On June 22, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported its inaugural event, NeXT Level Biomarkers Symposium, which will showcase novel research into emerging biomarkers using the Personalis NeXT Platform (Press release, Personalis, JUN 22, 2021, View Source [SID1234584247]).

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This event will detail the latest research from Personalis as well as a case study done in collaboration with the Parker Institute for Cancer Immunotherapy. Presentations from Personalis will focus on recently published research into HLA loss of heterozygosity, neoantigen prediction, as well as Personalis’ novel composite biomarker, the Neoantigen Presentation Score (NEOPS). In addition, Dr. Theresa LaVallee will be presenting findings from the PRINCE trial based on data developed and analyzed in collaboration with Personalis.

The agenda for NeXT Level Biomarkers Symposium will cover:

Biomarker Discovery with ImmunoID NeXT Platform
Exploring HLA LOH with the DASH (Deletion of Allele-Specific HLAs) Algorithm
Neoantigen Binding Prediction and Biomarker Discovery with SHERPA
Composite Biomarkers and our Neoantigen Presentation Score (NEOPS)
Parker Institute Case Study: The PRINCE Trial
NeXT Liquid Biopsy Overview and Review of AACR (Free AACR Whitepaper) Data
NeXT Dx and Companion Diagnostics (CDx) with Personalis
"We are excited to share our latest technology and product advances with our partners," said Richard Chen, MD, Personalis CSO. "Given the complex biology underlying cancer progression and response to treatment, our mission at Personalis is to provide broader, more comprehensive molecular profiling and testing for each patient’s cancer, thereby giving biopharma, physicians, and patients the information they need for precision oncology now and with an eye to the future. These new technologies help further that mission."

On June 22, 2021, BioXcel Therapeutics, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with BofA Securities, Inc., as representative of the several underwriters named therein (collectively, the "Underwriters") and the selling stockholder named therein (the "Selling Stockholder"), in connection with the issuance and sale by the Company in a public offering of 3,155,000 shares of the Company’s common stock at a public offering price of $31.70 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3ASR (Registration No. 333-240118) and a related prospectus supplement filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, BioXcel Therapeutics, JUN 22, 2021, View Source [SID1234584368]). Under the terms of the Underwriting Agreement, the Selling Stockholder has also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 473,250 shares of common stock at the public offering price, less underwriting discounts and commissions. The Company will not receive any of the proceeds from any sale of shares in the offering by the Selling Stockholder.

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The Company received net proceeds from the offering of approximately $96.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the offering to fund ongoing clinical trials, commercialization preparation and for general corporate purposes.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company and the Selling Stockholder, customary conditions to closing, indemnification obligations of the Company, the Selling Stockholder and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Underwriting Agreement is not complete and is qualified in its entirety by reference to the full text of the Underwriting Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated by reference herein. An opinion of Latham & Watkins LLP regarding the validity of the shares to be issued and sold in the offering by the Company is filed as Exhibits 5.1 and an opinion of the Company’s Chief Legal Officer regarding the validity of the shares to be sold in the offering by the Selling Stockholder is filed as Exhibit 5.2.

Based on the planned use of proceeds from the offering, the Company believes that the net proceeds from the offering and its existing cash and cash equivalents will be sufficient to enable it to fund operating expenses and capital expenditure requirements into the first half of 2023. The Company has based this estimate on assumptions that may prove to be incorrect, and could utilize available capital resources sooner than currently expected. The amounts and timing of the Company’s actual expenditures will depend on numerous factors, including the progress of the Company’s clinical trials and other development efforts and other factors, as well as the amount of cash used in the Company’s operations.

On June 22, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, ("Transgene" or the "Company") reported the successful completion of its capital increase through the issuance of ordinary shares through a private placement with waiver of preferential subscription rights, via an accelerated bookbuilding pursuant to Articles L. 225-136 of the French Commercial Code and L. 411-2 1° of the French Monetary and Financial Code for an amount of approximately 34,1 million euros (the "Capital Increase") (Press release, Transgene, JUN 22, 2021, View Source [SID1234621817]).

