On August 31, 2020 Oasmia Pharmaceutical’s CEO Francois Martelet reported that it will present at Aktiespararna’s Aktiedagen Digital (Press release, Oasmia, AUG 31, 2020, View Source [SID1234564165]). The presentation starts at 10:20 CEST and will be broadcasted live as a webcast at: www.aktiespararna.se/tv/live

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will also be available on Oasmia Pharmaceutical’s website after the seminar.

On August 31, 2020 FUJIFILM Toyama Chemical Co., Ltd. (Head Office: Chuo-ku, Tokyo; President: Junji Okada; hereinafter "FUJIFILM Toyama Chemical") reported that it filed an application to the Ministry of Health, Labour and Welfare for marketing authorization approval its new radiopharmaceutical compound F-1515 (INN: lutetium [177Lu] oxodotreotide) for the treatment of pancreatic, gastrointestinal, and pulmonary neuroendocrine tumors (Press release, Fujifilm, AUG 31, 2020, View Source [SID1234564164]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

F-1515 is an agent for peptide receptor radionuclide therapy (PRRT), a type of radioligand therapy (RLT)*1, using a somatostatin*2 analog labeled with a radioisotope, lutetium-177 (177Lu). Neuroendocrine tumors originate in neuroendocrine cells that secrete hormones and peptides. They develop in a variety of organs throughout the body, in particular the pancreas, gastrointestinal tract, and lungs. Many neuroendocrine tumors are diagnosed in relatively advanced stages. Once the disease has advanced to stages where surgical resection—the first-line treatment—is no longer possible, drug therapy is selected but choice is limited. It is therefore a disease with a high unmet medical need.

In 2015, FUJIFILM Toyama Chemical concluded a licensing agreement with Advanced Accelerator Applications International S.A. (hereinafter "AAA"), a Novartis company, for the domestic development and marketing of F-1515, also known as Lutathera in markets where the drug is already approved. Lutathera is currently approved in various countries and regions including 32 European countries, the United States, Canada, Israel, South Korea, Singapore and Hong Kong. Since then, FUJIFILM Toyama Chemical has carried out clinical development of the drug as "F-1515."

A phase I clinical study and a phase I-II clinical study conducted recently in Japan confirmed the drug’s efficacy and safety in Japanese patients with somatostatin receptor positive, pancreatic, gastrointestinal, and pulmonary neuroendocrine tumors.

Together with F-1515, the company also filed an application for marketing authorization of LysaKare*3 (INN: L-lysine hydrochloride/L-arginine hydrochloride. Domestic development code: F-1520), an amino acid solution used during administration of Lutathera, whose domestic development and marketing rights have been obtained from AAA.

By adding a radiopharmaceutical therapeutic F-1515 to the OctreoScan Injection Kit (for the preparation of indium pentetreotide [111In] injection), a radiopharmaceutical diagnostic for neuroendocrine tumors that is already being marketed in Japan, FUJIFILM Toyama Chemical will expand its offer of comprehensive solutions for disease management, from diagnosis imaging to therapy.

Going forward, FUJIFILM Toyama Chemical will continue to contribute to enhancing medicine even further by delivering high value-added drugs.

* 1 A type of therapy in which ligands, or targeting molecules that specifically bind to receptors expressed by a tumor are labeled with radioactive substances and administered to patients to irradiate the target foci from inside the body. PRRT is a style of RLT.

* 2 A peptide hormone consisting of fourteen amino acids that are produced in the hypothalamus, the pituitary gland, as well as the delta cells in the pancreatic islets of Langerhans. It has actions that inhibit the secretion of growth hormone, insulin, etc. Because somatostatin receptors are highly expressed in neuroendocrine tumors, somatostatin is considered one of the effective targets of neuroendocrine tumor treatment drugs.

* 3 An amino acid solution for reduction of renal (kidney) radiation exposure during therapy with Lutathera.

On August 31, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that the Centers for Medicare & Medicaid Services (CMS) did not issue the proposed decision memo for its National Coverage Analysis (NCA) for Screening for Colorectal Cancer with Blood-Based Biomarker Tests by the statutory due date of August 28, 2020 (Press release, Epigenomics, AUG 31, 2020, View Source [SID1234564163]). CMS is actively working on the decision, and its goal is to publish the decision as soon as possible.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While we are disappointed CMS did not meet its statutory timeline, we recognize the agency’s resources are stretched because of the pandemic," said Greg Hamilton CEO of Epigenomics. "We remain confident that CMS will issue a positive proposed decision based upon the clinical evidence and are hopeful the agency will publish it as quickly as possible."

