On August 11, 2023 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2023, as well as key clinical and corporate developments (Press release, Cel-Sci, AUG 11, 2023, View Source [SID1234634292]).

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Clinical and Corporate Developments this quarter include:

CEL-SCI had a productive pre-submission meeting with Canada’s regulator, Health Canada, to determine the best regulatory path toward market approval. Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy which facilitates earlier access for physicians and patients to promising new drugs for patients suffering from serious, life-threatening, or severely debilitating diseases. CEL-SCI is preparing an application for the NOCC approval as suggested and plans to file it by early next year. If Health Canada grants the NOCC, then it is possible that CEL-SCI could begin commercialization in 2024.
Europe is a priority market for CEL-SCI, as Europe has more than twice the number of head and neck cancer cases diagnosed each year as compared to the United States (US). CEL-SCI is seeking conditional marketing authorization for Multikine in Europe. Based on the published guidelines, the Company believes it meets the requirements for conditional approval of Multikine and has plans for meetings with regulators in the fall.

CEL-SCI had a collaborative and positive meeting with the U.S. Food and Drug Administration (FDA). The FDA acknowledged the great need for improved treatments for head and neck cancer, particularly the locally advanced oral cavity that CEL-SCI is targeting and is open to close collaboration with CEL-SCI to help demonstrate that Multikine could fill this need. Preliminary feedback from the FDA included that the selection criteria developed by CEL-SCI from its Phase 3 data could be used to determine which locally advanced oral cavity cancer patients might benefit from Multikine treatment. CEL-SCI is preparing additional information about its Multikine development plan for a follow-up meeting with the FDA based on this feedback. A confirmatory clinical trial will be conducted based on the agreed upon selection criteria for patients that will be treated with Multikine as assessed by methods including PET-CT/MRI screening. CEL-SCI will collaborate closely with the FDA on the design of a clinical protocol that will allow the Company to generate, as expeditiously as possible, the confirmatory data they will require for approval of Multikine in the US. Importantly, this study is also expected to have intermediate endpoints during study enrollment for potential accelerated approval based on interim results.

Potentially quite impactful PD-L1 biomarker data from CEL-SCI’s Phase 3 study was presented at the American Head and Neck Cancer Society’s 11th Annual International Conference on Head and Neck Cancer titled "Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study". The data demonstrated that the tumors of patients who responded best to Multikine in the Phase 3 study had low levels of the PD-L1 biomarker. Currently approved checkpoint inhibitors (Keytruda and Opdivo) which are indicated for treatment of unresectable or recurrent or metastatic head and neck cancer are known to work best in patients whose tumors express high PD-L1 levels and are less likely to work in patients whose tumors express low PD-L1. These contrasting PD-L1 data observed in patients responsive to Multikine vs those observed in patients treated with checkpoint inhibitors are very significant.

The data are expected to be helpful in key ways:

Supporting marketing approval by using PD-L1 as a marker to select patients who are most likely to benefit from Multikine

Positioning Multikine as a combination therapy with checkpoint inhibitors

Combination studies may be conducted in partnership with a larger pharma company that has an approved PD-L1 checkpoint inhibitor

Should combination studies with checkpoint inhibitors be successful not only would patients benefit substantially, but the financial benefits to CEL-SCI could be very large
The global PD-L1/PD-1 therapeutics market was valued at $34.8 billion in 2022
Data presented at the European Society for Radiotherapy and Oncology (ESTRO) 2023 Congress in May confirmed that Multikine significantly prolonged overall survival in head and neck cancer. The presentation titled "Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma SCCHN)" provided findings from a histopathology and tumor biomarker analysis of its Phase 3 study that confirmed Multikine-treated subjects had improved 5-year survival, showed improved progression free survival and improved local regional control, and a significantly lowered death rate compared to control subjects who received standard of care alone.
"The growing body of data on the efficacy of Multikine presented at peer-reviewed conferences is highly encouraging as we move forward with regulatory meetings and submissions with the world’s most respected regulators in the world in addition to FDA. The data has also allowed us to define very well the population of patients who have the greatest benefit from Multikine treatment. This is a crucial part of our approval strategy in this unmet medical need as we are aiming for conditional/accelerated approval pathways with multiple regulators," stated CEL-SCI CEO, Geert Kersten. "We are also excited about the new prospect of developing Multikine in conjunction with a pharma partner as a combination therapy with a checkpoint inhibitor to boost patient outcomes.

Financial Results

CEL-SCI reported a loss per share for the quarter ending June 30, 2023 of $0.19 versus a loss of $0.23 for the quarter of June 30, 2022.