Moderna Announces Clinical Updates on Personalized Cancer Vaccine Program
Interim data from Phase 1 dose expansion cohort of mRNA-4157 in combination with pembrolizumab shared at
Data support expansion of Head and Neck Squamous Cell Carcinoma (HNSCC) cancer patient cohort
Praveen Aanur,
MBBS joins
Tolerability data to date consistently demonstrate that mRNA-4157 is well tolerated. Adverse events are typically low grade and reversible. In the dose expansion cohort, the Overall Response Rate (ORR) in the HPV(-) HNSCC group of patients as measured by RECIST 1.1 is 50% (5/10) with two patients achieving a complete response (CR) with no detectable disease, and three patients achieving partial response (PR), all of which are ongoing. Median progression free survival (mPFS) is 9.8 months, which compares favorably to the published ORR and mPFS of 14.6% and 2.0 months respectively, for Keytruda monotherapy. Including four patients with stable disease, the Disease Control Rate (DCR) is 90% (9/10). Median duration of response has not been reached. The HPV(-) HNSCC cohort continues to recruit and
“We are encouraged by these interim data from our personalized cancer vaccine program, which involves designing and manufacturing a unique vaccine for each patient based on their specific tumor,” said
About Moderna’s Immuno-Oncology Programs
Moderna’s oncology programs are currently focused on two main areas: cancer vaccines and intratumoral immuno-oncology (I/O) therapies.
An advantage of Moderna’s mRNA platform is that it allows for investigational medicines that combine in a single mRNA therapy several different approaches to activate the immune system to attack cancer, either with mRNA encoding for common tumor proteins found across cancer types or multiple mRNAs encoding for various immunomodulatory proteins.
Moderna’s investigational PCVs are designed to use neoantigens identified from an individual’s tumor to program the body’s immune system to elicit a more effective anti-tumor response. Upon sequencing the tumor, Moderna’s proprietary algorithms predict the neoantigens (antigens encoded by tumor-specific mutated genes) most likely to trigger the immune system to attack a particular cancer. Today, mRNA encoding up to 34 unique neoantigens can be delivered in a single vaccine.
About
Headquartered in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the ability of Moderna’s personalized cancer vaccine (mRNA-4157) to elicit a response when given in combination with pembrolizumab, the tolerability of mRNA-4157 in patients, and the potential for mRNA-based therapies to activate the immune system to attack cancer. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our preclinical programs or development candidates may be delayed, terminated, or may never advance to or in the clinic; no commercial product using mRNA technology has been approved and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by
1 Keytruda® is a registered trademark of Merck & Co., Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005423/en/
Moderna Contacts
Media:
Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com
Investors:
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
Source:
Moderna Contacts
Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374
Colleen.Hussey@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com