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Hedi Ben Brahim, Chairman and CEO of Transgene, said: "We are very pleased to have concluded this successful fund raising, which has been supported by both historical shareholders and specialized healthcare investors, such as Invus. We are now well placed to execute on our ambitious corporate strategy of progressing our world leading myvac and Invir.IO technology platforms through first clinical validations of our personalized cancer vaccine TG4050 and our novel oncolytic virus BT-001 while advancing our randomized Phase II of TG4001. Transgene’s future has never looked brighter, and I am looking forward to the multiple key value-driving corporate milestones, we expect to announce over the next 18 months."

The capital increase results in the issuance of 13,930,000 new ordinary shares at a subscription price of 2.45 euros (including issue premium), representing 16,6 % of the current share capital of the Company for a total amount of approximately 34,1 million euros. The subscription price represents a discount of 6.5% compared to the closing price of Transgene on June 21, 2021 (€2.62).

Institut Mérieux, which currently holds 99.5% through its subsidiary TSGH, 60% of the company’s share capital, and SITAM Belgium, which holds 4.9% of the company’s share capital, subscribed for new ordinary shares in the capital increase for a total amount of 25 million euros and 1,67 million euros, respectively. Several specialized healthcare investors, including Invus, also participated in the Offering.

As a result of the Capital Increase, the company’s share capital will be made up of 97,771,334 shares, each having a nominal value of €0.50, for a total share capital of 48,885,667 euros.

The funds raised in the Capital Increase will be used to strengthen the Company’s financial structure until the fourth quarter of 2023, in order to be able to conduct its clinical development plan, in particular on its new innovative product platforms myvac and Invir.IO, with the finalization of clinical studies, and to be able to serenely negotiate partnership and codevelopment agreements based on the results obtained from the end of 2021.

Funds will be directly used by descending order of strategic priority:
• circa €25m for the finalization of clinical studies and the obtention of data with TG4001, TG4050, BT-001 and TG6002;
• circa €4m to launch the clinical development of new oncolytic viruses based on the Invir.IO platform and currently undergoing preclinical evaluation;
• for the remainder, to finance, together with operational products of the Company, R&D and operational costs, as well as current cash consumption.

The transaction will be carried out under the 22nd resolution of the Combined General Shareholders’ Meeting of May 27, 2020. The Capital increase was the subject of a placement agreement entered into by the Company and the Global Coordinators on June 21, 2021. The placement agreement may be terminated by the Global Coordinators at any time up to (and including) the settlement date of the Capital Increase which is expected to take place on June 24, 2021, subject to certain customary conditions. Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Canada, Australia or Japan

To the Company’s knowledge, the breakdown of its share capital after the Capital Increase is as follows

(1): (1) On a non-diluted basis: before the potential exercise of the 41,352 stock-options outstanding as of the date of this press release and representing 0,0004% of both share capital and voting rights of Transgene.

SHAREHOLDERS’ SUBSCRIPTION AND LOCK-UP AGREEMENTS TGSH and SITAM Belgique have agreed with the Global Coordinators for the contemplated transaction that they will not sell or transfer its shares of Transgene for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions. In connection with the Capital Increase, the Company will enter into a lock-up agreement with the Global Coordinators for a period ending 90 days after the settlement and delivery of the Capital Increase, subject to the customary exceptions.

RISKS FACTORS Transgene draws the attention of the public to:
• The risk factors presented in the Universal Registration Document; the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Transgene or on its ability to achieve its objectives.
• The main risks associated with the Capital Increase are the following: o the market price of the Company shares may fluctuate and fall below the subscription price of the new shares; o due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly; o the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price; o regarding the use of the expected proceeds of the issuance within the context of the Capital Increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term; and o a new market-based call by the Company, after the Capital Increase, could result in further dilution for the investors.

On June 22, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on June 21, 2021, for FoundationOne CDx Cancer Genomic Profile to be used as a companion diagnostic (CDx) for both a human anti-human PD-1 monoclonal antibody, Opdivo [generic name: nivolumab (genetical recombination)] and a humanized anti-human PD-1 monoclonal antibody, Keytruda [generic name: pembrolizumab (genetical recombination)] for the treatment of patients with microsatellite instability high (MSI-High) tumors (Press release, Chugai, JUN 22, 2021, View Source [SID1234584213]).

