On February 3, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that enrollment is now open for its new Phase 2 clinical trial evaluating the combination of stenoparib and temozolomide for the treatment of recurrent small cell lung cancer (SCLC).

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The trial is being conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA’s Special Emphasis Panel on Precision Oncology. The trial is officially registered as NCT06681220: Biomarker directed trial of temozolomide and stenoparib in relapsed SCLC and is now open for enrollment at 11 VA sites throughout the US.

This Phase 2 study will assess the safety and efficacy of stenoparib in combination with temozolomide, a DNA-alkylating chemotherapy agent, in patients with recurrent SCLC who have progressed after frontline treatment. Prior studies have shown that PARP inhibitors can enhance the activity of temozolomide, but widespread use has been limited by severe hematologic toxicity. The study includes a blood based biomarker developed in the VA Lung Precision Oncology Program to select patients most likely to benefit from this combination.

"The opening of recruitment marks an important step in exploring stenoparib’s potential as a combination agent," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "Based on clinical data to date from our ongoing trial in ovarian cancer, stenoparib has demonstrated a favorable safety profile, making it a strong candidate for combination therapies — particularly in settings where tolerability has been a limiting factor, as is the case in SCLC. More broadly, we believe stenoparib may offer meaningful clinical benefit in cancers where the WNT signaling pathway plays a key role, which applies to both SCLC and ovarian cancer. We’re particularly enthusiastic about taking this next step in stenoparib’s development as it allows us to explore stenoparib’s enormous potential in other indications and in combination with other agents."

Shadia Jalal, the study’s Principal Investigator and Professor of Medicine at the Lawrence H. Einhorn Chair in Oncology at Indiana University’s Melvin and Bren Comprehensive Cancer Center said, "We’re excited to explore this novel combination. Patients with relapsed SCLC including veterans have very few effective treatment options. Previous clinical work has shown that the combination of temozolomide with first generation PARP inhibitors is very active but also very limited by the toxicities of the two agents. Stenoparib has not only a unique mechanism of action that could provide benefit to these patients but also has a favorable safety profile that may allow veterans to tolerate this combination therapy and realize meaningful, durable clinical benefit."

While offering a potentially more favorable safety profile with temozolomide, stenoparib may offer additional anti-tumor benefit through suppression of WNT signaling, a pathway associated with SCLC progression and resistance.

In addition, stenoparib’s ability to cross the blood-brain barrier may offer therapeutic potential for patients with brain metastases, a common and challenging complication in advanced SCLC.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, FEB 3, 2026, View Source [SID1234662434])

On February 3, 2026 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported an invited presentation of clinical outcomes and safety data from the investigator sponsored Phase 1 clinical study (NCT03284268) evaluating the safety and tolerability of two intravitreal injections of VCN-01 (zabilugene almadenorepvec) in pediatric patients with intraocular retinoblastoma that was refractory to systemic, intra-arterial, or intravitreal chemotherapy, and for whom enucleation was the only recommended treatment. Preclinical data describing the synergistic antitumor effects observed when topotecan (a standard of care chemotherapy for retinoblastoma) is coadministered with VCN-01 will also be presented. These data will be presented during a retinoblastoma focused session at the upcoming Asia-Pacific Academy of Ophthalmology (APAO) Congress (held in conjunction with the 37th Annual Scientific Meeting Hong Kong Ophthalmological Symposium) taking place in Hong Kong, China, 5-8 February 2026.

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Details of the presentation can be found online and below.

Presenting Author: Dr. Jaume Català-Mora, Pediatric Ophthalmologist, Sant Joan de Déu-Barcelona Children’s Hospital
Title: Update on Oncolytic Adenovirus VCN-01 Trial in Retinoblastoma
Session: 0211 Retinoblastoma in Association With Asian Retinoblastoma Group
Date & Time: Saturday 07 February, 2026, at 4:46 PM HKT (3:46 AM US EDT)
Location: Rooms S224-225, Level 2, Hong Kong Convention and Exhibition Centre (HKCEC)
"We are very pleased with the on-going international interest in the novel clinical and preclinical findings by our collaborators treating retinoblastoma patients at Sant Joan de Déu-Barcelona Children’s Hospital," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Effective treatment of refractory retinoblastoma with vitreous seeds remains a significant unmet medical need for pediatric patients with this condition worldwide. Based on our previously reported Phase 1 clinical data, and the emerging preclinical findings, we believe that the intravitreal combination of VCN-01 and topotecan provides an exciting new opportunity to address this challenge and help preserve the eyes and quality-of-life of children with this rare but devastating cancer. VCN-01 has Orphan Drug and Rare Pediatric Disease designations for the treatment of retinoblastoma, and we are currently refining a potential pivotal clinical trial design in this indication for discussion with regulatory agencies."

