On August 16, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, AUG 16, 2021, View Source [SID1234586650]).

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Clinical and Corporate Developments include:

On June 28, 2021, CEL-SCI announced top line results from its 9.5 year global pivotal Phase 3 study for its immunotherapy Multikine (Leukocyte Interleukin, Injection)* in head and neck cancer. The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm receiving Multikine treatment regimen followed by surgery and radiation. This survival benefit was statistically significant, robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation): Multikine arm 62.7%, control arm 48.6% survival.
The OS benefit of 14.1% at 5 years for this treatment arm exceeded the >10% OS benefit set out for the study population as a whole in the protocol. The OS results for this treatment arm were significant (two-sided p=0.0236, HR=0.68) and the survival effect increased over time. The results from the Phase 3 cancer study proved that Multikine met all of the protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies. Based on the results of this pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application with U.S. Food and Drug Administration (FDA) for approval of this indication. We are assembling the information required to request a pre-BLA (Biologics License Application) meeting with the FDA to discuss the adequacy of the study results to support a license application and receive FDA input on any other issues that would have to be addressed for an approval to be granted.
Worldwide there are approximately 890,000 newly diagnosed head and neck cancer patients of which CEL-SCI’s target population when filing for FDA approval is about 210,000 patients. That would mean that approximately 29,000 patients could be alive at 5-years if all 210,000 eligible patients received the Multikine treatment regimen followed by surgery and radiation compared to receiving surgery and radiation alone, the current treatment paradigm/SOC for these patients.
CEL-SCI is near completion of the expansion of its existing dedicated cGMP manufacturing facility for Multikine. The construction, which began in 2020, will double the current facility’s capacity to accommodate two shifts for increased production of Multikine.
CEL-SCI raised net proceeds of $53.6 million during the nine months ended June 30, 2021 through the sale of common stock and the exercise of warrants and options. As of June 30, 2021, CEL-SCI had $47.1 million in cash, cash equivalents and U.S. Treasury Bills.

"The results of this 10-year landmark study proved our novel concept of cancer treatment, 1) that the use of our investigational cancer immunotherapy Multikine before the usual first cancer treatments (as neoadjuvant treatment) should significantly increase survival and 2) that a cancer drug can have a very favorable safety profile. Our Phase 3 study results are the first sign of real progress in the treatment of advanced primary head and neck cancer in many decades. We estimate about 210,000 patients per year globally who could potentially benefit from this drug once approved. Our goal is to seek FDA approval based on the data from our recently concluded pivotal Phase 3 study," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $27.7 million for the nine months ended June 30, 2021, versus an operating loss of $20.5 million for the nine months ended June 30, 2020. CEL-SCI reported an operating loss of $10.5 million for the quarter ended June 30, 2021, versus an operating loss of $7.0 million for the quarter ended June 30, 2020.