On March 15, 2021 Mersana Therapeutics, Inc. (Nasdaq: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the publication of two manuscripts in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Mersana Therapeutics, MAR 15, 2021, View Source [SID1234576649]). The manuscripts describe the preclinical development of the Dolaflexin ADC platform and XMT-1536, now called upifitamab rilsodotin (UpRi), Mersana’s first-in-class NaPi2b-targeted ADC developed using this platform.

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The first of these articles, "Dolaflexin: A Novel Antibody-Drug Conjugate Platform Featuring High Drug Loading and a Controlled Bystander Effect," provides detailed characterization of Dolaflexin, the Company’s novel ADC technology which is designed to overcome limitations of the most common ADC platforms with two key features: a higher drug-antibody ratio and a proprietary auristatin with a controlled bystander effect. The proprietary, cell permeable DolaLock payload auristatin F-hydroxypropylamide (AF-HPA) undergoes metabolic conversion to the highly potent but less cell-permeable auristatin F (AF) to balance the bystander effect through drug trapping within target cells and is designed to improve efficacy while avoiding the severe neutropenia, peripheral neuropathy and ocular toxicities commonly observed with other anti-tubulin ADC payloads.

The second article, "The Dolaflexin-based antibody-drug conjugate XMT-1536 targets the solid tumor lineage antigen SLC34A2/NaPi2b," describes pre-clinical discovery and characterization of UpRi, Mersana’s lead clinical-stage Dolaflexin ADC. NaPi2b is a sodium phosphate transporter expressed in a variety of human tumors. The broad expression of NaPi2b in epithelial ovarian cancer and lung adenocarcinoma is described, as is UpRi’s ability to selectively target human NaPi2b. In vivo data in preclinical models revealed target expression-dependent activity in a series of NSCLC adenocarcinoma patient derived xenografts (PDX) as well as profound activity in a panel of ovarian adenocarcinoma PDXs. Pharmacokinetic analyses showed approximately dose-proportional exposure across animal species as well as high serum stability of the conjugate, and systemic free AF-HPA and AF concentrations remaining low in all animal species.

"These studies demonstrate the differentiated design and advantages of the Dolaflexin platform in preclinical studies and its potential for creating a new and improved class of ADCs," said Timothy Lowinger, Ph.D., Chief Science and Technology Officer of Mersana Therapeutics. "In addition, the extensive preclinical data with UpRi, created by conjugating a NaPi2b-targeting antibody with Dolaflexin, gave us the confidence to proceed into the clinic. UpRi has since exhibited promising activity and a favorable tolerability profile in ongoing proof-of-concept studies in heavily pre-treated ovarian cancer patients with significant unmet medical need. We are very proud of the dedication and commitment of our team who have worked tirelessly to bring Dolaflexin and UpRi forward."

UpRi is in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma. Mersana intends to initiate a single-arm registration enabling strategy in platinum resistant ovarian cancer (UPLIFT) in the first quarter of 2021 as well as an umbrella combination study in earlier lines of therapy (UPGRADE) in the third quarter of 2021. More information on the ongoing clinical study can be found at clinicaltrials.gov (NCT03319628).

On March 15, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the company will host a virtual investor event to discuss Merck’s broad HIV program and the newly announced collaboration with Gilead Sciences (Press release, Merck & Co, MAR 15, 2021, View Source [SID1234576648]).

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On March 15, 2021 Immodulon, the immuno-oncology company, reported that its Chief Scientific Officer, Dr. Thomas Kleen, will present at the 11th World Clinical Biomarkers & Companion Diagnostic Europe Event taking place virtually 24-25 March 2021 (Press release, Immodulon Therapeutics, MAR 15, 2021, View Source [SID1234576647]). The presentation, titled ‘Clinical Biomarker Strategy with a Complex Immunomodulator: The Must-Haves & the Nice-To-Haves On a Limited Budget’, will be presented at 12:45 CET, 25 March.

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The presentation will discuss several topics including the challenges posed by the identification and validation of various circulatory immunological biomarkers in cancer patients during clinical trials, and the benefits and challenges of using novel technologies and classic immunological biomarkers.

