Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor

Rhea-AI Summary

CEL-SCI announced that Dr. Giovanni Selvaggi, a renowned oncology expert, has joined as a Clinical Advisor. Dr. Selvaggi has been pivotal in the approval of lung cancer drugs such as Zykadia and Opdivo. CEL-SCI's Multikine immunotherapy has shown significant efficacy in head and neck cancer, improving 5-year survival to 73% compared to 45% in controls. The FDA has approved a confirmatory Registration Study for Multikine. Dr. Selvaggi will support CEL-SCI in navigating this trial, aiming for regulatory approval.

Positive

• Dr. Giovanni Selvaggi, a key opinion leader in oncology, joins as Clinical Advisor.
• Multikine improves 5-year survival rate in head and neck cancer patients to 73%, compared to 45% in the control group.
• FDA approval for a confirmatory Registration Study for Multikine.
• No safety signals versus standard of care reported for Multikine.
• Statistically significant results with a p-value of 0.0015.
• Risk of death reduced by 50% over 5 years with Multikine.
• Robust safety and efficacy data from 750 treated patients.
• Dr. Selvaggi's experience in getting drugs like Zykadia and Opdivo approved adds credibility.

Negative

• Potential delays and risks associated with the confirmatory Registration Study.
• No revenue generation from Multikine until post-approval, contributing to financial risks.
• Dependence on regulatory approval for future market success.
• Uncertainty in achieving the same efficacy results in a larger population.

Financial Analyst

CEL-SCI Corporation's announcement that Dr. Giovanni Selvaggi is joining as a Clinical Advisor is noteworthy because of his proven track record in bringing oncology drugs to market. This expertise is especially valuable as CEL-SCI progresses with its Multikine immunotherapy, which has shown promising data.

The data shows a 5-year survival rate of 73% for Multikine-treated patients compared to 45% in the control group and a significant reduction in the 5-year risk of death—down to 27% from 55%. Such figures are exceptional and speak to the drug's potential success upon regulatory approval.

From an investor's perspective, the engagement of Dr. Selvaggi should be viewed as a positive signal. His background suggests he could effectively expedite the regulatory approval process, potentially reducing the time to market and associated costs. Furthermore, the FDA's green light for a confirmatory Registration Study adds another layer of reassurance. Regulatory approval and subsequent market entry are often significant catalysts for a company's stock, making this a development to watch closely.

However, it's important to remain cautious. The final outcome of clinical trials and the subsequent FDA approval process are still unknown variables that could affect CEL-SCI's performance. Investors should stay informed about any updates regarding the progression of these trials and any regulatory feedback.

Oncology Doctor

Dr. Giovanni Selvaggi's addition to CEL-SCI comes at a important juncture for the company’s Multikine immunotherapy, which targets head and neck cancer. This field has long been underserved, particularly in pre-surgical interventions. Multikine’s approach, leveraging the body's immune system to combat cancer right after diagnosis, is innovative and backed by robust clinical data from 750 patients.

Dr. Selvaggi's experience with drugs like Zykadia and Opdivo, which have become mainstays in oncology treatment, can't be overstated. His involvement could enhance the credibility and clinical strategy of CEL-SCI, particularly in navigating the complex landscape of cancer immunotherapy. This could lead to a smoother pathway through clinical trials and regulatory hurdles.

For retail investors, understanding the medical significance of Multikine’s clinical data is vital. The p-value of 0.0015 suggests a statistically significant improvement in survival rates, meaning the results are likely not due to chance. Additionally, the hazard ratio of 0.35 indicates a 65% reduction in the risk of death, which is substantial.

However, as with any clinical development, it’s essential to be aware of potential risks. Even with positive early data, later-stage trials might yield different results. Monitoring clinical updates and remaining aware of the regulatory environment will be key to making informed investment decisions.

Market Research Analyst

CEL-SCI’s strategic move to bring Dr. Giovanni Selvaggi on board adds significant value in terms of industry perception and potential market success of Multikine. Oncology is a highly competitive field and having a seasoned expert who has successfully navigated through drug approvals can substantially boost investor confidence and market interest.

The head and neck cancer market has been starved of novel treatments, especially in the pre-surgical phase. Multikine's innovative approach could carve out a unique niche, particularly given its compelling clinical data. The potential market size includes newly diagnosed patients who currently have limited options, offering a substantial first-mover advantage.

For investors, the FDA's approval for a confirmatory Registration Study is a significant milestone. It positions CEL-SCI closer to commercializing Multikine, potentially opening revenue streams and improving market positioning. Given that head and neck cancers represent a global market, the upside could be substantial.

Nevertheless, while the data is promising, the competitive landscape should not be overlooked. Advances in oncology treatments are rapid and any delays or setbacks in the trial process could affect CEL-SCI’s market potential. Investors should weigh the potential market advantages against the inherent risks of drug development.

