On January 15, 2026 Blue Earth Therapeutics reported that the first patients in the UK have been administered with the investigational radiopharmaceutical therapy Lutetium (177Lu) rhPSMA-10.1 Injection in an ongoing Phase 2 clinical trial (NCT05413850) at St Bartholomew’s Hospital and The James Cook University Hospital. This milestone marks continued expansion of the clinical development programme for the company’s radiohybrid, lutetium-labelled, PSMA-targeted investigational radiopharmaceutical therapy in men with metastatic castration-resistant prostate cancer (mCRPC).

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Dr Kenrick Ng, Medical Oncology Consultant, St Bartholomew’s Hospital, London, said: "Dosing one of the first patients in the UK in this Phase 2 study is an important milestone as we work to advance new therapeutic options for men with metastatic castration-resistant prostate cancer. Radiopharmaceuticals represent a promising area of investigation in this difficult-to-treat setting, and the team at our hospital is pleased to contribute to the generation of the clinical evidence needed to understand the potential of this investigational treatment."

Dr Darren Leaning, Consultant Clinical Oncologist, The James Cook University Hospital, Middlesbrough, said: "Bringing this study to the UK is an important step in expanding access to complex radiopharmaceutical trials. Delivering studies of this kind requires close collaboration across clinical, research, and nuclear medicine teams, we at the James Cook Cancer Institute pride ourselves on bringing studies like this to our Teesside patients and we are pleased to be working with colleagues at other NHS trusts and the radiopharmaceutical industry to support the generation of high-quality clinical data for patients with advanced prostate cancer."

The milestone of administering the first doses to patients in the UK highlights growing momentum for the Lutetium (177Lu) rhPSMA-10.1 Injection clinical programme. Other sites in the UK are actively screening patients for this study. Activation of UK clinical sites broadens the study’s international footprint and supports the generation of high-quality evidence across multiple healthcare settings. The expansion supports ongoing efforts to evaluate novel dosing strategies and contributes to the future global development of this PSMA-targeted radioligand therapy.

David Gauden, CEO of Blue Earth Therapeutics, said: "Dosing the first patients in the UK marks a pivotal step in our mission to advance radiopharmaceutical treatments for prostate cancer. With our company being headquartered in the UK, this milestone reflects our commitment to the UK’s life sciences vision to accelerate clinical research and translate innovation into meaningful patient benefit. We are proud to work in partnership with UK investigators, the NHS and patients to help strengthen the UK’s position as a global leader in life sciences excellence."

The Phase 2 is evaluating multiple strategies to optimise dosing by delivering higher radiation doses during the early treatment cycles when tumour burden is typically greatest. This approach differs from earlier pivotal studies of radioligand therapies where fixed dosing was applied uniformly across all cycles(2). The study design aligns with the US FDA’s Project Optimus initiative, which encourages dose optimisation early in development to support a favourable benefit–risk profile.

Front loading of radioactivity in Phase 2 will be achieved either by (a) giving higher radioactivity injections in the first two cycles or (b) shortening the interval between the first three injections of radioactivity from six weeks to three weeks. The study also evaluates the potential clinical benefit of delivering higher cumulative administered radioactivity, up to 60 GBq. As part of the study design, the primary measure of efficacy will be the proportion of patients achieving a ≥50% reduction in prostate-specific antigen (PSA) levels alongside a detailed assessment of safety and capturing radiation dosimetry data for all patients.

About metastatic prostate cancer

In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).(3) Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.(4) While death rates from prostate cancer have declined over the past three decades(4), there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA)

rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

(Press release, Blue Earth Therapeutics, JAN 15, 2026, View Source [SID1234662063])

On January 15, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing therapies for serious and underserved conditions, reported it has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies.

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The Company received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products. Hoth expects to activate clinical trial sites and initiate the study across multiple European countries.

In parallel, country-specific Part II regulatory decisions in Hungary, Spain, and Poland are expected by January 19, 2026, positioning the program for rapid, multi-national clinical execution.

"This marks a meaningful regulatory inflection point for Hoth and our oncology-focused pipeline," said Robb Knie at Hoth Therapeutics. "Regulators have confirmed the acceptability of our application for this cancer-related indication."

The HT-001 program is being developed to address EGFRI-induced dermatologic toxicities, a common and often dose-limiting complication experienced by cancer patients undergoing treatment. These side effects can negatively impact quality of life, disrupt treatment schedules, and increase overall healthcare burden.

Hoth expects to activate sites, initiate patient enrollment, and advance the program into active clinical execution, representing a critical step toward validating a potential new supportive-care therapy for oncology patients.

(Press release, Hoth Therapeutics, JAN 15, 2026, View Source [SID1234662062])

On January 15, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK), reported Dr. Ge Michael, President and CEO was invited to attend the conference and delivered a keynote speech on the morning of January 15 (local time) and presented the Company’s latest achievements in drug R&D, commercialization, and globalization, and outlined its innovation strategy and future development plans at the 44th J.P. Morgan Healthcare Conference (JPMHC) was held in San Francisco, California, USA..

