In an 18-month span, Abeona lost its CEO and was slapped with a (recently lifted) trial hold by the FDA; now, its president and chief scientific officer is walking out.
In a very brief Securities and Exchange Commission filing, the biotech said simply: “On January 7, 2020, Tim Miller, President and Chief Scientific Officer of Abeona Therapeutics, notified the Company he is resigning from the Company on January 10, 2020.”
Miller was a founding CEO of the company, becoming CSO and president last spring. In a post on LinkedIn, he said: “Ok .... this is one of those hard posts. Today we announced my resignation from Abeona, the company I founded almost 7 years ago. It’s been a tremendous, wondrous, inspiring journey allowing me to bring together a passion and vision of new gene therapies for rare disease families.
“There’s no easy way to express my gratitude and steadfast support for all of the warriors that passionately work for these families. I am thankful for the colleagues I’ve shared tears and joy with, as new milestones have been accomplished in the fight.”
The biotech made no other statement about Miller’s departure and has not issued a formal press release.
It’s been a tough time for the biotech: Last fall, the FDA hit the company with a trial hold for its planned phase 3 test of EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications.
The FDA told the biotech it won’t give a green light to this test “until it submits to the FDA additional data points on transport stability of EB-101 to clinical sites.” The hold was removed in December.
In November 2018, ex-CEO Carsten Thiel was sacked after an investigation into “allegations of misconduct towards colleagues” and was replaced by head of R&D João Siffert on an interim basis. Siffert became Abeona's CEO last February.
Industry veteran Thiel—who was formerly chief commercial officer and executive vice president at Alexion—had only been with Abeona for a few months, joining the company in April 2018 to spearhead its march toward commercialization of its cell and gene therapies.
In a strongly worded statement, Abeona said its decision stems from “personal misconduct that violated the company’s code of business conduct and ethics” and was not related to the condition of the company’s finances, operations or clinical programs. Thiel later became EUSA’s president of Europe.
It has several earlier-stage assets in its pipeline, including ABO-102 and ABO-101, AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively.