DBV's peanut allergy patch is finally under FDA review; Ritter swallows bitter pill to explore strategic alternatives
→ DBV Technologies $DBVT, which withdrew its application to market its peanut allergy patch late last year, essentially enabling rival Aimmune $AIMT to leapfrog it, on Friday announced that the FDA has accepted its latest BLA filing. The agency is expected to make its decision by August 5 — but will host an advisory panel meeting to discuss the immunotherapy.
→ Ritter Pharmaceuticals $RTTR did its best to make lemonade with the lemons it was dealt — by vaulting its lactose intolerance therapy toward a confirmatory trial, despite missing the main goal in the preceding Phase II/III study. Last month, the company reported its therapy, RP-G28, failed not only to secure a statistically significant improvement versus placebo in reducing lactose intolerance symptoms, but patients in the placebo group actually did better than the drug arm. Now, the LA-based company has appointed a financial advisor to explore strategic alternatives.
→ AstraZeneca-partnered French biotech, Innate Pharma, which announced plans for a US IPO worth up to $100 million a few weeks ago, said today that it plans to issue and sell about 10.7 million in an offering, to develop their lead product, monalizumab; fund their mid-stage trial of IPH4102 for patients with Sézary syndrome, MF and PTCL; and the phase I/II development of IPH5401 for solid tumors, including NSCLC and HCC.
→ The FDA has greenlighted Pfenex’s application to market PF708 to treat osteoporosis in certain patients at high risk of fracture. The therapeutic is similar to Amgen’s $AMGN blockbuster Forteo, which is made using a type of parathyroid hormone called teriparatide.
Although the FDA plans to designate certain products like insulins and hormones from drugs to biologics next year, teriparatide is not on that list. Therefore, Pfenex submitted a 505(b)(2) New Drug Application for PF708 rather than an abbreviated Biologics License Application. “We believe PF708 has the potential to significantly enhance patient access to an important therapy as a cost-effective alternative to Forteo, which had $1.6 billion in global sales in 2018,” said Eef Schimmelpennink, CEO of Pfenex. Pfenex is also conducting a separate study with the goal of getting PF708 designated as therapeutically equivalent to Forteo.
→ Adaptive Phage Therapeutics (APT), a company focused on the development of therapies to combat the rise of multi-drug resistant (MDR) pathogenic bacteria, has closed its oversubscribed, non-brokered financing — raising about $7 million in proceeds. Investors included Alexandria Venture Investments. The company said that proceeds will be used towards the support of Phase II clinical studies for its PhageBank therapy for antibiotic-resistant bacterial infections.