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Guardant Health Launches Guardant Reveal™ Liquid Biopsy Test for Residual Disease and Recurrence Monitoring in Patients with Early-Stage Colorectal Cancer

On February 16, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the availability of Guardant Reveal, the first blood-only liquid biopsy test for the detection of residual and recurrent disease from a simple blood draw (Press release, Guardant Health, FEB 16, 2021, View Source [SID1234575142]). The first-of-its-kind commercial test improves the management of early-stage colorectal cancer (CRC) patients 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

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The Guardant Reveal test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. 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 of indeterminate potential. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect early-stage cancers including CRC. Results are obtained from a simple blood draw and returned in as little as 7 days without the need for a tissue biopsy.

"For the more than 1.5 million colorectal cancer survivors today in the U.S.8, the risk of recurrence is a serious one. Colorectal cancer is the second leading cause of cancer death in the U.S. and an estimated 10-30 percent of early-stage patients recur8—so it’s vital that oncologists have better tools to manage these patients by quickly identifying those high-risk patients who may benefit from adjuvant therapy after surgery, and by detecting recurrence earlier as part of regular surveillance," said Helmy Eltoukhy, Guardant Health CEO. "At Guardant Health our goal is to help cancer patients across the care continuum, and with the Guardant Reveal test, we are now able to serve an earlier patient group, early-stage colorectal cancer patients, where an unmet medical need exists given the limitations of current tools."

"The use of liquid biopsies in clinical practice represents a new frontier in improving cancer care for patients at all stages of their disease," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "It’s exciting to see that Guardant Health’s liquid biopsy tests not only inform targeted therapies for advanced cancer patients, but can now detect signs of cancer in the blood after curative intent surgeries. With this test, clinicians now have an additional tool to evaluate whether a patient with early-stage colorectal cancer is at high risk for recurrence, helping to inform adjuvant treatment after surgery in certain settings, and to detect microscopic recurrence of cancer months earlier than today’s standard of care."

The Guardant Reveal test is Guardant Health’s first commercially available liquid biopsy test for clinical use in the management of early-stage cancer. The test will focus first on one indication where the unmet medical need exists, early-stage CRC, with additional cancer types to follow.

Silverback Therapeutics to Present at Upcoming Investor Conferences

On February 16, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that Laura Shawver, Ph.D., Silverback’s chief executive officer, will present at the following upcoming investor conferences (Press release, Silverback Therapeutics, FEB 16, 2021, View Source [SID1234575141]):

Event: Goldman Sachs West Coast Biotech Bus Tour
Location: Virtual
Date: Tuesday, February 23, 2021
Time: 2:00 PM ET / 11:00 AM PT

Event: SVB Leerink 10th Annual Global Healthcare Conference
Location: Virtual
Date: Wednesday, February 24, 2021
Time: 4:20 PM ET / 1:20 PM PT

Event: Cowen 41st Annual Healthcare Conference
Location: Virtual
Date: Wednesday, March 3, 2021
Time: 3:20 PM ET / 12:20 PM PT

Event: H.C. Wainwright Global Life Sciences Conference
Location: Virtual
Date: Tuesday, March 9, 2021
Time: 7:00 AM ET / 4:00 AM PT
The webcast and archived replay of the SVB Leerink, Cowen, and H.C. Wainwright presentations will be available on the Silverback website, www.silverbacktx.com, for 30 days.

Study Shows Biocept’s Target Selector™ Detects Mutations in “Quantity Not Sufficient” Specimens in Non-Small Cell Lung Cancer Patients

On February 16, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it will present data showing that its Target Selector molecular assay kit detects mutations in up to 50% of tissue biopsy specimens, from patients diagnosed with non-small cell lung cancer, that were deemed quantity not sufficient (QNS) (Press release, Biocept, FEB 16, 2021, View Source [SID1234575140]). The study will be presented at the Molecular Med Tri-Con Virtual Conference, Feb. 16-18, 2021.

Molecular testing of biopsy specimens is critical to identify genetic mutations and guide potential treatment with targeted therapies. However, in up to 40% of cases, specimens lack sufficient tissue to perform testing1 and are deemed insufficient. The presence of non-tumor cells can also be an obstacle in detecting specific mutations. As a result, QNS specimens are a significant issue in molecular diagnostic testing and a key challenge faced by oncologists and pathologists in managing cancer patients.

The pilot study utilized Biocept’s Target Selector molecular assay with Switch-Blocker technology, which offers ultra-high sensitivity and requires less tumor sample than most commercial assays. The assay was used to evaluate the presence of several key EGFR and KRAS mutations in formalin-fixed paraformaldehyde embedded (FFPE) tissue slides, supplied by NeoGenomics Laboratories, Inc. that were deemed QNS for next generation sequencing (NGS) analysis. Results showed that EGFR mutations were detected in 50% (3/6) of patient samples, and KRAS mutations in 17% (1/6) of samples.

"We’re looking for rare mutations from a very small tissue sample in a large background of non-tumor cells to help us guide treatment decisions for patients," said Michael C. Dugan, M.D., Senior Vice President, Chief Medical Officer and Medical Director of Biocept. "This collaboration with NeoGenomics confirms that our Target Selector assay used with FFPE samples has the potential to provide molecular results when other common platforms can’t, offering actionable information for physicians to help identify potential targeted therapy options."

