Omeros’ New Leukemia Drug Team Ignites Hope For Cancer Fight – Omeros (NASDAQ:OMER)

Omeros Corporation OMER on Thursday established the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia (AML).

AML is the most fatal form of leukemia. It accounts for approximately 80% of acute leukemias in adults and one-third of all cancers affecting the blood/bone marrow.

Omeros’ OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them.

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The steering committee will assist Omeros with developing the OncotoX-AML program, designing clinical trials, and interacting with institutional review boards, and it will also participate in OncotoX-AML clinical trials.

In vivo and ex vivo studies have shown that the OncotoX-AML therapeutic is highly effective even at very low doses, providing a significant survival benefit over currently approved combination therapy, like AbbVie Inc ABBV Roche Holdings AG’s RHHBY Genentech’s Venclexta (venetoclax) and Bristol Myers Squibb & Co’s BMY Vidaza azacitidine).

In studies using primary AML derived from patients, the OncotoX molecule preferentially and efficiently kills AML blasts (abnormal myeloid cells).

OncotoX-AML also targets leukemia stem cells (LSC), often refractory to chemotherapy.

The OncotoX-AML therapeutic is designed specifically to kill both AML blasts and LSCs that can lead to relapse.

Preliminary in vivo tolerability studies demonstrate that the OncotoX therapeutic is well tolerated at doses substantially greater than one order of magnitude above efficacious doses without causing neutropenia or meaningful changes in blood chemistry values.

Omeros is initiating IND-enabling work for its OncotoX-AML therapeutic.

D. Boral analyst Jason Kolbert writes, “This development is particularly important given the persistent challenges in AML treatment. Despite recent drug approvals, therapeutic options for AML remain limited, especially for patients who are elderly, relapse-prone, or harbor high-risk mutations.”

Kolbert adds that chemotherapy and existing antibody-drug conjugates often fail to provide durable responses due to narrow therapeutic indices and toxic side effects. By demonstrating high efficacy in preclinical models without significant toxicity, OncotoX-AML presents the potential to address long-standing gaps in AML care.

The analyst maintains a Buy rating on Omeros with a price target of $36 while modeling Omeros’ lead therapy, narsoplimab.

In February, the company resubmitted biologics license application for narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). Omeros expects the target date for FDA action under the Prescription Drug User Fee Act to be six months following the date of resubmission to the FDA, meaning, in this case, the PDUFA date would be September 2025.

The company expects to submit our European marketing authorization application for narsoplimab in TA-TMA in the first half of 2025. 

Price Action: OMER stock is up 13.2% at $6.64 at last check Friday.

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