On January 20, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported that a new provisional patent application has been filed for methods of producing trypinsogen and chymotrypsinogen with IP Australia. The patent application describes an optimized expression system to produce a world-first fully synthetic recombinant version of PRP, a long-term therapy for the treatment and prevention of metastatic cancer from solid tumors. According to Emergen Research, the global metastatic cancer market is projected to be worth $111 Billion by 2027.

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A fully synthetic version of trypsinogen and chymotrypsinogen, called Rec-PRP, could have additional benefits to a global healthcare system that further capitalizes on a new therapeutic approach to treating cancer. For example, both proenzymes are synthesized by an in vivo (living organism) expression system, such as yeast cells, to produce proteins that could be maintained for long periods of time without suffering degradation in the absence of refrigeration. This is useful for a longer self-life as well as global distribution, particularly in warmer climates and developing regions where refrigeration is not available. Further, the program could produce large quantities of trypsinogen and chymotrypsinogen for commercial use that exhibits minimal variation between lots and without sourcing from animals. Therefore, management believes a fully synthetic recombinant version of PRP would have tremendous implications from a regulatory perspective, but also a practical, commercial benefit for global distribution.

"This provisional patent application is the third one filed over the past two months and will enhance our IP portfolio significantly as we enter national phase in countries worldwide for each of these patent applications," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "We continue to execute our strategic plan building a platform technology that could be a world-first therapeutic approach to metastatic cancer from solid tumors, but without severe or serious side effects associated with standard treatments. Further, we are expanding our research into other therapeutic indications where there is a significant unmet medical need. We are building a strong and stable future for our Company and shareholders over the long term."

(Press release, Propanc, JAN 20, 2026, View Source [SID1234662098])

On January 20, 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. Phio reported a summary of the pathology results and safety outcomes across all cohorts in its Phase 1b dose escalation clinical trial with the INTASYL compound PH-762 for the treatment of skin cancer.

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A total of 22 patients with cutaneous carcinomas completed treatment across five cohorts in the Phase 1b trial and underwent excision of the treated lesional site. Among the 20 patients with cSCC, 14 patients were determined to be pathologic responders, including 10 patients with complete response (100% clearance), 2 patients with major/near clear response (greater than 90% clearance), and 2 patients with partial response (greater than 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response with greater than 50% clearance. Six cSCC patients and one melanoma patient had responses of less than 50%, however, none of the patients experienced a progression of the disease.

There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in any patients who received intratumoral PH-762 in this trial. PH-762 has been well tolerated in all enrolled patients in each of the five dose escalating cohorts, increasing drug concentration 20-fold from the first to the final cohort. Safety data through an extended follow-up period is expected to be reported in the second quarter of 2026.

"The pathology data is remarkable with an overall response rate of 70%, complemented by a favorable safety data. With this data in hand, we are now actively beginning the follow-on clinical trial design in the next step in the regulatory development pathway." said Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals.

The Phase 1b clinical trial is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. Per the trial’s protocol, patients received four injections of PH-762 at weekly intervals and pathologic response was assessed 2 weeks following the final injection of PH-762.

(Press release, Phio Pharmaceuticals, JAN 20, 2026, View Source [SID1234662097])

On January 20, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that the first patient has been randomized in the IMMUNOLIFE Phase 2 clinical trial, a randomized multicenter study evaluating the potential of an oral pooled fecal microbiotherapy (MaaT033) in combination with Regeneron’s Cemiplimab (CB) in enhancing disease control rate versus best investigator’s choice (BIC) in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis.

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The IMMUNOLIFE trial is evaluating MaaT033 in combination with CB vs BIC in 162 patients with advanced NSCLC who are refractory to immune checkpoint inhibitors (ICIs) and have received antibiotics. Patients are randomized (1:1) to receive either MaaT033 orally for one week prior to each cycle of CB (administered every 3 weeks for 6 months), followed by CB alone, or BIC. The primary objective is to assess whether the combination is associated with an improved disease control rate at 12 weeks compared to BIC. The study includes 14 centres in France, with patient enrolment of approximately 2 years and total CB treatment duration of 2 years. Primary results after 1-year follow-up post-treatment could be expected in late 2030. An interim futility analysis around H1 2027, after the 81st randomized patient.

"Gut dysbiosis is increasingly recognized as a risk factor for immunoresistance to immunotherapy. MaaT033 is designed to restore microbiome balance and may help improve patients’ response to treatment," said Lisa Derosa, MD, PhD at Gustave Roussy and coordinating investigator of the IMMUNOLIFE trial.

