On February 23, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428) and Keymed Biosciences (HKEX: 02162) jointly reported that the first subject has been dosed in clinical trial of ICP-B05 (CM369), an anti-CC chemokine receptor 8 (CCR8) monoclonal antibody, developed by a joint venture between the two companies called Tiannuojiancheng Pharma in China (Press release, InnoCare Pharma, FEB 23, 2023, View Source [SID1234627660]).

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ICP-B05 is a potential first-in-class drug co-developed by InnoCare and Keymed as a monotherapy or in combination with other therapies for the treatment of various cancers.

There are no CCR8-targeted drugs in the world. ICP-B05 selectively depletes Tregs in the tumor microenvironment, which is more specific than other immunotherapies. CM369 binds to CCR8 on Tregs and eradicates immunosuppressive Tregs through ADCC to augment the anti-tumor immunity in TME while preserving peripheral homeostasis. CM369 has the potential to deliver optimal tumor targeted Treg depletion and be more specific in anti-tumor activity than other immunotherapies.

Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said: "CCR8 is a highly promising immuno-oncology target. ICP-B05 will strengthen our large molecule pipeline in solid tumor and has a potential for combination with other therapies for synergistic effects. We will accelerate clinical development, diversify our innovative drug solutions to solve unmet clinical needs, and make unremitting efforts to benefit solid tumor patients."

Dr. Bo Chen, Co-founder, Chairman and CEO of Keymed Biosciences, said: "CM369 has the potential to specifically eliminate tumor-infiltrating Treg cells, and has a positive therapeutic effect on a variety of advanced tumors. We are mindful of the importance of this therapy and are committed to expediting the clinical development of a potentially transformative solution for patients in need."

On February 23, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies (Press release, Enlivex Therapeutics, FEB 23, 2023, View Source [SID1234627605]). The clearance of the Phase I/II by the AEMPS follows recent announcements by the Company that (i) the study received IND clearance from the U.S. Food And Drug Administration for recruitment of patients in the U.S., (ii) the independent Data Safety Monitoring Board has completed its prespecified data review for the first cohort of patients in the Phase I/II trial and (iii) the Israeli Ministry of Health had reviewed the data and provided regulatory clearance to continue the study and open the subsequent high dose monotherapy and combination cohorts.

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The Phase I/II multi-center clinical trial (clinicaltrials.gov Identifier: NCT05581719) has been designed to evaluate the safety, tolerability and preliminary efficacy of Allocetra alone, and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors.

The Phase I/II trial was initiated following encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra was combined with a PD1 checkpoint inhibitor in a murine model of ovarian cancer, and additional models that demonstrated statistically significant survival benefit when Allocetra was combined with a PD1 or CTLA-4 checkpoint inhibitors in a murine model of peritoneal mesothelioma.

Einat Galamidi, MD., Vice President, Medical of Enlivex, stated "We are pleased with the AEMPS’ regulatory clearance to expand our clinical trial into Spain. We believe that AllocetraTM has the potential to provide a paradigm shift in treatment of advanced solid tumors, and we look forward to data readouts, including safety and potential indication of effect in patients, currently expected during 2023 and 2024."

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On February 23, 2023 Cantargia (Cantargia AB) (NASDAQ Stockholm: CANTA) reported favorable safety and promising early signs of efficacy following an initial analysis of the phase Ib part of the clinical trial TRIFOUR (Press release, Cantargia, FEB 23, 2023, View Source [SID1234627659]). In collaboration with the Spanish Breast Cancer Group (GEICAM), this trial investigates the IL1RAP-binding antibody nadunolimab (CAN04) in combination with chemotherapy for treatment of triple-negative breast cancer (TNBC). In 12 patients treated long enough for evaluation, the response rate was well above previously reported data for chemotherapy alone. The trial is now expanding into the randomized phase II part where the combination will be compared to a control group given chemotherapy only.

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TNBC is a difficult-to-treat disease which accounts for 10-15% of all breast cancer cases. To date, 15 first- or second-line patients with metastatic TNBC have been enrolled and treated in the dose-escalation part of the phase Ib/II trial TRIFOUR. In an early efficacy assessment based on 12 patients, one showed confirmed complete response, while five showed confirmed partial response, equaling a preliminary response rate of 50%. This compares favorably to the historical response rate of approximately 30% reported for gemcitabine and carboplatin alone [1], the chemotherapy doublet used in combination with nadunolimab in the trial. Among the other six evaluated patients, four showed stable disease and two showed progressive disease.

