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Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8010, an Antibody Drug Conjugate Targeting HER2 for the Treatment of Advanced Solid Tumors

On March 6, 2023 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8010, an antibody-drug conjugate (ADC) that targets HER2 (Press release, BioThera Solutions, MAR 6, 2023, View Source [SID1234628232]). The multicenter, open-label Phase 1 clinical study in patients with local advanced or metastatic solid tumors aims to evaluate the safety and tolerability of BAT8010. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumor.

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BAT8010 is an antibody-drug conjugate (ADC) targeting HER2 designed for the treatment of solid tumors. HER2, a member of the epidermal growth factor receptor family (EGFR), is overexpressed in a variety of solid tumors, plays an important role in tumor proliferation, invasion, and metastasis, and is related to the poor prognosis of tumors. HER2 is a validated drug target with a number of approved drugs for the treatment of breast and gastric cancer and is still a target of high interest for new drug discovery.

BAT8010 was developed by using Bio-Thera’s proprietary ADC linker-payload that includes a cleavable but systemically stable linker, a small molecule topoisomerase I inhibitor and high DAR. The small molecule topoisomerase I inhibitor payload carried by BAT8010 has a strong cell membrane penetration ability, when the target cancer cells are killed, the payload has shown to be released and kill nearby cancer cells, producing a bystander effect, which has the potential to overcome the heterogeneity of the tumor. BAT8010 has demonstrated high anti-tumor activity, good stability, and safety in both in vitro and in vivo pharmacological studies. Bio-Thera Solutions is also developing additional ADCs based on its proprietary linker-payload, including ADCs targeting FRα, B7H3, Trop2, Nectin-4. All of the ADCs in Bio-Thera’s pipeline are currently in early-stage clinical studies.

In addition, Bio-Thera has developed an ADCC-enhanced anti-HER2 monoclonal antibody, BAT1006, that is also in early-stage clinical development. Different HER2 recognition sites can effectively inhibit the formation of HER2/HER3 heteromer. With different HER2 recognition sites and functional synergy, a combination therapy of BAT1006 and BAT8010 has the potential to improve the efficacy of targeting HER2. Bio-Thera intends to explore such a combination upon completion of the Phase 1 studies of each asset.

Roche receives FDA approval of label expansion for VENTANA PD-L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

On March 6, 2023 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has approved the VENTANA PD-L1 (SP263) Assay as a companion diagnostic to identify non-small cell lung cancer (NSCLC) patients eligible for treatment with Libtayo (cemiplimab), a PD-1 inhibitor therapy developed by Regeneron (Press release, Hoffmann-La Roche, MAR 6, 2023, View Source [SID1234628231]).

More than 60 percent of patients diagnosed with NSCLC are diagnosed at locally advanced or metastatic stage (Stage III-IV).2 With this launch, more patients may have access to an additional immunotherapy option with Libtayo, potentially improving their treatment pathway and outcomes.

"Diagnostics, like our high medical value PD-L1 assay portfolio, enable personalised medicine to help improve patient outcomes," said Jill German, Head of Pathology Lab, Roche Diagnostics. "This approval helps physicians make more confident treatment decisions by identifying patients with tumours that may respond to the immunotherapy Libtayo."

The VENTANA PD-L1 (SP263) Assay is the only FDA approved product available with NSCLC indications for four different immunotherapy drugs, offering oncologists a broad range of treatment options for patients. Treating NSCLC as early as possible may improve patient outcomes.

Lung cancer is the leading cause of cancer death worldwide. Every year, more than 2.2 million people are diagnosed with lung cancer globally and up to 85 percent of these cases are NSCLC.3,4

About the VENTANA PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in non-small cell lung carcinoma (NSCLC) patients. PD-L1 expression on tumour cells and immune cells has been shown in clinical studies to help predict the likelihood a patient may benefit from PD-L1/PD-1 immunotherapy drugs.5

VENTANA PD-L1 (SP263) Assay testing is performed on a BenchMark ULTRA instrument and is visualised using the OptiView DAB IHC Detection Kit.

Roche has developed a leading, comprehensive and differentiated lung cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.

Hummingbird Bioscience Exercises Its Option to License the Clinical Trial Results from Cancer Research UK to Support Further Development of HMBD-001

On March 6, 2023 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, and Cancer Research Horizons, the innovation arm of Cancer Research UK (CRUK), reported that Hummingbird Bioscience has exercised its option to license in the first-in-human (FIH) clinical trial results of HMBD-001, a differentiated and potentially best-in-class HER3-targeting antibody (Press release, Hummingbird Bioscience, MAR 6, 2023, View Source [SID1234628230]).

The Phase 1/2a clinical trial in the United Kingdom is being sponsored and managed by CRUK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The Phase 1a stage of the trial is currently enrolling multiple solid tumor cancer patients resistant to approved therapies, and is aimed at identifying a recommended Phase 2 dose for further evaluation.

"We decided to exercise the option at this time due to our enthusiasm for the promising data emerging from the ongoing Phase 1a study. We look forward to accelerating the opening of multiple Hummingbird-sponsored Phase 1b/2 studies. Our CRUK collaboration has been pivotal for the development of HMBD-001 and brings us one step closer to providing a precision therapy for patients with HER3-expressing cancers," said Piers Ingram, Ph.D., Chief Executive Officer, Hummingbird Bioscience.

