On February 14, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported more positive results from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, FEB 14, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7cb7e5ac-c469-4c73-907d-5e7846ef78e9/Azer_cel_demonstrates_two_additional_Complete_Responses.pdf [SID1234650267]). Following the previously reported results on 2 September 2024, two additional patients in the previously reported Cohort B – treatment with azer-cel, lymphodepletion (chemotherapy), and interleukin 2 (IL -2) – have now achieved a Complete Response (CR, being the disappearance of all signs of cancer in response to the treatment), bringing the total to four out of seven evaluable patients in this cohort.

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"All four Complete Responses in Cohort B were achieved in patients who had failed at least 4 lines of therapy in this hard-to-treat population, including autologous CAR T therapy," said Dr Paul Woodard, Chief Medical Officer of Imugene. "This suggests that azer-cel, in combination with IL-2, may offer a meaningful therapeutic option where other treatments have not succeeded. We are continuing to monitor these patients for persistence of response, with the longest durability ongoing at 10 months. We look forward to providing further updates as data matures."

The company remains focused on continuing enrolment in Cohort B and evaluating the long-term durability of responses. Azer-cel is being developed as a potential off-the-shelf CAR T-cell therapy, addressing key limitations of autologous CAR T approaches, including treatment accessibility and manufacturing constraints.

The 2025 Tandem Meetings event for the Transplantation & Cellular Therapy Meetings of ASTCT (American Society for Transplantation and Cellular Therapy) and CIBMTR (Center for International Blood and Marrow Transplant Research) highlights the latest research breakthroughs in hematopoietic cell transplantation (HCT), cellular therapy and gene therapy. Imugene poster presentation at this event takes place at 6:45pm Hawaii Standard Time on 13 February (3:45pm AEDT 14 February) can be viewed at the same time on Imugene’s website at View Source

The poster presentation is titled: Administration of Low-Dose, Subcutaneous (SC) Interleukin-2 (IL-2) Markedly Enhances the Pharmacokinetic (PK) Profile of Azercabtagene Zapreleucel (azer-cel), an Allogeneic Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, without Compromising Safety and Early Evidence of Clinical Activity in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Who Have Relapsed after Prior CD19-Directed CAR T-Cell Products.

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 patients with DLBCL, an aggressive type of non-Hodgkin’s lymphoma blood cancer (NHL), who relapsed after prior treatment with autologous CAR T therapies. Treatment with azer-cel, lymphodepletion (LD) and IL-2 in Cohort B 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 80,500 cases per year and approximately 30,000 new cases per year in the U.S.

Relapsed/refractory DLBCL has a high unmet medical need; 60-65% of patients treated with approved therapies, including autologous CD19 CAR T, relapse.

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 February 13, 2025 Alphamab Oncology (stock code: 9966.HK) reported that the first patient has been successfully dosed in the Phase III clinical study (Study ID: JSKN003-306) of anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. The study aims to compare the efficacy of JSKN003 versus investigator-selected chemotherapy for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

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JSKN003 is an anti-HER2 biparatopic ADC, which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. In 2022, JSKN003 initiated monotherapy dose-escalation and dose-expansion clinical studies in Australia and China (Study IDs: JSKN003-101, JSKN003-102). Results from the pooled analysis of both studies demonstrated a favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with platinum-resistant recurrent ovarian cancer. Notably, efficacy was observed in both HER2-expressing (IHC 1+/2+/3+) and HER2-negative (IHC 0) patients.

JSKN003-306 is a randomized, open-label, parallel-controlled, multi-center Phase III clinical study for patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, regardless of HER2 expression levels. The study aims to compare the efficacy and safety of JSKN003 versus investigator-selected chemotherapy in this patient population.

About JSKN003

JSKN003 is an anti-HER2 bispecific antibody-drug conjugate (bis-ADC), which is developed inhouse with Alphamab’s proprietary Glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exert anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window.

Multiple clinical studies at various stages of JSKN003 are currently being conducted in China and Australia. Clinical research results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with HER2-expressing breast cancer, platinum-resistant ovarian cancer (PROC) or high HER2-expressing solid tumors.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003.

(Press release, Alphamab, FEB 13, 2025, View Source [SID1234657005])

On February 13, 2025 Nain Bio, a leading global biopharmaceutical company focused on addressing the challenge of tumor drug resistance , reported that preclinical research results from its independently developed small molecule modulator targeting the PDIA6/IRE1 protein interaction will be presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held in Chicago, USA, April 25-30, 2025 (Press release, Nain Biotech, FEB 13, 2025, View Source [SID1234654626]). This groundbreaking research provides a new target and therapeutic strategy for selectively enhancing the sensitivity of tumor cells to endoplasmic reticulum stress (ER stress ) and inducing regulated cell death in tumors.

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Research Highlights:
Poster Topic: Development of a first-in-class PDIA6/IRE1 modulator for selectively sensitizing cancer cells to ER stress and regulated cell death.
Conference Section: Experimental and Molecular Therapeutics.
Panel Discussion: Novel Antitumor Agents 2.
Presentation Time: April 28, 2025, 2:00 PM–5:00 PM (Central Time).
Presentation Location: Booth 21, Poster #14 (Abstract #3045).

