On June 3, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) on June 2, 2022, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for non-small cell lung cancer (NSCLC) therapies, a tyrosine kinase inhibitor VIZIMPRO tablets (generic name: dacomitinib hydrate) and a tyrosine kinase inhibitor ALUNBRIG tablets (generic name: brigatinib), as well as for malignant melanoma therapies, a BRAF inhibitor BRAFTOVI capsules (generic name: encorafenib) and a MEK inhibitor MEKTOVI tablets (generic name: binimetinib) (Press release, Chugai, JUN 3, 2022, View Source [SID1234615490]).

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"With a single test, FoundationOne CDx Cancer Genomic Profile can identify genomic alterations of each patient’s cancer comprehensively. This enables them to develop treatment plans tailored to the individual patients, realizing advanced personalized healthcare," said Dr. Osamu Okuda, Chugai’s President and CEO. "We believe this portfolio expansion of companion diagnostics for four molecular-targeted drugs approved in Japan for the treatment of NSCLC and melanoma, will increase its value as a decision support and contribute to improved treatment access for patients with these types of cancer. We aim to further contribute to advancing cancer treatment by pursuing additional companion diagnostic indications."

As a companion diagnostic, FoundationOne CDx Cancer Genomic Profile will be used to identify patients with activated EGFR alteration positive or ALK fusion gene positive NSCLC who may benefit from dacomitinib hydrate or brigatinib, respectively. It will also be used to identify patients with BRAF alteration positive malignant melanoma who may benefit from encorafenib and binimetinib combination.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care and supporting to patients and healthcare professionals through improving access to comprehensive genomic profiling.

Approval information The underlined part has been newly added.

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
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 mesylate, dacomitinib hydrate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib, brigatinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib, encorafenib, binimetinib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden high pembrolizumab (genetical recombination)
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

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

On June 3, 2022 Scilex Holding Company ("Scilex"), a nearly 100% (or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a commercial biopharmaceutical company focused on developing and commercializing non-opioid therapies for patients with acute and chronic pain, reported that on June 3, 2022, it pre-emptively paid off and eliminated $41.4 million of the principal amount of its senior secured notes (the "Notes") (Press release, Sorrento Therapeutics, JUN 3, 2022, View Source [SID1234615489]). In connection with this payoff, the holders of the Notes agreed that Scilex can repurchase the remaining principal amount of the Notes at any time on or before September 30, 2022 for $41.4 million (subject to reduction for any quarterly royalty payments) and the holders of the Notes will forgive and discharge $28.0 million of the aggregate principal amount of the Notes.

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Scilex’s Executive Chairman and Sorrento Chairman and CEO, Henry Ji, Ph.D., stated, "We value our stockholders and our reputation as a stockholder-friendly company above all else. We have our sights set on some very big long-term objectives for Sorrento and Scilex. And we won’t get there by working against the interests of our equity holders. Paying down the Notes reduces uncertainty and further improves Scilex’s balance sheet. We look forward to identifying other opportunities to grow our stockholders’ interests and avoid unnecessary distractions in financing our progress as we move toward commercialization of additional non-opioid pain management solutions in the acute and chronic pain markets."

"As we prepare to complete our previously announced merger with Vickers Vantage Corp. I and begin our registration and pre-commercialization plans of our recently successfully completed SP-102 (SEMDEXATM) Phase 3 clinical trial program, this pre-emptive repurchase of part of the Notes is another important accomplishment of our company goals. It gives us the ability to attract new capital at competitive terms, preserve cash that would have been spent on royalty payments under the Notes, as well as being able to avoid the effects of negative debt leverage. We believe these advantages will be of significant benefit to Scilex and our stockholders as we continue to execute on our business plan," said Jaisim Shah, Chief Executive Officer of Scilex.

Scilex Holding Company and Vickers Vantage Corp. I (Nasdaq: VCKA) ("Vickers"), a special purpose acquisition company sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture Fund VI (Plan) Pte Ltd, have entered into a definitive business combination agreement ("BCA") on March 17, 2022. Upon the closing of the transaction, the combined company (the "Combined Company") will be renamed Scilex Holding Company, and its common stock and warrants to purchase common stock are expected to be listed on Nasdaq under the ticker symbol "SCLX" and "SCLXW", respectively. The boards of directors of each of Vickers, Scilex and Sorrento have unanimously approved the proposed transaction. The closing of the transaction, which is expected to occur by the third quarter of 2022, is subject to the approval of Vickers’s shareholders and the satisfaction or waiver of certain other customary closing conditions.

