fight disease. The second generation of immunotherapies for treatment of cancer, called CAR-T therapies, showed huge remission rates in severe blood cancers (i.e. lymphoma and leukemia). The major downside of immunotherapies is serious immuno-related side effects that land you in the hospital/ICU for several weeks, ultimately costing you as much as $1.5 million or more! The current immunotherapies are therefore too toxic and economically out of reach for the millions of patients who could potentially benefit.
Geneius Biotechnology wants to change this. We are developing a new immunotherapy approach that will democratize treatment so that patients with all cancer types can access immunotherapy at an affordable cost without having to recover from immuno-related side effects in the ICU.
The Geneius immunotherapy is an “adoptive T- cell therapy,” a form of treatment that uses the cells of our immune system to eliminate cancer. The Geneius T-cell approach is better at finding and killing tumor cells, and can more easily spread across the tumor, compared to CAR-T therapies.
Importantly, the Geneius immunotherapy would be available to patients through their community oncologist as an out-patient procedure.
In these times of pandemic, Geneius has adapted its immunotherapy to fight several viral infections including Covid-19. The company wants to urgently advance the development of its immunotherapy products for Covid-19.
What is the key product development milestone you seek to fund?
Geneius needs to achieve several important steps before its immunotherapy approach can be considered for use in patients. The immediate milestones are additional preclinical studies of Geneius’ T cells to help ensure the safety of its treatment in humans. This will be required before filing an Investigational New Drug Application with the FDA for future clinical trials. Geneius is already planning a phase I clinical trial in patients with EBV positive related lymphomas.
In addition, Geneius will need to secure its collaboration with its manufacturing partner who will provide clinical-grade material for the phase 1 trial.
How will funds be used?
Funds raised through this platform will be used for the following:
What key resources have/will you acquire to facilitate the accomplishment of the above R&D milestone?
Geneius has submitted an SBIR grant to the NIH for its EBV positive lymphoma program. Once we complete the above milestones, Geneius will be better positioned to apply and win additional NIH grants. These include SBIR grants which typically range from $200,000 to approximately $2 million. We will also seek funding from COVID-19 grant programs through NIAID and BARDA.
If your technology were to disappear in the “Valley of Death” funding gap, how might this impact society?
If the Geneius T-cell Therapy fails to advance due to a lack of funding, this would be a huge loss to society. There are 7 million people in the United States diagnosed with cancer each year. Our mission is for T-cell therapy to become accessible to any patient who can benefit from it. Because of the favorable cost and side effect profiles of our T-cell approach, we see a world and a future, where instead of chemotherapy and radiation, which have toxic side effects as well as downstream risks, the Geneius T-cell therapy becomes the standard of care for patients diagnosed with cancer.
Dr. Abrams was the former President and CEO of CEPTYR, Inc. CEPTYR worked on protein tyrosine phosphatases (PTP).
He was also the President and CEO of NeoRx. NeoRx was a publicly traded company developing a diagnostic imaging system for small cell lung cancer. Boehringer Ingelheim invested $21 million and took over manufacturing. NeoRx switched to cancer treatments.
Dr. Abrams was a Cancer Expert at the Biological Response Modifiers Program at the National Institutes of Health (NIH). He is the editor of the book “Biology of Lung Cancer.”
Dr. Abrams served on the Executive Committee of the Biotechnology Industry Organization. He earned his M.D. and J.D. at Yale University.
Dr. Alfred Slanetz, President and CEO of Geneius Biotechnology, Inc. has been in senior management of 5 successful biotech companies, all of which have provided blockbuster investment returns to their shareholders. He was previously CEO of Bluebird BIO (NASDAQ: Blue; $4B market cap), SVP, Corporate Development of Esbatech and Fovea (sold for $500 million each to Novartis and Sanofi, respectively), VP, Business Development of Transgene (IPO on Euronext: TNG) and was Head of New Product Planning at Genentech where he served on the core development team for five drugs that are currently on the market with billions of dollars of revenues (Rituxan, Herceptin, Avastin, Xolair and Lucentis). Dr. Slanetz received his Ph.D. in Immunology and Molecular Biology from Yale University.
Mr. Brand began advising the Company in early 2018 and joined full time as Chief Financial Officer in January 2020. Mr. Brand helped raise $86 million for a private health care company. Over 2 years, he helped generate a 9x return and best-performing biotech IPO for much of 2017 as CFO. Mr. Brand managed one-third of an institutional investment fund’s portfolio. He managed Robertson Stephens’ biotech private placement business to number 2 ranking. Mr. Brand received his M.B.A. from the University of Chicago and served as a Board member for the University’s and Business School’s NYC Alumni Clubs.
Dr. Marshall has had over 20yrs experience in clinical development in the industry including Kite Pharma (sold to Gilead for $12B), Pfizer, Kyowa Kirin Pharma, CancerVax, Cell Genesys, and Pasteur Merieux Connaught. Most recently, she was responsible for the pivotal studies of Yescarta®, one of the approved CAR-T cell products. She has broad experience in clinical trials of immunotherapy in solid and hematological cancers, including vaccines, checkpoint inhibitors, monoclonal antibodies, and antibody-drug conjugates. She received her BS in Biology from the California Institute of Technology, her MD from the University of California, San Diego (UCSD), completed her pediatric residency at the University of Washington, and then post-doctoral research at NCI Laboratory of Immunogenetics and Vaccines.
Dr. Froland was the Assistant Vice President and Leader of Center for Biopharmaceutical Manufacturing Sciences of Merck & Co. He established the manufacturing process for Merck’s blockbuster cancer drug, Keytruda, in a year and one-half which is quite an accomplishment in a large organization such as Merck. Dr. Froland led the enterprise development, technical and manufacturing team for Keytruda.
Prior to Merck, he was Vice President, Process Sciences of Aerovance Inc. Previously, Dr. Frolund was Associate Director, Senior Staff Scientist of Bayer Healthcare. He did his post-doc in Biochemistry at University of California, Berkeley