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Guardant Health Receives Regulatory Approval from Singapore’s Health Sciences Authority for Guardant360® CDx blood test for patients with advanced solid cancers

On May 29, 2023 Guardant Health, Inc. (Nasdaq: GH) reported that Singapore’s Health Sciences Authority (HSA) has granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers (Press release, Guardant Health, MAY 29, 2023, View Source [SID1234632181]). The Guardant360 CDx test was also approved as a companion diagnostic to identify patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations who may benefit from treatment with TAGRISSO (osimertinib).

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Guardant360 CDx is the first blood test to be approved by Singapore’s HSA for comprehensive genomic profiling for all solid tumors. Since being introduced as a laboratory developed test (LDT), the Guardant360 liquid biopsy has become widely accepted for blood-based CGP with more than 400 peer-reviewed publications.

"We are delighted to receive regulatory approval from HSA for our Guardant360 CDx test, as it supports the value liquid biopsy brings to oncologists and the patients they treat," said Simranjit Singh, CEO of Guardant Health AMEA. "With a simple blood draw from the patient, the Guardant360 CDx test provides CGP results in approximately seven days from receipt of the blood sample in the laboratory, enabling physicians to make faster treatment decisions compared to tissue biopsies. Our hope is that this approval will drive clinical adoption of liquid biopsy testing in Singapore and enable more patients to be matched to potentially life-changing precision medicines."

In 2020, over 23,600 people in Singapore were diagnosed with cancer and there were slightly over 12,000 cancer-related deaths. The most prevalent cancer types among men and women in Singapore include breast (15.5%), colorectal (15.1%) and lung (12.3%) cancer[1]. According to the Singapore Cancer Registry Annual Report 2020, over 70% of all lung cancer cases among men and women were diagnosed at the advanced stage[2]. Pancreatic, stomach and colorectal cancer cases among men and women were also diagnosed at the advanced stage respectively (71.9%, 62.1%, 58.3%)[2]. To improve cancer outcomes in Singapore, Guardant Health AMEA is currently collaborating with National Cancer Centre Singapore and National University Cancer Institute, Singapore for several clinical trials using the Guardant360 test in efforts to accelerate clinical trial enrollment by identifying genomic biomarkers in patients with cancer.

The Guardant360 CDx test was the first blood test to be approved by the U.S. Food and Drug Administration (FDA) for comprehensive genomic profiling for all solid tumors, and it is now FDA approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer. In March 2022, the test was also granted regulatory approval by Japan’s Ministry of Health, Labour and Welfare for tumor mutation profiling in patients with advanced solid cancers as well as a companion diagnostic to identify patients with microsatellite instability-high (MSI-High) solid tumors who may benefit from Keytruda (pembrolizumab) and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo (nivolumab). In addition, Guardant Health is currently involved in multiple studies with drug development companies to develop Guardant360 CDx as a companion diagnostic for new therapies.

About Guardant360 CDx

The Guardant360 CDx test provides comprehensive genomic results from a simple blood draw in seven days, helping oncologists move beyond the limitations of tissue biopsies to rapidly obtain clinically relevant information in time to match patients to the optimal personalized treatment.

The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO (osimertinib), RYBREVANT (amivantamab-vmjw), ENHERTU (fam-trastuzumab deruxtecan-nxki) or LUMAKRAS (sotorasib). It is also FDA approved to identify advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU (elacestrant). For more information, visit guardant360cdx.com.

Since being introduced, the Guardant360 test has become widely accepted for blood-based comprehensive genomic profiling, with more than 400 peer-reviewed publications. It has been trusted by more than 12,000 oncologists, with more than 300,000 tests performed to date, and is broadly covered by Medicare and many private payers in the U.S., representing over 300 million lives.

AMP945 Combined with FOLFIRINOX Enhances Treatment Effects in model of Pancreatic Cancer

On May 29, 2023 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported new data showing the efficacy of its investigational FAK inhibitor, AMP945, in a preclinical model of pancreatic cancer, when used in combination with FOLFIRINOX treatment (Press release, Amplia Therapeutics, MAY 29, 2023, View Source [SID1234632170]). FOLFIRINOX, a combination of four chemotherapies used in the treatment of pancreatic cancer patients, is currently a widely-used treatment in many major markets around the world including the US.

