On August 2, 2024 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported that it has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for PGDx elio plasma focus Dx – the industry’s first and only kitted, pan-solid tumor liquid biopsy test (Press release, LabCorp, AUG 2, 2024, View Source [SID1234645296]).

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PGDx elio plasma focus Dx builds on the success of PGDx elio tissue complete and enables laboratories to perform genomic profiling when tissue is limited or unavailable.

"The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions," said Shakti Ramkissoon, M.D., Ph.D., MBA, vice president, medical lead for oncology at Labcorp. "This latest liquid biopsy test offers laboratories and oncologists a convenient, cost-effective and highly targeted tumor-profiling solution that spans a wide range of solid-tumor types – particularly when tumor tissue is limited or unavailable. When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows. The ability to test tissue or liquid will provide critical data and insights needed to inform more personalized treatments and care plans for patients."

PGDx elio plasma focus Dx is a qualitative next-generation sequencing-based in vitro diagnostic device that uses targeted high throughput hybridization-based capture technology for the detection of single nucleotide variants (SNVs), insertions and deletions (indels) in 33 genes, copy number amplifications (CNAs) in five genes, and translocations in three genes. The assay targets guideline-recommended biomarkers to enable more accurate clinical assessments and is coupled with automated bioinformatics to deliver accelerated results. This solution enhances oncologists’ ability to make timely treatment decisions in conjunction with other laboratory and clinical findings while also promoting sample and data ownership.

PGDx elio plasma focus Dx is part of Labcorp’s comprehensive precision oncology portfolio of testing solutions. For more information, visit View Source

On August 2, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519, hereafter, Chugai) reported that Chugai Pharma Taiwan Ltd. (hereafter, CPT), a wholly-owned subsidiary of Chugai, obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Chugai’s Alecensa (alectinib) as an adjuvant treatment following tumor resection (tumors ≥ 4 cm or node positive) for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), on August 1, 2024 (Press release, Chugai, AUG 2, 2024, View Source [SID1234645275]). CPT is responsible for the development, regulatory submission, import, and sales of Chugai-originated products in Taiwan.

"We are very pleased that Alecensa has been approved in Taiwan as adjuvant therapy for early-stage ALK-positive NSCLC. The results of the ALINA study, which demonstrated a 76% reduction in the risk of recurrence or death, have generated significant anticipation in clinical settings. We believe this approval will have a positive impact on lung cancer treatment in Taiwan. We remain committed to delivering this medication to patients awaiting treatment as swiftly as possible," said Takashi Okamoto, President of CPT.

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The approval is based on results from the ALINA study, a global Phase 3 study of Alecensa as an adjuvant therapy in people with completely resected IB (tumor ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.

[Reference information]
Chugai’s Alecensa Reduces the Risk of Disease Recurrence or Death by 76% in People with ALK-Positive Early-Stage Non-Small Cell Lung Cancer (Press release on October 20, 2023)
View Source

About the ALINA study
The ALINA study [NCT03456076] is a Phase III, randomized, active-controlled, multicenter, open-label study evaluating the efficacy and safety of adjuvant Alecensa (alectinib) compared with platinum-based chemotherapy in people with resected Stage IB (tumors ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). The study included 257 patients who were randomly assigned to either the Alecensa or chemotherapy treatment arm. The primary endpoint is disease-free survival. Secondary outcome measures include overall survival and percentage of patients with adverse events.

About Alecensa
Alecensa is a highly selective, central nervous system-active, oral medicine created at Chugai, a member of the Roche Group, for people with NSCLC whose tumors are identified as ALK-positive. Alecensa is already approved in over 100 countries as an initial (first-line) and second-line treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan, China, and Taiwan. In Japan, Alecensa has also been approved for the treatment of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma.

Alecensa was approved by the U.S. Food and Drug Administration (FDA) in April 2024 as adjuvant treatment following tumor resection for patients with ALK-positive NSCLC (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test, and in June 2024 by the European Commission, as a monotherapy for adjuvant treatment following tumor resection for adult patients with ALK-positive NSCLC at high risk of recurrence (Stage IB [tumors ≥ 4 cm]–IIIA NSCLC [7ᵗʰ edition UICC/AJCC]).

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

On August 1, 2024 Kyowa Hakko Kirin reported its consolidated financial summary (IFRS) Fiscal 2024 Semi Annual report (Press release, Kyowa Hakko Kirin, AUG 1, 2024, View Source [SID1234646733]).

