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Chugai Obtains Approval for FoundationOne Liquid CDx Cancer Genomic Profile to Be Used as a Companion Diagnostic for Novartis’ MET Inhibitor, Capmatinib, Which Is Approved for MET Exon 14 Skipping Mutation-Positive Advanced and/or Recurrent Unresectable Non-Small Cell Lung Cancer

On May 26, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 25, 2023, for FoundationOneLiquid CDx Cancer Genomic Profile to be used as a companion diagnostic for an anti-cancer agent/MET inhibitor, Tabrecta (generic name: capmatinib hydrochloride hydrate) of Novartis Pharma K.K. (Novartis), which is approved for the treatment of MET exon 14 skipping mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC) (Press release, Chugai, MAY 26, 2023, View Source;category= [SID1234632087]). With this approval, patients with advanced NSCLC who may be eligible for treatment with capmatinib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests.

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"We are pleased that FoundationOne Liquid CDx Cancer Genomic Profile was approved as a companion diagnostic for capmatinib for advanced and/or recurrent unresectable NCSLC, in addition to the currently approved tissue-based FoundationOne CDx Cancer Genomic Profile," said Chugai’s President and CEO, Dr. Osamu Okuda. "Obtaining tissue samples can be a challenge for patients with NSCLC. Therefore, blood-based testing is an important option when considering treatment options for patient care. We are committed to advancing personalized healthcare by continuing to collaborate with many biopharma partners."

With this approval FoundationOne Liquid CDx Cancer Genomic Profile can be used as a companion diagnostic for capmatinib in advanced and/or recurrent unresectable NSCLC. It identifies patients eligible for the treatment by detecting MET exon 14 skipping gene alterations. The efficacy and safety of capmatinib in patients with advanced and/or metastatic NSCLC patients with MET exon 14 skipping alterations were investigated in the Phase II GEOMETRY mono-1 study conducted by Novartis. Novartis received approval from the MHLW in June 2020 for commercialization.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of CGP.

Approval information The underlined part has been newly added.
Intended uses or indications

The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations
Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile

Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing-based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through the detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report alterations (substitutions, insertion/deletion and select gene rearrangements) for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in the Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the approval information.

Trademarks used or mentioned in this release are protected by laws.

Triore, an ADC platform owner, raises 12 billion KRW in Series A investment

On May 25, 2023 Triore, a new drug development venture, reported that it has completed a Series A investment of 12 billion won through the issuance of convertible preferred shares (CPS).

This Series A investment was led by LSK Investment, a venture capital firm specializing in biotech. Enlight Ventures, Kiwoom Investment, Meditox Venture Investment, and Shinhan Capital participated as new investors. KB Investment and Bokwang Investment joined as follow-up investors following their participation in the Pre-Series A round. This investment comes one year after the Pre-Series A round in 2022. The total amount of investment raised reaches 19 billion won.

Triore, established in 2021, possesses a technology (ReleaDom) that improves the drug delivery limitations of existing antibody therapeutics and antibody-drug conjugates (ADCs), and a linker-payload system (TROSIG) that can enhance the efficacy of ADCs.

Triore’s platform technology can be applied to various applications, including ADCs, multispecific antibodies, immune checkpoint inhibitors, and tumor microenvironment activators. Triore explains that when this platform technology is combined with existing drugs, it is expected to enhance efficacy and reduce toxicity. With this investment, Triore plans to secure even more refined platform technologies and novel drug candidates.

Yoon Doo-cheon, Director at LSK Investment, stated, "Triore’s ADC platform is a highly scalable technology applicable to various antibody targets," adding, "We determined that it has the potential to grow into a commercially viable new drug development platform company through partnerships with global big pharma firms."

Woo Seong-ho, CEO of Triore, stated, "This investment holds great significance considering the global biotech investment environment has been frozen since the COVID-19 pandemic," adding, "It is the result of recognition for Triore’s core platform technology, human resource expertise, and systematic commercialization strategy."

(Press release, TriOar Biotechnology, MAY 25, 2023, View Source;idx=3 [SID1234664806])

Oxford BioTherapeutics and Boehringer Ingelheim Agree on 2 Year Extension to their Second Multi-Year Collaboration in Cancer Immunology

On May 25, 2023 Oxford BioTherapeutics Ltd. (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, reported that it has extended its second multi-year collaboration with Boehringer Ingelheim for an additional two years (Press release, Oxford BioTherapeutics, MAY 25, 2023, View Source [SID1234656436]). With this extension further programs will be added into the existing collaboration, with the goal to enable the development of novel cancer immunotherapies in areas of high unmet patient need.

The two partnerships between OBT and Boehringer Ingelheim were initiated in April 2013 and October 2020. They are both focused on the discovery of novel tumor targets enabled by OBT’s proprietary OGAP discovery platform for Boehringer Ingelheim’s unique immuno-oncology and ADC platforms, contributing to the company’s aspiration of transforming the lives of people living with cancer with the ultimate goal of curing a range of cancers.

Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, said: "Last month marked the 10-year anniversary of our partnership with Boehringer Ingelheim and it is fitting to mark this anniversary by extending our collaboration both in time and in value. Over the past decade, we have built a successful relationship with Boehringer Ingelheim’s cancer research, now in its third phase, through high-quality outputs enabled by our proprietary OGAP discovery platform. Since 2013, the company has selected three targets discovered using OGAP, of which two programs have led to therapeutic assets in Phase 1 clinical development. We look forward to the next phase of our highly successful partnership and to continuing to work together to develop innovative first-in-class treatments for patients with difficult to treat cancers."

