Kala Pharmaceuticals Acquires Combangio, Maker of Regenerative Biotherapies for Severe Ocular Surface Diseases

Kala Pharmaceuticals Acquires Combangio, Maker of Regenerative Biotherapies for Severe Ocular Surface Diseases

November 16, 2021

Kala Pharmaceuticals announced the acquisition of Combangio, a private, clinical-stage company developing regenerative biotherapies for severe ocular surface diseases.

Combangio is developing CMB-012, a novel investigational secretome treatment currently known as KPI-012, to address the complex wound healing process in persistent corneal epithelial defect (PCED) and other serious ocular illnesses characterized by poor corneal healing.

“Today’s acquisition marks a pivotal moment for Kala and a meaningful acceleration toward our goal of strengthening Kala’s pipeline for the treatment of front and back of the eye diseases,” Mark Iwicki, Chief Executive Officer of Kala, said in a company news release.

“KPI-012 is a highly innovative product, which leverages a multifactorial mechanism of action to address the complex process of healing severe corneal defects. KPI-012 is currently in development for PCED, with potential application across a wide range of orphan diseases of the eye.”

KPI-012 is a novel bone marrow-derived mesenchymal stem cell (MSC) secretome made up of biomolecules released by MSCs such as protease inhibitors, growth factors, and neurotrophic factors that have been processed into a topical ocular solution.

KPI-012 is currently in clinical development for the treatment of PCED, which is defined as a persistent non-healing corneal defect or wound that is refractory to conventional treatments.

It is a rare condition with an estimated 100,000 instances in the United States and 238,000 cases in the United States, the European Union, and Japan combined, and the FDA has granted KPI-012 Orphan Designation for the treatment of PCED.

PCED can be caused by a variety of factors, including neurotrophic keratitis, epithelial debridement, microbial/viral keratitis, corneal transplant, limbal stem cell shortage, and trauma, and can result in corneal ulceration, perforation, scarring, infection, and vision loss.

“KPI-012 is an exciting addition to the Kala pipeline and is an important component of our strategy to develop novel therapies for significant unmet needs in ophthalmic diseases. People living with severe ocular surface diseases are in desperate need of new and better therapeutic options to not only provide symptomatic relief but to avoid the potential vision-threatening consequences of these diseases,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala.

Clinical Development Plan for KPI-012 in PCED

Kala intends to submit an investigational new drug (IND) application to the FDA and begin a phase 2/3 study of KPI-012 in the third quarter of 2022, pending regulatory approval. This trial, Kala believes, could serve as the first of two required pivotal trials.

The FDA has granted KPI-012 as an orphan drug designation for the treatment of PCED, and the firm believes it will meet the requirements for fast-track and breakthrough designations.

In addition to PCED, Kala is evaluating other orphan diseases driven by impaired corneal wound healing, such as thermal/chemical injury, corneal ulcers, ocular graft vs host disease, Stevens-Johnson syndrome and limbal cell deficiency, and is looking to initiate clinical evaluation for an additional indication after the IND submission and initiation of the PCED trial.

Kala acquired all of Combangio's outstanding equity under the terms of the agreement, and former Combangio equity holders are entitled to an upfront payment of $5 million in cash, subject to customary adjustments, and an aggregate of 7,788,667 shares of Kala common stock with an aggregate value of approximately $16,122,541.

The Board of both companies have approved the transaction and the transaction closed simultaneously with execution of definitive agreements on November 15, 2021.

Board and Management Appointments

Following the acquisition, Mark S. Blumenkranz, MD, Chairman of Combangio, has been appointed to the Kala Board of Directors, and Darius Kharabi, President and Chief Executive Officer of Combangio, has been named as Chief Business Officer of Kala, both effective November 15, 2021.