On January 22, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, reported positive interim results from the open-label pharmacokinetic (PK) cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy.

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In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied by a ~50% reduction in investigator-assessed disease severity from baseline. In addition to the primary endpoint, supportive clinical endpoints showed meaningful improvements, including a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures.

Primary Endpoint: Marked Improvement in Disease Severity (ARIGA)

The primary endpoint of CLEER-001 assessed disease severity using the ARIGA scale. In the open-label PK cohort, mean ARIGA scores improved from 1.67 at baseline to 0.83 at Week 6, representing an approximate 50% reduction in severity.

Importantly, all evaluable patients reached ARIGA ≤1 by Week 6, placing the entire evaluable cohort within the low-severity disease range. Improvements were observed as early as Week 3 and were maintained through Week 6, demonstrating both rapid onset and durability of response.

Additional Endpoints: Improvement in Oncology Toxicity and Patient-Reported Symptoms

Beyond the primary endpoint, HT-001 demonstrated meaningful improvements across additional clinically relevant endpoints:

Oncology Toxicity (CTCAE):
Investigator-assessed CTCAE scores improved from 2.0 at baseline to 1.33 at Week 6, representing an approximate 34% improvement in treatment-related toxicity. CTCAE is a core oncology toxicity scale frequently used to guide dose modification, interruption, or discontinuation of cancer therapies.
Pruritus (Patient-Reported NRS):
Mean pruritus scores improved from 4.22 at baseline to 2.67 at Week 6, representing approximate 37% reduction in symptom severity. This level of improvement exceeds commonly accepted thresholds for clinically meaningful benefit and is directly relevant to patient comfort, quality of life, and treatment adherence.
Favorable Tolerability and PK-Supported Dosing

HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed. The PK portion of CLEER-001 was designed to evaluate exposure, tolerability, and early clinical signal, and the observed consistent improvements across investigator-assessed and patient-reported endpoints support the selected dosing regimen and continued clinical development.

Oncology Context and Unmet Need

EGFR inhibitors are cornerstone therapies across multiple major cancer indications, including lung, colorectal, and head-and-neck cancers. However, treatment-related toxicity and symptom burden remain among the most common and dose-limiting challenges, often impacting treatment continuity and outcomes. The CLEER-001 results highlight HT-001’s potential to serve as an important oncology supportive-care therapy, helping patients remain on effective, life-extending cancer treatments.

Management Commentary

"These results represent a meaningful milestone for HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Seeing 100% clinical response in the open-label PK cohort, along with a ~50% reduction in disease severity and additional improvements in oncology toxicity and patient-reported symptoms, underscores the potential of HT-001 to improve the treatment experience for cancer patients receiving EGFR inhibitors. We are encouraged by the breadth and consistency of these findings as the CLEER-001 trial continues."

About HT-001

HT-001 is Hoth Therapeutics’ proprietary topical therapy under investigation for the management of treatment-related toxicity and symptom burden in cancer patients receiving targeted therapies, including EGFR inhibitors.

(Press release, Hoth Therapeutics, JAN 22, 2026, View Source [SID1234662173])

On January 22, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that the first patient has been dosed in a clinical trial in the U.S. of its independently developed novel CDH17-targeting antibody-drug conjugate (ADC) (R&D code: 7MW4911) for the treatment of advanced colorectal cancer and other advanced gastrointestinal tumors.

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The Phase I/II study (NCT07216560) represents the first-in-human (FIH) study of 7MW4911 in the United States. The study aims to evaluate the safety, pharmacokinetics and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors. Previously, 7MW4911 received clinical trial approval and completed first patient dosing in China.

7MW4911 is a novel CDH17-targeting ADC developed by Mabwell based on its proprietary IDDC platform. It is composed of a highly specific CDH17 monoclonal antibody capable of efficient internalization into tumor cells, a novel cleavable linker with high plasma stability, and a proprietary DNA topoisomerase I inhibitor payload, MF-6, specifically designed to overcome the multidrug resistance.

Preclinical studies demonstrated that 7MW4911 exhibited potent antitumor activity in CDX/PDX models of various gastrointestinal tumors. In multidrug-resistant models, its antitumor effect was significantly superior to MMAE/DXd-based ADCs, and it was able to reverse tumor progression following treatment with such ADCs, highlighting its advantage in treating resistant tumors. Relevant research findings have been published in the 2025 AACR (Free AACR Whitepaper) and the internationally renowned journal Cell Reports Medicine (July 2025).