New data from preclinical studies conducted in the laboratory of Prof. Paul Timpson at the Garvan Institute of Medical Research in Sydney, demonstrate that mice treated with AMP945 in addition to FOLFIRINOX show improved overall survival compared to those treated with FOLFIRINOX alone. The data, available in the Meeting Abstracts for the forthcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in Chicago, USA, (here) 1 describe studies in mice bearing pancreatic cancer tumours derived from a human patient. AMP945 was given in the days preceding FOLFIRINOX treatment (given on a 12-day cycle) resulting in a statistically significant increase in survival (up to 35% approx.) compared to FOLFIRINOX-only treated mice.

Dr Chris Burns, Amplia’s CEO and Managing Director commented: "The exciting results from this mouse study further indicate the potential of AMP945 in pancreatic cancer treatment when used in combination with standard-of-care therapies. In light of this data, we have filed a patent to cover the use of FAK inhibitors, and particularly AMP945, in combination with FOLFIRINOX and related treatment regimes."

With this data, and the Company’s previously reported preclinical data demonstrating the benefit of combining AMP945 with gemcitabine and nab-paclitaxel, AMP945 has shown promising activity in models of pancreatic cancer with the two most common first-line chemotherapy regimens for treatment of the disease.

Prof. Nick Pavlakis, a medical oncologist at the Royal North Shore Hospital in Sydney, and an investigator in the current ACCENT trial, commented: "FOLFIRINOX is employed under certain conditions in Australia and more broadly in the USA and Europe, and the data from this study, coupled with the developing safety and tolerability data from Amplia’s current ACCENT trial, provide strong support to undertake a future clinical study of AMP945 with FOLFIRINOX."

Immutep Selects Charles River Laboratories for IMP761’s GLP Toxicology Study

On May 29, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported that it has entered into an agreement with Charles River under which Charles River will conduct a GLP toxicology study for IMP761, Immutep’s proprietary preclinical candidate for autoimmune diseases (Press release, Immutep, MAY 29, 2023, View Source [SID1234632168]). IMP761 is a first-in-class LAG-3 agonist antibody that aims to address the underlying cause of many autoimmune diseases, namely the overactivation of self-antigen-specific memory T cells expressing LAG-3.

Preclinical toxicology studies are an essential part of drug development as they help to evaluate the potential safety and toxicity of a drug candidate before it is tested in humans. With its well-established expertise assisting companies in early-stage drug development, Charles River is the partner of choice to help progress our IMP761 program through this key stage of IND-enabling studies.

"Immutep is continuing its pioneering work in the LAG-3 immunotherapy landscape, as we advance IMP761, the world’s first LAG-3 agonist antibody, towards the clinic in the first half of next year. With its novel ability to enhance the signalling of the LAG-3 inhibitory receptor and down-regulate auto-reactive memory T cells at the centre of many autoimmune diseases, we believe IMP761 has the potential to change how immune disorders are treated. We are pleased to be working with an established global company like Charles River for this next important step of our pre-clinical development," stated Immutep’s Chief Scientific Officer, Frédéric Triebel, M.D., Ph.D.

IMP761’s agonistic activation of LAG-3 is relevant for many diseases, including the Th1-driven autoimmune disease setting. In a pre-clinical oligoarticular juvenile idiopathic arthritis model IMP761 decreased secretion of nearly all measured cytokines, and several key cytokines (IL-10, IL-12, IL-1β, IL-4, and IL-6) reached the level of statistical-significance (p < 0.01). These results were published in Pediatric Research in May 2021. The GLP (Good Laboratory Practice) toxicology results and other preclinical studies will be an essential part of the Company’s clinical trial application for IMP761.

About IMP761

IMP761, a first-in-class immunosuppressive LAG-3 agonist antibody, has the potential to address the root cause of many autoimmune diseases by specifically silencing autoimmune memory T cells that accumulate at disease sites. These T cells express LAG-3 as an "exhaustion marker" after being repeatedly stimulated with dominant self-peptides. As published in the Journal of Immunology in January 2020, encouraging pre-clinical results were achieved with IMP761 leading to significant inhibition of inflammatory T cell infiltration. Additional pre-clinical findings published in Pediatric Research in May 2021 show IMP761 led to large decreases in effector T cell cytokine secretion in a juvenile arthritis model.

