Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor
06 Junio 2024 - 6:00AM
Business Wire
- 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
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.
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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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240606671425/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
Cel Sci (AMEX:CVM)
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