On October 13, 2020 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that it has dosed the first patient in its phase 1/2 adaptive-design clinical trial of its lead-product-candidate, LNS8801, in combination with KEYTRUDA (pembrolizumab) in patients who had previous clinical benefit from immune checkpoint inhibitors and then subsequently progressed (Press release, Linnaeus Therapeutics, OCT 16, 2020, View Source [SID1234568569]). This marks the first time any company has dosed a patient in a clinical trial specifically targeting the G protein-coupled estrogen receptor (GPER) in combination with pembrolizumab. The initiation of the study follows the successful identification of the recommended phase 2 dose (RP2D) in the Company’s ongoing study of LNS8801.

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LNS8801 is an orally bioavailable small molecule that is a highly specific and potent agonist of the GPER. LNS8801 is currently finishing the dose escalation portion of its phase 1/2 study assessing the safety, tolerability, pharmacokinetics and preliminary efficacy in patients with advanced cancer.

"We are extremely pleased to begin testing LNS8801 in combination with pembrolizumab in this patient population. In our phase 1 trial of LNS8801 we have seen biological and clinical signals that suggest LNS8801 in combination with pembrolizumab may have activity based on the preclinical rationale and reverse resistance to immune checkpoint inhibitors. We currently have six outstanding academic comprehensive cancer centers all enthusiastically recruiting patients for this promising study," commented Patrick Mooney, MD, chief executive officer of Linnaeus. "We believe that LNS8801 with pembrolizumab has potential to provide meaningful clinical benefit for patients with cancer, and we look forward to providing updates over the course of the study."

The study entitled, "A Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients with Advanced Cancer Including Immunotherapy Refractory Expansion Cohorts with and without Pembrolizumab," was designed in two parts. The phase 1 dose-escalation portion of the trial assessed the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of LNS8801. Data from the study has allowed Linnaeus to determine the RP2D and safely open the phase 2 dose-expansion cohorts. Linnaeus anticipates opening several more phase 2 dose-expansion cohorts exploring LNS8801 activity as a monotherapy and in combination with other compounds in defined patient populations in the coming year.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About LNS8801
LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing phase 1/2 study in humans, LNS8801 monotherapy has been safe and well-tolerated. Additionally, LNS8801 has demonstrated target engagement and clinical benefit in advanced cancer patients. Data from the phase 1/2 study is anticipated to be presented in a peer-reviewed setting in 2021.

On October 16, 2020 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported new data supporting the mechanism of action of NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3 is being presented in a video recorded presentation at the Epigenetics and Metabolism AACR (Free AACR Whitepaper) Special Virtual Conference by researchers at Tel-Aviv University (Press release, Kitov Pharmaceuticals , OCT 16, 2020, View Source [SID1234568556]). The data was generated as part of the Company’s collaboration with Professor Ido Wolf, Head of the Oncology Division, Tel Aviv Sourasky Medical Center.

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The new data demonstrates IRS2-amplified colorectal cancer (CRC) cells upregulate β-catenin expression, and treatment with NT219 significantly decreased the β-catenin transcriptional activity in these cells. In addition, NT219 markedly inhibited cell viability in a dose-dependent manner. Moreover, there was a unique role for IRS2 in promoting brain metastasis of CRC, suggesting AKT and β-catenin pathways downstream of IRS2 may be involved in mediating the enhanced aggressive phenotype of IRS2-amplified CRC cells in the brain microenvironment. β-catenin signaling by Wnt has been shown to have a number of different cellular influences. Besides cellular proliferation via protein stabilization to promote cellular growth, Wnt/ β-catenin has demonstrated a role in the establishment of the blood brain barrier and impacts the tumor microenvironment, associated with the therapeutic resistance of cancer cells (Dzobo et al, 2019).

"These new mechanism of action data, together with the compelling results from our preclinical studies of NT219, further support the rationale behind combining NT219 with various targeted and immune oncology approaches, both in peripheral and nervous system tumor tissues," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Kitov. "We are currently enrolling patients in our Phase 1/2 clinical trial of NT219 as monotherapy for the treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma. We expect top-line data from the first part of this important study in the second half of 2021."

