American Biotechnology Looks to Take Japanese Brain Cancer Drug to Critical Human Trials
ORLANDO, FL / ACCESSWIRE / April 11, 2019 / SmallCap Sentinel has a long history of seeking out the market disruptive, the trends, the game changers. We survey the small cap level where start-ups and the entrepreneurial spirit reigns supreme and where exceptional new ideas are fostered, nurtured and in a perfect world, monetized. Today’s featured company Nascent Biotech, Inc. (NBIO) is unique among all our previous offerings.
Today’s offering is complicated, at least by small cap standards and, well, perhaps typical of a company whose cancer technology has been created and developed since 1982, and which has now just received an incredibly critical permission to enter human trials for brain cancer. The company’s moment of truth is now at hand.
We sat down with Nascent Biotech’s CEO, Sean Carrick to help us better understand the history, science and most importantly, the future for the Company’s brain cancer drug Pritumumab. The story is compelling to say the very least.
In 1982, Japan-based Hideaki Hagiwara, Ph. D was seeking a way to help treat his mother’s cervical cancer and approached U.S.-based Dr. Mark Glassy, a professor at UCSD. The goal was to generate human antibodies that could be used to treat his mother’s cancer. After Dr. Glassy agreed to do the work, Hagiwara arranged for a biopsy of his mother’s lymph nodes, one of which was sent to Glassy. The cells were processed and Human Hybridomas were generated and one clone, CLNH11 was later renamed to Pritumumab by the World Health Organization.
In March 1982, Dr. Glassy gave Dr. Hagiwara a sample of what is now known as Pritumumab which he promptly took back to Japan to treat his mother. Sometime later his mother died from a heart attack and upon autopsy she was determined to be cervical cancer free. Soon after, Dr. Hagiwara funded a massive effort, under the aegis of a company (Japan Pharmaceutical Development (JPD) Corporation) specifically set up for this purpose, to develop the Pritumumab, which had had such a profound impact on their mother, into a commercial product. What was soon determined, based on antibody activity and over a 20-year period, was that there was a significant benefit to treat patients with brain cancer. A total of 249 patients were treated in Japan resulting in an overall response rate between 25-30% over 5 years, representing a 9-fold benefit over standard of care.
These surprising results led to Hagiwara’s continued clinical trial development until 2004 when JPD Corp submitted an application to the Japanese Ministry of Health and Welfare (MHW – Japan’s FDA) for commercial use. The application was rejected because it had only Phase II data (safety and dosage determination in humans). The MHW told the Hagiwara’s to return to the clinic and obtain Phase III data, which would require further testing of efficacy in a larger population of cancer patients
Enter Nascent Biologics Inc. which was run by Dr. Glassy. Glassy approached Hideaki Hagiwara in late 2008 and asked to place Pritumumab under control of Nascent. The license terms were signed in July 2009 and in 2011 a response was received from the FDA about what would be necessary to begin Pritumumab clinical trials with brain cancer patients in the US. In 2012, Catalent Pharma Solutions was chosen to generate a cost-effective recombinant version of Pritumumab, made in Chinese Hamster Ovary (CHO) cells, the most common manufacturing platform for monoclonal antibodies. New CHO-generated Pritumumab has been generated by Catalent which was shown to have similar immunologic activity (using animal brain cancer models) to the ”Japanese” antibody. Subsequently, an IND (Investigational New Drug) request was filed with the FDA to begin Phase I clinical trials in the United States. Then in March of 2013, Nascent Biotech (NBIO) was formed.
In December of 2018, Nascent Biotech was given permission by the FDA to enter human clinical trials, not only for brain cancer, but also metastatic brain cancers (where the cancer has spread to the brain, primarily from breast and colon cancers) – essentially putting Nascent Biotech and Pritumumab to the ultimate test, one that will tell us – and the market- if the Company can re-produce the successes it had with Mrs. Hagiwara’s cervical cancer, for brain cancer. A very important question to be addressed in these human clinical trials is one of dosage. The objective responses shown in Japanese patients were obtained at dosage levels hundreds of times less that is common for approved monoclonal antibodies now used for treatment of several disease conditions (including cancers).
Thus, if Pritumumab can succeed through Phase III human clinical trials, then Nascent Biotechnology will be entering a very important next phase for a Company looking to monetize a technology that started in Japan in 1982. Moreover, if by employing larger doses, the company can improve upon the Japanese data and, in addition, be employed to treat other cancers. Nascent Biotech has already received, from the FDA, ”orphan drug” status for both brain cancer and pancreatic cancer – unmet needs in the marketplace.
About Nascent Biotech, Inc.
Nascent Biotech is a clinical-stage biotech company engaged in the development of monoclonal antibodies to be used in the treatment of various cancers with an Investigational New Drug (IND) application cleared by the FDA for Phase 1 clinical trials. Its products are not commercially available. For further information please visit our website www.nascentbiotech.com.
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