On March 19, 2025 Jacobio Pharma (1167.HK) reported its 2024 annual results, with revenue of RMB160 million, R&D expense of RMB330 million (Press release, Jacobio Pharmaceuticals, MAR 19, 2025, View Source [SID1234651271]). Major operating and financing activities generated RMB320 million cash inflows. By the end of 2024, cash and bank balances and bank credit balances amounted to RMB1.45 billion. Jacobio also announced recent business progress and expected milestones.

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"2024 is a transforatmive year for Jacobio. We have submitted a New Drug Application (NDA) for the KRAS G12C inhibitor glecirasib and have licensed out the China rights of glecirasib and the SHP2 inhibitor sitneprotafib to our partner. This marks Jacobio’s successful transformation from the early R&D stage to an innovation-driven value realization stage," said Dr.Yinxiang Wang, the Chairman and CEO of Jacobio Pharma. "Looking ahead to 2025, glecirasib is expected to receive the official approval for marking, which will continuously generate cash flow to invest in Jacobio’ subsequent pipeline."

Development of core clinical stage products

Glecirasib (JAB-21822, KRAS G12C inhibitor) and sitneprotafib (JAB-3312, SHP2 inhibitor)

The commercialization and further clinical development in China of glecirasib and sitneprotafib were licensed to Allist on August 30, 2024.
Non-small cell lung cancer (NSCLC)
The NDA application of glecirasib monotherapy in second-line and above NSCLC was submitted to the CDE (China Drug Evaluation Center) in May 2024 and the priority review designation was granted in the same month. Glecirasib is expected to be approved in the first half of 2025.
The Phase III pivotal trial of glecirasib combined with sitneprotafib in front-line NSCLC enrolled the first patient in China on August 7, 2024.
Multi-tumor basket
The multi-tumor basket registration phase II trial of glecirasib for the treatment of pancreatic cancer, biliary tract cancer, gastric cancer, small bowel cancer, appendiceal cancer and other indications has been initiated in China. Glecirasib has received orphan drug designation (ODD) from FDA and EMA for pancreatic cancer.
Colorectal cancer
The Phase III trial of glecirasib mono or in combination with cetuximab in third line was approved by the CDE in May 2024
JAB-23E73 (pan-KRAS inhibitor)

The IND (Investigational New Drug) applications were approved in China and the United States in September 2024
The first patient was enrolled in November 2024
The dose escalation phase is expected to be completed in the second half of 2025
JAB-30355 (p53 Y220C activator)

The IND application of FIH (first-in-human) global trial of JAB-30355 was approved by the FDA in March 2024 and by the CDE in June 2024.
The first patient was enrolled in July 2024
The dose escalation is expected to be completed in the second half of 2025
JAB-8263 (BET inhibitor)

The dose escalation for JAB-8263 in solid tumors and hematologic malignancy were completed in the U.S. and China, respectively. The RP2D (phase II recommended doses) was obtained.
Dose expansion in patients with myelofibrosis is ongoing.
Solid tumor portion with specific biomarkers is being explored. .
JAB-2485 (Aurora A inhibitor)

A Phase I/IIa global trial of JAB-2485 is ongoing in the U.S. and China.
Dose escalation phase is expected to be completed in the first half of 2025
The expansion of monotherapy and combination with chemotherapy are being planned.
Development of pre-clinical pipelines

JAB-BX467 (HER2-STING iADC)

Clinical candidate of HER2-STING iADC has been nominated in the second half of 2024.
The IND application is being planned to be submitted in 2026.
JAB-BX600 (KRAS G12D ADC)

The clinical candidate is expected to be nominated in the second half of 2025.
As of December 31, 2024, Jacobio has filed more than 360 patent applications worldwide, including 126 authorized patents.

Conference call information

Jacobio Pharma will hold a conference call at 9:30 AM (Beijing time) on March 20, 2024. Participants, please register in advance through this link: View Source

On March 19, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, MAR 19, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/016deafa-b80d-5bf6-262c-0e50c1d6128c/Azer_cel_Granted_FDA_Fast_Track_Designation_in_Blood_Cancer.pdf [SID1234651235]).