Previously completed preclinical studies demonstrated NT219’s ability to overcome cancer drug resistance in patient-derived xenograft (PDX) models of various advanced cancer types, and to revert resistance to pembrolizumab (Keytruda). Mice treated concomitantly with a combination of pembrolizumab and NT219 demonstrated complete blockage of tumor progression. Similarly, the combination of NT219 with cetuximab sensitized resistant tumors to this therapy.

On October 16, 2020 Cellectis S.A. (NASDAQ: CLLS – EURONEXT GROWTH: ALCLS) reported that its majority-owned subsidiary Calyxt, Inc. (NASDAQ: CLXT), a plant-based technology company, has entered into definitive agreements with institutional investors for the purchase and sale of 3,750,000 shares of Calyxt’s common stock, at a purchase price of $4.00 per share, in a registered direct offering (Press release, Cellectis, OCT 16, 2020, View Source [SID1234568555]). Cellectis subscribed to purchase 1,250,000 shares in the offering. Following the registered direct offering, Cellectis will own approximately 64.7% of Calyxt’s outstanding shares of common stock.

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The closing of the offering is expected to occur on or about October 20, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the transaction.

The gross proceeds to Calyxt from this offering are expected to be $15 million, before deducting the placement agent’s fees and other offering expenses payable by Calyxt. Calyxt intends to use the net proceeds from this offering for general corporate purposes, including to advance its current product development pipeline, to continue to advance its TALEN technology and its intellectual property portfolio, and to support the execution of its streamlined business model.

The shares of Calyxt’s common stock are being offered by Calyxt pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233231) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on September 27, 2019. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

On October 16, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, reported that the German Federal Joint Committee (G-BA) has successfully completed the method evaluation assessment for the EndoPredict breast cancer prognostic test (Press release, Myriad Genetics, OCT 16, 2020, https://investor.myriad.com/news-releases/news-release-details/german-federal-joint-committee-g-ba-issues-nationwide [SID1234568554]). The positive decision means that EndoPredict can be made available to all patients with statutory health insurance in Germany as a benefit of the statutory health insurance scheme.

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EndoPredict is a second-generation biomarker test used to determine the risk of recurrence in patients with early-stage breast cancer (ER+/HER2-). The genomic test helps patients and physicians jointly decide for, or against, chemotherapy when uncertainties exist in the assessment of the expected benefit of chemotherapy.

"This decision (by G-BA) makes it possible for a biomarker test to be carried out quickly in Germany, providing more certainty with the difficult decisions relating to the pros and cons of chemotherapy," says Univ Prof. Dr. Marion Kiechle, Director of the Gynaecological Clinic of the University Hospital Rechts der Isar of the TU Munich.

Every year, approximately 70,000 women in Germany are diagnosed with early-stage, breast cancer. For up to 20,000 of these patients, clinical-pathological criteria alone are not sufficient to confidently make chemotherapy treatment decisions. The Federal Joint Committee supports the use of biomarkers, now including EndoPredict, to identify those patients who will likely benefit from chemotherapy treatment.

EndoPredict has been part of the recommendations of the leading national (AGO, S3) and international (St.Gallen, ESMO (Free ESMO Whitepaper), ASCO (Free ASCO Whitepaper) and NCCN) guidelines for many years and is already available to affected women in public health systems in France, England, Italy, Spain, Switzerland and Austria.

"We are pleased to make EndoPredict broadly available to gynecologists and pathologists in Germany within the framework of the GKV," said Raymond Francot, executive vice president of Myriad International. "This decision expands access to critical, life-changing insights for patients and their providers, and adds valuable information to aid in personalized treatment selection."

About EndoPredict
EndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 30,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: View Source

On October 15, 2020 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), reported that it has been invited to participate in the Cancer Innovation Summit (Press release, PLUS THERAPEUTICS, OCT 15, 2020, View Source [SID1234572293]). The meeting, which is hosted by Health Tech Austin, is being held virtually on Thursday, October 22 from 12.00 to 3.00 p.m. EDT.

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Gregory Stein, M.D., Senior Vice President of Clinical Development at Plus Therapeutics will present as part of the Cancer Drug Showcase, which features novel cancer technologies from across the industry.

Register for the meeting webcast here: View Source

The Cancer Innovation Summit brings together thought leaders and innovators to share knowledge, experience, research and insights about cancer innovation.