(Press release, Mabwell Biotech, JAN 22, 2026, View Source [SID1234662172])

On January 22, 2026 Plus Therapeutics, Inc. (NASDAQ: PSTV) (the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported a business update and highlights REYOBIQ clinical progress and CNSide US commercialization.

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"Our 2 key goals in 2026 are CNSide commercial scale-up and REYOBIQ pivotal trial readiness," said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. "Our recently completed upsized $15 million offering will fuel faster progress in these core areas of the business and extend our cash runway through 2027."

Overview of anticipated company milestones for 2026:

REYOBIQ clinical program:

Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in Q3 2026
Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an end of phase meeting with the FDA to align on pivotal trial design, with data expected in Q4 2026
Complete commercial manufacturing scale up for REYOBIQ
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
CNSide commercial roll out:

Obtain a total of 150 million US lives covered under multiple commercial payor agreements
Obtain Medicare and Medicaid coverage
Achieve a commercial order rate in excess of 1,250 tests per year
Launch portfolio of additional CSF tumor characterization tests that expand the CNSide testing platform
For additional information, the Company’s corporate presentation can be found here.

Webcast and Conference Call
Plus Therapeutics will host a conference call and webcast today, January 22, 2026, at 9:00 a.m. ET to discuss and provide additional details on the business update. Participants can dial in to the call using 1-888-349-0106. Please dial in 15 minutes prior to the start time and ask to be joined to the Plus Therapeutics, Inc. conference call. A live webcast of the conference call will be available here as well as on the Investor Relations section of the Company’s website at ir.plustherapeutics.com. The webcast will be archived on the website following the completion of the call.

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, JAN 22, 2026, View Source [SID1234662171])

On January 22, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that updated interim data from the cohort of BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 will be featured at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place from February 26, 2026 to February 28, 2026 in San Francisco.

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The poster presentation will include updated safety and efficacy data from approximately 25 six-month evaluable BCG-Unresponsive NMIBC patients in the ongoing Phase 2 ADVANCED-2 trial.

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

Details of the poster presentations are as follows:

Title: ADVANCED-2: Interim efficacy and safety data in BCG-Unresponsive participants with high-grade non-muscle invasive bladder cancer

Poster Number: F15

Poster Track: Urothelial Carcinoma

Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma

Session Date and Time: Friday, February 27, 2026

In addition, interim safety and tolerability data from both BCG-Naïve and BCG-Unresponsive patients enrolled in ADVANCED-2 will also be presented.

Title: Interim safety and tolerability of TARA-002 in patients with BCG-Naïve and Unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2

Poster Number: H8

Poster Track: Urothelial Carcinoma

Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma

Session Date: Friday, February 27, 2026

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the sixth most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle

(Press release, Protara Therapeutics, JAN 22, 2026, View Source [SID1234662169])

On January 22, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that the U.S. Patent Office has issued a Notice of Allowance for the Company’s lead asset, PDS0101.

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Once issued, the new patent (U.S. Application No. 16/210,750), titled "Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes," will grant broad composition of method of use claims. It enhances the Company’s robust intellectual property estate, which includes previously granted patents in the U.S., Europe, Japan, China, Australia, Canada, Israel, Mexico, and Hong Kong.

"This patent reinforces the value of our proprietary Versamune platform and our lead asset PDS0101 as we advance through late-stage development," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "With VERSATILE-003 progressing and a robust intellectual property portfolio now extending across multiple major markets, we are well-positioned to bring this promising immunotherapy to patients with head and neck cancers."

The new patent, combined with anticipated U.S. biologics exclusivity, should provide approximately twenty years of market protections for PDS0101, which is currently being evaluated in the Phase 3 VERSATILE-003 clinical trial in HPV16-positive head and neck cancers. The Company recently submitted a protocol amendment to the U.S. Food and Drug Administration ("FDA") for the clinical trial that would provide the basis for accelerated approval of PDS0101. The amendment proposes changing the progression free survival ("PFS") endpoint to a primary endpoint that can be evaluated earlier with significant statistical power. Median overall survival ("mOS") remains the primary endpoint for full approval as originally recommended by FDA.

(Press release, PDS Biotechnology, JAN 22, 2026, View Source [SID1234662168])