Cel-Sci Q3 report and clinical update

 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2022, as well as key clinical and corporate developments.

Clinical and Corporate Developments:

CEL-SCI’s main focus throughout fiscal year 2022 has been to complete and submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Multikine®* (Leukocyte Interleukin, Injection) in the treatment of advanced primary head and neck cancer.

Current drug therapies for squamous cell carcinoma of the head and neck (SCCHN) from Merck and Bristol Myers Squibb (BMS) are approved as a last resort for recurrent tumors after treatments have failed or for patients who are not candidates for surgery. By contrast, Multikine is given to newly-diagnosed patients following initial diagnosis and ahead of surgery— it’s the first of its kind with substantial survival benefit in a randomized Phase 3 trial in locally advanced primary SCCHN.

The Multikine treated study population who receive surgery and radiotherapy as their standard of care treatments showed the following advantages over control:

• • A median overall survival improvement of 46.5 months— nearly four years.

  • 62.7% of Multikine patients were alive after five years vs. 48.6% in the control.

  • Nearly one out of every six patients had their tumors shrink by more than 30% in just 3 weeks and prior to surgery.

  • Five patients had their tumors completely disappear in just 3 weeks and prior to surgery.

  • Tumor shrinkage/disappearance cut the death rate by a factor of three.

• CEL-SCI published and presented data from its pivotal randomized controlled Phase 3 Multikine head and neck cancer clinical trial at two prestigious cancer conferences.

  • 2022 ASCO Annual Meeting in Chicago, Illinois

    • "Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only." – Abstract

    • "Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study." – Abstract and Poster Presentation

  • European Society for Medical Oncology (ESMO) annual Congress in Paris, France

    • Early response to Neoadjuvant Leukocyte Interleukin Injection (LI) immunotherapy extends overall survival (OS) in locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN): the IT-MATTERS Study – Poster Presentation and Video Presentation

    • Histopathology (HP) biomarkers confirm Leukocyte Interleukin Injection (LI) treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN) the IT-MATTERS Study – Poster Presentation

• Additional results from the Phase 3 clinical trial of Multikine in advanced primary head and neck cancer were posted to the U.S. government clinical trial website www.clinicaltrials.gov.

• CEL-SCI has submitted additional abstracts/manuscripts to be published/presented.

• CEL-SCI’s dedicated manufacturing facility in which it manufactures Multikine is being validated following the completion of its commercial scale build out during the first quarter of 2022. The construction was designed to ensure the facility will be compliant with all FDA GMP and European regulations.

• As of September 30, 2022, CEL-SCI had $22.7 million in cash and cash equivalents.

"We are the first to have achieved successful neoadjuvant (before surgery) immunotherapy in head and neck cancer. Keytruda and Opdivo, the two most successful cancer drugs today, have not shown a survival benefit as a neoadjuvant for advanced primary head and neck cancer, and the last FDA approval for this disease was decades ago. We have shown a very large improvement in survival for the patients scheduled to receive surgery and radiotherapy as their standard of care treatments. We have presented at top cancer conferences. We are very proud of this success, but I would like to increase the speed of our progress towards submitting a BLA and gaining marketing approval in the U.S. as well as in Canada. A number of factors are responsible for the rate at which we have been progressing. First, we have succeeded at something that has never been done successfully before—show improvement in survival from a neoadjuvant for advanced primary head and neck cancer patients. Second, the study that supports this achievement was long, enrolled a large number (928) of patients, and produced an extensive amount of data that had to be analyzed and interpreted. Third, because we are not a big pharma company with virtually unlimited staff and resources, we have not been able to complete our milestones as quickly as bigger companies would have done. But, as has always been the case with CEL-SCI, our tenacity gets the job done and done well. The Phase 3 study results bear this out. I am looking forward to a lot of positive activity and progress next year as we continue in our efforts to bring Multikine to market for patients with a severe unmet medical need," stated CEL-SCI CEO, Geert Kersten.

https://finance.yahoo.com/news/cel-sci-reports-fiscal-2022-140000607.html