iVolve

Compugen progressing in Phase 1 Trials

Transcript

Overall CGEN's ongoing studies are reporting safety metrics. Efficacy is still a question.

Platform

A quick note about their platform, emphasis added:

In addition, we have advanced COM902, our anti-TIGIT antibody to the clinic, announcing the first patient dose, in April. This marks a third program discovered computationally by us that is now in clinical studies.

Studies

COM701

COM701 focuses on PVRIG pathway. CGEN has the only PVRIG asset:

Having access to the only clinical stage PVRIG asset, to our knowledge, highly differentiates us on testing the clinical relevance of this axis.

There is an ongoing COM701 monotherapy study:

We reported additional encouraging data from our Phase 1 COM701 dose escalation study, both as monotherapy and in combination with Opdivo. These further support the potential of our overall science-driven clinical strategy.

...

We still plan to initiate and complete enrollment in our COM701 monotherapy expansion cohort, with initial data expected to be disclosed in the first-half of 2021, ...

Safety:

The data we reported demonstrated that COM701 was well tolerated with no dose limiting toxicities across all seven dose cohorts with dosing up to 10 milligrams per kilogram IV every three weeks.

COM701 triple combination study with Bristol-Meyers:

Earlier in the quarter, we also announced an important strategic step by extending our ongoing collaboration with Bristol-Myers Squibb to include a Phase 1/2 triple combination study testing COM701 with BMS Opdivo and their investigational TIGIT inhibitor. This study will enable us to directly test our hypothesis of an intersection between the PVRIG TIGIT and PD-1 pathways in which the simultaneous blockade of these pathways has the potential to synergistically enhance anti-tumor immune response in selected patient population not responsive or refractory to PD-1 blockers alone.

COM701 triple combination study will be initiated in the "second-half of 2020."

COM902

COM902 focuses on TIGIT pathway.

Moving to our TIGIT program, we were pleased to announce first patient dose in our Phase 1 dose escalation trial of COM902 in patients with advanced malignancies.

CGEN plans to "disclose initial data from our COM902 dose escalation studies in 2021."

ROCHE also has a TIGIT asset they will be presenting efficacy data on in the near future at ASCO.

How does CGEN differentiate from ROCHE?

It's an interesting question. So, just with respect to differentiation, our antibodies are ultra-high affinity antibodies. So that is a differentiating factor, but we don't know how it will translate to in the clinic. So I wouldn't think about our TIGIT test completely differentiating. I think that the key differentiation for us to comprehend is the fact that we have COM701, we have a clinical stage PVRIG anti-body and we think that it is needed in specific patient populations, in specific cancer indications. So this is our key differentiator.

COM701 + COM902 = PVRIG + TGIT = DNAM

PVRIG + TIGIT makes the DNAM axis (emphasis added):

Our research and preclinical data indicate that these two pathways are parallel and complementary inhibitory pathways in the DNAM axis, and have further strengthened our belief that in certain tumor types and patient populations where the two pathways are operative there may be a need to block both PVRIG and TIGIT in order to enhance potent anti-tumor immune response. In addition, our preclinical data supports recent scientific findings by others indicating a molecular intersection between the DNAM axis and the PD-1 pathway, thus suggesting that various drug combinations that address PVRIG, TIGIT, and PD-1 may be required to target these three pathways in different cancer patient population and in cancer indications. While in some of the patients blocking the PD-1 pathway will be sufficient, in others the blockade of one or two of the other inhibitory pathways with or without PD-1 blockade may be required to generate potent immunotherapy treatment responses.

BAY 1905254 collaboration with BAYER

Targets ILDR2.

We were proud to recently announce the publication of preclinical data originating from our collaboration with Bayer on BAY 1905254, a first-in-class immune-oncology therapeutic antibody targeting ILDR2, which we discovered computationally and which is currently being evaluated by Bayer in a phase 1 study in advanced solid tumor.