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The FDA’s Fast Track Designation is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of this designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria.

Azer-cel is an off-the-shelf, CD19-directed CAR T-cell therapy engineered to overcome the logistical challenges of autologous CAR T therapies, such as prolonged manufacturing times and limited patient access. By leveraging pre-manufactured donor T-cells, azer-cel allows for rapid treatment delivery. Clinical data from the ongoing Phase 1b trial has demonstrated significant promise to date, particularly in patients who failed multiple prior therapies including autologous CAR T.

The therapy incorporates a novel combination of lymphodepletion chemotherapy and interleukin-2 (IL-2) to enhance CAR T persistence and efficacy. Azer-cel has shown a manageable safety profile, with no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) observed in key patient cohorts.

Leslie Chong, Managing Director and CEO of Imugene, commented: "Receiving FDA Fast Track Designation is a testament to the transformative potential of azer-cel for patients battling relapsed or refractory DLBCL. We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible."

DLBCL is the most common and aggressive form of non-Hodgkin’s lymphoma, with a significant portion of patients experiencing relapse or resistance to standard treatments. Azer-cel addresses this critical unmet need by offering a novel therapeutic approach for this challenging blood cancer.

On March 19, 2025 Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology and a leader in cell-based therapeutics, reported a €20 million ($21.9 million) financing through the issuance of a Mandatory Convertible Bond to ENEA Tech and Biomedical (ETB) to support the expansion of its pipeline by advancing Temferon in metastatic Renal Cell Cancer (mRCC) (Press release, Genenta Science, MAR 19, 2025, View Source [SID1234651255]). ETB is a leading private foundation, supervised by the Italian Ministry of Enterprises and Made in Italy, managing over €1,7 billion in assets under management through two funds. With deep expertise in the biomedical sector, ETB is an established authority in identifying and supporting high-potential biotech companies.

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"ETB conducted a deep and thorough scientific and legal due diligence before committing to this investment. We spent several months in negotiations," said Pierluigi Paracchi, CEO of Genenta. "We believe the mandatory convertible bond terms are indicative of the potential long-term value of Genenta’s shares. The bond will not result in immediate dilution to Genenta’s shareholders, and is expected to provide the necessary capital to achieve key milestones in the Company’s new mRCC trial. Conversion to equity is set for March 2028, followed by a two-year lock-up period. Naturally, the process will be accelerated in the event of a change of control of our Company. ETB is a trusted partner with strong financial backing, which will help ensure the financial stability required to advance the validation of the Temferon platform and our ability to pursue strategic collaborations."

The February data cutoff from the Phase 1/2a Glioblastoma Multiforme (GBM) uMGMT trial shows an increase in the percentage of patients surviving at two years, now reaching 29%, compared to 25% in October. Additionally, there is a marginal improvement in median overall survival, which now stands at 17 months. Historically reported data showed the overall survival of uMGMT patients undergoing standard of care to be approximately 14% at two years with a median overall survival of 13–15 months.

Notably, the Phase 1/2a trial in metastatic Renal Cell Carcinoma has recently begun enrolling patients, further strengthening the Company’s clinical pipeline for Temferon.

Prof. Luigi Naldini, Co-founder of Genenta, added: "We are continuing to demonstrate at pre-clinical and clinical levels Temferon’s ability to reprogram the tumor microenvironment, which in turn induces cell-mediated immune responses, as suggested by Genenta’s ongoing GBM trial and which will be under testing in the Company’s mRCC trial."

ETB Mandatory Convertible Bond Investment Terms:

Total Bond: €20 million ($21.9M), subscribed by ETB;
Maturity: three years, with mandatory conversion at maturity (March 2028);
Lock-up: two years following conversion (March 2030);
Funding Structure:
First Tranche: €7.5 million ($8.2M), which is expected to provide sufficient funding to assess safety in the ongoing Phase 1/2a trial for mRCC.
Second Tranche: €12.5 million ($13.7M), conditional upon achieving safety and tolerability in the ongoing Phase 1/2a trial for mRCC, among other conditions.
ETB equity in Genenta will be capped at 29%.
The maximum conversion price is $17.64 per share based on an Independent Evaluation conducted by ETB’s Advisor on Genenta.