On August 31, 2020 Sun BioPharma, Inc. (OTCQB:SNBP Nasdaq:SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported the pricing of an underwritten public offering of 2,545,454 shares of common stock and the same number of warrants to purchase shares of common stock for a price to the public of $4.125 per share and warrant (Press release, Sun BioPharma, AUG 31, 2020, View Source [SID1234564155]). Gross proceeds to the company are expected to be approximately $10.5 million. Each warrant entitles the holder to purchase one share of common stock at an exercise price of $4.54 per share.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sun BioPharma also announced that, in connection with the offering, its common stock has been approved for listing on the Nasdaq Capital Market and will begin trading on the Nasdaq Capital Market under the symbol "SNBP" on August 28, 2020.

The offering is expected to close on September 1, 2020, subject to the satisfaction of customary closing conditions. The company intends to use the net proceeds of the offering for working capital and general corporate purposes, including the continued development of our initial product candidate SBP-101.

Craig-Hallum Capital Group is acting as sole book-running manager for the offering.

A registration statement relating to the securities being sold in this offering was filed with the Securities and Exchange Commission (SEC) on July 2, 2020 and was declared effective on August 27, 2020. 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. Copies of the final prospectus will be filed with the Securities and Exchange Commission and, when available, electronic copies of the final prospectus may be obtained by contacting Craig-Hallum Capital Group at 222 South Ninth Street, Suite 350, Minneapolis, Minnesota 55402, Attention: Equity Capital Markets, by telephone at 612-334-6300, by email [email protected], or by accessing the SEC’s website, www.sec.gov.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial.

On August 31, 2020 Addario Lung Cancer Medical Institute (ALCMI) and Biodesix, Inc. reported they will begin an observational study to prospectively evaluate the clinical utility of biomarkers, including the proteomic Primary Immune Response (PIR) test, for front-line non-small cell lung cancer (NSCLC) patients receiving immunotherapy with and without the addition of systemic platinum-based chemotherapy who have high expression of program death ligand-1 (PD-L1) on their tumor cells (Press release, Biodesix, AUG 31, 2020, View Source [SID1234564154]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Biodesix is a leader in lung cancer diagnostic solutions, and has developed a serum-based proteomic test, Primary Immune Response (PIR) that, in retrospective studies, identified a pretreatment immune profile that predicts response to anti-PD-1 therapy.

ALCMI is a patient-founded not-for-profit global research consortium dedicated to catalyzing and accelerating the discovery, development, and delivery of new and more effective treatment options for lung cancer patients.

Together, they aim to enroll 390 treatment naïve advanced stage non-squamous NSCLC patients with ≥50 percent expression of PD-L1 at leading cancer institutions in the U.S.

"Immunotherapy has revolutionized our treatment of lung cancer patients. Many patients, especially those with high expression of the associated PD-L1 marker, prefer a nonchemotherapy treatment option. Clinical experience, however, suggests that this may not be the best therapy for all of these patients," said Mary Jo Fidler, MD, Rush University Medical Center.

Adding systemic chemotherapy (carboplatin and pemetrexed) to pembrolizumab, an FDAapproved triplet immunotherapy regimen (Langer Lancet Oncol. 2016) independent of PD-L1 status, may be a way to mitigate rapidly progressive disease in high PD-L1 expressers receiving pembrolizumab monotherapy. However, applying the triplet combination to all patients with PDL1 ≥50 percent may expose them to increased side effects and cost of therapy without additional benefit.

"ALCMI is dedicated to improving overall survival for all lung cancer patients in the most targeted way possible," said Tony Addario, ALCMI chair and CEO. "This study reflects that commitment and will drive the pursuit of new and better care options for patients with NSCLC."

"ALCMI is dedicated to improving overall survival for all lung cancer patients in the most targeted way possible," said Tony Addario, ALCMI chair and CEO. "This study reflects that commitment and will drive the pursuit of new and better care options for patients with NSCLC."

In a study presented at the European Society for Medical Oncology, the Biodesix PIR test demonstrated utility in retrospectively classifying second-line NSCLC patients treated with nivolumab by overall survival. The immunotherapy resistant subgroup in the test demonstrated activation in the complement, acute phase, extra-cellular matrix and wound healing pathways. The proteomic test classification is independent of PD-L1 status and uses mass spectrometry in combination with machine learning to analyze circulating proteins in blood.

"We know that immunotherapy by itself does not work for everyone," said Scott Hutton, CEO of Biodesix. "With the physical and financial toxicity associated with these therapies, a biomarker that can predict survival or early death would be critical in determining the best therapeutic regimen for lung cancer patients."