Abbisko to present the updated clinical phase Ib data of Pimicotinib (ABSK021) at the 2023 ASCO Annual Meeting

On May 28, 2023 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) reported that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor ("TGCT"), will be released at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting to be held in Chicago, USA from June 2 to June 6, 2023 (Press release, Abbisko Therapeutics, MAY 28, 2023, View Source [SID1234632169]).

The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of "EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE" in a poster presentation with the poster Bd# of "493".

Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% (24/31), including two complete responses (CR) and 22 partial responses (PR). Additionally, 87.5% (21/24) of patients with objective response were observed within the first 25 weeks.

In addition, Pimicotinib (ABSK021) also presented apparent advantages in terms of safety profile.

Currently Pexidartinib developed by Daiichi Sankyo is the only drug approved for the treatment of TGCT (tenosynovial giant cell tumor) in the global market. However, it has been given a "black box warning" by the FDA due to the potential risk of fatal liver damage, and its objective response (ORR) is only 38%. Nevertheless, Daiichi Sankyo achieved sales of approximately US$40 million in the global market with Pexidartinib. CICC predicts that the global market of TGCT could amount to around 1 billion US dollars. Compared with Pexidartinib of Daiichi Sankyo, Abbisko’s Pimicotinib shows better efficacy and safety in the treatment of TGCT. Thus, it is expected to become a best-in-class drug. Assuming that Pimicotinib could be approved for the indication of TGCT in the United States in 2025 with a market penetration rate of 20%, its peak sales is expected to reach 3.14 billion yuan (after risk adjustment) with listing price reference to Pexidartinib of $250,000 per year.

About Pimicotinib

Pimicotinib is a novel, orally available, highly selective, and highly potent small molecule inhibitor of CSF-1R independently discovered and developed by Abbisko Therapeutics. A number of studies have shown that blocking the CSF-1R signaling pathway could effectively modulate and change macrophage functions, and potentially treat many macrophage-dependent human diseases. Pimicotinib has been granted the breakthrough therapy designation from both CDE on July 20, 2022 and FDA on January 30, 2023 for the treatment of tenosynovial giant cell tumor (TGCT) patients who are not amenable to surgery.

Pimicotinib is the first highly selective CSF-1R inhibitor discovered by a Chinese company that entered into a global phase III clinical trial. April 27, 2023, the first patient dosing of "A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor" was completed in Beijing Jishuitan Hospital. This study is the first global Phase III study of TGCT to be conducted simultaneously in China and the US. Approximately 100 participants are scheduled to be enrolled in approximately 50 centers worldwide, including 30 centers in China.

About TGCT

TGCT is a locally aggressive neoplasm which usually affects synovial joints, mucous sacs, and tendon membranes, resulting in swelling, pain, stiffness, and decreased activity of the affected joints which seriously affect the patient’s quality of life. According to the 2013 World Health Organization classification, TGCTs were classified as localized TGCT and diffuse TGCT. Diffuse TGCT encompasses formerly known nodular tenosynovitis and pigmented villonodular synovitis (PVNS). Overexpression of CSF-1 occurs in most TGCTs. Surgical resection is the standard treatment for TGCT. However, not all patients are suitable for surgical treatment. It is difficult to remove tumors of diffuse TGCT patients by surgery, which may possibly lead to severe joint damage, total synovectomy, joint replacement, or even amputation, and the risk of surgical complications can be high. It has been reported that more than 50% of patients with diffuse TGCT will undergo recurrence after surgical resection. For TGCT patients not amenable to surgery, there is currently no approved drug available in China.

Nascent Biotech Regains Worldwide Rights for Pritumumab

On May 26, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in therapeutic monoclonal antibody space, reported that the Company and China based BioRay Pharmaceutical Co have mutually agreed to terminate the license agreement entered into on March 31, 2021 (Press release, Nascent Biotech, MAY 27, 2023, View Source [SID1234632167]). Nascent gains back worldwide marketing and distribution rights previously licensed to BioRay. Management concludes with gaining back the worldwide rights, the company is in a stronger position going forward.