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 140 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov. VCN-01 has Orphan Drug designation from the EMA and both Orphan Drug designation and Fast Track designation from the FDA for the treatment of pancreatic cancer. VCN-01 also has Orphan Drug designation and Rare Pediatric Diseases designation from the FDA for the treatment of retinoblastoma.

About Retinoblastoma

Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 – 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In Europe, retinoblastoma has an estimated incidence rate of 1 per 13,844 live births (14.1 per million children under the age of 5) with approximately 300 children diagnosed per year (Stacey et al. 2021). Preserving life and preventing the loss of an eye, blindness, and other serious effects of treatment that reduce the patient’s life span or the quality of life remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.

(Press release, Theriva Biologics, FEB 3, 2026, View Source [SID1234662435])

On February 3, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company focused on the discovery and development of novel antibody therapeutics in immunology and oncology, reported a positive profit alert for the year ended December 31, 2025.

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Based on a preliminary review of the Company’s unaudited management accounts for the Reporting Period, total profit is expected to range between US$88 million (equivalent to approximately HK$685 million) and US$95 million (equivalent to approximately HK$739 million), as compared to a profit of approximately US$2.7 million for the year ended December 31, 2024. Total adjusted profit[1] is expected to range between US$91 million (equivalent to approximately HK$708 million) and US$98 million (equivalent to approximately HK$763 million).

The anticipated increase in profit is primarily attributable to:

Continued growth of recurring revenue stream of the Company, such as the platform-based research collaboration with AstraZeneca and Bristol Myers Squibb.
Accelerated expansion of global partner network, as the revenue generated from out-licensing and collaboration of innovative products has transformed into recurring revenue stream of the Company, such as the licensing collaboration with Otsuka, the licensing collaboration with Windward Bio.
Rapid business growth of Nona Biosciences, such as the revenue generated from both technology license and platform-based service, as well as the milestone inflow from existing collaborations, such as the research and technology license collaboration with Pfizer.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "This anticipated profit marks a key milestone for Harbour BioMed, validating the value of our unique business model. The strength of our proprietary technology platforms is being recognized through a growing number of deep, strategic collaboration with global leaders. Most importantly, these partnerships are not one-time events; they are evolving into a sustainable financial foundation that fuels our mission to discover and develop novel antibody therapeutics for patients worldwide. Looking ahead, we will build on this momentum through continued innovation and high-impact collaborations to deliver sustainable growth."

(Press release, Harbour BioMed, FEB 3, 2026, View Source [SID1234662436])

On February 3, 2026 Insilico Medicine ("Insilico"), a clinical-stage, generative artificial intelligence (AI)-driven biotechnology company, reported that it has received USD 5 million from Menarini Group ("Menarini") as an additional milestone payment, following the completion of first-in-patient dosing in a Phase 1 study of MEN2501, which was licensed to Menarini in January 2025. MEN2501 (previously known as ISM9682) is a highly differentiated small molecule inhibitor of kinesin KIF18A motor protein with potent activity in cancers with chromosome instability.

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As part of a strategic collaboration to accelerate the development and delivery of transformative cancer therapies, the asset was subsequently licensed to Stemline Therapeutics, Inc. ("Stemline"), a wholly owned subsidiary of the Menarini Group, with the combined value of the agreements exceeding USD 550 million. Pursuant to the partnership, both parties actively advanced the program transition and subsequent development activities. Following IND approval for this program, Insilico received the first development and regulatory milestone payment of USD 3 million in July 2025.

"The program rapidly advanced into a Phase I clinical trial and successfully completed first patient dosing, fully demonstrating Menarini and Stemline’s exceptional agility and clinical expertise," said Alex Zhavoronkov, PhD, Founder and CEO of Insilico Medicine. "This milestone shows our shared commitment to delivering innovative therapies for cancer treatment. We are proud to further strengthen our partnership and encouraged to see AI-discovered drug candidates reaching such a critical stage, bringing us closer to providing novel treatment options for patients worldwide."

"Getting the first patient dosed in our MEN2501 Phase 1 study is a meaningful milestone that underscores how quickly promising science can move forward through focused clinical execution," said Elcin Barker Ergun, CEO of the Menarini Group. "We value our partnership with Insilico as we translate AI-enabled discovery into clinical programs, with the goal of bringing new, transformational treatment options to patients facing aggressive cancers."