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On August 1, 2024 Vir Biotechnology, Inc. (Nasdaq: VIR) reported that it has entered into an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs) and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, acquired by Sanofi from Amunix Pharmaceuticals (Press release, Vir Biotechnology, AUG 1, 2024, View Source [SID1234646506]). The clinical-stage assets include SAR446309 (AMX-818), a dual-masked HER2-targeted TCE; SAR446329 (AMX-500), a dual-masked PSMA-targeted TCE; and SAR446368 (AMX-525), a dual-masked EGFR-targeted TCE. Sanofi’s proprietary masking platform can be applied to TCEs, cytokines, and other molecules by exploiting the intrinsically high protease activity of the tumor microenvironment to specifically activate drugs in tumor tissues. The selective activation of the molecules in the tumor microenvironment potentially increases the therapeutic index (TI) and mitigates toxicities associated with the systemic immune activation seen with traditional TCEs.

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"At Vir, the cornerstone of our commitment is and always will be patient-centered, with the aim to advance transformative medicines for patients facing severe diseases with unmet medical needs. Despite recent innovation in cancer therapeutics, the prognosis for many patients remains poor and treatment-associated toxicity is a major problem," said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. "These potential best-in-class T-cell engagers aim to help address these problems and further us in our mission of powering the immune system to transform lives."

This deal announcement coincides with the Company’s statement today on its strategic restructuring initiatives to prioritize its clinical-stage pipeline opportunities.

Sanofi’s masking platform has yielded three promising clinical-stage TCE programs:

SAR446309 is a dual-masked HER2xCD3 TCE in Phase 1 clinical study including participants with metastatic treatment resistant HER2+ tumors such as breast and colorectal cancers. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations with checkpoint inhibitors.
SAR446329 is a dual-masked PSMAxCD3 TCE in Phase 1 clinical study including participants with metastatic castration-resistant prostate cancer. Increasing the TI through this proprietary dual masking may allow for both monotherapy and combinations.
SAR446368 is a dual-masked EGFRxCD3 TCE with a cleared IND. Phase 1 clinical study, which is expected to begin enrollment in the first quarter of 2025 or sooner, will include participants with EGFR-expressing tumors of various types such as colorectal, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma.
As part of the strategic agreement with Sanofi, key employees with extensive scientific and development expertise in TCEs, and in-depth experience using the masking platform technology, will join Vir upon receipt of Hart-Scott-Rodino (HSR) Act clearance.

"A central focus of our discovery team has been conditionally activated biologics, so adding this platform and key talents is highly strategic for us," said Jennifer Towne, Ph.D., Vir’s Executive Vice President and Chief Scientific Officer. "Our demonstrated deep understanding of T-cell immunology, robust infrastructure, and leading machine learning and antibody engineering capabilities will create opportunities for real synergies and patient-centric innovation."

Pursuant to this agreement, Sanofi will receive an upfront payment and is eligible to receive future development, regulatory and commercial net sales-based milestone payments and tiered royalties on worldwide net sales. This agreement is subject to regulatory approval.

This strategic licensing transaction marks a significant milestone in Vir’s commitment to develop transformative therapeutics for some of the most severe diseases. Across its portfolio of clinical assets, below are anticipated upcoming catalysts:

Tobevibart +/- Elebsiran : Phase 2 SOLSTICE 24-week treatment data for chronic hepatitis delta virus infection expected in the fourth quarter of 2024.
Tobevibart + Elebsiran +/- PEG-IFN-⍺: Phase 2 MARCH Part B 48-week end of treatment data for hepatitis B virus infection expected in the fourth quarter of 2024.
SAR446309 : Phase 1 monotherapy and combination study data expected in the second half of 2025.
SAR446329 : Phase 1 monotherapy study data expected in the second half of 2025.
SAR446368 : Phase 1 study to begin enrollment in the first quarter of 2025 or sooner.
Evercore Group L.L.C. acted as Vir’s exclusive financial advisor and Ropes & Gray LLP acted as Vir’s legal advisor for this transaction.

On August 1, 2024 Otsuka reported its consolidated Financial Results for the Six-Month Period Ended June 30, 2024 (Filing, 3 mnth, JUN 30, Otsuka, 2024, AUG 1, 2024, View Source [SID1234646145]).

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