On April 1, 2021 Guardant Health, Inc. (Nasdaq: GH) announced that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved the Guardant Reveal liquid biopsy test for the detection and monitoring of minimal residual disease (MRD) in patients with early-stage cancer (stage II and III). Guardant Reveal is the first blood-only test able to detect, with 7-day turnaround time, a patient’s status for residual disease, without the need for a tissue biopsy.

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The Guardant Reveal blood test was introduced earlier this year and is Guardant Health’s first commercially available liquid biopsy for clinical use in the management of early-stage cancer. The test is focused first on one indication where the unmet medical need exists, early-stage colorectal cancer (CRC), with additional cancer types to follow. The Guardant Reveal blood test improves the management of CRC by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6

The test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic and epigenomic alterations. The test accurately reports genomic alterations down to allele frequencies of 0.01 percent and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect residual disease in early-stage cancers including CRC.

"Securing New York State CLEP approval for Guardant Reveal means that oncologists in New York can now use the test to identify high-risk patients with colorectal cancer, our first indication, who may benefit from adjuvant therapy after surgery, and to detect recurrence earlier as part of regular surveillance," said, Helmy Eltoukhy, Guardant Health CEO. "This approval is consistent with our commitment to improving care for all cancer patients by expanding access to our tests by complying with appropriate clinical laboratory regulations."

There are over 1.5 million colorectal cancer survivors today in the U.S. and an estimated 10 percent to 30 percent of early-stage patients recur.8 An unmet medical need exists to offer new tests that can overcome the limitations of current tools.

On April 1, 2021 AbCellera (Nasdaq: ABCL) reported agreements to expand its collaboration with Gilead Sciences, Inc. (Gilead) including a multi-year, multi-target antibody discovery collaboration and access to AbCellera’s humanized mouse technology, the Trianni Mouse (Press release, AbCellera, APR 1, 2021, View Source [SID1234577539]). Under the financial terms of the agreements, AbCellera will receive an upfront payment and is eligible for milestone payments and royalties based on the development and commercialization of antibodies generated by AbCellera under this collaboration.

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Building on the successful completion of the first collaboration together, under the new agreement AbCellera will generate panels of antibodies for up to eight new targets, across multiple indications, selected by Gilead. The expanded collaboration will leverage the full breadth of AbCellera’s technology stack, including the recently added capabilities for sourcing diverse, fully-humanized antibodies using the Trianni Mouse platform and combining any two antibodies to create native bispecifics using the OrthoMabTM protein engineering platform.

"We are excited to build on the success of the first program and deepen our relationship with the team at Gilead," said Carl Hansen, Ph.D., CEO and President of AbCellera. "We are particularly pleased to see the value created for our partners by quickly integrating the Trianni Mouse and OrthoMabTM platforms, which we acquired in second half of 2020."

AbCellera’s partners benefit from an operating system designed to support many antibody modalities, unlock new targets, and increase the speed and the probability of success of their therapeutic antibody discovery programs. AbCellera’s AI-powered technology stack brings together microfluidics, single cell analysis, machine learning, computation, custom robotics, and automation to compound the power of each step in the discovery process.

On April 1, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported the successful completion of the cash tender offer, through a subsidiary, for all of the outstanding shares of common stock of Pandion Therapeutics, Inc. (Nasdaq: PAND) at a purchase price of $60 per share (Press release, Merck & Co, APR 1, 2021, View Source [SID1234577502]). As of the tender offer expiration, 27,770,123 shares of common stock of Pandion were validly tendered and not withdrawn from the tender offer, representing approximately 88.6% percent of the outstanding common stock of Pandion on a fully diluted basis. All such shares have been accepted for payment in accordance with the terms of the tender offer, and Merck expects to promptly pay for such shares.

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Following the finalization of the tender offer, Merck completed the acquisition of Pandion today through a merger of Merck’s wholly-owned subsidiary with and into Pandion in which all shares not tendered into the offer were cancelled and converted into the right to receive cash equal to the $60 offer price per share, without interest, less any applicable tax withholding. At the completion of the merger, Pandion became a wholly-owned subsidiary of Merck. The common stock of Pandion will no longer be listed or traded on the Nasdaq Global Select Market.

