Precision BioSciences to Participate in Upcoming Jefferies Healthcare Conference

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.

Biodesix Announces Research Agreement with Top US Cancer Center

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.

Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to be Used as Companion Diagnostic of Four Drugs for the Treatment of Non-Small Cell Lung Cancer and Malignant Melanoma

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.

Scilex Holding Company, a Sorrento Company, Announces Pre-Emptive Repurchase of $41.4 Million of its Senior Secured Notes

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.

Boehringer Ingelheim Enters Global Licensing Agreement To Develop And Commercialize Innovative Antibodies From A*Star For Targeted Cancer Therapies

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."