Hoth Therapeutics Advances Cancer Fighting HT-KIT Program with New Patent Filing and Preclinical Study Initiation
Hoth Therapeutics (NASDAQ: HOTH) has announced two major developments for its cancer-fighting drug candidate HT-KIT:
1. Filed amended patent claims with the USPTO for its antisense oligonucleotide (ASO) technology targeting MS4A6A and FcεRIβ genes, strengthening intellectual property protection for treating conditions like anaphylaxis, mastocytosis, and allergic asthma.
2. Initiated a GLP-compliant 4-week intravenous toxicity study in C57BL/6 mice with a 14-day recovery period, conducted in partnership with OnTargetx R&D Inc. and ITR Laboratories. The study will assess multiple dose groups, pathology, and pharmacokinetic profiling to support upcoming regulatory filings.
The company is conducting additional preclinical studies to validate HT-KIT's efficacy and safety profile, with plans to initiate regulatory discussions for first-in-human trials.
Hoth Therapeutics (NASDAQ: HOTH) ha annunciato due importanti sviluppi per il suo candidato farmaco contro il cancro HT-KIT:
1. Ha presentato richieste di brevetto modificate all'USPTO per la sua tecnologia di oligonucleotidi antisenso (ASO) mirata ai geni MS4A6A e FcεRIβ, rafforzando la protezione della proprietà intellettuale per il trattamento di condizioni come l'anafilassi, la mastocitosi e l'asma allergico.
2. Ha avviato uno studio di tossicità endovenosa di 4 settimane conforme alle GLP in topi C57BL/6 con un periodo di recupero di 14 giorni, condotto in collaborazione con OnTargetx R&D Inc. e ITR Laboratories. Lo studio valuterà diversi gruppi di dosaggio, patologia e profili farmacocinetici per supportare le prossime domande normative.
L'azienda sta conducendo ulteriori studi preclinici per convalidare l'efficacia e il profilo di sicurezza di HT-KIT, con piani per avviare discussioni normative per i trial clinici di prima-in-umano.
Hoth Therapeutics (NASDAQ: HOTH) ha anunciado dos desarrollos importantes para su candidato a fármaco contra el cáncer HT-KIT:
1. Presentó solicitudes de patente enmendadas ante la USPTO para su tecnología de oligonucleótidos antisenso (ASO) dirigida a los genes MS4A6A y FcεRIβ, fortaleciendo la protección de la propiedad intelectual para tratar condiciones como la anafilaxis, la mastocitosis y el asma alérgico.
2. Inició un estudio de toxicidad intravenosa de 4 semanas conforme a GLP en ratones C57BL/6 con un período de recuperación de 14 días, realizado en colaboración con OnTargetx R&D Inc. y ITR Laboratories. El estudio evaluará múltiples grupos de dosis, patología y perfiles farmacocinéticos para apoyar las próximas presentaciones regulatorias.
La empresa está llevando a cabo estudios preclínicos adicionales para validar la eficacia y el perfil de seguridad de HT-KIT, con planes de iniciar discusiones regulatorias para ensayos en humanos por primera vez.
호스 테라퓨틱스 (NASDAQ: HOTH)는 암 치료 후보 약물 HT-KIT에 대한 두 가지 주요 개발 사항을 발표했습니다:
1. 아나필락시스, 비만세포증 및 알레르기 천식과 같은 질환 치료를 위한 MS4A6A 및 FcεRIβ 유전자를 타겟으로 하는 항센스 올리고뉴클레오타이드(ASO) 기술에 대한 수정된 특허 출원을 USPTO에 제출하여 지적 재산 보호를 강화했습니다.
2. OnTargetx R&D Inc. 및 ITR Laboratories와 협력하여 C57BL/6 마우스를 대상으로 14일 회복 기간이 포함된 GLP 준수 4주간 정맥 독성 연구를 시작했습니다. 이 연구는 여러 용량 그룹, 병리학 및 약리학적 프로파일을 평가하여 향후 규제 제출을 지원할 것입니다.
회사는 HT-KIT의 효능 및 안전성 프로파일을 검증하기 위해 추가적인 전임상 연구를 진행 중이며, 최초의 인간 임상 시험을 위한 규제 논의를 시작할 계획입니다.
Hoth Therapeutics (NASDAQ: HOTH) a annoncé deux développements majeurs pour son candidat médicament anticancéreux HT-KIT :
1. A déposé des demandes de brevet modifiées auprès de l'USPTO pour sa technologie d'oligonucléotides antisens (ASO) ciblant les gènes MS4A6A et FcεRIβ, renforçant la protection de la propriété intellectuelle pour le traitement de conditions telles que l'anaphylaxie, la mastocytose et l'asthme allergique.
2. A lancé une étude de toxicité intraveineuse de 4 semaines conforme aux GLP chez des souris C57BL/6 avec une période de récupération de 14 jours, réalisée en partenariat avec OnTargetx R&D Inc. et ITR Laboratories. L'étude évaluera plusieurs groupes de doses, la pathologie et le profil pharmacocinétique pour soutenir les prochaines soumissions réglementaires.
