On September 9, 2021 Navigation Sciences reported that the company has been awarded a $400,000 Phase 1 Small Business Technology Transfer Program (SBIR/STTR) grant from the National Cancer Institute (NCI) to advance the development of a bronchoscope-based tissue marker (NaviSci EndoMarker) for use in its NaviSci Intelligent Surgical System for tissue conserving removal of early-stage lung tumors (Press release, Navigation Sciences, SEP 9, 2021, View Source [SID1234587553]). The NaviSci System, currently undergoing a clinical feasibility study, is designed to accurately determine surgical margins in real-time and enable tumor removal through a targeted, minimally invasive surgery.

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"The EndoMarker we are developing provides a second-generation tumor localization approach to simplify clinical workflow and expand adoption of the system," said Jayender Jagadeesan, Ph.D. Principal Investigator on the grant, Associate Professor at Harvard Medical School, and a Navigation Sciences co-founder. "The initial system in clinical development relies on visual localization or C-arm CT imaging to guide placement of the marker. Bronchoscopy-based placement of the EndoMarker prior to surgery will facilitate use of the NaviSci technology in hospitals that do not have interoperative imaging capabilities."

"Surgery, the standard of care for lung tumors, is evolving as more cancers are being detected early, allowing surgeons to remove less tissue with wedge resections and segmentectomies to conserve lung function," said Raphael Bueno, M.D., a co-investigator on the grant, Chief, Division of Thoracic and Cardiac Surgery, Brigham and Women’s Hospital and a Navigation Sciences co-founder. "The NaviSci System aims to address the critical need in this environment to assess margins in real-time and remove tumors completely, reducing the risk of recurrence."

The NaviSci System localizes a tumor by marking the nodule with a sensor-enabled fiducial marker called a J-Bar that tracks its position. The marker couples with a second sensor on a surgical stapler used to cut the lung during surgery. Use of proprietary software, along with the sensors, provides the surgeon with ‘GPS’ guidance so the distance from the marker (i.e., tumor) to the resection margin can be measured in real time. With support from the grant, the EndoMarker will be developed for bronchoscopy-based placement of the J-Bar.

"The NCI grant programs are highly competitive, and this award provides validation of our innovative approach and the clinical need for tissue-conserving lung surgery and potentially other soft tissue cancers," said Alan D. Lucas, Navigation Science’s CEO. "The number of patients is expected to grow substantially in the coming years with increased adoption of CT screening, driven in part by recommendations that a larger population be tested, along with more favorable reimbursement." Currently, there are more than 225,000 new cases of lung cancer diagnosed in the U.S. annually, of which more than 76,000 are early-stage tumors.

The grant is titled, "Bronchoscopic lung navigation system for accurately excising lung nodules." Hisashi Tsukada, M.D., Ph.D., Assistant Professor of Surgery at Brigham and Women’s Hospital is a co-investigator on the grant, along with Dr. Bueno and Dr. Jagadeesan, the Principal Investigator.

On September 9, 2021 Novocure (NASDAQ: NVCR) reported the United States Food and Drug Administration (FDA) has granted breakthrough designation to the NovoTTF-200T System, a Tumor Treating Fields (TTFields) delivery system intended for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer (Press release, NovoCure, SEP 9, 2021, View Source [SID1234587552]). The designation offers Novocure an opportunity to interact with FDA experts through several different program options to address regulatory topics efficiently as they arise during the premarket review phase and allows for prioritized review of regulatory submissions.

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The FDA granted breakthrough device designation in part based on clinical data from Novocure’s phase 2 pilot HEPANOVA trial testing the safety and efficacy of TTFields together with sorafenib for the treatment of advanced liver cancer. In granting the designation, the FDA determined that the TTFields delivery system for advanced liver cancer is a breakthrough technology that has the potential to be a more effective treatment for this life-threatening condition, and therefore meets the FDA’s stringent requirements for breakthrough device designation.

"We are very pleased that the FDA has granted breakthrough designation for Tumor Treating Fields together with atezolizumab and bevacizumab to treat advanced liver cancer," said Asaf Danziger, Novocure’s CEO. "Our data suggest that TTFields have the potential to extend survival in this particularly aggressive disease. We are working closely with trial investigators and intend to initiate a randomized controlled trial studying TTFields in combination with atezolizumab and bevacizumab as soon as possible."

TTFields are electric fields that disrupt cancer cell division. TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields have exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

Use of Tumor Treating Fields for the treatment of liver cancer is investigational only.

About Liver Cancer

Liver cancer is a leading cause of cancer deaths worldwide and is the sixth leading cause of cancer deaths annually in the U.S. The incidence of liver cancer is approximately 42,000 new cases annually in the U.S. The five-year survival rate with existing standards of care is less than 20%.

Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver. Advanced liver cancer has spread either to the lymph nodes or to other organs and because these cancers are widespread, they cannot be treated with surgery. The current common standard treatment for patients with advanced disease and those who progressed on loco-regional therapy is systemic therapy with sorafenib, lenvatinib, or atezolizumab plus bevacizumab.

On September 9, 2021 Vitalgenics Inc, a clinical stage biopharmaceutical company specializing in pancreatic cancer, reported that it has unraveled the etiology of pancreatic ductal adenocarcinoma (PDAC) with their FDA repurposed immunotherapy drug called Excindogen. 95% of all pancreatic cancers are PDAC with a 7%- 9% survival rate after 5 yearsb (Press release, Vitalgenics, SEP 9, 2021, View Source [SID1234587551]).

