On September 2, 2024 : Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported promising results from its Phase 1b clinical trial with azer-cel (azercabtagene zapreleucel, an allogeneic off-the-shelf CD19 CAR T), in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL), a type of non-Hodgkin’s lymphoma (NHL) (Press release, Imugene, SEP 2, 2024, View Source [SID1234646253]). All enrolled patients had cancer that had returned following autologous CAR T therapy, a high unmet need for this patient population.

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"We are delighted that the first 2 patients in the Cohort B in our azer-cel Phase 1b trial achieved a complete response and continue to maintain their complete responses, one for over 120 days and the other for over 90 days," said Paul Woodard, MD, Imugene’s Chief Medical Officer. "All four patients enrolled in Cohort B have failed 4 to 5 prior treatments, including autologous CAR T therapy. All 4 patients remain on the study and given the robust response rates and durability seen to date, we will continue to enrol patients in the azer-cel plus IL-2 cohort and will closely follow all patients for further responses and durability."

Patients in the trial are being recruited across 15 leading cancer centres in the U.S. including, Columbia University, University of Minnesota, Emory, and Moffitt Cancer Centres and plans are ongoing to open up to 5 sites in Australia.

Nine (9) patients total from Cohorts A and B are considered evaluable (qualified for at least day 28 scan). One (1) patient (Cohort B) has been treated and is awaiting their 28- day scan:

• Of the 6 evaluable patients in Cohort A:
o 1 CR, 1 PR = 33% Overall Response Rate (ORR)
o 1 CR = 17% CR
o Durability of response was < 60 days o All patients no longer on trial

• Of the 3 evaluable patients in Cohort B:
o 2 CRs = 67% ORR o 2 CRs = 67% CR
o 1 Stable Disease (SD)*: On PET/CT scan imaging, patient’s tumour has decreased however, due to potential T-cell infiltration, noted an increase in signal intensity. This could represent pseudoprogression. The patient remains on trial and continues to be assessed for response at the follow up scans.
o Durability of response thus far: >120 days and >90 days (all patients are ongoing)
o All 4 patients (including 1 patient awaiting 28-day scan) continue on trial.

"I am proud of our clinical development team who assessed ways to enhance azer-cel’s durability of response, as one of the biggest challenges in CAR T therapy is ensuring that the modified T-cells stay in the body long enough to kill cancer cells," said Leslie Chong, Managing Director and CEO of Imugene. "

To maximise the response rates and durability further, we added a very low dose of IL-2 to the regimen in Cohort B. We are pleased with the results, which suggest improved outcomes in patients, and we look forward to amassing more data using this dosing regimen. We will continue to seek biomarker evidence from Cohort B patients that suggest our strategy is improving the performance of azer-cel."

The company will continue to enrol additional patients in Cohort B and follow patients for durability of response with the goal of providing a comprehensive package to the FDA for the potential Phase 2/3 registrational trial. Subject to patient recruitment, the company aims to provide an interim Phase 1b data update.

If successful, azer-cel has the potential to become the first approved allogeneic CAR T cell therapy for blood cancer. Beyond studying its efficacy in blood cancers, in the future, Imugene plans to combine azer-cel with its novel onCARlytics program for the treatment of patients with solid tumours, opening a potentially large market for azer-cel in the 90% of cancer not classified as blood cancers.

About the Phase 1b azer-cel trial

acceptable safety profile. In addition, the current patients in Cohort B, treated with azercel, LD, and IL-2 are demonstrating clinically meaningful activity and durability.

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.2 Relapsed/refractory DLBCL has a high unmet medical need; 60-65% of patients treated with treatments, 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 September 1, 2024 Collagen Medical, dba Lumina Pharmaceuticals, reported that the company has been awarded a $2 million Small Business Innovation Research (SBIR) Phase II Fast Track grant from the National Cancer Institute (NCI), a member of the US National Institutes of Health (NIH) (Press release, Lumina Pharmaceuticals, SEP 1, 2024, View Source [SID1234656611]). This award will focus on the development of an image-guided therapy paradigm for improving the management of gastric cancer by targeting fibrin in the tumor microenvironment. This SBIR grant follows numerous earlier NIH grants awarded to Lumina.

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"The Fast Track award from NCI represents another important milestone for Lumina as we continue to advance our platform of targeted molecular probes for medical imaging and radioligand therapy," said co-founder Dr. Gregory Sorensen. "This award will enable Lumina to further optimize our lead theranostic pair and acquire additional early clinical imaging data to inform our development plan."

Gastric cancer ranks as the fifth most prevalent malignancy and is the third leading cause of cancer-related mortality globally. Despite advancements in the management of advanced gastric cancer, prognosis remains unfavorable, with median survival limited to 12–14 months even with combination chemotherapy.

Lumina’s theranostic strategy holds the potential to significantly enhance the quality of patient care in solid tumor cancers with high unmet need such as gastric cancer. The approach combines the use of a diagnostic imaging agent for patient selection with a precision medicine of targeted radioligand therapy.

This grant is provided by the National Cancer Institute under Award Number R44CA275590. The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

On August 30, 2024 Innocure Therapeutics (CEO Yoo Hye-dong, Innocure), a company specializing in the development of targeted protein degradation (TPD) drugs, reported that Chief Strategy Officer (CSO) Kang Jong-seok will present the research results related to the company’s non-clinical candidate substance ‘ICT-1402’ decomposition agent at ‘BioCentury’s Grand Rounds R&D Conference 2024’ to be held in Nashville, Tennessee, USA from September 9th to 11th (local time) (Press release, InnoCure Therapeutics, AUG 30, 2024, View Source [SID1234651743]).

