AmbioPharm Supports ONL Therapeutics with Peptide Manufacturing to Prepare for IND Application for Phase 2 Study

• ONL closed the second tranche of a $46.9 million Series B financing round earlier this year
• ONL now preparing IND filing for a Phase 2 study of ONL1204 Ophthalmic Solution
• AmbioPharm providing manufacturing support for ONL1204

NORTH AUGUSTA, S.C. & ANN ARBOR, Mich.–(BUSINESS WIRE)–#CPHI–AmbioPharm, a global peptide CDMO, is a key partner in peptide manufacturing and development for ONL Therapeutics (ONL), a clinical-stage biopharmaceutical company developing novel therapies for protecting the vision of patients with retinal disease.

ONL1204 Ophthalmic Solution

ONL Therapeutics’ lead candidate ONL1204 Ophthalmic Solution is a novel, first-in-class small peptide Fas inhibitor designed to protect key retinal cells, including photoreceptors, from cell death that occurs in a range of retinal diseases and conditions. The company currently has three ongoing Phase I studies across three indications (rhegmatogenous retinal detachment (RRD), geographic atrophy associated with associated with age-related macular degeneration, and open-angle glaucoma). Enrollment is complete for the RRD study, and preparations are underway to file an IND in early 2023 for a Phase II clinical trial.

Funding

ONL B Series funding was completed earlier this year after meeting critical milestones, and ONL is looking forward to expanding their team and partnerships as they advance toward later-stage Phase 2 clinical studies and beyond.

AmbioPharm and ONL Partnership

Since 2015, AmbioPharm has been performing the peptide manufacturing and development support for ONL1204. “AmbioPharm is proud to partner with ONL on this important molecule for treating serious ophthalmic conditions and look forward to the continued success of this molecule so that patients have access to important new therapies,” said Michael Pennington, Ph.D., CSO of AmbioPharm. “AmbioPharm has been an important partner in supporting our development of ONL1204,” commented David Esposito, CEO of ONL Therapeutics. “The scientific expertise and client-focused culture at AmbioPharm have been critical factors to our team’s achievements.”

Upcoming Conferences

ONL CEO David Esposito will be speaking at the OIS Retina Innovation Summit on July 13, 2022 on the company’s progress and future development plans for ONL1204 Ophthalmic Solution.

AmbioPharm will be participating in CPhI Frankfurt and other industry events in the fall.

About ONL Therapeutics

ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD. Further information is available at: http://www.onltherapeutics.com/

About AmbioPharm

AmbioPharm, a part of the Ambio Pharmaceuticals Group, is a leading and innovation-driven company specializing in the development and manufacture of peptides and peptide-related products. With a comprehensive range of services, AmbioPharm produces custom products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide. Further information is available at: https://www.ambiopharm.com

Contacts

AmbioPharm Inc.
Mark DaFonseca, EVP, Sales & Global Business Development

[email protected]

ONL Therapeutics, Inc.
Linda Kemnitz

[email protected]