• Dr. Selvaggi was instrumental in the development and approval of lung cancer drugs Zykadia for Novartis and Opdivo for Bristol Myers Squibb
• CEL-SCI’s Multikine immunotherapy improves the 5-year survival of head and neck cancer patients to 73% compared to 45% in controls and cuts the 5-year risk of death by 50%
• FDA has given CEL-SCI the go-ahead to commence a confirmatory Registration Study for Multikine for the target population in head and neck cancer
• Dr. Selvaggi will be supporting CEL-SCI to bring Multikine to patients through a confirmatory registrational path that has been agreed with regulatory authorities and that has a potential for cure

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced Dr. Giovanni Selvaggi, an oncology key opinion leader instrumental in successfully bringing several drugs to market has joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi joins CEL-SCI as the Company recently received its go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer.

(Graphic: Business Wire)

Multikine is the first investigational pre-surgical cancer drug in newly diagnosed head and neck cancer. Multikine is a copy of the pro-inflammatory cytokine immune response human bodies produce every day and is designed to empower a person’s intact immune system cells to attack their own cancer. Patients are treated with Multikine right after diagnosis, before any other standard of care treatment (surgery and radiation therapy) since that is when the immune system is strongest. There is robust safety and efficacy data from 750 patients who have been treated with Multikine.

Based on the following efficacy data, the FDA has agreed to CEL-SCI’s 212-person Registration Study to confirm the findings for regulatory approval:

• No safety signals vs standard of care
• 73% survival for Multikine vs 45% in the control arm at 5 years
• Statistically significant p = 0.0015
• 5-year risk of death cut in half from 55% to 27% (Hazard ratio = 0.35 (95% CIs [0.19, 0.66])
• More detailed results may be viewed here: LINK

Dr. Selvaggi is a US-based drug developer, cancer researcher, and strategic advisor to big pharma and early-to-late stage biotech companies. He is currently Chief Medical Officer at Xcovery Holdings, where he manages an ongoing New Drug Application with the FDA for ensartinib, an ALK-TKI for non-small cell lung cancer (NSCLC). He is also a Clinical Consultant to Tubulis GmBH for a first-in-class ADC program in solid tumors, and Clinical Strategy Senior Advisor to Alira Health. He formerly served as Medical Director, Cancer Immunotherapy, in the MAGE-A3 lung cancer vaccine program at GSK. Later, Dr. Selvaggi played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis. At Oncolytics he was VP of Clinical Development. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line small cell lung cancer. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 20 years.

Dr. Selvaggi commented, “Multikine is a first in class immunotherapy that has demonstrated to meaningfully and safely prolong survival in a selected orphan population of newly diagnosed head and neck cancer. The importance of tackling cancer at the earliest stages to guarantee the most relevant impact in patients’ lives is undeniable, especially in head and neck cancer which has no approved therapeutic options before surgery. I am fully committed to supporting CEL-SCI leadership to bring this asset to patients through an expedited registrational path that has been agreed with regulatory authorities and that has a potential for cure.”

“Dr. Selvaggi has a passion for bringing cancer drugs to market to save lives and lead clinical research toward a cure for cancer. We are excited to have him join CEL-SCI as a Clinical Advisor at this pivotal point for Multikine which is set to commence a confirmatory FDA Registration Study,” stated CEL-SCI CEO, Geert Kersten. “The data on Multikine is excellent, and as we proceed with and wrap up this final study, Dr. Selvaggi’s experience and successful track record in navigating late-stage development, clinical trials, and the regulatory approval process will be hugely valuable for us.”

Dr. Selvaggi joins several other top-tier physician consultants and head and neck cancer key opinion leaders who are advisors to CEL-SCI.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240606671425/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

Who is Dr. Giovanni Selvaggi?

Dr. Giovanni Selvaggi is an oncology expert known for his role in the approval of lung cancer drugs like Zykadia and Opdivo.

What is CEL-SCI's Multikine?

Multikine is an immunotherapy for head and neck cancer, shown to improve 5-year survival rates to 73% compared to 45% in controls.

What is the purpose of the confirmatory Registration Study for Multikine?

The confirmatory Registration Study aims to validate the efficacy and safety of Multikine for regulatory approval.

What are the survival rates associated with Multikine?

Multikine has demonstrated a 5-year survival rate of 73% for treated patients compared to 45% in the control group.

What role will Dr. Giovanni Selvaggi play at CEL-SCI?

Dr. Giovanni Selvaggi will serve as a Clinical Advisor, supporting CEL-SCI in the regulatory and clinical development of Multikine.

What are the risks associated with CEL-SCI's new study?

Potential delays, financial risks, and uncertainties in achieving the same results in a larger population are key concerns.

What is the FDA's involvement with Multikine?

The FDA has approved CEL-SCI to commence a confirmatory Registration Study for Multikine in head and neck cancer.