As the world’s oldest and largest academic oncology conference, the AACR (Free AACR Whitepaper) Annual Meeting has always been a touchstone for the development of innovative drugs. The inclusion of this research result not only validates Nain Bio’s original innovation capabilities in the field of tumor drug resistance , but also highlights the significant clinical translational value of this drug candidate. By precisely regulating the endoplasmic reticulum stress pathway , the company’s R&D team has opened up a new therapeutic dimension for overcoming tumor drug resistance .

On February 13, 2025 (the "Closing Date"), Sarepta Therapeutics, Inc. (the "Company") and Sarepta Therapeutics Investments, Inc., a wholly owned subsidiary of the Company (together with the Company, the "Obligors") reported to have entered into a credit agreement (the "Credit Agreement") with JPMorgan Chase Bank, N.A., as administrative agent (in such capacity, the "Administrative Agent") and as collateral agent (in such capacity, the "Collateral Agent") and the lenders party thereto (Filing, 8-K, Sarepta Therapeutics, FEB 13, 2025, View Source [SID1234650287]). The Credit Agreement provides for a five-year, $600 million senior secured revolving credit facility (the "Revolving Credit Facility").

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Interest rates under the Revolving Credit Facility are variable and equal to the Secured Overnight Financing Rate plus a credit spread adjustment of 0.10% per annum ("Adjusted SOFR"), plus a margin of 1.125% to 1.75% per annum based on the Company’s total gross leverage ratio, or, at the Company’s option, at a base reference rate equal to the highest of (a) the federal funds rate plus 0.50%, (b) the rate of interest last quoted by the Administrative Agent as its "base rate" and (c) the one-month Adjusted SOFR rate plus 1.00%, plus a margin of 0.125% to 0.75% per annum based on the Company’s total gross leverage ratio.

The Company will pay customary agency fees and a commitment fee based on the daily unused portion of the Revolving Credit Facility at a rate of 0.20% to 0.35% per annum based on the Borrower’s total gross leverage ratio. The Revolving Credit Facility is not subject to amortization and will mature on the fifth anniversary of the Closing Date.

On the Closing Date, each of the Obligors and the Collateral Agent entered into a pledge and security agreement, pursuant to which the Obligors granted a security interest in substantially all of their respective assets, in each case, subject to customary exceptions and exclusions.

The Credit Agreement contains customary representations and warranties, affirmative covenants, negative covenants and events of default. The Credit Agreement also contains financial covenants that are tested on the last day of each of the Company’s fiscal quarters. These financial covenants include a (x) maximum secured net leverage ratio of 3.5:1.0, subject to a 4.0:1.0 covenant holiday following certain permitted acquisitions or permitted collaborations, and (y) minimum consolidated interest coverage ratio of 2.5:1.0.

The foregoing description of the Credit Agreement does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Credit Agreement, attached hereto as Exhibit 10.1 and incorporated herein by reference.

On February 13, 2025 CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – reported new AlloHeme data presented at the 2025 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held February 12-15, 2025 in Honolulu, Hawaii (Press release, CareDx, FEB 13, 2025, View Source [SID1234650275]).

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In an oral presentation, a one-year interim analysis of the ACROBAT prospective, multi-center study showed that AlloHeme is an accurate and sensitive test for monitoring relapse after allogeneic stem cell transplantation in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). By measuring small changes in mixed chimerism, AlloHeme demonstrated excellent performance characteristics with a hazard ratio (HR) of 40.5 (p<0.001) for relapse, and a clinically meaningful median lead time to relapse of 36 days. The analysis included one-year interim follow-up data from a cohort of 229 patients with AML and MDS from 11 stem cell transplant centers across the U.S.

"We are extremely pleased with the results of the ACROBAT study which demonstrates that AlloHeme is highly accurate in predicting risk of relapse in patients who have undergone a hematopoietic cell transplant," said Dr. Monzr M. Al Malki, Associate Professor, and Director of Unrelated Donor Bone Marrow Transplant Program at City of Hope National Medical Center. "This study gets us one step closer to having a highly reliable molecular biomarker that enables us to assess the status of the stem cell engraftment and predict risk of relapse."

CareDx’s AlloHeme is an NGS-based test that has been shown to be more sensitive than the current standard of care methods for monitoring engraftment and relapse post-allogeneic hemopoietic stem cell transplantation for hematologic malignancies.

"The interim results of the ACROBAT study build upon our growth strategy to expand into hematology oncology. With AlloHeme, we can detect relapse after allogeneic stem cell transplantation prior to conventional methods, giving clinicians the significant lead time they need to intervene sooner," said Marica Grskovic, PhD, CareDx Chief Strategy Officer. "We are very pleased with these results demonstrating the high sensitivity of the AlloHeme assay and its selection for an oral presentation at the Tandem Meetings given the significant impact it may have on patient outcomes through earlier detection of malignancy recurrence."