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Since initiating its innovation journey in 2012, Kelun-Biotech has rapidly emerged as a leader in China’s innovative drug field, building differentiated technology platforms and robust R&D pipelines. Leveraging its global leading OptiDC platform for antibody-drug conjugates (ADCs) and novel drug conjugates (DCs), the Company continuously advances the differentiated development of ADCs and novel DCs, forming a gradient portfolio for treating multiple tumor types. Currently, Kelun-Biotech has two ADC products on market: sacituzumab tirumotecan (sac-TMT, 佳泰莱) and trastuzumab botidotin (舒泰莱), covering breast cancer and lung cancer indications. Additionally, nine uniquely designed ADC and novel DC drugs—including cutting-edge directions such as bispecific ADC and radiopharmaceutical conjugate (RDC) are in clinical stage. For high-incidence tumor types in China, such as breast cancer, lung cancer, and gastrointestinal tumors, the Company has initiated nine pivotal studies, while multiple Phase II clinical studies targeting gynecological tumors are progressing steadily. Furthermore, Kelun-Biotech has also developed several non-DC candidates and expanded indications into non-oncology areas.

Over the past year, Kelun-Biotech has presented multiple research findings at international academic conferences and published in authoritative journals: three were selected for oral presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, and three were selected as Late-Breaking Abstracts (LBA) for oral presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Among these, the results of the OptiTROP-Lung04 study of sac-TMT for treating EGFR-mutant Non-Small Cell Lung Cancer (NSCLC) after TKI therapy were presented at the Presidential Symposium session of ESMO (Free ESMO Whitepaper) and simultaneously published in The New England Journal of Medicine, highlighting its global academic and clinical value.

In terms of commercialization, Kelun-Biotech has formed a competitive initial product portfolio. Its core product, the TROP2-directed ADC sac-TMT, has been approved in China for three indications: second-line and above triple-negative breast cancer, second-line and third-line EGFR-mutated NSCLC. The HER2-directed ADC trastuzumab botidotin was approved last year for second-line and above HER2-positive breast cancer, becoming the first domestically developed HER2-directed ADC approved for this indication. Furthermore, the anti-EGFR monoclonal antibody Cetuximab N01 (达泰莱) for RAS wild-type colorectal cancer and the anti-PD-L1 monoclonal antibody tagitanlimab (科泰莱) for nasopharyngeal carcinoma have been launched. Another small-molecule RET inhibitor A400 is expected to be approved within the year, bringing the total number of commercialized products in China to five. Currently, three of the Company’s commercialized products, covering five indications, have been included in the National Reimbursement Drug List (NRDL), further benefiting a broad population of cancer patients.

While strengthening its presence in the domestic market, Kelun-Biotech is actively expanding overseas. It has established collaborations with MSD, Ellipses, Windward Bio and Crescent Biopharma to maximize the value of its pipeline value and corporate worth. Among these, MSD is evaluating 16 global Phase III clinical studies of sac-TMT.

The breakthroughs in both clinical development and commercialization are driven by the Company’s sustained investment in innovative R&D. With over a decade of accumulation in the ADC field, Kelun-Biotech’s proprietary OptiDC platform enables differentiated design of drug candidates, which combines specific targets or targeting mechanisms with the most suitable payload-linker strategy to balance efficacy and safety. Additionally, the company is adopting a "multi-pronged" innovation strategy to continuously enhance platform capabilities. By exploring novel targets, new payloads, and diverse conjugation technologies, it is expanding the application boundaries across both oncology and non-oncology fields.

Looking ahead, Kelun-Biotech will consolidate its foundations in R&D, technologies, platforms, and operations by executing five key development strategies. Concurrently, the Company will elevate its globalization strategy, enhancing its capabilities in product development, registration, and commercialization in ex-China market, advancing on its path to becoming a world-class biopharmaceutical company.

On January 15, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune disease, solid tumors and hematological malignancies indications, reported that it recently presented at the 44th Annual J.P. Morgan Healthcare Conference held in San Francisco. At the conference, Antengene shared the latest data and clinical development plans for its core clinical asset, ATG-022 (a CLDN18.2 antibody-drug conjugate [ADC]), as well as R&D progress on ATG-125 (a B7-H3 x PD-L1 bispecific ADC), its steric hindrance masking AnTenGager T cell engager (TCE) platform, and other key preclinical programs.

