On May 20, 2019 Early research using blood-based methylated DNA markers, identified through the longstanding collaboration between Exact Sciences and Mayo Clinic, reported a potential to achieve 92% sensitivity and 92% specificity for detecting the most common type of pancreatic cancer (Press release, Exact Sciences, MAY 20, 2019, View Source [SID1234536475]). Researchers presented the findings at Digestive Disease Week (DDW) 2019, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

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"These pancreatic cancer data showcase the strength of our marker discovery collaboration with Mayo Clinic, a partnership that is fueling our product pipeline," said Kevin Conroy, chairman and CEO of Exact Sciences. "We aim to identify a minimally-invasive marker for a disease that often goes undetected until it progresses to an advanced stage, when fewer treatment options exist."

Pancreatic cancer is the third-leading cause of cancer-related deaths in the United States. According to the American Cancer Society, half of all pancreatic cancer patients are diagnosed in later stages when the five-year median survival rate is only 3%. No major guidelines recommend routine screening for average risk patients because the current detection options have not shown to lower a patient’s risk of death.

Lead author and Mayo Clinic gastroenterologist Shounak Majumder, M.D. presented results from the 340-sample, case-control study. A panel of methylated DNA markers in plasma in combination with CA 19-9, achieved a cross-validated sensitivity of 79% in Stage 1, 82% in Stage 2, 94% in Stage 3 and 99% in Stage 4 pancreatic ductal adenocarcinoma (PDAC) with 92% specificity (81-100%). This combination was significantly better than CA 19-9 alone. As Majumder writes in the abstract, "CA 19-9 is unreliable for early detection and may be normal in advanced disease."

Statistical modeling was used to identify the best algorithm to predict disease status in this sample set. Subsequently, the panel was cross validated by randomly splitting the entire data set into training and testing sets. The fitted model from the training set was used to predict disease status in the test set over multiple iterations. This study used a small number of archival patient blood samples, which could lead to over-fitting to this particular sample set and cause subsequent sensitivity and specificity to decline in a larger, prospective population. A prospective validation study is currently underway at Mayo Clinic.

"Powered by more than a decade of work with Exact Sciences, Mayo Clinic researchers continue producing promising data, in this case on blood-based biomarkers for pancreatic cancer detection," said Paul Limburg, MD, MPH, AGAF, Exact Sciences chief medical officer and Mayo Clinic gastroenterologist.i "While further research must be completed, this serves as an early indicator of encouraging news in the fight against this deadly disease."

The Exact Sciences and Mayo Clinic collaboration focuses on identifying biomarkers for 15 of the deadliest cancers. A poster showing Mayo Clinic researchers work on esophageal cancer will also be presented at DDW.

On May 20, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that it has dosed the first patient in the combination arm of its Phase 1 study, combining escalating doses of COM701 with a fixed dose of Opdivo (nivolumab) in patients with advanced solid tumors (Press release, Compugen, MAY 20, 2019, View Source [SID1234536492]). The combination dose escalation arm was initiated following the determination of well-tolerated doses with no dose-limiting toxicities reported of COM701 from the monotherapy dose escalation arm of the trial. Bristol-Myers Squibb will supply Opdivo, a PD-1 inhibitor, for the combination arms of the Phase 1 study under the clinical trial collaboration announced in October 2018.

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"Our successful progression through the COM701 monotherapy dose escalation arm, enabled us to initiate the combination study with COM701 and Opdivo," stated Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "Enrollment in the monotherapy dose escalation arm is expected to be completed by the end of the third quarter, while the combination dose escalation arm is expected to finish enrolling patients later this year. As a first-in-class drug candidate against a novel drug target backed by a solid biological rationale and biomarker strategy, COM701 has generated interest in our Phase 1 study. We look forward to exploring the clinical potential of the therapy to improve response rates in patients with refractory or relapsed disease across multiple indications with the study’s investigators and our strategic partner, Bristol-Myers Squibb."

The Phase 1 study now has ten participating sites, having recently added Columbia University, MD Anderson Cancer Center, UCLA, the Cleveland Clinic and START Midwest. The primary endpoints for the study are safety and tolerability; secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with Bristol-Myers Squibb’s Opdivo in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as monotherapy as well as in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting patients in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).

About the Compugen-Bristol-Myers Squibb Clinical Collaboration

In October 2018, Compugen entered into a clinical trial collaboration with Bristol-Myers Squibb to evaluate the safety and tolerability of Compugen’s COM701 in combination with Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab), in patients with advanced solid tumors. Under the terms of the collaboration agreement, Compugen will sponsor the ongoing two-part Phase 1 trial, which includes the evaluation of the combination of COM701 and Opdivo in four tumor types, including non-small cell lung, ovarian, breast and endometrial cancer. The collaboration is also designed to address potential future combinations, including trials sponsored by Bristol-Myers Squibb to investigate combined inhibition of checkpoint mechanisms, such as PVRIG and TIGIT. The clinical combination of multiple immune checkpoint inhibition is designed to test the biological rationale of the PVRIG pathway and its synergistic activity with other checkpoint inhibitors demonstrated in preclinical models. In conjunction with this collaboration, Bristol-Myers Squibb made a strategic $12 million investment in Compugen.

