A PhII flop triggers an ugly rout for micro-cap biotech Aridis; Genfit CEO passes baton to successor
→ Micro-cap biotech Aridis Pharmaceuticals $ARDS got hammered this morning as investigators revealed that one of its clinical-stage drugs failed a mid-stage study, triggering safety fears and forcing the company to dump the program.
The anti-infective outfit says that AR-105 — an antibody — failed to beat out a placebo in treating ventilator-associated pneumonia caused by gram-negative Pseudomonas aeruginosa. And there was an imbalance in deaths and serious adverse events that left the therapy with a worse safety profile.
The failure touched off a rout among investors as the stock plunged more than 30%, carving into a market cap of $104 million.
Now that the mid-stage program is gone, Aridis CEO Vu Truong — a MedImmune vet — says they will focus on their Phase III therapy AR-301, also for VAP. The interim data is due in the first half of next year.
→ A couple months after NASH hopeful Genfit was awarded orphan drug status by US and EU regulators for its experimental drug, elafibranor, to treat patients with primary biliary cholangitis (PBC), CEO Jean-François Mouney is handing the reins to Pascal Prignet — who joined the company less than a year and a half ago from GSK as EVP of marketing and commercial development. Mouney will remain as chairman of the company’s board of directors.
Mouney said there was no external search, having identified Prigent as a natural successor. “It’s a personal decision taken after thoughtful consideration, following two decades of intensive work dedicated to developing GENFIT. I’ve asked Pascal to accept the CEO position because I’m convinced he is best positioned to oversee our future corporate growth.”
Prignet joined the company in May 2018 after various stints at Eli Lilly and GSK, where he ran their US vaccines division. In addition, the company announced that they will be adding three new board members (currently unidentified) in the next eight to nine months to help steer the company towards a stronger presence in the US.
→ T cell therapy player Immunotech Biopharm has filed for an IPO in Hong Kong. The listing would represent the next chapter in its single mission to advance cellular immunotherapy for cancer in China, the company wrote, which began back in 2006. Its lead product candidate, EAL — which consists of autologous CD8+ T cells activated and expanded ex vivo — is currently in a 272-patient Phase II clinical trial for postsurgical liver cancer, a prevalent indication in China.
With R&D and manufacturing sites in Beijing as well as a research center in Korea, the company is also seeking to bring several CAR-T treatments into the clinic — the frontrunner being an anti-CD19 product. One of the others targeting BCMA would pit Immunotech against Legend Biotech, a J&J-partnered player owned by CRO GenScript (also listed on HKEX).
The IPO is expected to bring in $100 million to $200 million, Reuters‘ IFR reported. Wang Yu, who had shaped the company as it is known today from a predecessor firm dubbed Beijing Yongtai, continues to lead Immunotech’s team of 110 as CEO and co-chief technology officer.
→ Troubled Abeona Therapeutics $ABEO announced that Jefferies will remain its financial advisor for the company’s strategic review. This comes less than a year after the company booted their CEO, Carsten Thiel, for unspecified “personal misconduct” involving his interactions with colleagues at the company.
“There can be no assurance this strategic review will result in the completion of any particular course of action. There is no defined timeline for completion of the review process and the company does not intend to comment further unless a specific initiative is approved by the Board of Directors, the review process is concluded, or it is otherwise determined that other disclosure is appropriate,” the company stated.