On June 2, 2022 Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) reported a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop, and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR (Press release, Boehringer Ingelheim, JUN 2, 2022, View Source [SID1234654032]). Boehringer Ingelheim aims to use these antibodies to direct therapeutic effector mechanisms such as antibody-drug conjugates (ADCs) and T-cell engagers exclusively to tumor cells, and to that end develop a range of highly targeted cancer treatments.

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"Boehringer Ingelheim believes that these promising antibodies in-licensed from A*STAR will help us advance potent therapeutic candidates against key molecular cancer targets," says Clive R. Wood, Senior Corporate Vice President and Global Head of Discovery Research at Boehringer Ingelheim and continues: "We look forward to developing these assets for a broad range of cancers with the goal to deliver breakthrough opportunities for patients."

Boehringer Ingelheim is pioneering a range of versatile therapeutic platforms in order to develop innovative medicines that target the tumor directly (tumor cell-directed therapies) or that enable the immune system to target the tumor (immune cell-targeted therapies). One tumor cell-directed modality is antibody drug conjugates, which allows for delivery of toxins directly into tumor cells. Another is T-cell engagers facilitating direct contact between T-cells and tumor cells, leading to T-cell-mediated killing of the tumor. Both technologies are directed towards markers on the surface of cancer cells, also known as antigens, in order to attack tumor cells but spare healthy tissues.

The innovative antibodies from A*STAR can potentially enable the development of safer, more efficacious therapies as they selectively bind to antigens that are highly expressed on tumor cells but are absent on normal healthy tissues.

Under the terms of the agreement, Boehringer Ingelheim will be responsible for further research, preclinical and clinical development as well as commercialization of targeted cancer therapies using the antibodies from A*STAR. A*STAR may receive payments totaling >100 million EUR in upfront and success-based development and commercialization milestones.

The technology used to identify the unique A*STAR antibodies resulted from a multi-institutional collaboration in Singapore. A*STAR’s Genome Institute of Singapore (GIS) and Institute of Bioengineering & Bioimaging (IBB) generated antibodies which exclusively target antigens that were initially identified from gastric cancer cells. Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by A*STAR, then optimized the antibodies and confirmed their applicability to a range of other solid cancers. EDDC also demonstrated the utility of these antibodies in directing different therapeutic modalities selectively to cancer cells.

Professor Damian O’Connell, Chief Executive Officer of EDDC, says, "As Singapore’s national drug discovery and development platform, EDDC is proud to translate great science in Singapore into valuable assets that can enable the precise treatment of cancer. We believe that Boehringer Ingelheim, with its broad expertise and technologies, is the right partner to maximize the potential of these antibodies for the development of safer, more targeted therapies for cancer patients."

Professor Tan Sze Wee, Assistant Chief Executive (Enterprise) of A*STAR, says, "These antibodies were developed in Singapore through close collaboration across multiple institutions. There was also strong support by the Singapore Gastric Cancer Consortium. The agreement is testament to the best-in-class research taking place in Singapore. Cancer is a devastating disease, and we hope the fruits of our research can improve patient outcomes."

Professor Patrick Tan, Executive Director of GIS, says: "We are excited at this development in the research ecosystem’s continuous inroads in cancer treatments and therapies. IBB developed the initial antibody technologies with the support of GIS and SGCC, who identified the tumor-associated targets, and EDDC who optimized the antibodies. Such multidisciplinary collaborations maximize the value and impact of A*STAR’s research for potential patient outcomes."

On June 02, 2022 Transition Bio, Inc., a microfluidics-driven drug discovery platform company using biophysical sciences and artificial intelligence tools to map and modulate biomolecular condensates, reported its $50 million Series A financing, led by Northpond Ventures and joined by Taiho Ventures, Bristol Myers Squibb and Magnetic Ventures (Press release, Transition Bio, JUN 2, 2022, View Source [SID1234648795]). Lifeforce Capital, the lead investor from the Company’s seed financing, also participated and was joined by other existing seed investors.

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"We are excited to have such a high-quality group of investors alongside us as we apply and expand our one-of-a-kind predictive approach to analyzing and modulating biomolecular condensates," said Greg Miller, chief executive officer of Transition Bio. "The technology and tools we have built – and the data we are generating – are unmatched in capability and scale, and the pace and depth of our progress across all areas of the company has been extraordinary. Our team is uniquely suited to harness the fundamental and largely untapped biology of condensates which is at the center of many disease pathways."

