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Tuesday, December 29, 2015

Immune Licenses Bi-Specific Antibody Technology - Will Focus On Checkpoint Inhibitors

Two week ago I wrote a brief article on Immune Pharmaceuticals (IMNP) and the company's initial efforts in Immuno-Oncology. Investors can view that article >> HERE <<. Company scientists, in collaboration with a consortium of leading European research centers, developed a prototype HLA-DRx-CD5 bi-specific antibody construct consisting of tandemly arranged Fab fragments with direct anti-cancer effects in vitro, as well as anti-tumor activity and improved survival in a mouse xenograft model of disseminated leukemia.

I noted in my article that this very interesting and somewhat "under the radar" news for Immune, a company that most investors follow because of the lead Phase 2 asset, Bertilimumab, for bullous pemphigoid and ulcerative colitis. Bertilimumab is still the most important driver for Immune, but Immuno-Oncology is hot, and Immune's efforts in bi-specific antibodies, an area where big pharma has been investing heavily over the past few years, could lead to significant value creation for investors as the development progresses.

Earlier in the week, Immune further strengthened its efforts in Immuno-Oncology and bi-specific antibodies with the licensing of technology and patents from Atlante Biotech SAS, a privately-held European biotech company that was part of the aforementioned European consortium working with Immune on the initial bi-specific antibody prototype. Work at Atlante Biotech SAS was lead by Dr. Jean Kadouche, a scientific co-founder of Immune Pharma. The technology in-licensed by Immune expands the company's platform to target immune checkpoint inhibitors and will help the company generate additional pre-clinical data with selected bi-specific drug candidates in 2016.

Checkpoint Inhibitors - All The Rave

An important part of the immune system is its ability to distinguish between normal cells and foreign invaders. This identification allows the immune system to attack and destroy foreign or malignant cells while leaving the normal cells alone. To do this, the body uses “checkpoints” – molecules on certain immune cells that need to be activated (or inactivated) to elicit an immune response. Cancer cells sometimes find ways to use these checkpoints to avoid being attacked by the immune system. As such, drugs that target these checkpoints hold significant promise for the treatment of cancer. 

Bristol-Myers was first to gain approval for a checkpoint inhibitor with Yervoy® (ipilimumab) in 2011. Yervoy® is a monoclonal antibody that targets the immune checkpoint cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The drug is approved for the treatment of advanced melanoma. Two other checkpoint inhibitors, Merck's Keytruda® (pembrolizumab) and Bristol's Opdivo® (nivolumab) target another checkpoint molecule, programmed death-1 (PD-1). Both are also approved for advanced melanoma and a specific form of advanced non-small cell lung cancer. Beyond these three approved drugs, several other companies, including Roche and AstraZeneca, are working on immune checkpoint inhibitors targeting PD-1 and programmed death-ligand 1 (PD-L1). 

Immune's Focus On Multiple Checkpoint Inhibitors

By licensing the technology and patents from Atlante Biotech SAS, Immune's R&D effort, lead by Dr. Boris Shor, Ph.D., who only just recently joined Immune in September 2015 from Pfizer's Oncology Research Unit, will now be able to develop bi-specific antibody constructs targeting multiple immune checkpoint inhibitors. It's a novel strategy, but one that could pay off with significant dividends if successful. For example, only a few months ago the U.S. FDA approved the combination therapy of Yervoy® and Opdivo® for the treatment of unresectable or metastatic melanoma. These are two monoclonal antibodies targeting two different checkpoint inhibitors.

Immune's strategy with its bi-specific platform is to develop one antibody with two Fab fragments that might be able to accomplish what only combination therapy can do today. The plan is reminiscent of what AnaptysBio did with TESARO back in March 2014 by signing an initial collaboration that netted $17 million upfront, and then expanding that collaboration around immune checkpoints only a few months later.


I think 2016 will be a pivotal year for Immune Pharma. Both Phase 2 clinical trials with Bertilimumab are enrolling patients, with data from the bullous pemphigoid trial likely in the second quarter of the year. I'm also expecting that the company will provide an update on its Immune-Dermatology and NanomAbs programs in 2016 as outlined by Dr. Teper's shareholder letter released earlier in the month. At only $25 million in market value, upside in the stock is significant in my opinion.


- Read about Immune's clinical program with Bertilimumab in bullous pemphigoid and ulcerative colitis, both enrolling patients in Phase 2. 


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