Oncothyreon secured an equity financing facility that will allow it to sell up to $20 million of its shares of common stock to Small Cap Biotech Value over a two-year period. Small Cap Biotech’s commitment to the facility means it will receive nearly 60,000 of Oncothyreon’s common stock.
The facility for Oncothyreon to sell up to 5,150,680 shares to Small Cap is not binding. However, the cancer therapeutics firm says that if it does exercise its right to sell some or all of the shares allowed under the agreement, the proceeds will be used for general corporate purposes. The total amount of funds that could be raised would depend on the number of shares sold and the market value of Oncothyreon’s stock during the pricing period.
Oncothyreon has two in-house small molecule candidates progressing through Phase I development. PX-866 targets the PI3K/AKT pathway. The firm claims that in contrast with other therapies that target PI3K, PX-866’s inhibition of PI3K is irreversible, which contributes to the drug’s potency in vivo. PX-478 is a novel small molecule inhibitor of HIF-1α protein. The firm claims this candidate has been found effective when delivered orally in animal models and has demonstrated marked tumor regression and growth inhibition in model systems of various solid tumors.
In early June Oncothyreon presented data from Phase I trials of both PX-866 and PX-478 at the American Society of Clinical Oncology Annual Meeting. The company also confirmed plans to start a Phase I/II trial evaluating PX-866 in combination with docetaxel during the third quarter of this year. The Phase II stage of the new trial will evaluate the PX-855-docetaxel combination in patients with advanced non-small-cell lung cancer or squamous cell carcinoma of the head and neck and in a third cancer indication.
Oncothyreon’s cancer vaccine, Stimuvax®, is being taken through Phase III development by Merck KGaA, the product’s global licensee. The vaccine incorporates a 25-amino acid sequence of the tumor-associated marker MUC-1 in a liposomal formulation and is designed to stimulate the immune system to recognize and kill cancer cells.
Stimuvax is not moving through its multitrial Phase III program without upset, however. A full clinical hold on Stimuvax trials was instigated by FDA in March and was only partially lifted by the agency in mid-June. The clinical hold related to a suspected treatment-related case of encephalitis in a patient involved in an exploratory Phase II trial of the BLP25 liposome vaccine for multiple myeloma.
Partial lift of the hold means that once local authorities have also given their go-ahead. Merck Serono in Europe and EMD Serono in the U.S. will be able to resume worldwide clinical development for Stimuvax in non-small-cell lung cancer patients. The program includes the Phase III Start and Inspire trials. An advanced breast cancer Phase III trial known as Stride remains on FDA clinical hold, however. Merck Serono says it is continuing to work closely with regulatory authorities including FDA to decide the next steps for this study.