11th World Clinical Biomarkers & Companion Diagnostic Europe Event
The annual Clinical Biomarkers & CDx Europe Summit brings stakeholders together to fast-track precision medicine through clinically validated biomarkers and companion diagnostics partnerships in Europe. The meeting will tackle key conversations spanning biomarker discovery through to drug-Dx market penetration, enabling innovation to power pipeline progression. Featuring the latest tools and techniques validating biomarker utility, overcoming patient selection challenges in rare disease, key clinical case-study learnings shaping diagnostic strategy in addition to the much needed core EU focus on navigating a tricky regulatory and reimbursement landscape to prevent incoming regulations hindering the delivery of critical drugs to patients in need. Find out more at www.worldcdxeurope.com

On March 15, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) and GenMark Diagnostics (NASDAQ: GNMK) reported that they have entered into a definitive merger agreement for Roche to fully acquire GenMark at a price of US$ 24.05 per share in an all-cash transaction (Press release, Hoffmann-La Roche, MAR 15, 2021, View Source [SID1234576646]). This corresponds to a total transaction value of approximately US$ 1.8 billion on a fully diluted basis. This price represents a premium of approximately 43% to GenMark’s unaffected closing share price on February 10, 2021, the last trading day before a media report was published speculating about a potential sale process. The merger agreement has been unanimously approved by the boards of directors of GenMark and Roche. Once the acquisition is completed, GenMark’s principal operations will continue at its current location in Carlsbad, California, USA.

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Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all outstanding shares of GenMark’s common stock, and GenMark will file a recommendation statement containing the unanimous recommendation of the GenMark board that GenMark stockholders tender their shares to Roche.

GenMark’s syndromic panel testing portfolio will complement Roche’s current molecular diagnostics portfolio and the Roche global network will enable expanded reach for GenMark’s products. GenMark’s ePlex system drives lab efficiency through streamlined order-to-reporting workflow and enables better patient outcomes by rapidly diagnosing a patient’s symptoms. Infectious diseases are a leading cause of death globally, and earlier detection of the cause of an infection has been shown to improve patient outcomes and improve key hospital initiatives such as antibiotic stewardship and length of stay.

"Acquiring GenMark Diagnostics will broaden our molecular diagnostics portfolio to include solutions that can provide lifesaving information quickly to patients and their healthcare providers in the fight against infectious diseases," said Thomas Schinecker, CEO Roche Diagnostics. "Their proven expertise in syndromic panel testing provides faster targeted therapeutic intervention, resulting in improved patient outcomes and reduced hospital stays, and will contribute to Roche’s commitment to helping control infectious diseases and antibiotic resistance. The rapid identification of bloodstream infections and the detection of antimicrobial resistance genes are more essential than ever for hospitals and their patients."

"As a part of Roche, we can accelerate our mission to enable rapid diagnosis of infectious disease to improve patient outcomes. Together with Roche’s diagnostics healthcare solutions, we will be able to provide a full suite of molecular diagnostic solutions to customers around the world," said Scott Mendel, CEO of GenMark Diagnostics. "We are thrilled to become a part of Roche and are confident that this is the right path forward for GenMark and our customers."

GenMark’s Respiratory Pathogen Panels identify the most common viral and bacterial organisms associated with upper respiratory infection, including SARS-CoV-2, complementing Roche’s extensive portfolio of COVID-19 diagnostics solutions.

Terms of the Agreement
Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of GenMark’s common stock for US$ 24.05 per share in cash. Following the completion of the tender offer, Roche will acquire all remaining shares at the same price of US$ 24.05 per share in cash through a second step merger.

The transaction is expected to close in the 2nd quarter of 2021 and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of GenMark’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. J.P. Morgan Securities LLC is acting as exclusive financial advisor to GenMark and DLA Piper LLP is acting as legal counsel to GenMark.

On March 15, 2021 CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer approximately $1.3 million of the total $1.3 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s application to participate in the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2020 (Press release, CorMedix, MAR 15, 2021, View Source [SID1234576645]). The Company anticipates receiving approximately $1.3 million in cash proceeds from the sale of its NOLs during the second quarter of 2021. Closing is subject to NJEDA’s typical closing conditions, which are in process.

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"We are pleased to receive an allocation from this program for the third consecutive year," said Khoso Baluch, Chief Executive Officer of CorMedix. "The funding will help us continue to advance DefenCath toward an anticipated commercial launch upon approval for the U.S. market."

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. CorMedix is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.