Edge Therapeutics Inc.'s hunt for a "strategic alternative" after the failure of its flagship candidate, EG-1962 (nimodipine microparticles), ended with a stock-for-stock merger deal with privately held immuno-oncology (I-O) specialist Protein Delivery Sciences Biotechnology Corp. (PDS).
Boards of Berkeley Heights, N.J.-based Edge and PDS, of North Brunswick, N.J., have given their approval of the marriage, expected to finalize in the first quarter of next year. When it's done, former PDS security holders will own about 70 percent of the combined company and existing Edge security holders will own the rest, subject to potential adjustments, the firms said. PDS CEO Frank Bedu-Addo will continue in his role and Edge CEO Brian Leuthner will serve as president of the newly formed company, which will bear PDS' name. Of seven board members, the merged firm will list four from PDS and three from Edge.
In late March, Edge reported that the data monitoring committee (DMC) said, after an interim peek at phase III data with EG-1962, there was a low probability that the drug would make a statistically significant difference compared to the standard of care: an oral form of nimodipine, a calcium channel blocker. The primary endpoint of the Newton 2 study in adults with aneurysmal subarachnoid hemorrhage (aSAH) was a score at the 90-day mark of six to eight on the extended Glasgow Outcome Scale, which is used to predict long-term functional outcome in patients with brain injuries. The DMC, examining results from the day 90 visits of the first 210 subjects randomized and treated, recommended that the trial stop. The blowup puzzled Wall Street, coming despite EG-1962's passing of the futility analysis the previous December. (See BioWorld, March 29, 2018.)
Optimism had run high enough that in February, Edge management was already talking with Leerink analyst Paul Matteis about marketed products that could provide an idea regarding how EG-1962 might be priced. Cited was the acute myeloid leukemia drug Vyxeos (daunorubicin and cytarabine, Jazz Pharmaceuticals plc) that sells, depending on the regimen, for about $50,000 to $100,000 per patient. Also mentioned were the likes of Defitelio (defibrotide, Jazz Pharmaceuticals plc) for hepatic veno-occlusive disease, Virazole (ribavirin, Valeant Pharmaceuticals Inc.) for severe infections, and Voraxaze (glucarpidase, BTG International Ltd.) for the treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. Each of those is an expensive hospital drug that bears a new technology add-on payment of about $45,000 to $150,000 per patient.
HPV vaccinations below goal
But that's all potential revenue under the bridge now. Since the bad DMC news with EG-1962 in aSAH, Edge provided updated results and said the final analysis of Newton 2 likely will be available later this year. The company said in late June that it had largely completed the process of streamlining operations, reducing the workforce from 37 to 13 employees. Piper Jaffray & Co. was retained to help explore next steps.
Enter PDS, with a platform called Versamune that uses synthetic cationic lipids to promote intracellular delivery of tumor-related antigens and activate immunologic signaling pathways, which leads to the priming and proliferation of killer T cells. Specifically, Versamune activates a targeted T-cell response via stimulation of type I interferon (IFN) genes. Lymph-node studies have demonstrated strong stimulation of type I interferons such as IFNα1 and IFNβ1, as well as downstream chemokines such as CCL2 and CxCL10, PDS said. Also, in preclinical studies, subcutaneous administration was associated with significant reduction in both the regulatory T-cell and myeloid-derived suppressor cell populations.
The company has PDS-0101 in the works for human papillomavirus (HPV)-induced cancers, including cervical, anal, and head and neck, and "multiple" phase II/III trials are slated to start soon in HPV-related tumors. At the preclinical stage, PDS has PDS-0102 for prostate and breast cancers; PDS-0103, which may be useful in ovarian, colorectal, lung and breast cancers; and PDS-0104 for melanoma and glioma. Officials could not be reached, but during a 25-minute conference call with investors, after which no questions were taken, Leuthner said Edge had weighed almost 150 different options before selecting the merger with PDS. Bedu-Addo said the combined firm will have about $25 million in cash, enough to "accomplish near-term objectives" such as getting the phase II/III experiments underway and moving the earlier-stage prospects toward clinical research.
HPV remains a major problem despite better vaccines, according to a report issued this month by the U.S. president's panel on cancer. Barbara Rimer, chairperson of the panel, noted in a letter to the president that the group, in its 2012-2013 findings, called "underuse of HPV vaccines a serious but correctable threat to progress against cancer" and identified ways to boost deployment of them. "Although vaccine uptake has improved in recent years, the fact remains that less than 50 percent of boys and girls in the U.S. are fully vaccinated against HPV," she wrote. "We are still far short of the government's Healthy People 2020 goal of 80 percent of age-eligible adolescents," although the target "is achievable with the continued work and support of federal agencies, organizations, health care providers and researchers," in her view. "Cancer and immunization partners have risen to the challenge of accelerating HPV vaccine uptake," she added.
Shares of Edge (NASDAQ:EDGE) closed Monday at 67 cents, down about 3 cents, after trading as high as 84 cents.