On March 19, 2025 Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, reported positive results from the VERIFI study, the second clinical validation study of its next-generation pancreatic cancer test (Press release, Immunovia, MAR 19, 2025, View Source [SID1234651272]). The study met its primary endpoint, with the test successfully detecting 77% of stage I and II cases of pancreatic cancer.

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"The high accuracy of the Immunovia test in detecting stage I and II PDAC in a second independent clinical population of high-risk patients is very encouraging," said Dr. Patricio Polanco, Co-Director of the Pancreatic Cancer Program and the Pancreatic Cancer Prevention Clinic at the Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center. "Additional biomarkers to support the diagnosis of patients with early-stage disease are critical for improving long-term oncologic outcomes in pancreatic cancer."

"We are excited to see additional proof of the accuracy of our next-generation test," said Jeff Borcherding, CEO of Immunovia. "Completing a second successful clinical validation study will strengthen our efforts to secure insurance reimbursement for the test. We look forward to sharing additional data and analysis from the VERIFI study in upcoming scientific meetings and publications."

Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test’s clinical impact and evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption.

About the VERIFI Study

The VERIFI study was conducted using 385 blood samples from six leading pancreatic cancer centers in the U.S. Researchers analyzed 115 samples from patients with Stage I and II pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. These were compared to 270 control samples from people without pancreatic cancer classified as high risk. These high-risk individuals had a family history of pancreatic cancer, concerning genetic mutations, pancreatic cysts (fluid-filled sacs in the pancreas that sometimes develop into pancreatic cancer), or a combination of these risk factors.

About Pancreatic Cancer

Pancreatic cancer is one of the most aggressive cancers, with a five-year survival rate of just 13%. Early detection is critical for improving patient outcomes, particularly for individuals at high risk of pancreatic cancer. Individuals with certain genetic mutations or family history of PDAC face higher risk. Certain pancreatic cysts, such as intraductal papillary mucinous neoplasms (IPMNs), also pose a significant cancer risk, with up to 15% progressing to pancreatic cancer within 15 years.

On March 19, 2025 Daiichi Sankyo (TSE:4568) reported that DATROWAY (datopotamab deruxtecan) has been launched in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy (Press release, Daiichi Sankyo, MAR 19, 2025, View Source [SID1234651236]).

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DATROWAY is the first ever TROP2 directed medicine to be launched in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) available based on Daiichi Sankyo’s DXd ADC Technology.

Marketing approval of DATROWAY was granted by the Japan Ministry of Health, Labour and Welfare (MHLW) in December 2024 based on the results from the TROPION-Breast01 phase 3 trial where DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those treated with chemotherapy.

"HR positive, HER2 negative unresectable or recurrent breast cancer has historically been treated with conventional chemotherapy after progression with hormone therapy, which is associated with poor response rates and a low five-year survival rate," said Kei Kiuchi, Vice President, Oncology Marketing Department, Japan Business Unit, Daiichi Sankyo. "Patients now will have access to DATROWAY, the first TROP2 directed medicine available in Japan for this specific type of metastatic breast cancer."

In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients (including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm. The most common adverse reactions included nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%) and dry eye (21.7%). In Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY. DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in DATROWAY-treated patients, DATROWAY is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for DATROWAY therapy.

Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China and other regions.

About TROPION-Breast01

TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of singleagent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease.

Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted.

The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival (OS). Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology. The OS data were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025.

TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Hormone Receptor Positive, HER2 Negative Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases diagnosed in 2022.2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.

Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2
negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).3 Endocrine therapy is
widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer.
However, after initial treatment, further efficacy from endocrine therapy is often limited. The current
standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates
and outcomes.

About DATROWAY

DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. 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 programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized 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 Japan and the U.S. for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

About the DATROWAY Clinical Development Program

A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings.