Castle Biosciences Signs Definitive Agreement to Acquire Myriad myPath® Laboratory

On April 27, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported it has signed a definitive agreement to acquire all of the equity of Myriad myPath, LLC (Myriad myPath Laboratory), from Myriad Genetics (Press release, Castle Biosciences, APR 27, 2021, View Source [SID1234578578]). Myriad myPath Laboratory is a CLIA-certified laboratory in Salt Lake City, where the myPath Melanoma 23-gene expression profile (GEP) test was developed and is currently owned and offered. Castle is acquiring Myriad myPath Laboratory for $32.5 million. Castle will finance the acquisition price with cash and cash equivalents on hand. The transaction is expected to close approximately four weeks post signing, at which time Castle will be the successor owner of Myriad myPath Laboratory. The transaction is subject to customary conditions to closing.

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"With the acquisition of Myriad myPath Laboratory, Castle strategically expands its suite of genomic tests for skin cancer and expects to offer the most comprehensive testing solution for difficult-to-diagnose melanocytic lesions"

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myPath Melanoma is a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. Castle currently offers DecisionDx DiffDx-Melanoma, a 35-GEP test designed to characterize difficult-to-diagnose melanocytic lesions. myPath Melanoma is a distinct test, which Castle anticipates will complement its current offerings and enable Castle to provide the most comprehensive molecular testing solution for difficult-to-diagnose melanocytic lesions.

"With the acquisition of Myriad myPath Laboratory, Castle strategically expands its suite of genomic tests for skin cancer and expects to offer the most comprehensive testing solution for difficult-to-diagnose melanocytic lesions," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe this acquisition will add incremental value to both myPath Melanoma and DiffDx-Melanoma by leveraging the strengths of these two distinct, validated tests. Thus, through this acquisition, we believe that more patients will receive actionable results more of the time, enabling a more confident diagnosis and clearer treatment path."

DecisionDx DiffDx-Melanoma and myPath Melanoma are both commercially available and will remain available through Castle and Myriad, respectively, throughout the transaction period. As the successor owner, upon closing, Castle will be the sole provider of myPath Melanoma.

National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2021 state that ancillary tests, including GEP tests such as myPath Melanoma and DecisionDx DiffDx-Melanoma, may facilitate interpretation of cases (melanocytic neoplasms of uncertain biologic potential) that are diagnostically uncertain or controversial by histopathology. Additionally, myPath Melanoma is currently covered under a MolDX Local Coverage Determination policy through Noridian Healthcare Solutions, LLC, the Medicare Administrative Contractor that oversees laboratories in both Utah and Arizona.

Company management will host a conference call and webcast to discuss this transaction at 7:30 a.m. Eastern time today.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website (View Source). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 17, 2021.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 8479479.

There will be a brief Question & Answer session following management commentary.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

Crescendo to Participate in Upcoming Investor Conferences

On April 27, 2021 Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, reported that senior members of the executive team will be participating at the following two investor conferences (Press release, Crescendo Biologics, APR 27, 2021, View Source [SID1234578577]):

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SVB Leerink Biopharma Private Company Connect Event, 6-7 May 2021
Theodora Harold (CEO), Phil Bland-Ward (CDO) and Mike Booth (CFO) will be attending to meet investors to discuss the Company’s business strategy, technology, discovery and development programmes.
Bio€quity Europe 2021, 17-19 May
Theodora Harold (CEO) and Mike Booth (CFO) will be attending, and Theodora will also be a panelist in the faculty session, BioCentury Scene Setter: Reading the Next Act, on Monday 17 May.
Both events will be virtual. If you are interested in meeting the team at these events, please contact the Company via email at [email protected].

Please refer to individual conference websites for further information and updated schedules.

Transgene reports business update and end Q1 2021 financial position

On April 27, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ending March 31, 2021, and provides an update on the progress of its portfolio of clinical trials (Press release, Transgene, APR 27, 2021, View Source [SID1234578576]).

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Since January 2021, Transgene has achieved significant milestones on all candidates of its clinical portfolio, with:

ü the first patients dosed with TG4050, the individualized therapeutic vaccine against cancer based on Transgene’s myvac technology – the first data from the two ongoing Phase I clinical trials are expected in 4Q 2021;

ü regulatory clearance received in the United States, in France and in Spain, which are expected to allow enrolment of patients with HPV-positive anogenital cancers in the randomized Phase II trial of TG4001 + avelumab versus avelumab alone in 2Q 2021;

ü first patients dosed in the Phase I trial evaluating BT-001, an oncolytic virus based on the Invir.IO platform – first data are expected in 1H 2022;

ü TG6002 initial data, presented at AACR (Free AACR Whitepaper), providing the clinical proof of concept of the intravenous administration of an oncolytic virus. After intravenous administration, TG6002 reached the tumor, multiplied within tumor cells, and induced the local expression of its payload (the FCU1 gene). These data also suggest that candidates derived from Transgene’s unique Invir.IO platform could also be given intravenously, extending the use of these therapies to a broad range of solid tumors – Next data with TG6002 are expected in 2H 2021 (intra-hepatic artery route).

SUMMARY OF KEY ONGOING CLINICAL TRIALS
AND EXPECTED MILESTONES

myvac

TG4050

Phase I

NCT03839524

Targets: tumor neoantigens

Ovarian cancer – after surgery and first-line chemotherapy

ü Trial ongoing in the United States and in France

ü Inclusions and patient dosing progressing in line with forecast

Ü First data expected in 4Q 2021

myvac

TG4050

Phase I

NCT04183166

HPV-negative head and neck cancer – after surgery and adjuvant therapy

ü Trial ongoing in the United Kingdom and in France

ü First patient treated in Jan. 2021 – Inclusions and patient dosing progressing in line with forecast

Ü First data expected in 4Q 2021

TG4001

+ avelumab
Phase II

NCT03260023

Targets: HPV16 E6 and E7 oncoproteins

Recurrent/metastatic anogenital HPV-positive – 1st and 2nd line

ü A Phase II randomized trial comparing the efficacy of TG4001 + avelumab versus avelumab single-agent benefits from the extended clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

ü Regulatory authorizations received in the Unites States, Spain, and France

Ü Patient enrollment in the randomized trial expected to start in 2Q 2021

Ü First data from the randomized trial are expected around the end of 2022. This timeline is based on patient enrollment starting in 2Q 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Invir.IO

BT-001

Phase I/IIa

NCT04725331

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

ü Co-development with BioInvent

ü Trial ongoing in France and Belgium

ü First patient enrolled in February 2021 – Inclusions and patient dosing progressing in line with forecast

Ü US IND expected in 2021

Ü First Phase I data expected in 1H 2022

TG6002

Phase I/IIa

NCT03724071

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

ü Multicenter trial ongoing in Belgium, France and Spain

ü Poster presentation at AACR (Free AACR Whitepaper) 2021 on initial data of the trial, demonstrating the clinical proof of concept of the intravenous route of administration

Ü Phase I part ongoing

TG6002

Phase I/IIa

NCT04194034

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration

ü Multicenter trial ongoing in the United Kingdom

Ü First observations expected in 2H 2021

During the first quarter of 2021, revenue from collaborative and licensing agreements was mainly composed of the revenue from the collaboration with AstraZeneca.

As of March 31, 2021, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2021 (€1.5 million in the first quarter of 2021, in line with the same period in 2020).

CASH, CASH EQUIVALENTS

AND OTHER FINANCIAL ASSETS

Cash, cash equivalents and other financial assets stood at €19.1 million as of March 31, 2021, compared to €26.3 million as of December 31, 2020. In the first quarter of 2021, Transgene’s cash burn was €7.2 million, compared to €8.0 million for the same period in 2020.

In addition, Transgene has access to a €15 million credit line available from Natixis, the maturity date of which has been extended to April 15, 2023. The Company holds shares of Tasly BioPharmaceuticals valued at €32.3 million at the end of December 2020.

As a result, the Company has a financial visibility until the second half of 2022.

CohBar Appoints Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director

On April 27, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported the appointment of Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director, effective May 3, 2021 (Press release, CohBar, APR 27, 2021, View Source [SID1234578575]). The Board of Directors expresses appreciation for the contribution of Mr. Steven Engle during his tenure as CEO and Director of the company. In addition, Mr. David Greenwood, a current Director with 40 years of financial and operational experience in biotechnology and investment banking, has assumed the role of Chairman of the Board.

