On February 16, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2020, as well as key clinical and corporate developments (Press release, Cel-Sci, FEB 16, 2021, View Source [SID1234575143]).

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Clinical and Corporate Developments include:

In December 2020, CEL-SCI updated the status of its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection). Data lock has been completed, and the study entered its final stage of statistical analysis. CEL-SCI remains blinded to the study data and is not involved in this process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define the clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The analysis looks at multiple parameters to gain the most information on the possible benefits of using Multikine immunotherapy as a first line treatment before standard of care for these patients.
CEL-SCI continued expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction, which began in 2020, is expected to be completed in the coming months and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.
In December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a 40% survival rate in human ACE2 transgenic mouse model as compared to 0% survival in the two control groups. These studies were conducted at the University of Georgia Center for Vaccines and Immunology. As COVID-19 mutations increase, LEAPS COV-19’s mechanism of action which targets the non-mutating part of the SARS-CoV-2 virus is becoming more important.
In December 2020, CEL-SCI sold 1,000,000 shares of common stock at a public offering price of $14.65 per share and received aggregate proceeds of approximately $13.6 million. On December 31, 2020, CEL-SCI’s cash position was approximately $21.9 million. After December 31, 2020, CEL-SCI has received approximately $3.9 million through the exercise of warrants and stock options.
"As the data analysis for our Phase 3 trial is being conducted, we are focused on expanding manufacturing of Multikine so that we will be ready to produce significant commercial quantities for this unmet medical need. We believe that Multikine may add substantial clinical benefit and help these patients." stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss of approximately $7.9 million for the quarter ended December 31, 2020 versus net loss of approximately $5.5 million for the quarter ended December 31, 2019.

During the three months ended December 31, 2020, CEL-SCI incurred approximately $3.6 million in costs to upgrade its manufacturing facility to prepare for the potential commercial production of Multikine. Total estimated costs of this upgrade are approximately $10.5 million, of which approximately $6.7 million has been incurred through December 31, 2020.

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.

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]):

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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.

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.

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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.

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.

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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.