The capital raised will accelerate the progress made to date with the Company’s novel Condensomics platform. This platform utilizes microfluidics to drive high-throughput generation of proprietary data to enable machine learning-guided condensate target identification and drug discovery. The funding allows rapid expansion of the technology by scaling up the platform and translating the science across a variety of targets and disease areas.

In addition, Shilpi Arora, Ph.D., joined Transition Bio as senior vice president of discovery research and brings extensive experience in leading multiple aspects of drug discovery, target identification and validation, pharmacology and translational sciences from previous roles in both academia and the biotech industry. Prior to joining Transition Bio, Shilpi was vice president of discovery and translational biology at Exo Therapeutics and previously held roles at X-Chem Pharmaceuticals, Constellation Pharmaceuticals and the Translational Genomics Research Institute.

Transition Bio also announced updates to its board of directors. Shaan C. Gandhi, M.D., D.Phil., director and head of the biotechnologies group at Northpond Ventures, has been appointed to the Company’s board. In addition, Alfred W. Sandrock, Jr., M.D., Ph.D., chief executive officer of Voyager Therapeutics and former head of research and development at Biogen, has been appointed to the board as an independent director. Co-founders Kelly Martin and Samuel Cohen, Ph.D., will continue to serve on the board as executive chairman and director, respectively.

"The Northpond team has been engaging with condensate biology for a long time. The encouraging data and caliber of people involved drive our collaboration with Transition Bio," said Dr. Gandhi. "The experience and creativity of the founders, management team and scientists, as well as the progress with the platform, convince us that Transition Bio will develop therapeutic approaches that will address significant unmet medical needs."

"The right tools are essential to translate this evolving biological space into meaningful therapeutics. I have been impressed with the Transition Bio team’s methodical and thoughtful approach to rapidly identify small molecules which can impact an expanse of human diseases," commented Dr. Sandrock.

"On behalf of the founders, we are delighted and amazed by how far the team has come in such a short period of time," said Mr. Martin. "This financing is a testament both to the underlying scientific foundation, created through the tremendous work and innovation of Dave Weitz and Tuomas Knowles over the past decade, as well as to the talented team of dedicated and enthusiastic professionals working with us in the U.S., U.K. and beyond. In addition, we welcome Al and Shaan to the board and look forward to benefiting from their unique skills and experiences."

Transition Bio launched in September 2020 with a seed round led by Lifeforce Capital.

On June 2, 2022 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 a trial to investigate the ERK1/2 inhibitor ERAS-007 in combination with a KRAS G12C inhibitor in KRAS G12C-driven non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (Press release, Erasca, JUN 2, 2022, View Source [SID1234639378]).

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"We look forward to ERAS-007 being evaluated in this trial, based in part on ERAS-007’s ability in preclinical studies to robustly shut down oncogenic signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "This trial not only helps to broaden the therapeutic development of ERAS-007, but also complements the patient subgroups within our ongoing HERKULES-2 and HERKULES-3 master protocols. Additionally, it may provide proof-of-concept data supporting the addition of ERAS-007 as a treatment option to overcome RAS/MAPK resistance with KRAS G12C inhibitors. We look forward to potentially partnering with the team to explore the therapeutic potential of this combination."

Ryan Corcoran, M.D., Ph.D., Director of the Gastrointestinal Cancer Center Program at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, added, "While adaptive feedback mechanisms can overwhelm MEK inhibitors, ERK inhibitors potentially can overcome drug resistance mechanisms that involve reactivation of RAS/MAPK pathway signaling. We look forward to evaluating whether the ERK1/2 inhibitor ERAS-007 has the potential to overcome feedback mechanisms and help address the limited efficacy of single agent KRAS G12C inhibitors."

A Phase 1b clinical proof-of-concept trial will evaluate ERAS-007 in combination with a KRAS G12C inhibitor in patients with NSCLC and CRC harboring a KRAS G12C mutation. Additional preclinical and clinical laboratory research will be conducted to further understand the activity and safety of this combination in these patient populations. The trial will be led by principal investigators Scott Kopetz, M.D., Ph.D., Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Dr. Corcoran, and Pasi Janne, M.D., Ph.D., Professor of Medicine at Harvard Medical School. Drs. Corcoran and Kopetz recently received a grant from Stand Up To Cancer (SU2C).

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. The broad therapeutic potential of ERAS-007 is being investigated initially across four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.