A major differentiator between OBT’s discovery platform and other approaches is the retention of the link between individual patient samples through to the design of therapeutic antibodies and diagnostic patient selection tools, which increases the overall success rate of these novel compounds transitioning into clinical development.

Under the terms of the extended agreement, Boehringer Ingelheim is responsible for the development and commercialization of treatment candidates that interact with the novel targets identified by OGAP. OBT will receive research funding as well as success-based development and regulatory milestone payments and royalties on potential future product sales.

Erasca to Present Promising Preliminary HERKULES-3 Phase 1b Data at the 2023 ASCO Annual Meeting

On May 25, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported preliminary Phase 1b data for ERAS-007 combinations in patients with GI malignancies from two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Erasca, MAY 25, 2023, View Source [SID1234639355]). The posters will be available online at Erasca.com/science/presentations.

"Early clinical data from HERKULES-3 continue to reinforce the potential to combine ERAS-007 with multiple agents and its potential as a backbone therapy to treat patients with GI malignancies. Importantly, these preliminary findings support a data-driven approach to refine the focus of our initial clinical development efforts on indications holding significant promise," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Our initial evaluation of the ERAS-007 + EC combination in patients with BRAF-mutated metastatic CRC will focus on EC-naïve patients based on the preliminary activity observed in HERKULES-3. By evaluating efficacy and safety in a larger sample size of patients treated at the 100 mg BID-QW dose of ERAS-007 with EC, we believe we will be able to better assess whether the promising response rate and duration of treatment observed with the triplet can be maintained."

Poster Presentation Highlights

Abstract 3557 – Preliminary results from ERAS-007 plus encorafenib and cetuximab (EC) in patients (pts) with metastatic BRAF V600E-mutated colorectal cancer (CRC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers)

ERAS-007 in combination with encorafenib (BRAFTOVI) + cetuximab (ERBITUX) demonstrated promising preliminary clinical activity in EC-naïve patients with metastatic BRAF V600E-mutated CRC. EC is currently approved for the treatment of patients with metastatic BRAF V600E-mutated CRC, as detected by an FDA-approved test, after prior therapy; however, only approximately 20% of patients experience an objective response in the second and later line of treatment setting. Downstream ERK inhibition through ERAS-007 may prevent resistance to upstream BRAF/EGFR inhibition when combined with EC. As of the data cutoff date of March 23, 2023:

40% (2/5) response rate and 60% (3/5) disease control rate (complete response + partial response + stable disease) in EC-naïve response evaluable patients at the highest dose of ERAS-007 tested (100 mg BID-QW), with duration of exposure for both responders > 34 weeks as of the data cutoff date; across all dose levels in EC-naïve response evaluable patients, 29% (2/7) response rate and 57% (4/7) disease control rate
ERAS-007 + EC was generally well-tolerated with mostly low-grade adverse events at all combination doses tested
One dose-limiting toxicity (DLT) was reported for ERAS-007 100 mg BID-QW + EC (Grade 3 macular edema)
Pharmacokinetic (PK) exposures of ERAS-007, encorafenib, and cetuximab were comparable to monotherapy values, suggesting no clinically significant PK drug-drug interactions between the study drugs
Additional HERKULES-3 Phase 1b combination data in EC-naïve patients with BRAF-mutated CRC expected between H2 2023 and H1 2024

Abstract 3558 – Preliminary results from ERAS-007 plus palbociclib (palbo) in patients (pts) with KRAS/NRAS mutant (m) colorectal cancer (CRC) or KRASm pancreatic ductal adenocarcinoma (PDAC) in HERKULES-3 study: A phase 1b/2 study of agents targeting the mitogen-activated protein kinase (MAPK) pathway in pts with advanced gastrointestinal malignancies (GI cancers)

ERAS-007 in combination with palbociclib (IBRANCE) demonstrated a lack of clinical activity in patients with KRAS/NRAS mutant CRC and KRAS mutant PDAC. Palbociclib is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy or with fulvestrant in patients with disease progression following endocrine therapy. Based on these data, the combination of ERAS-007 and palbociclib will not be pursued further in this patient population.

Dr. Lim continued, "Our pioneering efforts exploring the potential of targeting adjacent pathways with terminal node inhibition of the RAS/MAPK pathway (ERAS-007) and cell cycle inhibition (palbociclib) did not demonstrate clinical activity in the initial evaluation. While we will not pursue further development of this combination in this patient population, it has contributed to our understanding and characterization of ERAS-007."

The Investigator Initiated Phase II Trial at MD Anderson Cancer Center combining CB-103 and Venetoclax for the treatment of rr/r-T-ALL patients is now open for recruitment

On May 25, 2023 Cellestia Biotech reported that the Investigator Initiated Phase II Trial at MD Anderson Cancer Center combining CB-103 and Venetoclax for the treatment of relapsed-refractory T cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL /LBL) is now open for recruitment (Press release, Cellestia Biotech, MAY 25, 2023, View Source [SID1234632333]).

CB-103 is a small molecule transcriptional pan-NOTCH inhibitor with a novel mechanism of action. A Phase I clinical trial has shown promising safety and tolerability, proof of biological activity, and signs of efficacy. A new investigator- initiated trial (IIT) is starting at The University of Texas MD Anderson Cancer Center, in the departments of Pediatrics and Adult Leukemia, to combine the potential of NOTCH and BCL2 inhibition considering the biological synergies between the two pathways. CB-103, in combination with Venetoclax, will be tested for the treatment of relapsed-refractory T cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL in patients 12-40 years old). Added to the ongoing anti-leukemia treatment, CB-103 administration to a r/r T-ALL patient under a compassionate use program resulted in a complete response making the patient eligible for Hematopoietic Stem Cell Transplant. The IIT trial at MD Anderson is now open for patient recruitment.