"Hummingbird Bio’s decision to exercise a licensing option for HMBD-001, early in the clinical development process, speaks to the urgency needed to bring promising therapeutic advances to patients," explained Nigel Blackburn, Director of the Cancer Research UK’s Centre for Drug Development. "We are pleased to have partnered with Hummingbird Bioscience to provide the clinical trial expertise and funding support needed to help navigate HMBD-001 through the high-risk, early-stages of therapeutic development."

Based on the FIH dose escalation data, Hummingbird Bioscience plans to initiate multiple studies in biomarker-selected populations during the second half of 2023. In parallel, CRUK will continue the ongoing Phase 1/2a study by completing the ongoing dose escalation portion, followed by a dose expansion study in metastatic castrate-resistant prostate cancer (in combination with anti-androgen therapy) later this year.

Therapeutic Solutions International Announces Plans to Initiate Breast Cancer Clinical Trial Using FloraStilbene™ Immune Stimulator Through Res Nova Bio Subsidiary

On March 6, 2023 Therapeutic Solutions International (TSOI) reported plans to initiate ten patient proof-of-concept clinical trial aimed at demonstrating the ability of FloraStilbene to stimulate the immune system in advanced breast cancer patients (Press release, Therapeutics Solutions International, MAR 6, 2023, View Source [SID1234628228]).

"Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015"

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The Company has previously been granted a patent on utilization of pterostilbene and pterostilbene compositions for synergy with cancer immunotherapy such as interleukin-21, as well as suppression of cancer derived immune inhibitory agent enzymes such as indolamine 2,3 dioxygenase2. By combining previous experiences with immune modulation, the Company announced the creation of a novel immune stimulatory adjuvant combining pterostilbene with RU-486, termed "FloraStilbene". Preclinical data, for which intellectual property has been filed, demonstrated FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.

"FloraStilbene represents a non-toxic approach to overcoming breast cancer induced immune suppression, which acts as a significant barrier to efficacy of oncology immunotherapy," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "I am eager to lead this clinical trial, which if successful, will serve as the basis for a new approach to increase efficacy of drugs such as Herceptin and checkpoint inhibitors."

"Therapeutic Solutions International has been working on, and filing patents, in the area of cancer immunotherapy with internationally renowned opinion leaders such as Dr. Santosh Kesari since 2015," said Famela Ramos, President and Chief Executive Officer of Res Nova Bio. "We are excited to leverage these deep and broad resources to rapidly enter the clinic to address such a major unmet medical need."

"One of the guiding principles of our Company has been to bring hope to patients for which limited options exist," said Timothy Dixon, President, and Chief Executive Officer of Therapeutic Solutions International. "We strongly believe that immuno-adjuvant approaches such as FloraStilbene will greatly increase the potency of numerous existing therapies, as well as reducing various toxicities."

VieCure and Exact Sciences Enter Strategic Collaboration Aimed at Improving Patient Access to Genomic Testing

On March 6, 2023 VieCure, a cancer care company with a market-leading artificial intelligence, informatics, and clinical decision support platform, reported a strategic collaboration with Exact Sciences, a leading provider of cancer screening and diagnostic tests, to improve access to precision oncology diagnostics for patients and community oncologists within the United States (Press release, VieCure, MAR 6, 2023, View Source [SID1234628227]).

As part of the agreement, VieCure will facilitate the integration and interpretation of Exact Sciences’ growing portfolio of diagnostic tests into the clinical workflow of its oncology care management platform at the community oncology level, starting with the Oncotype DX Breast Recurrence Score test. VieCure’s proprietary artificial intelligence (A.I.) platform, which prompts clinical rules and guidelines within its interface, will help clinicians interpret test results and provide patient-specific treatment plans.

"VieCure and Exact Sciences, together, are accelerating the adoption of precision oncology in the community cancer care setting," said Dr. Fred Ashbury, Chief Scientific Officer at VieCure. "Our goal through this collaboration is to improve clinical workflow and make it easier for community oncologists to order the right tests and generate patient-specific treatment plans."

Personalizing cancer treatment to respond to the molecular profile of an individual’s cancer is rapidly becoming the standard of care and leading to improved patient outcomes. Exact Sciences’ tests provide critical diagnostic, prognostic, and therapeutic insights to inform patient-specific treatment plans. These data are complex, considerable, and can be difficult to access and interpret in the community oncology setting. Together, VieCure and Exact Sciences aim to help overcome the potential challenges clinicians face in managing the growing amount of genomic information required to care for patients and keep current with rapidly evolving medical guidelines.

"At Exact Sciences, we know that cancer care is complex. Our growing portfolio of precision oncology tests helps doctors and patients determine the most effective treatment plan by providing actionable insights about the molecular makeup of a patient’s specific cancer," said Brian Baranick, general manager of Precision Oncology for Exact Sciences. "By streamlining the workflow, our VieCure partnership will help accelerate access to our test portfolio for community oncologists and their patients."