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"High microsatellite instability has been identified in tumors in various organs, and immune-checkpoint inhibitors can be a therapeutic option. FoundationOne CDx Cancer Genomic Profile is characterized by the ability to comprehensively capture information on individual gene alterations, as well as the ability to detect microsatellite instability," said Dr. Osamu Okuda, Chugai’s President and CEO. "Through testing with FoundationOne CDx Cancer Genomic Profile, we will contribute to ensuring as many patients as possible to have access to optimal treatments."

As a companion diagnostic, FoundationOne CDx Cancer Genomic Profile will be used to identify patients with MSI-High unresectable advanced or recurrent colorectal cancer that have progressed following chemotherapy who may benefit from nivolumab. It will also be used to identify patients with microsatellite instability (MSI-H) solid tumors that have advanced or relapsed after chemotherapy (limited to use when difficult to treat with standard of care), who may benefit from pembrolizumab.

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

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
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
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
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)
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.

About Microsatellite instability high (MSI-High)
The genome contains several short strings of DNA (deoxyribonucleic acid) called microsatellites that are repeated many times. High-frequency microsatellite instability (MSI-High) is an abnormal number of microsatellite repeats1). Abnormal microsatellites do not lead to cancer, but tissues that show MSI-High are thought to be more likely to develop cancer. MSI-High has been found in patients with cancer of various organs, including endometrial, gastric, small intestine, colorectal, ovarian, renal pelvis/ureteral, prostate, and breast cancers2, 3). MSI-High is also a hallmark of people with Lynch syndrome who are born with genomic alterations that predispose them to developing cancer3).

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

[Reference]

Nojadeh, J.N. et al.: Microsatellite instability in colorectal cancer. EXCLI J. 17: 159-168, 2018.
Japan Society of Cancer Therapy/Japanese Society of Clinical Oncology: Guidelines for Transversal Genomic Practice in Organs in Adult and Pediatric Advanced Solid Tumors, Second Edition, October 2019
Colorectal Cancer Study Group: Hereditary Colorectal Cancer Guidelines 2020 Version

On June 22, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported the appointment of Katherine Stueland as President and Chief Executive Officer of GeneDx, Inc., the global genomics subsidiary of OPKO’s BioReference Laboratories (Press release, Opko Health, JUN 22, 2021, View Source [SID1234584229]). Ms. Stueland joins GeneDx from Invitae Corporation (NYSE: NVTA), where she served most recently as Chief Commercial Officer, establishing the corporate brand as Invitae evolved from a private company to a public entity with a market capitalization exceeding $6 billion.

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"We’re thrilled to have Katherine lead the team at GeneDx, which has served clinicians and patients for more than two decades with novel and differentiated technologies for diagnosing the most difficult human diseases," said Jon R. Cohen, MD, Executive Chairman of BioReference Laboratories. "With her depth of experience, focus on patient-centric business strategies and ability to lead and inspire, we look forward to a new era of genomics with GeneDx at the forefront."

Ms. Stueland’s career is rooted in bringing transformational technologies to patients and crafting strategies to enable broader access to diagnostics and therapeutics. She has overseen multiple commercial organizations and corporate brand transformations, and helped bring the first cancer immunotherapy to market, enabling a new standard of care for patients.

"The global opportunity is clear regarding the growing role of genomic information in providing better care to patients. We can readily and rapidly provide critical information to improve health outcomes, and GeneDx has been at the forefront of these efforts for more than 20 years," said Ms. Stueland, incoming President and CEO of GeneDx. "I’m honored to be joining this world-class team and couldn’t be more excited about what’s possible by bringing the GeneDx technologies to broader patient populations."

With more than two decades in the healthcare industry, Ms. Stueland previously held roles at Dendreon Corporation and TAP Pharmaceuticals (a joint venture of Takeda and Abbott), and consulted for biotech and pharmaceutical companies.