On June 8, 2020 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has rescheduled its investor conference call to discuss data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) EHA (Free EHA Whitepaper)25 Virtual Congress to 12 June 2020 at 7:30 am EDT, 12:30 pm BST (Press release, Autolus, JUN 8, 2020, View Source [SID1234560937]). This call was previously announced and scheduled for 15 June 2020.

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On the call Dr. Christian Itin, chairman and chief executive officer, along with the AUTO1 and AUTO3 clinical teams, will discuss presentations related to the company’s AUTO1 and AUTO3 programs, CAR T cell therapies being investigated in Phase 1/2 studies of adult Acute Lymphocytic Leukemia (ALL) and relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL), respectively.

Investor call on Friday June 12, 2020

Management will host a conference call and webcast at 7:30 am EDT/12:30 pm BST to discuss the EHA (Free EHA Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to: View Source

On June 8, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that the company plans to present at the following virtual conferences in June (Press release, Iovance Biotherapeutics, JUN 8, 2020, View Source [SID1234560936]):

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Goldman Sachs 41st Annual Global Healthcare Conference
Date/Time: Thursday, June 11, at 3:00 p.m. ET

JMP Securities Hematology and Oncology Forum
Date/Time: Thursday, June 18, at 2:20 p.m. ET
Live and archived webcasts of the presentations will be available in the Investors section of the Iovance website at View Source

On June 8, 2020 Cytokinetics, Incorporated (Nasdaq:CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in a virtual fireside chat at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10 at 4:40 PM EDT, and to participate in the Raymond James Human Health Innovation Conference on June 18, 2020 (Press release, Cytokinetics, JUN 8, 2020, View Source [SID1234560935]).

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Interested parties may access the live webcast of the presentation at the Goldman Sachs 41st Annual Global Healthcare Conference by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On June 8, 2020 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) ("OV" or the "Company") reported that it has acquired the remaining 37% ownership in its priority Dovitinib program from investor Sass & Larsen ApS (Press release, Oncology Venture, JUN 8, 2020, View Source(8%20June%202020,from%20investor%20Sass%20%26%20Larsen%20ApS. [SID1234560934]). As a result of the transaction, the Company now has full control of its most advanced pipeline program.

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The price of the remaining 37 % of OV-SPV2 ApS is agreed to SEK 36 million and a potential royalty payment of 10 % for the first 24 months following the signature of the agreement. The royalty payment, if any, will be of net sales revenues. The payment of the SEK 36 million is made by conversion of the payment into Oncology Venture A/S shares. The conversion price is SEK 1.388 per nominal DKK 0.05 share corresponding to today’s closing price of OV’s share. In total Sass & Larsen will receive 25,936,599 OV shares.

The new shares hold no special rights and will rank pari passus with all other shares in OV. Following the conversion, the Company’s share capital will be nominal DKK 7,974,053.90 divided into 25,936,599 shares of nominal DKK 0.05 each.

In March 2020, the Company announced details of its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential path to approval for Dovitinib used to treat Renal Cell Carcinoma (RCC) (kidney cancer), the current lead indication for the drug. The Company’s proposal is to seek approval based on "non-inferiority" against the already approved compound Sorafenib (Bayer), based on prior Phase 3 trial results (by Novartis). At that time, the Company also announced its plan to file a New Drug Application (NDA) for the approval of Dovitinib for the treatment of RCC late in the second half of 2020.

Dovitinib, a pan-tyrosine kinase inhibitor (TKI) originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of Renal Cell Carcinoma. Annual sales of Sorafenib, under the trade name Nexavar, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billion by 2022. In addition to the RCC market, Dovitinib has promising potential as a monotherapy in a number of other indications, including metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.

Steve Carchedi, CEO of Oncology Venture, stated "We are excited to gain full ownership of our priority Dovitinib program, as we advance towards U.S. submission of our first NDA and towards approval, marketing and sale of this key asset. Our acquisition of the remaining investor interest in this program now provides our Company and our shareholders with the full potential upside of this promising drug, as we bring it towards the market and to cancer patients."

On June 8, 2020 Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, reported that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a "Study May Proceed" letter for the Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities (Press release, Helsinn, JUN 8, 2020, View Source [SID1234560919]).

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The study is intended to be conducted globally and is due to commence in the third quarter of 2020.

TAS0953/HM06 is being developed together with its partner Taiho Pharmaceutical Co., Ltd. In 2017, Helsinn and Taiho signed a global co-development and commercialization agreement for TAS0953/HM06.

TAS0953/HM06 is an investigational oral treatment which inhibits several RET abnormalities identified as oncogenic driver alterations in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. This innovative drug candidate offers several differentiating features as compared to other RET inhibitors.

Sergio Cantoreggi, Group Chief Scientific Officer and Head of R&D at Helsinn, commented: "Helsinn and Taiho have been working closely together as part of a global development partnership and we’re delighted to have reached this latest milestone that will allow us to start treating patients with TAS0953/HM06 in a Phase 1/2 clinical trial starting in the next quarter. We are excited by the potential of TAS0953/HM06 to treat NSCLC and other tumors which harbor RET abnormalities and look forward to working with Taiho to progress the treatment through the clinic."

TAS0953/HM06 is an investigational agent and is not approved for commercial use in any country.

About TAS0953/HM06

TAS0953/HM06 is an oral RET inhibitor in development for advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) and other tumors which express RET gene abnormalities. Preclinical data showed several differentiating features in comparison to other targeted therapies acting on RET abnormalities.

Taiho and Helsinn signed a co-development and commercialization agreement for TAS0953/HM06 in 2017 and will continue to pursue together all preclinical, clinical and CMC developments. This alliance also includes efforts to reach as many patients as possible around the world through their own commercial infrastructures or through valued partners.

About RET abnormalities in NSCLC and other cancers1

RET kinase abnormalities have been identified as targetable oncogenic drivers in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. In NSCLC, RET fusions are more common in younger patients with no prior history of smoking and in those with adenocarcinomas, however the underlying mechanisms remain unknown.

1Helsinn and Taiho research and analysis of ASCO (Free ASCO Whitepaper) 2018; ASCO (Free ASCO Whitepaper) 2019; Cancer Biol Ther 2015; Cell Rep 2017; JCO 2018; Johns Hopkins 2019; Nat Med 2012; Nat Rev Clin Oncol 2018; OMIM; Onco Targets Ther 2019