On May 20, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that it has entered into a research agreement with FLX Bio, Inc., a biopharmaceutical company developing orally-available, small molecule drugs targeting the immune drivers of cancer and inflammatory diseases (Press release, FLX Bio, MAY 20, 2019, View Source [SID1234536476]). Under the terms of the agreement, FLX Bio will utilize Personalis’ universal cancer immunogenomics platform, ImmunoID NeXT, to evaluate therapy-related changes in tumors of advanced cancer patients participating in a Phase 1/2 clinical trial evaluating FLX475, a CCR4 antagonist, as monotherapy or in combination with pembrolizumab.

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"Using the ImmunoID NeXT Platform for our FLX475 studies will help confirm its mechanism of action and demonstrate that inhibiting the CCR4 receptor with FLX475 blocks the migration of regulatory T-cells (Treg) into tumors," said Brian Wong, M.D., Ph.D., President and CEO of FLX Bio, Inc. "With this cutting edge platform, we may be able to show that FLX475, by blocking Treg migration, decreases immune suppression and stimulates an immune response against cancer cells in the tumor microenvironment."

Via the deep interrogation and analysis of ~20,000 genes in both DNA and RNA, ImmunoID NeXT consolidates multiple biomarker assays into one; providing a multidimensional view of the tumor and the tumor microenvironment (TME) from a single sample. The platform is an end-to-end solution for immuno- and precision oncology biomarker discovery applications, simultaneously enabling the analysis of: tumor escape mechanisms (including HLA typing and somatic mutation detection), immune repertoire profiles, neoantigen load, tumor mutational burden (TMB), microsatellite instability (MSI), oncoviruses, and immune checkpoint gene expression.

With the ImmunoID NeXT Platform, FLX Bio will be able to compare pre- and post-treatment tumor biopsy samples, providing a comprehensive picture of treatment-related changes in tumors. In addition, FLX Bio will use the platform to assess levels of a variety of inflammation-related and immune cell type-related markers in its ongoing Phase 2 clinical studies of FLX475.

FLX Bio is now enrolling patients with multiple types of cancer in the Phase 1 portion of its open-label, dose-escalation and cohort expansion Phase 1/2 study. The study is being conducted at leading cancer centers across the United States, Australia and Asia. The study will evaluate the tolerability profile of FLX475 as a monotherapy and in combination with pembrolizumab. Additionally, using Personalis’ ImmunoID NeXT Platform as well as other biomarkers, the study will also assess changes in the tumor microenvironment of both monotherapy and combination therapy. For more information please visit clinicaltrials.gov identifier NCT03674567.

"We’re delighted to work with FLX Bio, innovators who share our vision that a more comprehensive approach to tumor immunogenomic profiling is necessary to enable the development of more efficacious, next-generation cancer therapies," Personalis CEO, John West, said. "ImmunoID NeXT is ideal for applications such as this: maximizing the data generated from a single tumor sample with the goal of characterizing the complex interplay between the tumor cells and immune cells of the tumor microenvironment. Our companies share a common belief that the complexity and dynamic nature of the tumor-immune interactions demands that combinatorial biomarkers will likely be required to most effectively predict responders and non-responders to these therapies."

On May 20, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that it closed its previously announced financing for gross proceeds of $10 million (Press release, Cellectar Biosciences, MAY 20, 2019, View Source [SID1234536494]). In a registered direct offering, Cellectar issued 1,982,000 shares of common stock at an offering price of $2.50 per share.

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In a concurrent private placement, Cellectar issued to the purchasers of our common stock in the registered direct offering, Series F warrants to purchase an aggregate of 1,982,000 shares of common stock. The Series F warrants will be exercisable immediately, expire five years after the date of issuance, and have an exercise price of $2.40.

In a separate concurrent private placement transaction, Cellectar sold 2,018,000 shares of common stock together with Series G warrants to purchase an aggregate of up to 2,018,000 shares of common stock. The shares of common stock and Series G warrants were priced at $2.50 per fixed combination. The warrants sold in the private placement will be exercisable immediately, expire five years after the date of issuance, and have an exercise price of $2.40.

Roth Capital Partners served as sole placement agent for the transaction. After placement agent fees and estimated offering expenses payable by the company, the company expects to receive net proceeds of approximately $9.0 million.

The company intends to use the net proceeds from the offering for research and development, funding clinical studies, working capital and general corporate purposes.

The registered offering described above is being made pursuant to a Registration Statement previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). Copies of the prospectus supplement and accompanying base prospectus relating to the registered offering may be obtained from Roth Capital Partners, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660, (800) 678-9147 or by accessing the SEC’s website, www.sec.gov.

The unregistered common shares and warrants were offered pursuant to the exemption from registration afforded by Section 4(a)(2) under the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder. Such common shares, warrants and common shares issuable upon exercise of such warrants have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 20, 2019 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing therapies designed to activate a patient’s immune system against cancer, reported that it will be presenting at the 20th Annual B. Riley FBR Institutional Investor Conference on Thursday, May 23rd, at 3:00 PM, PST at The Beverly Hilton in Beverly Hills, California. Jeff Wolf, Chief Executive Officer of Heat Biologics, will be presenting a company overview (Press release, Heat Biologics, MAY 20, 2019, View Source [SID1234536477]).

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