The collaboration between Insilico and Menarini has continued to expand since its inception. Prior to MEN2501, in January 2024, Insilico announced that it entered into an exclusive global license collaboration with Menarini for MEN2312, a novel KAT6 inhibitor for breast cancer and other oncology indications, with the combined value of the agreements exceeding USD 500 million. The MEN2312 program has progressed smoothly into clinical development, and Insilico has received early development milestone payments.

In addition to the collaboration pipelines, Insilico has extensive experience in AI-driven oncology, drug discovery and development. The company has established a robust oncology pipeline that targets multiple cancer indications, leveraging both moderately novel and well-established mechanisms. Among its most promising assets, the potential best-in-class pan-TEAD inhibitor ISM6331 and the MAT2A inhibitor ISM3412 are both undergoing global, multicenter Phase I clinical trials.

Harnessing state-of-the-art AI and automation technologies, Insilico has significantly improved the efficiency of preclinical drug development, setting a benchmark for AI-driven drug R&D. While traditional early-stage drug discovery typically requires an average of 4.5 years, Insilico has nominated 20 preclinical candidates from 2021 to 2024, with an average timeline—from project initiation to preclinical candidate (PCC) nomination—of just 12 to 18 months per program, with only 60 to 200 molecules synthesized and tested in each program.

(Press release, Insilico Medicine, FEB 3, 2026, View Source [SID1234662437])

On February 3, 2026 Biosion, Inc. ("Biosion"), a global, clinical-stage biotechnology company developing innovative antibody-based therapeutics, reported that the first patient has been dosed in a Phase 1a/1b Investigator-Initiated Trial (IIT) evaluating BSI-082, a highly differentiated, fully human anti-SIRPα monoclonal antibody. The study is sponsored by and being conducted at the Mays Cancer Center, a National Cancer Institute (NCI)-designated Cancer Center and part of The University of Texas at San Antonio’s Health Science Center.

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This clinical milestone highlights the medical community’s strong interest in Biosion’s oncology assets and follows the company’s recent transformative partnership with Aclaris Therapeutics for its immunology portfolio.

Collaborating to Unlock Innate Immunity

BSI-082 is engineered to block the CD47-SIRPα "don’t eat me" signal, a critical checkpoint tumor cells use to evade macrophage phagocytosis. Unlike other candidates in the class, BSI-082 was designed using Biosion’s proprietary H³ Antibody Discovery Platform to overcome historical development challenges.

Key differentiators of BSI-082 include:

Broad Population Coverage: High-affinity binding to SIRPα variants V1, V2, and V8, covering >90% of the human population.
Superior Safety Profile: Engineered Fc domain minimizes binding to red blood cells (RBCs) and platelets, significantly reducing the risk of anemia and thrombocytopenia often seen with anti-CD47 therapies.
Preserved T-Cell Function: No binding to SIRPγ, ensuring that adaptive immune responses remain active and uninhibited.
"The initiation of this trial by a premier institution like the Mays Cancer Center serves as powerful validation of BSI-082’s scientific rationale and therapeutic potential," said Mingjiu Chen, Ph.D., Founder and CEO of Biosion. "BSI-082’s unique profile—specifically its ability to potently block the ‘don’t eat me’ signal without compromising patient safety—positions it as an ideal combination partner for standard-of-care therapies, particularly antibody-drug conjugates (ADCs). We are honored to support Dr. Sarantopoulos and his team in this study, which represents a key step in our strategy to maximize the value of our oncology assets through high-quality clinical partnerships."

Study Design and Strategic Combinations

The Phase 1a/1b study is an open-label, dose-escalation and dose-expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BSI-082 in patients with locally advanced or metastatic solid tumors.

Phase 1a: Will establish the Recommended Dose for Expansion (RDE) of BSI-082 as a monotherapy.
Phase 1b: Will evaluate BSI-082 in combination with trastuzumab deruxtecan (T-DXd) in patients with HER2-positive solid tumors. Preclinical data has demonstrated that SIRPα blockade can synergistically enhance the antitumor activity of ADCs by promoting antibody-dependent cellular phagocytosis (ADCP).
"Targeting the innate immune system via the SIRPα-CD47 axis offers a compelling therapeutic strategy for refractory tumors," said John Sarantopoulos, M.D., associate professor of medicine in the Division of Hematology and Oncology, medical oncologist, and principal investigator at the Mays Cancer Center. "We are excited to lead the clinical evaluation of BSI-082, whose design addresses key limitations of earlier generation agents. We look forward to exploring its potential to improve outcomes for patients, particularly in combination with ADCs."

(Press release, Biosion, FEB 3, 2026, View Source [SID1234662438])