Biocept’s Target Selector assay kits, available for research-use-only and CE-IVD, detect mutations in DNA derived from FFPE or blood plasma to give insight into a patient’s cancer characteristics and provide tumor biomarker status. Target Selector utilizes patented Switch-Blocker technology to enrich specimens for mutations of interest and block DNA amplification from normal cells, resulting in ultra-high assay sensitivity and specificity compared to other methods currently used in laboratories. The kits allow molecular laboratories around the world to use Target Selector assays to detect key oncogene mutations through the analysis of both FFPE tissue from surgical biopsies and ctDNA from blood-based liquid biopsies. Biocept also offers Target Selector ctDNA-based tests in its CLIA-certified, CAP-accredited laboratory.

Biocept’s virtual exhibit at the Tri-Con conference will offer information about the company’s molecular assay technologies that assist clinicians and researchers in understanding the genomic basis of cancer. Also at the conference, Dr. Dugan will participate in a roundtable discussion on understanding the value and analytical requirements of circulating tumor cell (CTC) analysis as part of a comprehensive liquid biopsy analysis. The panel, titled "Introducing CTC Assays to Service Laboratories," will be held Wednesday, Feb. 17, at 12:55 p.m. ET. More information about the roundtable can be found here.

Sesen Bio Announces FDA Acceptance and Priority Review of its Biologics License Application for Vicineum™

On February 16, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review (Press release, Sesen Bio, FEB 16, 2021, View Source [SID1234575139]). In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

The FDA grants Priority Review for medicines that treat a serious condition and, if approved, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of such serious condition. Priority Review designation shortens the review period goal from the standard ten months to six months from the filing acceptance of the BLA. With Priority Review, the anticipated target Prescription Drug User Fee Act (PDUFA) date for a decision on the BLA is August 18, 2021.

"We have been meeting with the FDA regularly for the past two years on the application for Vicineum," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "We understand the FDA’s position and guidance very clearly and have found the review process to be collaborative and engaging. With these critical FDA decisions, we have reached an inflection point for the Company. In addition to a clear regulatory path forward, we have continued to strengthen our balance sheet in preparation for the potential launch of a product we believe represents a significant advancement over available therapies. We remain focused on the patient and our mission to save and improve lives and expect to continue to make progress around the world in the coming months."

In the next one to two months, the Company expects to submit its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and receive an update from the Company’s partner, Qilu Pharmaceutical, regarding the possible approval of the Investigational New Drug (IND) application for Vicineum in China by the Center for Drug Evaluation (CDE).

Conference Call and Webcast Information
Dr. Thomas Cannell Presided and CEO of Sesen Bio will host a conference call today at 8:00 AM ET. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 1290313. The conference call can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. A replay of the call will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and granted the application Priority Review with a PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicineum in high-risk, BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

Gamida Cell Announces $75 Million Financing with Highbridge Capital Management

On February 16, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to developing and commercializing cures for blood cancers and serious hematologic diseases, reported the sale of $75 million of 5.875% exchangeable senior notes due in 2026 (the "notes") to certain funds managed by Highbridge Capital Management, LLC (Press release, Gamida Cell, FEB 16, 2021, View Source [SID1234575138]).

The proceeds from this sale of notes, together with the net proceeds of Gamida Cell’s sale of $75 million of ordinary shares in December 2020, are expected to provide Gamida Cell with sufficient liquidity to fund the company’s operations into the second half of 2022. These capital infusions will be used to support manufacturing, regulatory and commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.

"Securing this financing from a respected industry investor strengthens Gamida Cell’s financials at a pivotal time for our company. It enables us to capitalize on positive Phase 3 clinical results generated from omidubicel and to fund the key activities required to bring this therapy forward to patients," said Julian Adams, CEO of Gamida Cell. "Moreover, these additional funds help us to advance clinical development of GDA-201 by enabling us to file an IND for this product candidate."

"We are pleased to be able to provide this financing to Gamida Cell, to meaningfully advance their vision of developing cures for blood cancers and serious hematological diseases," commented Jonathan Segal, Co-Chief Investment Officer of Highbridge Capital Management. "Following our extensive due diligence, we are enthusiastic about the commercial potential for omidubicel. We are also excited about the potential for GDA-201 to be an important therapy and leader in the emerging field of NK cell therapy. We look forward to continuing to work collaboratively with Gamida Cell’s management team and board" added Jason Hempel, Co-Chief Investment Officer of Highbridge Capital Management.

The notes were sold at 100% of the principal amount thereof, are senior unsecured obligations of Gamida Cell and its wholly owned subsidiary and will accrue interest at a rate of 5.875% per year. Subject to certain limitations, the holders of the notes can elect to exchange the notes for Gamida Cell’s ordinary shares at an initial exchange rate of 56.3063 shares per $1,000 principal amount of notes (equivalent to an exchange price of $17.76 per share). The initial exchange price of the notes represents a premium of approximately 50% over the closing price of Gamida Cell’s ordinary shares on February 12, 2021 and a premium of approximately 122% over the public offering price of Gamida Cell’s shares on December 17, 2020.

Gamida Cell may redeem all or a portion of the notes for cash, at its option, at 100% of the principal amount plus accrued and unpaid interest on the notes to be redeemed if the closing price of its ordinary shares has been at least 130% of the exchange price for at least 20 trading days during any 30 consecutive trading day period.

Moelis & Company served as a transaction advisor to Gamida Cell.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the US Food and Drug Administration. In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.12 Based on the recently completed Phase 3 clinical study, in which omidubicel achieved statistically significant and clinical meaningful results in the prespecified primary and secondary endpoints, Gamida Cell plans to submit the full Biologics License Application (BLA) to the FDA in the second half of 2021. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is currently in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy has not been established by the FDA or any other health authority.