Upstart Pivot Pharmaceuticals (OTCQB:PVOTF), which was launched in the fourth quarter last year, is in talks with investors to raise up to $8-million in 2016 to initiate proof-of-concept studies for one of its two lead drug candidates for the treatment of endometrial and triple-negative breast cancers.
“These women’s cancers represent areas of high unmet medical need due to genomic mutations and our focus is to develop fast-to-market novel drugs that can be used in combination with other anticancer drugs,” CEO, Pravin Chaturvedi, says in an interview with BioTuesdays.com.
Funds raised this year also will be used to expand the company’s business development programs, including plans to acquire additional later-stage drug candidates for the treatment of women’s health.
Dr. Chaturvedi says the company met with potential investors at the JP Morgan Health Care Conference in San Francisco in January and several groups expressed an interest in financing its drug development programs. Discussions with interested parties are ongoing.
“Within 12 months post-financing, we will complete preclinical toxicology studies for both compounds, file an IND with the FDA and initiate a human clinical trial, within that 12-month period, with at least one development candidate,” he adds.
Dr. Chaturvedi explains that Pivot’s patent-protected drug portfolio is based on PBDs, or pyrrolobenzodiazepine dimers, which represent a new mechanism of action, known as DNA damage response (DDR) inhibitors, and have the potential to treat “genetically resistant” cancers in women.
Metastatic endometrial cancer has genomic mutations addressed by novel anticancer PBDs, he contends. And a significant subset of triple-negative breast cancer patients have DNA repair deficiencies that can be addressed by PBDs.
“The DNA in these cancers are inherently resistant to existing treatments, so we envision adding our products to existing chemotherapies in order to improve therapeutic outcomes,” he suggests.
At the end of November, Pivot acquired IndUS Pharmaceuticals, a closely-held U.S.-India cross-border pharmaceutical company. IndUS has an existing partnership with the Indian Institute of Chemical Technology (IICT), a member of the Council of Scientific and Industrial Research. Dr. Chaturvedi was the founder and chairman of IndUS, before moving into the executive suite at Pivot.
Through IICT, Pivot licensed its anticancer portfolio of PBDs, including PVT-005 and PVT-006. Pivot also has a memorandum of understanding with IICT for exclusive rights for additional drug leads from screening efforts by IICT.
Dr. Chaturvedi points out that the IICT relationship is important because it would allow Pivot to conduct simultaneous clinical trials in the U.S. and India for its anticancer drugs. “This would allow us to reduce the time and money to develop these therapies,” he adds.
According to Dr. Chaturvedi, metastatic endometrial and triple-negative breast cancer are orphan indications, with about 50,000 patients and 40,000 patients, respectively, and represent a potential total market opportunity of about $500-million for the company.
Pivot’s PVT-005 compound is targeting metastatic endometrial cancer and PVT-006 for triple-negative breast cancer. Depending on which compound Pivot advances first, Dr. Chaturvedi figures all of the proof-of-concept studies would be completed between 2017 and 2019.
“We plan to start the toxicology studies for both of them simultaneously and prioritize one of them, depending on which molecule we can scale up faster and which one formulates easier,” he adds.
With proceeds of this year’s financing, Pivot also plans to expand management and its scientific advisory board with additional key opinion leaders, and evaluate additional acquisition opportunities for targeted drug delivery technologies as part of a 505b(2) regulatory pathway.
Dr. Chaturvedi says the company, as part of a short-term 505b(2) value driver program, intends to repurpose approved drugs for addressing women health issues, such as lower urinary tract symptoms and possibly dysmenorrhea, or menstrual cramps.
Some of the drug delivery technologies Pivot is reviewing include vaginal rings, modified-release vehicles, transdermal patches and/or foam. “We have identified companies with these technologies and are having discussions with some of them,” he adds
* This article does not constitute an offer to sell or the solicitation of an offer to buy any securities of Pivot Pharmaceuticals, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.