"We have built substantial evidence in our hemato-oncology programs that complex donor-derived products restore immune homeostasis in the context of pre-existing dysbiosis. This study represents an opportunity to further explore these findings in immuno-oncology in a well-defined patient population expected to show antibiotic-mediated dysbiosis," said Hervé Affagard, CEO and co-founder of MaaT Pharma.

This trial, sponsored by Gustave Roussy, is part of MaaT Pharma’s exploratory strategy launched in 2022, which also includes the PICASSO trial, a Phase 2a randomized controlled trial sponsored by AP-HP in Paris evaluating Xervyteg (MaaT013) in combination with ICIs, ipilimumab (Yervoy) and nivolumab (Opdivo) for patients with metastatic melanoma. The Company has been informed by PICASSO’s academic sponsor that topline results could not be available in Q4 2025 (as previously announced) and could now be expected in H1 2026. Overall, IMMUNOLIFE and PICASSO studies aim to contribute to the ongoing assessment of the Company’s research strategy, including indication, treatment line, and patient population. This will also inform on the clinical development of MaaT034, a co-cultured microbiome-based therapy and the Company’s next-generation drug candidate, designed to target large indications in solid tumors.

In parallel, data already generated and to be generated during the IMMUNOLIFE consortium will also fuel the Company’s AI platform and support the development of all the Company’s microbiome-based drug candidates.

The IMMUNOLIFE consortium includes leading academic institutions such as Gustave Roussy, INSERM, Paris Saclay University, INRAe, Hospital-University Institute (IHU) Méditerranée Infection and biotech companies. The consortium aims to address the challenge of primary resistance to ICI observed in advanced NSCLC patients following antibiotic exposure. The IMMUNOLIFE consortium receives funding from the French National Research Agency ("ANR-21-5 RHUS-0017 IMMUNOLIFE").

For more information on the IMMUNOLIFE (IMMUNOLIFE2) study: NCT07001618

About MaaT033

MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

(Press release, MaaT Pharma, JAN 20, 2026, View Source [SID1234662096])

On January 20, 2026 Immunomic Therapeutics, Inc. ("ITI"), a privately held clinical-stage biotechnology company pioneering nucleic acid-based immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has cleared ITI’s Investigational New Drug (IND) application for ITI-5000. This clearance allows ITI to initiate the first-in-human clinical trial evaluating ITI-5000, a UNITE-based self-amplifying RNA vaccine, as monotherapy and in combination with pembrolizumab (Keytruda), in patients with Stage II–III Triple-Negative Breast Cancer (TNBC).

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The Phase 1, multicenter, open-label, two-part study—known as VITALITI (VITAL-TNBC Study of ITI-5000)—is designed to assess safety, tolerability, and preliminary immunologic activity of ITI-5000 alone and in combination with pembrolizumab. TNBC represents approximately 15%–20% of breast cancer diagnoses and remains associated with poorer outcomes and fewer targeted treatment options, underscoring a substantial unmet medical need. Breast cancer is the fifth leading cause of cancer mortality globally.

ITI-5000 utilizes nucleic acid vaccine constructs engineered to preferentially deliver tumor-associated antigens (TAAs) to the MHC II compartment via LAMP-1, potentially enhancing antigen presentation, antibody generation, and CD4+ T-cell responses.

Pembrolizumab (Keytruda), a humanized monoclonal antibody and PD-1 inhibitor, is widely used in cancer immunotherapy and has demonstrated benefit across numerous tumor types, including TNBC.

"Preclinical data have demonstrated enhanced efficacy in animal models without additional safety concerns. The FDA’s clearance of our IND application for ITI-5000 marks a significant milestone for us as we advance this program into its first clinical trial," said DG Kim, Chief Executive Officer of ITI. "This achievement reflects years of innovative research and the dedication of our scientific and technical teams, and it brings us another step closer to offering a potentially transformative therapy for patients with TNBC."

Dr. Teri Heiland, Chief Scientific Officer of ITI, added, "The ITI-5000 program represents an important evolution of our UNITE technology, leveraging LAMP-mediated antigen presentation to drive robust CD4+ T cell activation. Our preclinical findings provide strong scientific rationale for advancing ITI-5000 into human studies, particularly in a disease area where new therapeutic approaches are urgently needed. We are excited to translate this promising data into the clinic and further explore the potential of this platform in TNBC."

ITI expects to begin patient enrollment in the second quarter of 2026 across up to eight U.S. clinical sites.

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

(Press release, Immunomic Therapeutics, JAN 20, 2026, View Source [SID1234662095])

On January 20, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

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The Company presented an overview of the clinical status of its papillary disease program, including more than five years of follow-up data supporting the papillary indication. Highlights included durable disease-specific survival of approximately 96% at 36 months, with the median survival not yet reached even with five years of follow-up; high rates of cystectomy avoidance of 92% and 82% at one and three years, respectively; and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors. In addition, several thought-leading urologists who attended the meeting presented real-world treatment approaches for patients with BCG-unresponsive disease, where the remaining alternative is often radical cystectomy.

Based on these discussions, the FDA recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication. ImmunityBio has compiled the requested information and will submit it to the Agency within the next 30 days. This additional information does not contemplate the initiation or design of a new clinical trial.

This submission follows a productive face-to-face meeting with senior FDA officials, during which the regulatory path forward for ANKTIVA in papillary NMIBC was collaboratively defined. Topics included current standards of care, challenges associated with chemotherapy, patient management considerations, and perspectives on the interpretation of the Company’s data. BCG-unresponsive disease remains a serious condition, with risks of progression to muscle-invasiveness disease, higher mortality, and limited bladder-sparing treatment options for patients.

"We appreciate the FDA’s collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency’s review."

About the Papillary Indication: The proposed submission for the BCG-unresponsive NMBIC papillary indication is supported by long-term results from the QUILT-3.032 Phase 2/3 trial (Cohort B) in 80 patients with BCG-unresponsive high-grade papillary-only NMIBC. As recently published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% confidence interval: 46.6-68.2%. Patients treated with intravesical ANKTIVA plus BCG demonstrated a 96.0% disease-specific survival (DSS) rate at 36 months, with the median DSS not yet reached. Progression-free survival (PFS) was 94.9% at 12 months and 83.1% at 36 months, indicating durable prevention of progression to muscle-invasive disease. Notably, the therapy conferred a bladder-sparing benefit: cystectomy-free survival was 92.2% at 12 months and 81.8% at 36 months, meaning over 80% of patients avoided radical cystectomy through three years of follow-up. These long-term outcomes, including ≥82% bladder preservation and ≥96% bladder cancer-specific survival at 36 months, are unprecedented in this high-risk population and underscore the potential of ANKTIVA to offer a curative-intent, chemo-free immunotherapy alternative to surgery. (Clinical reference: Chang et al., 2025, Journal of Urology)

"The 12- and 36-month survival rates observed with ANKTIVA plus BCG are higher than those reported for other investigational therapies in this patient population," said Dr. Patrick Soon-Shiong. "Together with the high rate of bladder preservation – with over 80% of patients remaining cystectomy-free at three years – these data demonstrate the effectiveness of ANKTIVA in enhancing the immune response against bladder cancer. We remain committed to bringing this important therapy to patients as quickly as possible. Patients with BCG-unresponsive papillary NMIBC currently have no approved treatment options aside from life-altering radical cystectomy, so our mission is to deliver a safe and effective bladder-sparing treatment to address this urgent unmet need."

Global Regulatory Status: ANKTIVA in combination with BCG is already approved in multiple regions for BCG-unresponsive NMIBC CIS. The product received FDA approval in April 2024 for patients with carcinoma in situ (CIS) with or without papillary tumors. It is also approved by the United Kingdom’s MHRA and has a positive opinion for Conditional Marketing Authorization in the European Union for NMIBC with CIS with or without papillary tumors. Most recently, the Saudi Food and Drug Authority (SFDA) granted approval to ANKTIVA for NMIBC CIS (with or without papillary disease) in January 2026. These approvals reflect ImmunityBio’s commitment to expanding patient access to ANKTIVA globally as a potentially bladder-sparing option. The Company is actively engaging with additional regulatory agencies, including the European Medicines Agency (EMA) and authorities in other regions, to extend the label to papillary-only disease pending U.S. approval.

Unmet Medical Need: High-grade papillary NMIBC that is unresponsive to BCG poses a serious treatment challenge, as no targeted therapies are currently approved for these patients. Standard of care for BCG-unresponsive, papillary-only disease has been radical cystectomy (complete removal of the bladder), an invasive surgery associated with significant morbidity and impact on quality of life. ImmunityBio’s pursuit of the papillary NMIBC indication is aimed at providing an alternative to cystectomy – a therapy that can eradicate disease while preserving the bladder. The long-term data from QUILT-3.032 suggest that ANKTIVA plus BCG can achieve durable remissions in papillary NMIBC, delaying or avoiding the need for radical surgery in the majority of responders. If approved, ANKTIVA would become the first immunotherapy option for BCG-unresponsive papillary NMIBC, expanding on its existing approved use in CIS and potentially transforming the treatment paradigm for these patients.

About ANKTIVA (nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, JAN 20, 2026, View Source [SID1234662094])