On October 3, 2023 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported a collaboration with Hengenix Biotech, Inc. (Henlius USA), affiliated with Shanghai Henlius Biotech, Inc., a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Henlius USA will utilize OncoHost’s PROphet platform to identify exploratory, correlative biomarkers for patients recruited in its comprehensive Phase III clinical trial (NCT05468489). The trial is evaluating the efficacy and safety of Serplulimab plus chemotherapy (carboplatin – etoposide) in previously untreated US-based patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

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OncoHost’s PROphet platform combines bioinformatics, system biology, proteomic pattern recognition and machine learning to predict clinical benefit probability (defined as prolonged progression-free survival) in response to immunotherapy. PROphet analyzes 7,000 proteins in patient blood samples using aptamer-based assays (SomaScan by Somalogic (NASDAQ: SLGC)) and combines data collection with machine learning models for patient selection, OS (overall survival)/PFS (progression-free survival) prediction, MoA (Mechanisms of Action) discovery, AE (adverse events) prediction, and response prediction. The platform is applicable in oncology, autoimmune diseases, inflammation, and inflammatory bowel disease.

PROphet has been added to the comprehensive Phase III clinical trial to evaluate the efficacy of Serplulimab combined with chemotherapy in comparison to the standard-of-care atezolizumab combined with chemotherapy, identifying potential proteomics-based biomarkers to better characterize possible resistance patterns in recruited patients. The goal of this collaboration is to add another layer of information to the study by offering insight into who will benefit from the targeted combination therapy.

"We stand at the height of a transformative era in cancer therapeutics, and we are honored to support Henlius USA in better understanding resistance mechanisms to truly personalize care," said Ofer Sharon, MD, CEO of OncoHost. "Our shared goal is to improve cancer patients’ outcomes by developing robust, scientifically sound technologies to support them and their caregivers. We believe that such collaborations hold the potential to bring new hope to those affected by this challenging disease."

On October 5, 2023 Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP), a biotechnology company advancing a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics and small molecule drugs reported that it will be presenting at the Emerging Growth Conference on October 5 2023 (View Source) (Press release, Regen BioPharma, OCT 3, 2023, View Source [SID1234635609]).

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This live, interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO, Dr. David Koos, in real time. Please ask your questions during the event and Dr. Koos and his team will do their best to address as many of them as possible.

"We plan to use this time to discuss our recent S-1 filing in which we discuss an equity facility that can be accessed by the Company and contemplated use of funds. The Company will also provide update on the Company’s scientific programs," says Dr. David Koos, CEO and Chairman of the Company.

Regen BioPharma, Inc. will be presenting at 3:55 – 4:05 Eastern time on Thursday, October 5, 2023. Please register here to ensure you are able to attend the conference and receive any updates that are released View Source;tp_key=5580ab2cb9&sti=rgbp.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com.

On October 3, 2023 SciTech reported that it has successfully manufactured the clinical supply of its lead drug candidate, ST-001 nanoFenretinide, to initiate its upcoming clinical trial in T-cell non-Hodgkin lymphomas (NCT04234048) (Press release, SciTech Development, OCT 3, 2023, View Source [SID1234635608]).

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SciTech’s contract drug manufacturing partner has successfully manufactured ST-001 under strict QA/QC quality standards. Through a combination of innovative science and advanced nanotechnology, SciTech has developed ST-001, a new and patented formulation that enables the safe and rapid infusion of high-dose fenretinide for cancer treatment. SciTech’s Delivery Platform maximizes the bioavailability of water-insoluble drugs. ST-001 has passed extensive testing required for IV-administered drug products, including United States Pharmacopeia (USP) testing for sterility, endotoxins, particle sizing, and particulate matter as well as International Conference on Harmonization (ICH) guidelines for heavy metals and drug impurities.

"SciTech is thrilled to announce the successful manufacturing of ST-001 as we begin our human clinical trials. This is another major milestone for the company. Our team and investors are passionate about bringing ST-001 to the market for the treatment of T-cell lymphomas and other broader indications," said Earle Holsapple, President of SciTech Development. "We know that both patients and clinicians are looking for innovative and cost-effective ways to solve this cancer epidemic. SciTech is proud to be part of the medical community offering a new therapeutic and a giant step forward to help conquer cancer."

SciTech’s specialized drug formulation increases the bioavailability of fenretinide, which allows more of the active drug to reach the cancer cells. ST-001 binds to the cancer cells and disrupts the nucleus, causing the cancer cells to die. With ST-001, our goal is to reduce drug-related toxicities and achieve optimal drug concentrations for better patient outcomes.

To learn more, watch the video on How ST-001 Works.