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"We are pleased to welcome Dr. Sarret to CohBar," stated David Greenwood, Chairman of CohBar. "We look forward to his leadership in continuing to realize our vision for CohBar’s novel platform of mitochondria based therapeutics. His expertise as a seasoned executive with a track record of success will guide CohBar in its goal to become a company with a number of pipeline products in the clinic and on the market."

"I look forward to leading CohBar as we continue to advance its pipeline of novel analogs derived from natural sequences encoded in the mitochondrial genome," said Dr. Joseph Sarret. "This is an exciting time to join CohBar with many potential milestones on the horizon. I am delighted to work with the team and Board of Directors to translate this groundbreaking science into novel therapeutics and realize the value of CohBar’s pioneering platform."

Most recently, Dr. Sarret served as Chief Business Officer at Corium International, a commercial-stage biopharmaceutical company leading the development of new transdermal healthcare products, until its merger with Gurnet Point Capital. He previously served as Senior Vice President, Strategic Accounts at Solazyme, Inc., a company focused on developing renewable natural based products, and as Chief Executive Officer and a member of the Board of Directors of Sevident, Inc., a start-up biotechnology company developing medical diagnostics and life science research products.

Prior to joining Sevident, Dr. Sarret held multiple positions at Codexis, Inc., a publicly traded international industrial biotechnology company, including Senior Vice President and Chief Business Officer, and President, Pharmaceutical Services and Enzyme Products. At Codexis, he was responsible for numerous strategic partnerships in the pharmaceutical and bioindustrial sectors, including acquisitions and licensing transactions. In addition, Dr. Sarret had P&L responsibility for the company’s global pharmaceutical ingredient manufacturing business unit. Previously, he practiced corporate and transactional law at Latham & Watkins LLP. Dr. Sarret also served as Attending Physician and Acting Medical Director for the HIV Clinic at the University of California, San Francisco Medical Center. Dr. Sarret holds a B.A. in Human Biology from Stanford University, an M.D. from the University of California, San Francisco School of Medicine and a J.D. from Stanford Law School, and is a member of the Phi Beta Kappa, Alpha Omega Alpha and Order of the Coif honor societies.

In connection with his appointment as Chief Executive Officer, CohBar announced it has granted Dr. Sarret equity awards that were approved by the Compensation Committee of its Board of Directors, with a grant date of May 3, 2021, as a material inducement to employment. As further described below, a portion of the equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

CohBar granted Dr. Sarret an option to purchase 2,600,000 shares of CohBar common stock. One-fourth of the shares underlying this option will vest on May 3, 2022 and thereafter 1/48th of the shares underlying the option will vest monthly, such that the shares underlying the option will be fully vested on May 3, 2025, subject to Dr. Sarret’s continued employment with CohBar on such vesting dates (the "Time Based Grant"). Of the shares subject to the Time Based Grant, shares with a fair market value of $100,000 based on the closing price of CohBar’s common stock on the effective date of the Time Based Grant will be issued pursuant to CohBar’s Amended and Restated 2011 Equity Incentive Plan, and the balance of the shares subject to the Time Based Grant will be granted pursuant to the inducement grant.

CohBar also granted Dr. Sarret as an additional inducement grant an option to purchase 1,300,000 shares of CohBar common stock, with a grant date of May 3, 2021, which will vest over a two-year period, subject to Dr. Sarret’s continued employment with CohBar on such vesting dates and the achievement of certain performance metrics that will be determined by the Board no later than June 30, 2021.

Each of the options will have an exercise price equal to the closing price of CohBar’s common stock on May 3, 2021.

DURECT Corporation to Announce First Quarter 2021 Financial Results and Provide Business Update on May 4

On April 27, 2021 DURECT Corporation (Nasdaq: DRRX) reported that it will report its first quarter 2021 financial results and host a conference call after the market close on Tuesday, May 4, 2021 (Press release, DURECT, APR 27, 2021, https://investors.durect.com/news-releases/news-release-details/durect-corporation-announce-first-quarter-2021-financial-results [SID1234578574]).

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Tuesday, May 4 @ 4:30pm Eastern Time / 1:30 p.m. Pacific Time

Toll Free:

877-407-0784

International:

201-689-8560

Conference ID:

13718713

Webcast:

View Source