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PDAC consist of 40 continuous biological sequences within the pancreatic duct that upsets pancreatic duct homeostasis, initiated by bile toxicity, which starts a chain of events that make up tumor formation, tumor growth and metastasis. Some of the major sequences within the duct consist of neurotransmitters, cell signaling, ion channels, efflux pumps, hypoxia, DNA damage, several gene expressions such as KRAS, metabolic imbalances, manufacture of dense stroma and most important T- Cell exhaustion where the T- cells cannot attack and kill off the tumor. CEO Charles Owen states "it is like a faucet on full that cannot be turned off." To turn off the faucet, homeostasis of the pancreatic duct needs to be stabilized so the T-cells can be reactivated to attack and kill off the tumor. The tumor consists of three major cells- The acinar "cancer" cell, the hijacked macrophage cell and the inflammatory cell, causing a "vicious cycle" where they feed on each other and where they proliferate that cannot be resolved with current chemotherapy.

In preclinical studies, immunotherapy drug Excindogen, has proven to inhibit the major sequences listed above, having the capability of "turning off the faucet" and returning homeostasis back to normal so that T-cells can reactivate, attack and kill tumors, while programming adaptive immunity so the tumor has a less of a chance of returning. Preclinical studies have also shown that Excindogen is non- toxic with no major side effects which will make a huge impact with patients. Toxicity and side effects are the main reason patients are non-compliant with current chemotherapy drugs. Excindogen has received orphan drug designation.

Vitalgenics Inc, is seeking capital to enter a phase 1/2 clinical trial and FDA submissions for advanced stage pancreatic cancer. For more information on the biological sequences or Excindogen please contact:

On September 9, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the first patient has been dosed in the SELECT-AML-1 clinical trial of tamibarotene, its first-in-class selective retinoic acid receptor alpha (RARα) agonist, in combination with venetoclax and azacitidine (Press release, Syros Pharmaceuticals, SEP 9, 2021, View Source [SID1234587550]). The randomized Phase 2 trial is enrolling RARA-positive newly diagnosed unfit patients with acute myeloid leukemia (AML).

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"Despite recent advances, one third of newly diagnosed unfit AML patients still don’t respond to front-line treatment and many more relapse," said Eytan M. Stein, M.D., Assistant Professor of Medicine and Director of the Program for Drug Development in Leukemia at Memorial Sloan Kettering Cancer Center. "These patients need new therapies that can deliver durable remissions with minimal or manageable toxicities. I am encouraged by tamibarotene’s distinct safety profile, as well as the compelling clinical and translational data that has emerged, suggesting it may benefit patients in the greatest need of new treatment options. I look forward to further exploring its potential in this clinical trial as part of a triplet regimen with venetoclax and azacitidine."

Tamibarotene has demonstrated promising results in combination with azacitidine in RARA-positive newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. At the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020, Syros presented data from a Phase 2 clinical trial, demonstrating a 67% overall response rate and a 61% composite complete response (CR/CRi) rate. The data also showed that tamibarotene in combination with azacitidine was generally well-tolerated, with no evidence of increased myelosuppression compared to single-agent azacitidine.

Also at ASH (Free ASH Whitepaper), Syros presented translational data demonstrating that most RARA-positive newly diagnosed unfit AML patients in the Phase 2 trial of tamibarotene had a monocytic disease phenotype associated with resistance to venetoclax, which, in combination with azacitidine, is the standard of care for newly diagnosed unfit patients. These data suggest that the RARA biomarker selects for patients who are more likely to benefit from tamibarotene and who may be less likely to benefit from venetoclax.

"AML is a complex, heterogenous disease, and many patients may present upfront with both monocytic and non-monocytic leukemia cells," said David A. Roth, M.D., Chief Medical Officer at Syros. "By employing a triplet strategy that combines tamibarotene with venetoclax and azacitidine, we believe we can simultaneously target both cell types, reducing the emergence of resistant disease and increasing the likelihood of deeper and more durable responses. We are excited to be actively enrolling patients in this study, as we advance our portfolio of targeted hematology therapies with the aim of setting new standards of care for people with acute leukemias and myelodysplastic syndrome."

The SELECT-AML-1 trial is designed with a single-arm safety lead-in, followed by the randomized portion of the trial, which will evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in approximately 80 patients randomized 1:1. The trial will also evaluate the triplet regimen as a salvage strategy in patients in the control arm who do not respond to venetoclax and azacitidine. The primary endpoint of the trial will be composite CR rate.

Syros is also evaluating tamibarotene in combination with azacitidine in the SELECT-MDS-1 Phase 3 clinical trial in RARA-positive patients with newly diagnosed higher-risk myelodysplastic syndrome.

On September 9, 2021 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, today announces that 4D pharma management will present at the following virtual investor conferences (Press release, 4d Pharma, SEP 9, 2021, View Source [SID1234587549]):

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H.C. Wainwright 23rd Annual Global Investment Conference at 07:00 ET (12:00 BST) on Monday, September 13, 2021
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 08:15 ET (13:15 BST) on Wednesday, September 22, 2021
A webcast of each presentation will be available via the ‘Events’ section of the 4D pharma website at www.4dpharmaplc.com. Archived replays of the webcasts will be available for 90 days following the presentation.