On August 31, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported new preclinical data providing the first evidence that an E-selectin targeting strategy with uproleselan may help patients with acute myeloid leukemia (AML) to overcome resistance to venetoclax and hypomethylating agent (HMA)-based therapy (Press release, GlycoMimetics, AUG 31, 2020, View Source [SID1234564168]). The poster (Abstract #AML-337) entitled "Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy," will be presented September 9 from 6:15-8:15 p.m. CDT on the virtual platform of the virtual meeting of the Society of Hematologic Oncology (SOHO).

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The data presented are from an animal model created using tissue derived from a patient who had developed resistance to venetoclax/HMA. In this model, the addition of uproleselan to the treatment regimen demonstrated robust anti-leukemic activity and a statistically significant prolongation of survival. The research strongly supports the opportunity for additional clinical evaluation of the triple combination of uproleselan, venetoclax and HMA in the frontline, unfit AML patient population.

"We know that binding leukemic cells to E-selectin within the bone marrow niche up-regulates pro-survival mechanisms. This preclinical study shows that by blocking this activity with uproleselan, we can enhance the sensitivity to venetoclax/HMAs. This supports using this treatment regimen to potentially improve outcomes in patients whose duration of response is typically very short," said John Magnani, Ph.D., GlycoMimetics’ Senior Vice-President of Research and Chief Scientific Officer. "We are excited to share this encouraging data and hope that additional clinical evaluation will provide more insight on the potential of this combination-therapy approach."

Visit the meeting’s website for more information: View Source, The virtual meeting will be held September 9-12, 2020.

About Uproleselan (GMI-1271)

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

On August 31, 2020 Erasca, a company whose mission is to erase cancer, reported the completion of a $36 million extension of its Series B financing round, which brings the total round to $236 million (Press release, Erasca, AUG 31, 2020, View Source [SID1234564167]). New investors include Partner Fund Management and OrbiMed.

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This financing brings the total capital raised by the company to $300 million. Erasca will use the proceeds to finance the clinical development of multiple promising oncology programs, continue driving corporate development efforts and further advance the company’s in-house drug discovery pipeline.

"Erasca is honored to welcome Partner Fund Management and OrbiMed as partners in our bold mission of erasing cancer," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO and co-founder. "We are doing everything we can to help patients live longer and healthier lives. Because cancer is such a formidable foe, we are grateful to have the support of our new and existing investors to tackle this terrible disease."

The company has assembled a robust pipeline of precision therapies directed at undisclosed targets through in-house drug discovery as well as active pipeline expansion via collaborations with world-class academic and biopharmaceutical organizations.

"Erasca has demonstrated impressive progress in less than two years since its founding," said Mark Karvosky, a partner at Partner Fund Management. "The company’s portfolio of potentially first-in-class and best-in-class assets will target significant unmet medical needs across multiple cancer types. We are excited to support this team and its programs, as Erasca strives to deliver practice-changing precision oncology therapies."

On August 31, 2020 The board of directors of Targovax ASA (OSE:TRVX) ("Targovax" or the "Company") reported that it has resolved to increase the share capital of the Company following the completion of a settlement period for vested restricted stock units ("RSUs") (Press release, Targovax, AUG 31, 2020, View Source [SID1234564166]). The settlement period commenced on 21 August 2020 at 10:00 hours (CEST) and ended on 28 August 2020 at 10:00 hours (CEST).

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In total were 88,272 RSUs settled, giving the RSU holders the right to subscribe for in total 88,272 shares, each with a par value of NOK 0.10, at a subscription price of NOK 0.10 per share.

1. Settlement of RSUs by primary insider

Bente-Lill Romøren, member of the board of directors and primary insider in the Company (the "Primary Insider"), settled 9,399 RSUs on 28 August 2020, which were granted at the AGM in 2017 and 2018, giving the Primary Insider the right to subscribe for an equal amount of shares in the Company at a price of NOK 0.10 per share.

The Primary Insider received the RSUs as part of her remuneration for her directorship at the board. The number of RSUs granted was calculated as the NOK amount of the RSU selected portion of the total remuneration to the board member, divided by the market price for the shares, calculated as the volume weighted average share price for the 10 trading days prior to the AGM, being NOK 23.88 per share in 2017 and NOK 14.33 per share in 2018.

2. Resolution to increase the share capital in Targovax ASA

The Company’s board of directors has on 30 August 2020, in accordance with the authorisation granted by the general meeting on 29 April 2020, resolved to increase the share capital of the Company with NOK 8,827.20 by issuance of 88,272 new shares, each with a par value of NOK 0.10, in order to facilitate the settlement of RSUs.

The share capital increase will be registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret) as soon as practically possible. The new share capital of the Company will be NOK 7,617,576.40, divided into 76,175,764 shares, each with a par value of NOK 0.10.

3. New shareholding for primary insider

Following the Primary Insider’s subscription of shares and registration of the Company’s new share capital, the Primary Insider and her close associates will hold 20,327 shares, 15,250 RSUs and nil options in the Company.

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

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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]).

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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.