On October 3, 2023 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that FDA has granted it clearance to proceed with TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma (Press release, Transcenta, OCT 3, 2023, View Source [SID1234635607]). This clearance marks a major step forward in the global development of Osemitamab (TST001) and another important milestone following the approvals by the Center for Drug Evaluation (CDE) in China and MFDS in South Korea for the Phase III pivotal trial of Osemitamab (TST001) in July 2023.

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This milestone marks a crucial advancement in the progression of Osemitamab (TST001) toward becoming a global therapy that elevates the current standard of care for HER2-negative metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. By specifically targeting CLDN18.2 and combining it with Nivolumab and chemotherapy, Osemitamab (TST001) is poised to reshape the treatment paradigm for G/GEJ cancer.

Stomach cancer remains an important cancer worldwide and is responsible for over one million new cases in 2020 and an estimated 769,000 deaths (equating to one in every 13 deaths globally), ranking fifth for incidence and fourth for mortality globally1. Combinations of platinum and fluoropyrimidine represent the backbone chemotherapy regimen for patients with HER2-negative advanced gastric cancer2. Nivolumab was approved in combination with chemotherapy for first-line treatment of patients with advanced or metastatic gastric cancer. Though treatment outcomes have improved, the median overall survival of nivolumab plus chemotherapy is still less than 14 months3.

Osemitamab (TST001) is a second-generation humanized CLDN18.2 targeting antibody with improved CLDN18.2 binding affinity and enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown anti-tumor activities in preclinical tumor models with a broad range of CLDN18.2 expression.

To support the global Phase III trial application and FDA EOP2 meeting, Transcenta has conducted Phase II clinical trials in both the U.S. and China of the combination of Osemitamab (TST001) with chemotherapy or nivolumab and chemotherapy with multiple Osemitamab (TST001) doses cohorts to optimize the dose for the global Phase III trial. Furthermore, Transcenta has developed a CLDN18.2 specific companion diagnostic assay with a credible CDx developer in the U.S.

At the 2023 ASCO (Free ASCO Whitepaper) annual meeting and 2023 ESMO (Free ESMO Whitepaper) GI conference, Transcenta presented encouraging efficacy data of Osemitamab (TST001) in combination with CAPOX as the first-line treatment of G/GEJ cancer. A total of 64 patients were enrolled and treated with Osemitamab (TST001) at doses ranging between 1 and 8mg/kg Q3W in a dose escalation and dose expansion cohort. CLDN18.2 positivity (defined as: IHC membrane staining ≥10% tumor cells with ≥1+ intensity per LDT assay, selecting approximately 55% of the screened patients) was required for the efficacy expansion. The data showed that the estimated median progression-free survival (PFS) was 9.5 months for all dose groups, consistent across all CLDN18.2 expression levels, with a median duration of response (DOR) of 9.9 months. PFS and DOR data for the 49 patients treated at the dose of 6mg/kg Q3W in the efficacy expansion will be presented at ESMO (Free ESMO Whitepaper) 2023. These data also show that the CLDN18.2 positive patients benefiting from the addition of Osemitamab (TST001) to standard of care could represent more than 55% of all G/GEJ adenocarcinomas.

"We are delighted with the positive outcome of the EOP2 meeting," said Dr. Caroline Germa, Transcenta Executive Vice President, Global Medicine Development and Chief Medical Officer. "The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. Securing FDA endorsement on critical program elements represents a pivotal milestone in advancing our Phase III trial in the U.S."

References:
[1] Hyuna Sung, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185
Countries. CA CANCER J CLIN 2021;71:209–249
[2] NCCN guideline for Gastric Cancer Version 2.2022
[3] Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet 2021;398:27-40

About Osemitamab (TST001)
Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer.

On October 3, 2023 The U.S. Food and Drug Administration (FDA) reported that it has granted approval for EntroGen’s CRCdx RAS Mutation Detection Kit as a companion diagnostic for Vectibix (panitumumab), a targeted therapy used in the treatment of colorectal cancer (Press release, EntroGen, OCT 3, 2023, View Source [SID1234635606]). This landmark premarket approval (PMA) marks a significant advancement in precision medicine for colorectal cancer patients in that CRCdx is the first approved real-time PCR-based test in the U.S. that fully meets the biomarker identification requirement for Vectibix.

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The CRCdx RAS Mutation Detection Kit is a cutting-edge molecular diagnostic tool designed to accurately detect KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients. The kit’s high sensitivity and specificity enable clinicians to quickly and easily identify patients most likely to benefit from Vectibix therapy and avoid unnecessary side effects and costs from treatment.

"We expect CRCdx to improve access to RAS testing at small and mid-size laboratories by simplifying the testing procedure while improving the turnaround time and lowering the diagnostic costs," said Matthew Minkovsky, CEO of EntroGen. "CRCdx is available immediately," he added.