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1. Core Clinical Program: ATG-022

Latest data from the Phase I/II CLINCH study: As of December 25, 2025, among patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 40% (12/30) and the disease control rate (DCR) was 90% (27/30), with a median progression-free survival (mPFS) of 5.09 months and a median overall survival (mOS) of 14.72 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), the mPFS was 6.97 months, and the mOS has not yet been reached. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%) treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21). In addition, one patient in each of the three dose groups achieved a complete response (CR). These results demonstrated the potent anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
Promising frontline combination potential: Compared with the data presented at the Company’s R&D Day in November last year, the 1.8 mg/kg dose group demonstrated a further improvement in ORR and a meaningful prolongation in mPFS, while maintaining a favorable safety profile. The incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was only 19.4%. This differentiated safety profile positions ATG-022 as a potentially best-in-class ADC in terms of safety, with the potential to be combined with checkpoint inhibitors (CPIs) and chemotherapy to transform the current frontline standard-of-care regimen.
First Disclosure of Positive Clinical Signals of ATG-022 in Non-Gastrointestinal Tumors: As of January 6, 2025, among 9 efficacy evaluable patients, the ORR was 22.2% (2/9), and DCR was 88.9% (8/9). These data suggest that ATG-022 may have the potential to treat CLDN18.2-positive non-gastrointestinal tumors, which could expand the treatable patient population beyond gastrointestinal cancers. The efficacy observed to date also supports further exploration of CLDN18.2 as a pan-tumor therapeutic target.
Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase I/II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with checkpoint inhibitors (CPIs) and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with CPIs; and third-line therapy as monotherapy, covering patients with varying levels of CLDN18.2 expression. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment.
2. Next-Generation ADCs and Proprietary TCEs

ATG-125 (B7-H3 × PD-L1 bispecific ADC): ATG-125 is an "IO+ADC " dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of immuno-oncology (IO) therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target B7-H3-ADC or PD-L1-ADC approaches. The Company plans to submit an IND for ATG-125 in Q1 2027.

TCE platform with steric hindrance masking technology: AnTenGager is Antengene’s proprietary, second-generation T cell engager (TCE) platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:

ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGager TCE platform for the treatment of B cell related autoimmune diseases. Preclinical data presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that in non-human primate (NHP) models, the monkey surrogate of ATG-201 achieved deep and durable depletion of naïve B cells with a favorable safety profile, characterized by only a very mild and transient increase in cytokine levels. The IND-enabling study of ATG-201 has been completed and the IND-submission is under preparation.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer. The Company plans to submit an IND for ATG-106 in the first half of 2027.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecologic tumor, non-small cell lung cancer, and pancreatic ductal adenocarcinoma. The Company has nominated a preclinical candidate (PCC) in January 2026.
Additional TCE programs for solid tumors: Antengene plans to submit an IND for ATG-110 (LY6G6D × CD3 TCE) in the first half of 2027 for the treatment of microsatellite-stable colorectal cancer. In addition, ATG-115 (an undisclosed bispecific antibody) and two undisclosed trispecific antibody programs are currently in preclinical development.
3. Innovative Treatment for Autoimmune Diseases: Globally First-in-Class ATG-207

ATG-207 is a globally first-in-class dual-function biologic being developed for the treatment of T cell–mediated autoimmune diseases. The Company plans to present the preclinical data for ATG-207 for the first time at an international scientific conference in 2026.

(Press release, Antengene, JAN 15, 2026, View Source [SID1234662060])

On January 15, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will present an update on the company’s proprietary INTASYL siRNA technology and progress on the on-going clinical trial with lead compound PH-762 for treatment of skin cancers.

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"All stakeholders and investors are invited to join the presentation and register for one-on-one meetings to learn more about Phio Pharmaceuticals in our continuing pursuit of innovative pathways towards a cancer free future using our INTASYL technology," stated Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

Phio’s presentation will begin at 1:45 PM ET on January 22, 2026 and can be accessed live here: WEBCAST LINK FOR PHIO’S PRESENTATION: Webinar Registration – Zoom

Mr. Bitterman will also host one-on-one meetings with investors at the conference, taking place on Wednesday Jan 21, 2026 8:30 AM ET through Thursday Jan 22, 2026 at 5:00 PM ET. Registration is free and you don’t need to be a Sidoti client. REGISTRATION LINK FOR ONE-ON-ONE MEETINGS:  www.sidoti.com/events.

About Sidoti Events, LLC ("Events") and Sidoti & Company, LLC ("Sidoti")

In 2023, Sidoti & Company, LLC , Sidoti & Company, LLC (www.sidoti.com) formed an affiliate company, Sidoti Events, LLC in order to focus exclusively on its rapidly growing conference business and to more directly serve the needs of presenters and attendees.  The relationship allows Events to draw on the 25 years of experience Sidoti has as a premier provider of independent securities research focused specifically on small and microcap companies and the institutions that invest in their securities, with most of its coverage in the $200 million-$5 billion market cap range. Sidoti’s coverage universe comprises approximately 160 equities, of which 50 percent participate in the firm’s rapidly growing Company Sponsored Research ("CSR") program.  Events is a leading provider of corporate access through the eight investor conferences it hosts each year. By virtue of its direct ties to Sidoti, Events benefits from Sidoti’s small- and microcap-focused nationwide sales force, which has connections with approximately 2,500 institutional relationships in North America.  This enables Events to provide multiple forums for meaningful interaction for small and microcap issuers and investors specifically interested in companies in the sector.

(Press release, Phio Pharmaceuticals, JAN 15, 2026, View Source [SID1234662059])