L'entreprise mène des études précliniques supplémentaires pour valider l'efficacité et le profil de sécurité de HT-KIT, avec des plans pour initier des discussions réglementaires pour des essais cliniques chez l'homme.
Hoth Therapeutics (NASDAQ: HOTH) hat zwei wichtige Entwicklungen für seinen krebsbekämpfenden Arzneimittelkandidaten HT-KIT angekündigt:
1. Hat geänderte Patentanmeldungen beim USPTO für seine antisense Oligonukleotid (ASO) Technologie eingereicht, die auf die Gene MS4A6A und FcεRIβ abzielt, und damit den Schutz des geistigen Eigentums zur Behandlung von Erkrankungen wie Anaphylaxie, Mastocytose und allergischem Asthma gestärkt.
2. Hat eine GLP-konforme 4-wöchige intravenöse Toxizitätsstudie an C57BL/6-Mäusen mit einer 14-tägigen Erholungsphase initiiert, die in Zusammenarbeit mit OnTargetx R&D Inc. und ITR Laboratories durchgeführt wird. Die Studie wird mehrere Dosierungsgruppen, Pathologie und pharmakokinetische Profile bewerten, um bevorstehende regulatorische Einreichungen zu unterstützen.
Das Unternehmen führt weitere präklinische Studien durch, um die Wirksamkeit und das Sicherheitsprofil von HT-KIT zu validieren, mit dem Ziel, regulatorische Gespräche für erste klinische Studien am Menschen zu beginnen.
- Patent protection strengthened for HT-KIT technology
- Advancement to GLP-compliant toxicity studies indicates progress toward clinical trials
- Expanded potential therapeutic applications including anaphylaxis, mastocytosis, and allergic asthma
- Still in preclinical phase with no immediate revenue potential
- Timeline to clinical trials remains undefined
- Additional studies required before regulatory submissions
Insights
Hoth Therapeutics' dual announcements represent meaningful progress for their HT-KIT antisense oligonucleotide program. The filing of amended patent claims strengthens their intellectual property position - a critical asset for any biotech company developing novel therapeutics. These refined claims specifically target the MS4A6A and FcεRIβ genes, which are implicated in allergic inflammation and mast cell-related conditions.
The initiation of a GLP-compliant toxicity study is an essential step in preparing for regulatory submissions. This 4-week intravenous toxicity study with recovery period will generate critical safety data through multiple dose groups, pathology assessments, and pharmacokinetic profiling - all standard requirements before advancing to human trials. Conducting this work with established partners (OnTargetx R&D and ITR Laboratories) suggests proper adherence to regulatory standards.
There appears to be a disconnect between the article's title mentioning "cancer fighting" and the body text focusing on allergic and inflammatory conditions like anaphylaxis, mastocytosis, and allergic asthma. This suggests HT-KIT may have applications across multiple therapeutic areas, potentially broadening its market opportunity.
While these developments show methodical pipeline progression, investors should note these remain preclinical activities. Many hurdles exist before potential commercialization, including successful IND filing, clinical trials, and regulatory approvals. For a small-cap company like Hoth, maintaining development momentum is crucial but requires continued funding to advance through these expensive clinical phases.
For a micro-cap biotech with a
The initiation of the GLP toxicity study signals Hoth's commitment to advancing toward clinical testing. This preclinical work represents a tangible R&D investment and milestone achievement that moves the program closer to an Investigational New Drug (IND) application - the gateway to human clinical trials.
From a financial perspective, while no monetary details were disclosed, these activities require capital investment during a challenging funding environment for small biotechs. The company's ability to continue advancing its pipeline suggests adequate near-term resources, though investors should monitor cash runway closely.
The therapeutic applications in allergic inflammation and mast cell-related diseases potentially address substantial markets. However, the timeline to potential revenue remains distant given the early development stage. The CEO's mention of "exploring partnerships" suggests potential for non-dilutive funding opportunities that could extend cash runway.
These developments represent incremental but meaningful value-building activities that demonstrate the company is executing on its development strategy for a key pipeline asset, though significant development risks remain given the early stage.
The Company has filed amended claims with the
In parallel, Hoth has initiated a GLP-compliant 4-week intravenous toxicity study with a 14-day recovery period in C57BL/6 mice. This preclinical study, conducted in partnership with OnTargetx R&D Inc. and ITR Laboratories, is designed to evaluate the safety profile of HT-KIT in support of upcoming regulatory filings. The study will include multiple dose groups, detailed pathology assessments, and pharmacokinetic profiling.
"These strategic milestones mark significant momentum for HT-KIT as we move toward clinical readiness, "said Robb Knie, CEO of Hoth Therapeutics. "The strengthened patent position and robust preclinical package will be instrumental as we explore partnerships and advance our discussions with regulators."
Next Steps in Development
Hoth Therapeutics is committed to advancing HT-KIT toward clinical evaluation. The company is currently conducting additional preclinical studies to further validate HT-KIT's efficacy and safety profile, with plans to initiate regulatory discussions for first-in-human trials.
For more information on Hoth Therapeutics and its innovative pipeline, please visit www.hoththerapeutics.com.
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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