On June 3, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will participate in the Jefferies Healthcare Conference taking place June 8-10, 2022 (Press release, Precision Biosciences, JUN 3, 2022, View Source [SID1234615492]).

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Details for the in-person fireside chat are as follows:

Date: Thursday, June 9, 2022
Time: 4:00 PM ET
Location: New York Marriott Marquis

The fireside chat will be available via a live webcast accessible on Precision’s website in the Investors section under Events & Presentations: View Source An archived replay will be available for approximately 30 days following the event.

On June 3, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK) (Press release, Biodesix, JUN 3, 2022, View Source [SID1234615491]). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer.

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"The initiation of this research program with MSK is a significant milestone for Biodesix. While the initial focus will be on developing a novel MRD test for solid tumors as an addition to our pipeline, Biodesix hopes to co-develop and validate a number of new test concepts under the agreement", said Scott Hutton, CEO, Biodesix.

Biodesix will utilize its array of genomics, proteomics, artificial intelligence, and machine learning capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK. Initially, the teams will collaborate to develop a highly sensitive molecular MRD test on the new ddPCR platform, the Bio-Rad QX600 ddPCR System.

"As part of Bio-Rad’s continued growth in oncology and expansion into the field of molecular MRD monitoring, we are pleased that Biodesix is utilizing the advanced multiplexing QX600 ddPCR System that will be launching later this year," said Simon May, EVP & President, Life Science Group, Bio-Rad Laboratories.

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 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.