CERo Therapeutics Holdings, Inc. is a biotechnology company pioneering engineered T cell immunotherapies to combat cancer, with a focus on hematologic malignancies and solid tumors. In an email conversation with AlphaStreet, chief executive officer Chris Ehrlich discussed CERo’s novel approach to T cell engineering and its implications for treating solid tumors and hematologic cancers.
What core advantage does CERo’s engineered receptor platform offer over traditional CAR-T approaches?
The primary advantage of CERo’s engineered CER receptor is the use of a native human protein, TIM-4, as the antigen binding domain as opposed to an scFv, which is typical for CAR-T cells. ScFv receptors are well understood and easy to manipulate, but they only do one thing very well, which is bind proteins. Outside of that, they don’t contribute a lot to the function of a CAR-T cell. TIM-4 is a completely different case. It naturally binds efficiently to a structural lipid component of the tumor cell, which gives us a unique target that healthy cells don’t express, but cancer cells often express.
We believe this will help the CER-T cell differentiate itself from competitors, as we anticipate little to no on-target off-tumor toxicity, which has been a hurdle for other CAR-T cells in Acute Myeloid Leukemia (AML) and solid tumors.
Secondarily, TIM-4 has a number of intrinsic functions that it keeps performing even when added to CER-1236, namely phagocytosis. TIM-4 by itself can impart the ability to phagocytose to our CER-T cell, and we’ve further enhanced that function with the signaling domains we’ve engineered into CER-1236. This unique receptor, combined with well-understood T cell signaling domains, creates a T cell that can potently kill and ‘eat’ tumor cells while interacting with the native immune system to create a more comprehensive, full-body, anti-cancer response.
How do you see CERo’s platform scaling commercially, especially in competitive oncology markets?
One of the strengths of targeting a unique, broadly expressed target is that we see potential for use on many different types of cancers, including many that affect tens or hundreds of thousands a year in the US alone. Because of this broad expression of TIM-4-L, we think that patients with various types of cancer may be prime candidates for CER-1236 therapy, instead of only a few select indications. In addition, we’ve tooled our manufacturing process to follow processes that are well established for CAR-T cells, allowing us to have a streamlined, cost-efficient process with a rapid ‘vein-to-vein’ timeline, shortening the amount of interim therapy needed to keep patients stable. We think this will let us scale rapidly to initiate a pivotal trial and expand manufacturing capacity if we see efficacy and durability of response, which is really the goal for a long-live T cell therapy.
What are your top priorities over the next 12 months to strengthen CERo’s clinical and commercial position?
A lot of our priorities are focused on the clinical work we are engaged in. Since CERo’s early days, we’ve been focused on creating a therapy that would work in solid tumors, and we’re keen to initiate our CertainT-2 trial in ovarian cancer and non-small cell lung cancer in early 2026. This will help to build upon the safety results we are tracking in our AML trial, CertainT-1, and determine if CER-1236 can make a difference in these late-stage cancers with few other clinical options.
In addition, we’re encouraged by the lack of dose-limiting toxicity so far and the potent T cell expansion we are observing in our AML trial, and hope to progress the dose escalation phase of our trial to find an optimal safe dose and proceed to dose expansion, where we can start gathering solid data on efficacy. We think that by demonstrating safety and functionality in multiple hard-to-treat tumor types and being transparent and timely in our data reporting, we can demonstrate the promise of CER-1236 to patients, doctors, and investors while enhancing our clinical and commercial position.
What’s your broader vision for CERo’s role in shaping the future of immune cell therapy?
CAR-T cell therapies have had transformative success in B-cell malignancies, but that hasn’t translated to other tumor types yet, of which there are many. There are a lot of great ideas in the field on how to expand the reach of an engineered T cell, but their design usually limits them to use in a few indications. What’s novel about CER-T cells is the target, TIM-4-L, which is so broadly expressed in tumor cells and can even be induced on cancer cells by the CER-T cell, as we’ve demonstrated and presented in our recent Society for Immunotherapy of Cancer (SITC) 2025 poster presentation. We think that this means we can treat multiple types of cancers with a single product, which would be transformative for a field that is often focused on designing an exquisitely specific therapy for a single type of cancer. This could also have a powerful impact in rare cancers where the economics of designing, optimizing, and testing a novel therapy are not great and have to be weighed against a limited patient population. For CER-T therapy, it would just be a matter of demonstrating that the TIM-4-L is present on those rare tumors to justify moving to the clinic, because the drug is already there.
Are strategic partnerships or collaborations part of CERo’s near-term plan to expand its pipeline or reach?
We’re excited to be working with world-class institutions to conduct our clinical trials, as well as our partners in the manufacturing space that have allowed for an expedited drug development timeline, and we are looking forward to continuing our collaborations with them to analyze and improve the many translational samples we are collecting. Understanding at the molecular level how CER-T cells are responding to the cancer cells, and in turn how the cancer cells are responding to the CER-T therapy, will yield some highly valuable insights that might point to new avenues in CER-T design.
(Disclaimer: The views expressed in this interview are solely those of the interviewee and do not necessarily reflect the views or opinions of AlphaStreet. It is for informational purposes only and does not constitute investment advice, financial guidance, or a recommendation to buy or sell any securities.)
