Hoth Therapeutics and Aronnax Inc. Enter Master Services Agreement For HT-KIT Cancer Therapeutic

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) has entered a Master Services Agreement with Aronnax Inc. for its HT-KIT cancer therapeutic. Aronnax will oversee ITR Laboratories in conducting intravenous injection studies to determine the Maximum-Tolerated Dose (MTD) and perform a Dose Range-Finding Phase for HT-KIT.

HT-KIT, an antisense oligonucleotide targeting the proto-oncogene cKIT, has shown promising results in killing human mast cells and reducing KIT expression in GIST and AML cells. It has received Orphan Drug Designation from the FDA for treating mast cell-derived cancers and anaphylaxis.

This study aims to provide Hoth with key metrics for formulating its proposed clinical trial, advancing HT-KIT towards an IND-enabling study.

Positive

• HT-KIT effectively kills human mast cells relying on KIT receptor signaling
• HT-KIT reduces KIT expression in GIST cells and kills within 48-72 hours
• HT-KIT lowers KIT expression in AML cells over 72 hours
• HT-KIT has received Orphan Drug Designation from FDA
• Progress towards IND-enabling study for HT-KIT

Negative

• None.

Medical Research Analyst

The agreement between Hoth Therapeutics and Aronnax for HT-KIT development marks a significant step towards clinical trials. HT-KIT, an antisense oligonucleotide targeting cKIT, shows promise in treating mast cell-derived cancers and anaphylaxis. Key points:

• HT-KIT effectively kills human mast cells reliant on KIT receptor signaling
• Single dose effects last about two weeks, with reduced KIT expression for 7 days
• Demonstrates potential in GIST and AML cells
• Aronnax will oversee dose-finding studies, important for IND submission

This progress is encouraging, but investors should note that we're still in pre-clinical stages. The upcoming dose-finding study is critical for determining safety and efficacy parameters for human trials. While promising, many candidates fail in later stages, so cautious optimism is warranted.

Financial Analyst

This agreement represents a positive development for Hoth Therapeutics (NASDAQ: HOTH), potentially increasing the company's value proposition. Key financial implications:

• Advancement towards clinical trials could attract investor interest
• Orphan Drug Designation for HT-KIT may provide market exclusivity and tax benefits
• Partnership with Aronnax might streamline development, potentially reducing costs
• Successful development could open lucrative markets in oncology and immunology

However, investors should consider that biopharmaceutical R&D is high-risk. Hoth will likely need substantial capital to fund clinical trials, which could lead to dilution. The company's financial health and burn rate should be closely monitored. While this news is positive, it's early-stage and commercial viability remains uncertain.

Aronnax to Determine the Maximum-Tolerated Dose (MTD) Post Intravenous Injection Followed by a Dose Range-Finding Phase of Hoth's Orphan Drug HT-KIT

NEW YORK, Aug. 15, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it has entered into a Master Services Agreement with Aronnax, Inc. for its HT-KIT cancer therapeutic. 

HT-KIT research, which was conducted at NC State University to evaluate the efficacy of HT-KIT in cancerous and non-cancerous cells, has demonstrated that HT-KIT effectively kills human mast cells that rely on signaling through the KIT receptor to survive. The effect of a single dose lasted for about two weeks, while reduced KIT expression lasted for 7 days. This result also demonstrated HT-KIT's potential to reduce KIT expression using GIST cells and kill within 48 and 72 hours along with lower KIT expression in AML cells over 72 hours.

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT being developed for the treatment of mast cell-derived cancers and anaphylaxis and previously received Orphan Drug Designation from FDA.

Aronnax will oversee the third-party provider, ITR Laboratories, conducting intravenous injection using increasing/decreasing doses for each subsequent group. A timeframe of forty-eight hours will be allowed between each dose group. This study will provide Hoth key metrics in both max dose and range finding elements which will help formulate its proposed clinical trial.

"We continue to make quick progress in moving HT-KIT from the lab to patients. This further analysis will help us with that process, finalizing the protocols in our upcoming IND-enabling study," stated Robb Knie, Chief Executive Officer. "We are pleased to further engage Aronnax and ITR Laboratories on these key studies given their reputation for IND-enabling studies."

About Hoth Therapeutics, Inc.  

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.

Forward-Looking Statement

This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.

Investor Contact: 
LR Advisors LLC 
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.

FAQ

What is the purpose of Hoth Therapeutics' agreement with Aronnax Inc. for HT-KIT?

Hoth Therapeutics has entered a Master Services Agreement with Aronnax Inc. to determine the Maximum-Tolerated Dose (MTD) and conduct a Dose Range-Finding Phase for its HT-KIT cancer therapeutic through intravenous injection studies.

What are the potential applications of Hoth Therapeutics' HT-KIT (HOTH)?

HT-KIT is being developed for the treatment of mast cell-derived cancers and anaphylaxis. It has shown potential in killing human mast cells, reducing KIT expression in GIST cells, and lowering KIT expression in AML cells.

Has Hoth Therapeutics' HT-KIT (HOTH) received any FDA designations?

Yes, HT-KIT has received Orphan Drug Designation from the FDA for the treatment of mast cell-derived cancers and anaphylaxis.

What is the mechanism of action for Hoth Therapeutics' HT-KIT (HOTH)?

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT, which is involved in the signaling pathway for mast cell survival and proliferation.