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This inaugural event, hosted by BioCentury, is a global conference that presents groundbreaking research, clinical insights, and innovative technologies with commercial potential for the next generation of biotech innovation.

InnoCure announced at the conference that its non-clinical non-small cell lung cancer decomposition agent ICT-1402 showed a tumor growth factor receptor (TGI) of 110% compared to the vehicle group in a patient-derived xenograft (PDX) model experiment with epidermal growth factor receptor (EGFR) exon 19 deletion and mesenchymal-to-epithelial transition (MET) amplification mutation in the 6 mpk group, and was more effective than the control drug Tepotinib 6 mpk group with a TGI of 75%.

Yoo Hye-dong, CEO of Innocure, said, "Through this event, we will promote ICT-1402, a global leading MET decomposer, and achieve business results that will accelerate future technology transfer (L/O) efforts." Meanwhile, Innocure was selected as a baby unicorn company for the ‘Global Unicorn Development Project’ last June.

On August 30, 2024 Sihuan Pharmaceutical reported 2024 Interim Results Presentation (Presentation, Sihuan Pharmaceutical, AUG 30, 2024, View Source [SID1234647127]).

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On August 30, 2024 Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported that it has granted the China rights (including mainland China, Hong Kong, Macau, and Taiwan) of KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals Co., Ltd (688578.SH) (Press release, Jacobio Pharmaceuticals, AUG 30, 2024, View Source [SID1234646259]).

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According to the terms of the agreement, Jacobio shall receive around RMB200 million in the near term, which includes an upfront payment of RMB150 million, and around RMB50 million of compensation for research and development expenses and other payments. Additionally, the potential milestone payments upon achieving certain development, regulatory and commercial milestones are up to RMB700 million. Jacobio is also entitled to receive tiered double-digit royalty payments on net sales of glecirasib and JAB-3312 from Allist, among which the royalty payments on net sales of JAB-3312 is up to 20%. The above amount includes value-added tax. Allist will be responsible for the commercialization of glecirasib and JAB-3312 in China and pay the subsequent clinical development costs in China. This marks that Jacobio has officially entered the commercialization stage, and the research and development of SHP2 has also ushered in a new milestone.

Dr. Wang Yinxiang, Chairman and CEO of Jacobio, said: "We are delighted to reach this cooperation with Allist. Allist has strong commercialization capabilities in the field of lung cancer, and the first indication for glecirasib submitted the new drug application is lung cancer. We believe that with the deep fit of the advantages of both parties, this collaboration will demonstrate great clinical and commercial value. In addition to the cooperation with glecirasib, Allist also licensed-in the SHP2 inhibitor JAB-3312, which is the first SHP2 inhibitor entering a registrational trial globally. It is expected to become a first-line therapy in combo with glecirasib, which reflects Allist’s foresight into the future of pipelines. We also look forward to jointly accelerating the development and commercialization of the two products to meet the clinical needs of more patients. "

Jinhao Du, the Chairman and general manger of Allist, said: "we are please to cooperate with Jacobio, and the cooperation will surely benefit the growth of both companies. For many years, Allist has taken ‘Technology Cares for Life’ as our corporate mission, focusing on scientific exploration and drug development in the field of cancer therapies, and is committed to developing and introducing superior pipelines consisting of best-in-class and first-in-class drugs. While we successfully independently developed and launched furmonertinib, we have built a commercial team that focuses on lung cancer, has professional academic promotion capabilities, and has a wide sales channel coverage. Since its launch, furmonertinib has achieved remarkable sales performance. Jacobio is a very outstanding innovative biotech company that has successfully developed and promoted a number of excellent products with great clinical value, including the KRAS G12C inhibitor glecirasib and the SHP2 inhibitor JAB-3312. We are very optimistic about the clinical advantages and market prospects of these two products. In this cooperation, Allist will give full play to its advantages in clinical development and commercialization capabilities to benefit more Chinese patients and create value for both companies."

The new drug application for glecirasib monotherapy for second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation was granted priority review on May 21, 2024. In December 2022, it was granted breakthrough therapy designation (BTD) Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the second-line and above treatment of patients with advanced or metastatic NSCLC with KRAS G12C mutation. In April 2024, the data of the pivotal Phase II study of glecirasib published by Jacobio in the ASCO (Free ASCO Whitepaper) Plenary Series showed that in patients with second-line NSCLC, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months.

The first patient dosed in the Phase III clinical trial of KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 versus standard care (chemotherapy and anti-PD-1 antibody) in front-line KRAS G12C mutant NSCLC in August 2024. According to the Phase I/IIa data presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, the optimal dose group was glecirasib at 800mg daily combined with JAB-3312 at 2mg daily one week on and one week off. The cORR of the optimal dose group was 77.4% (24/31), and 54.8% (17/31) of patients achieved a deep response with tumors shrinking by more than 50%. Regarding on the safety data, among the 194 all-dosage patients, the incidence of grade 3 or 4 treatment-related adverse events (TRAE) was 43.8%, and there was no treatment-related death. The overall safety is manageable.

In addition, the pivotal studies of glecirasib monotherapy for second-line or above pancreatic cancer, glecirasib monotherapy and in combination with cetuximab for colorectal cancer with are also undergoing. In terms of pancreatic cancer, in April 2024, glecirasib was granted orphan drug designation from Food and Drug Administration (FDA) for pancreatic cancer indications; in August 2023, it was granted BTD by CDE of NMPA for the treatment of second-line or above pancreatic cancer patients with KRAS G12C mutations. The combination of glecirasib and cetuximab for the treatment of colorectal cancer was approved for registrational phase III clinical trial in China in May 2024.

About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

About JAB-3312
JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor glecirasib has been approved by China CDE in Feb 2024.