On September 17, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported further encouraging efficacy data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer (Press release, Imugene, SEP 17, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/eb0aad51-27f2-1fa7-4e15-300441221a2f/Overall_Response_Rate_increases_to_81_in_azer_cel_trial.pdf [SID1234656038]).

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In August 2025, Imugene announced that a total of eleven out of fourteen patients had achieved an ORR of 79%, defined as either Complete Response, (the disappearance of signs of cancer in response to treatment) or Partial Response, (defined as cancer reduction by at least 50%). Since then, two new patients have become evaluable for responses with both achieving a Partial Response and another patient transitioning from PR to CR at Day 90 scan evaluation increasing the best ORR to 81% with thirteen out of sixteen patients showing response to treatment. The Complete Response (CR) rate continues to evolve as enrollment progresses and patients transition from partial to complete response, with an average time to best response seen in 1–3 months. The durability of response is also deepening in patients treated with azer-cel in combination with interleukin-2 (IL-2).

Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand).

Imugene is actively enrolling patients to the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000¹ global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse.

¹Science Direct Volume 60, Issue 5, November 2023

About primary central nervous system lymphoma (PCNSL)

PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients.

About other types of B Cell Lymphoma

Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments.

About Interleukin 2 (IL-2)

IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.

On September 17, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA (Press release, Candel Therapeutics, SEP 17, 2025, View Source [SID1234656037]). The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer.

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Details are as follows:

CAN-2409 – Localized Prostate Cancer

Abstract Title: Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation (EBRT) for Newly Diagnosed Localized Prostate Cancer
Presenter: Glen Gejerman, MD, MBA, Hackensack University Medical Center, Hackensack, NJ
Session Title: SS 03 – GU 1: Advances in Localized Prostate Cancer
Session Date/Time: Sunday, September 28, 2025; 2:30 PM – 2:40 PM PT
Location: Room 24, Moscone Center, San Francisco, CA

The abstract has also been selected for inclusion in ASTRO’s Science Highlights – Genitourinary Cancer session on Sunday, September 28 at 8:00 a.m. PT in Room 24, which will provide a high-level overview of top-rated research in the field.

On September 17, 2025 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025 (Press release, Rezolute, SEP 17, 2025, View Source [SID1234656036]).

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"We have made substantial progress this year across our two indications for ersodetug in both congenital and tumor hyperinsulinism," said Nevan Charles Elam, Chief Executive Officer and Founder of Rezolute. "We believe that FDA alignment on a streamlined Phase 3 trial in tumor hyperinsulinism is further recognition of ersodetug’s broad applicability across multiple forms of hyperinsulinism and highlights both the urgent need and the transformative potential of our therapy for patients and families living with this condition. We remain on track to report topline results from the sunRIZE trial in December and look forward to progressing towards potential commercialization."

Recent Pipeline Progress and Anticipated Milestones

Congenital Hyperinsulinism (HI)

· Completed enrollment in sunRIZE, a Phase 3, multicenter, double-blind, randomized, controlled safety and efficacy registrational study of ersodetug for the treatment of congenital HI.

○ Exceeded enrollment with 62 participants enrolled, including approximately 15 percent from U.S. sites.

○ Topline results expected in December 2025.

· Presented "Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress" at the Annual Meeting of the Endocrine Society (ENDO 2025). The enrolled population is comparable to the Phase 2 RIZE study and include:

○ 3.4y average age: 35% <2 years old

○ 15 (average) hypoglycemia events/week

○ 19% daily percent time in hypoglycemia

○ 95% taking ≥1 SOC treatments

Tumor HI

· In August 2025, the Company achieved alignment with FDA on a significantly streamlined clinical development path for its ongoing Phase 3 study (upLIFT) of ersodetug for the treatment tumor HI.

o The truncated study will include as few as 16 participants and will be limited to the single-arm open-label portion of the upLIFT study, removing the need to conduct a double-blind randomized placebo-controlled trial.

o Enrollment is underway and topline results are expected in the second half of 2026.

Corporate Updates

· In August 2025 the Company appointed Dr. Sunil Karnawat as Chief Commercial Officer.

o Dr. Karnawat has over 25 years of experience in global commercialization of biopharmaceuticals and medical devices and will spearhead launch strategy and global market readiness for ersodetug.

o Before joining Rezolute, Dr. Karnawat served as a Vice President at Cytokinetics and Ultragenyx. At Ultragenyx, he was responsible for leading key commercial functions in launching four ultra-rare disease products, including Crysvita.

Fourth Quarter and Full Year Fiscal 2025 Financial Results

Cash, cash equivalents and investments in marketable securities were $167.9 million as of June 30, 2025, compared with $127.1 million as of June 30, 2024.

Research and development (R&D) expenses were $20.9 million for the fourth quarter of fiscal 2025, compared with $19.1 million for the same period a year ago. Full fiscal year 2025 R&D expenses were $61.5 million, compared to $55.7 million in fiscal year 2024. The increase from fiscal year 2024 to fiscal year 2025 was primarily due to (i) increased expenditures in clinical trial activities, (ii) manufacturing costs for ersodetug, and (iii) higher employee-related expenses, which included employee compensation and stock-based compensation.

General and administrative (G&A) expenses were $5.0 million for the fourth quarter of fiscal 2025, compared with $4.0 million for the same period a year ago. Full fiscal year 2025 G&A expenses were $18.4 million, compared to $14.7 million in fiscal year 2024. The increase was primarily attributable to professional fees and employee-related expenses due to increased headcount.

Net loss was $24.4 million for the fourth quarter of fiscal 2025 compared with a net loss of $23.0 million for the same period a year ago. Full year fiscal 2025 net loss was $74.4 million compared to net loss of $68.5 million for the fiscal year 2024.

About Ersodetug

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI.

On September 17, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a certificate of grant for the Company’s "proenzyme composition" patent was received from the US Patent & Trademark Office (USPTO) (Press release, Propanc, SEP 17, 2025, View Source [SID1234656035]). The patent specifically captures a future clinical dose of the Company’s lead asset, PRP. This is the fourth US patent granted in this key strategic jurisdiction. Currently, the Company’s intellectual property portfolio consists of 90 patents filed in major jurisdictions relating to the use of PRP against solid tumors.

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The proenzymes composition patent is an important part of the IP portfolio covering a possible future clinical dose of PRP, as the Company advances to a Phase 1B, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The patent has also been granted in other major jurisdictions such as Europe, Japan and throughout Southeast Asia. PRP is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 billion by 2027, according to Emergen Research.

"We continue to grow our intellectual property portfolio in the United States, which is our most important jurisdiction," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Our lead asset, PRP, is an exciting method to prevent and treat metastatic cancer from solid tumors without the severe, or even serious side effects often associated with standard therapies. PRP is relatively non-toxic because it does not kill cancer cells directly but induces cell differentiation so that they become less malignant and die off naturally. This unique phenomenon is specific to PRP, which acts as an ‘EMT (epithelial to mesenechymal transition) modulator’, enforcing the cancer cells to behave more as a normalized cell so that it is no longer a threat. We are pushing towards the commencement of the Phase 1B study next year. We are also pursuing every avenue for raising sufficient capital and employing a digital asset diversification strategy to ensure optimal cash flow as we advance PRP towards important clinical milestones."

On September 17, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a certificate of grant for the Company’s "proenzyme composition" patent was received from the US Patent & Trademark Office (USPTO) (Press release, Propanc, SEP 17, 2025, View Source [SID1234656035]). The patent specifically captures a future clinical dose of the Company’s lead asset, PRP. This is the fourth US patent granted in this key strategic jurisdiction. Currently, the Company’s intellectual property portfolio consists of 90 patents filed in major jurisdictions relating to the use of PRP against solid tumors.

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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

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The proenzymes composition patent is an important part of the IP portfolio covering a possible future clinical dose of PRP, as the Company advances to a Phase 1B, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The patent has also been granted in other major jurisdictions such as Europe, Japan and throughout Southeast Asia. PRP is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 billion by 2027, according to Emergen Research.

"We continue to grow our intellectual property portfolio in the United States, which is our most important jurisdiction," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "Our lead asset, PRP, is an exciting method to prevent and treat metastatic cancer from solid tumors without the severe, or even serious side effects often associated with standard therapies. PRP is relatively non-toxic because it does not kill cancer cells directly but induces cell differentiation so that they become less malignant and die off naturally. This unique phenomenon is specific to PRP, which acts as an ‘EMT (epithelial to mesenechymal transition) modulator’, enforcing the cancer cells to behave more as a normalized cell so that it is no longer a threat. We are pushing towards the commencement of the Phase 1B study next year. We are also pursuing every avenue for raising sufficient capital and employing a digital asset diversification strategy to ensure optimal cash flow as we advance PRP towards important clinical milestones."