Oncology and neuroscience-focused biopharmaceutical company Immuneering Corp. (IMRX:NASDAQ), which is engaged in creating and developing novel medicines for patients afflicted with solid tumors driven by RAS mutations and other MAPK pathway activation events, today announced that "the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IMM-1-104, paving the way for the company to initiate a Phase 1/2a clinical trial of this oral, once-daily small molecule, in development for the treatment of advanced RAS mutant solid tumors."
The company's Chief Medical Officer Scott Barrett, M.D. remarked, "This decision from the FDA is a critical achievement, as we are dedicated to developing better treatment options for patients with RAS mutated solid tumors."
Immuneering Corp.'s CEO Ben Zeskind commented, "Clearance of the IND for IMM-1-104 brings us one step closer to our goal of developing medicines with the potential to benefit every cancer patient with a RAS mutant solid tumor, not just those harboring specific mutations."
Zeskind continued, "In keeping with this goal, the Phase 1 portion of the clinical trial is designed to enroll solid tumor patients with evidence of any RAS mutation. This design is driven by 104's novel deep cyclic inhibition mechanism, which aims to selectively target tumor cells in a mutation-agnostic way while largely sparing healthy cells. We believe this will be the first all-comers RAS clinical trial conducted to date."
The company's Chief Medical Officer Scott Barrett, M.D. remarked, "Based on the robust preclinical, single-agent anti-tumor activity seen in RAS mutated pancreatic, melanoma, colorectal, and lung cancers, we eagerly anticipate evaluating IMM-1-104 in patients . . . This decision from the FDA is a critical achievement, as we are dedicated to developing better treatment options for patients with RAS mutated solid tumors."
Dr. Barret added that the firm's clinical team is now focused on initiating enrollment in the upcoming study in Q4/22.
The firm noted that the Phase 1/2a trial is designed to evaluate "the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-cancer activity of IMM-1-104 for the treatment of advanced RAS mutant solid tumors."
The company expects to kick off enrollment in the Phase 1/2a IMM-1-104 clinical study in Q4/22. The study is to be conducted across five clinical sites in the U.S. and will be implemented using a Bayesian mTPI-2 escalation design method with the goal of determining a recommended Phase 2 dose (RP2D) for IMM-1-104.
Immuneering noted that following completion of Phase 1, it intends to proceed with a Phase 2a dose expansion study with the goal of assessing the efficacy of IMM-1-104 in treating RAS mutated colorectal, lung, melanoma, and pancreatic cancers.
The firm lists on its website that "each of the programs in its oncology pipeline is designed to cause cyclical disruption of abnormal activation of the MAPK and mTOR signaling pathways." The company explained that IMM-1-104 works by increasing pan-RAS activity that specifically targets cancer cells rather than healthy ones.
Immuneering is headquartered in Cambridge, Mass., and is focused on the development of novel therapies using its disease-agnostic platform to address high unmet medical needs in the areas of oncology and neurology. The company strives to create medicines that target solid tumors driven by RAS mutations and other MAPK pathway activation events in patients of all ages and ethnicity.
The firm mentioned that it leverages and utilizes its proprietary, human-aligned 3D tumor modeling platform, together with its expertise in translational bioinformatics, to gain insight into potential drug mechanisms of action and projected treatment responses by patients.
Immuneering Corp. started the day with a market cap of around $346.3 million with approximately 26.4 million shares outstanding and a short interest of about 2.8%. IMRX shares opened nearly 5% higher today at $13.77 (+$0.65, +4.95%) over yesterday's $13.12 closing price. The stock traded between $12.85 and $16.17 per share today and closed for trading at $14.32 (+$1.20, +9.15%).
| Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. | Subscribe |
Disclosures:
1) Stephen Hytha wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