The combination showed an acceptable safety profile, in line with previous trials combining nadunolimab and chemotherapy. Notably, prophylactic use of G-CSF was incorporated to the study protocol to control neutropenia. TRIFOUR, which is conducted at 24 clinical sites in Spain, will immediately progress to the randomized phase II part, which may include up to 98 additional patients. An interim futility analysis is planned for Q4 2023. Data from the study are also planned for presentation in H2 2023.

"These initial results in triple-negative breast cancer are exciting for several reasons. Most importantly, they show an early signal of efficacy in line with our previous data in pancreatic cancer and non-small cell lung cancer, which further illustrates the magnitude of opportunities for nadunolimab. Based on these results, we look forward to immediately progressing into the controlled part of this trial, and continuing our fruitful collaboration with GEICAM," said Göran Forsberg, CEO of Cantargia.

"Triple-negative breast cancer is a very aggressive type of breast cancer with limited therapeutic options. The initial results from the TRIFOUR trial are very promising, and certainly warrant further investigation of nadunolimab in the subsequent, randomized, part of the study," said Dr. Agostina Stradella, medical oncologist, member of GEICAM, and Principal Investigator in TRIFOUR at the Catalan Institute of Oncology, Duran i Reynals Hospital.

Additionally, various biomarker analyses will be performed on patient samples collected in TRIFOUR. The FERO Foundation, a private Spanish entity dedicated to the promotion of cancer research, recently awarded GEICAM with a grant for a research project aiming to identify predictive markers of nadunolimab efficacy. This project will be based on TRIFOUR patient samples and provide further insights into the mechanisms behind the apparent synergy between nadunolimab and chemotherapy.

On February 23, 2023 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for advanced breast cancer, reported that the Company has begun receiving payments from third party payors for its advanced breast cancer assay (Press release, Theralink Technologies, FEB 23, 2023, View Source [SID1234627658]).

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Mick Ruxin, M.D., CEO of Theralink said, "We are extremely pleased to bring our game-changing testing technology to all beneficiaries in the U.S. Access to the latest cancer testing technology is paramount in order to make informed treatment decisions that will affect patient outcomes. The milestone of receiving third party payor paymentsis a testament to the value that Theralink provides to cancer patients and their oncologists by way of actionable information for expanded treatment options."

Theralink empowers physicians with new sources of actionable information with its patented, predictive, proteomic biomarker assay that assists oncologists with treatment decisions for their advanced breast cancer patients. Theralink’s patented Reverse Phase Protein Array (RPPA) technology measures the tumor cell levels of activated proteins, which no other US technology can do in a commercial, multiplexed environment. These activated proteins are the primary targets of most FDA-approved therapies and investigational drugs.

Dr. Ruxin concluded, "The above announcement speaks to our continued business growth and clinical influence as we work in a collaborative way with several U.S.-based cancer programs and private community practices as well as other stakeholders to improve access to care for all Americans affected by cancer."

On February 23, 2023 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that Amplia Head of Translational Biology, Dr Terrie-Anne Cock, will present a lecture at the 2nd Next Generation Kinase Inhibitors Summit currently underway in Boston, USA (Press release, Amplia Therapeutics, FEB 23, 2023, View Source;[email protected] [SID1234627657]).

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The presentation, entitled ‘Targeting Focal Adhesion Kinase (FAK) for the treatment of cancer and fibrotic diseases’ describes preclinical and Phase 1 clinical data for Amplia’s lead FAK inhibitor AMP945. A copy of the presentation, to be given at Friday 6:30am AEDT, is attached to this announcement.

Amplia CEO, Dr Chris Burns, commented: "Being invited to present our research at such a highly respected, industry-focused conference devoted to kinase inhibitor drug development, reflects the importance of our research at Amplia and our standing in the kinase field, internationally. Further, it allows us to promote the quality of the work being conducted at Amplia to biotech and pharma companies around the world."

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.