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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Daiichi Sankyo and AstraZeneca reported its supplemental Biologics License Application (sBLA) for Datroway (datopotamab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is anticipated during the second quarter of 2026.

The sBLA is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumours do not express PD-L1 as well as patients with PD-L1-expressing tumours who cannot receive immunotherapy due to other factors. Chemotherapy remains the only approved 1st-line treatment for these patients.1,2

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Datroway is the only medicine to significantly improve overall survival compared to chemotherapy in this patient population as demonstrated in the TROPION-Breast02 trial – the results of which are even more striking considering the trial enrolled a subset of patients with highly aggressive disease. The Priority Review of our submission underscores the impact of these results and its review under Project Orbis signals a widely shared commitment to bringing Datroway to patients around the world as quickly as possible."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "Datroway potentially could be the first medicine approved in the 1st-line setting to significantly extend overall survival and nearly double the time without disease progression or death compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy was not an option. We are eager to work with the FDA to bring this much needed treatment option to patients with metastatic triple-negative breast cancer."

The sBLA is based on results from the TROPION-Breast02 Phase III trial which showed Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0291) and a 43% reduction in patients’ risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. Datroway was also associated with more robust and durable treatment responses, including an objective response rate (ORR) of 62.5% and duration of response (DoR) of 12.3 months, compared to an ORR of 29.3% and DoR of 7.1 months with chemotherapy. These results were presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

The safety profile of Datroway in TROPION-Breast02 was consistent with previous clinical trials of Datroway in breast cancer.

Additional regulatory submissions for Datroway in breast and lung cancer are underway globally.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

Triple-negative breast cancer

TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025.5,6 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.7-9 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.7,10,11

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.7 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.7 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.12,13 However, for the approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the only approved 1st-line treatment.1,2

TROP2 is a protein broadly expressed in several solid tumours including TNBC.14 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.15,16

TROPION-Breast02

TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, DoR, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway

Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway is approved in Russia for the same population.

Datroway clinical development programme

A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer and one Phase II/III trial in urothelial cancer evaluating Datroway as a monotherapy and in combination with other cancer treatments in various settings.

(Press release, Daiichi Sankyo, FEB 3, 2026, View Source [SID1234665022])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported a leadership transition to continue execution and advancement of the Company’s strategic and clinical goals.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Thomas Civik, a member of Pyxis Oncology’s Board of Directors since the Company’s IPO and a highly experienced biotechnology executive with a proven track record in advancing cancer therapeutics, has been appointed Interim Chief Executive Officer, effective immediately. Lara S. Sullivan, M.D., has stepped down from her roles as President, Chief Executive Officer and Chief Medical Officer.

With Mr. Civik’s appointment, Pyxis Oncology enters this transition with experienced leadership deeply familiar with the Company, its strategy, and its programs. The Company’s established clinical development leadership team will continue to execute ongoing trials and operational priorities without interruption. In parallel, the Board of Directors has initiated a structured search for a permanent Chief Executive Officer.

"The Board has appointed Tom as Interim CEO to ensure strong leadership and continuity," said John Flavin, Chairman of the Board of Pyxis Oncology. "Tom brings decades of proven experience across oncology development, commercialization, and company building. As a long-term and current Director, he has a deep understanding of Pyxis Oncology’s science and strategy, and we are confident in his ability to guide the organization forward while the Board conducts a comprehensive search for permanent leadership. On behalf of the Board, I would like to thank Lara for her commitment and contributions to Pyxis Oncology throughout a formative period for the Company, including advancing MICVO into the clinic and guiding the Company through a critical period of growth."

"Serving as President, Chief Executive Officer, and Chief Medical Officer of Pyxis Oncology has been a privilege," said Lara S. Sullivan, M.D. "I have had the honor to lead Pyxis Oncology over the last six years and am proud of the progress the team has made in advancing MICVO. I am confident in the leadership team’s track record of expertise advancing later stage oncology assets and their ability to lead MICVO through its next stage of clinical development."

Pyxis Oncology’s lead program, micvotabart pelidotin (MICVO), continues to advance in a Phase 1 monotherapy study in second-line and later recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), as well as a Phase 1/2 study evaluating MICVO in combination with Merck’s anti-PD-1 therapy, pembrolizumab, in first-line and second-line R/M HNSCC. The Company remains focused on prioritizing execution of its current clinical programs and upcoming milestones.

"As we move forward, I am committed to ensuring that we put our collective efforts towards evaluating the potential of MICVO in a timely fashion," said Thomas Civik, Interim Chief Executive Officer. "Pyxis Oncology has built a strong scientific and clinical foundation, and we remain confident in the potential of our lead program."

Mr. Civik most recently served as President and Chief Executive Officer of Five Prime Therapeutics, where he led the company through its acquisition by Amgen for $1.9 billion in April 2021. Prior to Five Prime Therapeutics, he was Chief Commercial Officer at Foundation Medicine, where he drove significant growth and oversaw the launch of the first FDA-approved pan-cancer comprehensive genomic profiling test. He most recently served as Chairperson of the Board of ImCheck Therapeutics and Repare Therapeutics, providing strategic and governance oversight, including through their respective acquisitions by Ipsen and XOMA.

Earlier in his career, Mr. Civik spent 17 years at Genentech, holding leadership roles with responsibility for several cornerstone oncology therapies, including Avastin, Tecentriq, Alecensa, and Tarceva. He earned a B.A. from St. Norbert College and an M.B.A. from Northwestern University’s Kellogg School of Management.

(Press release, Pyxis Oncology, FEB 3, 2026, View Source [SID1234662526])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])