On April 1, 2021 Fresenius Kabi, a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, reported it has signed an exclusive distribution agreement for the U.S. with Corvida Medical (Press release, Fresenius, APR 1, 2021, View Source [SID1234577519]).

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Under the terms of the agreement, Fresenius Kabi will be the exclusive U.S. distributor for the HALO Closed System Drug-Transfer Device (CSTD). The HALO system is an airtight and leak-proof CSTD that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and droplets. These are common challenges during the compounding and administration of hazardous drugs like chemotherapy.

"Fresenius Kabi is committed to offering solutions that provide the safe preparation and delivery of medications across the continuum of care," said John Ducker, president and CEO of Fresenius Kabi USA. "CSTDs play a critical role in protecting health care professionals from the risks of exposure to hazardous drugs during the preparation in the pharmacy and during patient administration by nurses. The combination of Fresenius Kabi freeflex/freeflex+ IV solution containers, oncology medicines and Corvida Medical’s HALO CSTD allows Fresenius Kabi to provide customers a broad range of products to assist with their oncology needs."

Mitch Moeller, CEO of Corvida Medical added, "We believe Fresenius Kabi is a great partner for the HALO Closed System Drug-Transfer Device. Their reputation for quality and patient focus along with their commercial infrastructure, distribution experience, customer relationships and extensive product portfolio will help our efforts to make HALO a leading CSTD option for U.S. customers. We are pleased that Fresenius Kabi recognized the design benefits, innovation and quality of the HALO product portfolio."

The distribution agreement may be expanded to other territories in the future. Financial terms of the agreement were not disclosed.

On April 1, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the completion of enrollment for the first-line patient cohort in the DisTinGuish study, a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ) (Press release, Leap Therapeutics, APR 1, 2021, View Source [SID1234577503]).

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"The completion of enrollment for the first-line patients in the DisTinGuish study is an important milestone for the DKN-01 and tislelizumab combination development program," said Cynthia Sirard, M.D., Chief Medical Officer of Leap Therapeutics. "In collaboration with our partner, BeiGene, we are committed to realizing the potential of DKN-01 as part of a new combination therapy with tislelizumab aimed at treating gastric and gastroesophageal junction cancer patients, where a high global unmet medical need remains."

The DisTinGuish trial (NCT04363801) is a Phase 2a, nonrandomized, open-label, multicenter study of DKN-01 in combination with tislelizumab with or without chemotherapy as first-line or second-line therapy in adult patients with inoperable, locally advanced G/GEJ adenocarcinoma. The study, which will be conducted in two parts in the United States and the Republic of Korea, includes up to 24 patients with first-line G/GEJ cancer and up to 48 patients with second-line G/GEJ cancer whose tumors express high levels of DKK1. Initial data is expected in the second half of 2021. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand. Leap retains exclusive rights for the development, manufacturing, and commercialization of DKN-01 for the rest of the world.

About gastric / gastroesophageal junction cancer
Gastric adenocarcinoma (gastric cancer) remains one of the most common and deadly cancers worldwide, especially among older malesi. Based on GLOBOCAN 2018 data, stomach cancer is the 5th most common neoplasm and the 3rd most deadly cancer, with an estimated 783,000 deaths globally in 2018i. Ninety-five percent of cancers of the stomach are adenocarcinomasi. Gastric cancer incidence and mortality are highly variable by region and highly dependent on diet and Helicobacter pylori infectioni. The gastroesophageal junction (GEJ) is the area where the esophagus and stomach join together. Given its anatomic location, GEJ adenocarcinomas have often been grouped together with either esophageal or gastric cancers in clinical trials.

About DKN-01
DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein. DKK1 modulates the Wnt/Beta-catenin and PI3kinase/AKT signaling pathways, which have an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment through enhancing the activity of myeloid-derived suppressor cells and downregulating NK cell ligands on tumor cells. The U.S. Food and Drug Administration has granted DKN-01 Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer and Fast Track Designation in combination with tislelizumab for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express high DKK1 protein, following disease progression on or after prior fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.