On September 3, 2024 Nkarta, Inc., a biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported its participation in the following investor conference (Press release, Nkarta, SEP 3, 2024, View Source [SID1234646301]):

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H.C. Wainwright 26th Annual Global Investment Conference
September 10, 2024
12:30 p.m. ET – fireside chat

A simultaneous webcast of each event will be available on the Investors section of Nkarta’s website, www.nkartatx.com, and a replay will be archived on the website for approximately 90 days.

On September 3, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein (R&D code: IBI363) for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor (Press release, Innovent Biologics, SEP 3, 2024, View Source [SID1234646318]). Phase 1/2 clinical trials are currently underway in China, the U.S., and Australia to assess IBI363’s efficacy and safety in various advanced malignant tumors.

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At the ESMO (Free ESMO Whitepaper) Plenary meeting on June 14, 2024, Innovent presented promising efficacy signals in melanoma patients who had previously undergone immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively. (Link)

Dr. Hui Zhou, Senior Vice President of Innovent, said, "Melanoma is the most common fatal skin cancer in Europe and the United States. In China, while melanoma is a rare malignant tumor, it has a high fatality rate, and its incidence is steadily increasing each year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma."

Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.

About Melanoma

Melanoma is a malignant tumor that develops from melanocytes and is the fifth most common cause of cancer in the United States[3]. Although melanoma represents only 3% of all skin cancer cases, it has the highest mortality rate and is the most prone to metastasize. In China, both the incidence and mortality rates of melanoma have been steadily rising over the years. According to the classification of the disease site, melanoma is mainly divided into skin melanoma, acral and mucosal melanoma. Chinese melanoma differs greatly from European and American Caucasian melanoma in pathogenesis, biological behavior, histological morphology, treatment and prognosis[4]. For advanced cutaneous and acral melanomas, for those carrying BRAF V600 mutation, BRAF inhibitor combined with MEK inhibitor is the preferred molecular targeted therapy. For patients without a BRAF V600 mutation, comination of chemotherapy and anti-angiogenic drugs may be considered as the first-line treatment. Immunotherapy has not been approved as the first-line treatment indication for advanced melanoma in China. For second-line treatment, therapies not used in the first-line are recommended. If a PD-1 monoclonal antibody was not administered initially, it can be selected for the second-line. In advanced mucosal melanoma, chemotherapy or a combination of PD-1 monoclonal antibody and anti-angiogenic drugs may be considered as first-line options. For patients with BRAF V600 mutation, a BRAF inhibitor ±MEK inhibitor can be chosen. Currently, posterior treatment options for melanoma are very limited[5].

About IBI363 (PD-1/IL-2α)

IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 functions by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, enabling more precise and efficient targeting and activation of tumor specific T cells. IBI363 has demonstrated notable anti-tumor activity across various tumor-bearing pharmacological models and showed significant antitumor efficacy in both PD-1 resistant and metastatic models. Additionally, IBI363 exhibited a favorable safety profile in preclinical models. Clinical studies of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies.

On September 2, 2024 Simcere Zaiming, an innovative oncology company under Simcere Pharmaceutical Group (2096.HK), reported a collaboration agreement with Shenzhen TargetRx Inc (Press release, Jiangsu Simcere Pharmaceutical Company, SEP 2, 2024, View Source [SID1234646270]). The partnership focuses on the ALK/ROS1 dual receptor tyrosine kinase inhibitor TGRX-326, a clinical-stage anti-tumor candidate.

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According to the terms of the agreement, Simcere Zaiming will acquire exclusive commercial rights to TGRX-326 in Mainland China. These rights encompass but are not limited to marketing promotion, strategy formulation and adjustment, and the right to obtain relevant benefits from TGRX-326. TargetRx will receive an initial payment exceeding $20 million. Additionally, TargetRx will compensate Simcere Zaiming for promotional services.

TGRX-326 is a third-generation anaplastic lymphoma kinase (ALK) inhibitor independently developed by TargetRx. It is a potent and highly selective small molecule inhibitor that targets ALK and c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinases (RTKs). This inhibitor holds significant therapeutic potential for ALK/ROS1 fusion gene-positive non-small cell lung cancer (NSCLC) patients, especially those with multiple ALK-resistant mutations, including G1202R.

In preclinical studies and a Phase 1 clinical trial, TGRX-326 demonstrated robust anti-tumor activity and a favorable safety profile. Moreover, the molecule effectively crosses the blood-brain barrier, exhibiting exceptional efficacy in NSCLC patients with brain metastases.

Dr. Renhong Tang, Chairman of Simcere Zaiming, said, "We are pleased to collaborate with TargetRx on novel dual-targeted therapy for lung cancer, a major malignancy that Simcere Zaiming strategically focuses on. This partnership will further enhance our innovative product portfolio. ALK/ROS1 fusion is a critical genetic mutation in non-small cell lung cancer. The advancement of targeted therapies has significantly improved survival rates for these patients. However, there remains a substantial need for new treatments with better efficacy and the ability to overcome drug resistance. We look forward to working closely with TargetRx to provide Chinese lung cancer patients with more effective treatment options as soon as possible."

Dr. Yihan Wang, Chairman of TargetRx, said, "TGRX-326 is a potentially best-in-class novel anti-tumor molecule independently developed by TargetRx. It is a third-generation ALK inhibitor in late-stage clinical development which may bring a better option for patients. We believe that with the support of Simcere Zaiming, we will be able to bring this product quickly to the market. TargetRx aims to continuously deliver innovative therapies that will transform the lives of cancer patients."

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 2, 2024 Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, "Median" or "The Company") reported that it will host two live webcasts on September 5, 2024 (Press release, MEDIAN Technologies, SEP 2, 2024, View Source [SID1234646271]).

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Following the recent release of results of the eyonis LCS REALITY study, Fredrik Brag, CEO and Founder of Median Technologies, will offer further insights into the significance of eyonis LCS and discuss the next steps for Median’s novel Software as a Medical Device.

September 5, 2024 – 4:00 pm CEST / 10:00 am EDT (English)
September 5, 2024 – 6:00 pm CEST / 12:00 pm EDT (French)

Webcast replays will be available on Median’s corporate website shortly after the live sessions.