Pertuzumab

The data will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, which takes place March 7-11, 2025, highlighting HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities. The recent case study will be highlighted that demonstrated the efficacy of HT-001 2% cream in a 59-year-old patient with metastatic breast cancer undergoing treatment with paclitaxel, trastuzumab, and pertuzumab. The patient developed pruritic, burning red papules on the face, scalp, and upper back, a known dermatologic side effect of EGFR inhibitors. After just one week of applying HT-001 2% cream twice daily, the patient experienced full symptom and lesion resolution, with no recurrence of lesions in the following three weeks. NEW YORK, March 5, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, is excited to announce promising findings for its novel therapeutic candidate, HT-001, a topical neurokinin 1 receptor (NK1R) antagonist, in the treatment of Epidermal Growth Factor Receptor Inhibitor-Associated Papulopustular Eruptions (EGFRi PPEs). The data will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, which takes place March 7-11, 2025, highlighting HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities. A recent case study demonstrated the efficacy of HT-001 2% cream in a 59-year-old patient with metastatic breast cancer undergoing treatment with paclitaxel, trastuzumab, and pertuzumab. The patient developed pruritic, burning red papules on the face, scalp, and upper back, a known dermatologic side effect of EGFR inhibitors. After just one week of applying HT-001 2% cream twice daily, the patient experienced full symptom and lesion resolution, with no recurrence of lesions in the following three weeks. "These findings demonstrate the potential of HT-001 as a safe and effective therapy for EGFR inhibitor-associated skin toxicities," said Robb Knie, CEO at Hoth Therapeutics. "With a significant unmet need for long-term, well-tolerated treatment options, HT-001 could offer relief to cancer patients experiencing debilitating skin reactions." HT-001 works by blocking the pro-inflammatory effects of the Substance P (SP)-NK1R pathway, a key mediator of neurogenic inflammation. Preclinical research has shown that HT-001 reduces inflammation and hair loss associated with EGFR inhibitor therapy. These latest clinical observations further support its potential role in dermatologic oncology. Hoth Therapeutics is currently conducting a Phase 2A clinical trial to evaluate the efficacy and safety of HT-001 in a broader patient population. The trial will assess the treatment's effectiveness across varying severities of EGFRi PPEs and explore its impact on other dermatologic manifestations induced by EGFR inhibitors. For more information about HT-001 and ongoing clinical trials, visit 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 . 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: [email protected] Phone: (678) 570-6791 SOURCE Hoth Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A landmark FDA approval last week in breast cancer defined a new cancer target, expanding the number of patients that can be treated. Mersana Therapeutics is going after that same new target with a drug from the same class of therapies and the biotech is readying for a clinical trial that could show whether its twist on the approach works in other cancers. GSK wants a piece of that potential and it is paying the biotech $100 million to begin a partnership. The sum announced after the market close Monday is an upfront payment that gives GSK an exclusive option to license and co-develop the Mersana drug, XMT-2056. Exercising that option would give the pharmaceutical giant the opportunity to add another drug to its portfolio from the class of therapies called antibody drug conjugates (ADCs), but one that works in a slightly different way. ADCs are traditionally comprised of a tumor-target targeting antibody that’s linked to a tumor-killing drug payload. The goal is to provide a targeted effect that spares healthy tissue. More than a dozen such therapies have passed FDA muster, most recently last Friday’s expanded approval of AstraZeneca and Daiichi Sankyo drug Enhertu to including treatment of breast cancers that express low levels of the protein HER2. Cambridge, Massachusetts-based Mersana aims to take ADCs beyond the delivery of toxic drug payloads. XMT-2056 still offers targeted delivery to tumors, but its cargo instead activates stimulator of interferon genes (STING), a pathway of the innate immune system. Other biotechs are developing STING-activating drugs for cancer, some of them given as injections into the tumor. Mersana said in an investor presentation that its approach leverages the targeting ability of an ADC to elicit an immune response in both tumor cells as well as immune cells found inside the tumors. This “one-two punch” to both is intended to provide a more potent therapeutic effect while at the same time reducing toxic effects elsewhere in the body. In preclinical research, Mersana has reported that its drug showed robust anti-tumor activity in animal models expressing high HER2 levels as well as those with low HER2. The company said the efficacy of the therapy was enhanced when the drug was used in combination with other cancer drugs, including Roche’ drugs transtuzumab and pertuzumab, checkpoint-blocking drugs that target the protein PD-1, and the AstraZeneca and Daiichi drug Enhertu. In a prepared statement, John Lepore, GSK’s senior vice president of research, said that XMT-2056’s “preclinical data demonstrate how it might work to harness the immune system by activating the STING pathway, and its differentiated mechanism of action offers the potential for additional clinical benefit in patients with HER2-expressing tumors.” Though Enhertu and XMT-2056 both target HER2, Mersana’s drug is designed to target a novel part of that protein. A Phase 1 test of the drug is expected to begin “imminently,” Mersana said in the investor presentation. That study will span a range of HER2-expressing tumors. In addition to breast cancer, the study will include gastric cancer and non-small cell lung cancer. GSK’s oncology portfolio already includes Blenrep, an ADC that won its FDA approval two years ago for treating multiple myeloma. According to a Mersana regulatory filing, the pharma giant may exercise its option on the Mersana-partnered ADC after it delivers dose-escalation data from the Phase 1 study that includes investigation into the subgroups of breast cancer patients most likely to benefit from the therapy. If GSK elects to exercise its option on the Mersana drug, it’s on the hook for a $90 million option exercise payment. Achieving clinical, regulatory, and commercial milestones could bring Mersana up to $1.27 billion more. GSK is the second Mersana partner that the biotech has signed on this year. In February, the company unveiled a partnership with Johnson & Johnson’s Janssen Biotech subsidiary. According to terms of that deal, Mersana will work with antibodies provided by Janssen for three unspecified targets. Janssen paid Mersana $40 million up front. Mersana could receive up to $1 billion in milestone payments.