On March 8, 2018 Kitov Pharmaceuticals (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, reported that Dr. Gil Ben-Menachem, VP Business Development of TyrNovo, a Kitov Pharmaceuticals company, will present recent results from pre-clinical studies with NT219, a novel dual inhibitor of STAT3 and IRS1/2, at the 2018 BIO-Europe Spring Conference at the RAI Convention Center, in Amsterdam, The Netherlands (Press release, Kitov Pharmaceuticals , MAR 8, 2018, View Source [SID1234524562]).

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NT219 is an innovative, unique small molecule targeting IRS1/2 and STAT, two signal proteins that are part of an anti-cancer drug resistance mechanism. In various preclinical models where NT219 was administered in combination with various oncology therapies, outstanding efficacy in preventing acquired resistance and reversing tumor resistance was demonstrated.

Details on the presentation are as follows:

Presenter: Dr. Gil Ben-Menachem
Category: Oncology
Date and Time: Tuesday, 13 March, 2018, 4:45 PM
Location: Room E105, RAI Convention Center

BIO-Europe Spring is a registered trademark of EBD Group AG and the Biotechnology Industry Organization

About NT219

NT219 is a small molecule that presents a new concept in cancer therapy by promoting the degradation and the phosphorylation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and signal transducer and activator of transcription 3 (STAT3), respectively. While targeted anti-cancer drugs inhibit the "ON" signal, NT219 activates the "OFF" switch, extensively blocking major oncogenic pathways. In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers, by preventing the tumors from developing drug resistance and reversing resistance after it has been acquired

On March 8, 2018 Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, reported that approval of Clinical Trial Application (CTA) for its cancer neoantigen phase I/IIa trial by German regulatory authorities (Paul Ehrlich Institute (PEI) (Press release, Vaccibody, MAR 8, 2018, View Source [SID1234525139]).

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Dr. Martin Bonde, Chief Executive Officer in Vaccibody, said "The regulatory approval of this sophisticated study with our individualized neoantigen vaccine VB10.NEO is a critical milestone for the company. We are evaluating the safety, feasibility, and efficacy of VB10.NEO in combination with standard of care checkpoint inhibitor therapy. The clinical trial will enroll patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder, and head&neck cancer. A total of 40 patients are planned to be enrolled in the phase I part of the trial."

Calithera Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Calithera Biosciences, 2018, MAR 8, 2018, View Source [SID1234524606]).

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On March 8, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that members of the company’s management team will present at Cowen & Company’s 38th Annual Healthcare Conference on Wednesday, March 14, 2018, at 10:40 a.m. ET in Boston (Press release, Foundation Medicine, MAR 8, 2018, View Source [SID1234524540]).

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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

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A live, listen-only webcast of the presentation may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the presentation and will be archived on the company’s website for 90 days.

On March 8, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the fourth quarter and full-year ended December 31, 2017 (Press release, Mirati, MAR 8, 2018, View Source [SID1234524564]).

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"We made significant progress in our key programs in 2017," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Promising data from the sitravatinib and KRAS programs encouraged us to pursue a more aggressive approach to accelerate development, supported by the successful financing we completed in November. In early 2018, we initiated a strategic regional partnership with BeiGene Ltd. that we anticipate will rapidly expand the development of sitravatinib in multiple tumor types. We expect to report multiple key catalysts in 2018, including a mid-year clinical update for our sitravatinib program. Our KRAS inhibitor program, an important yet elusive target, is growing and we remain on track for an IND filing in the fourth quarter of 2018."

Recent Corporate Highlights

Sitravatinib clinical data presented at 2017 IASLC World Conference on Lung Cancer
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Combination of sitravatinib and nivolumab in non-small cell lung cancer (NSCLC) patients with documented progression following checkpoint inhibitor therapy demonstrated 3 confirmed Partial Responses in first 11 evaluable patients
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First evaluable NSCLC patient with CBL inactivating mutation treated with single agent sitravatinib demonstrated confirmed Partial Response with 77% tumor reduction

KRAS G12C lead candidates selected and advanced into IND-enabling development activities
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Significant achievement in development of a direct inhibitor of KRAS, a well-known but previously undruggable cancer mutation
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A potentially transformational, first-in-class treatment for 14% of NSCLC and 5% of colorectal cancer patients
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Program is on track to advance to IND filing in the fourth quarter of 2018

Exclusive license agreement initiated with BeiGene Ltd. for the development, manufacture and commercialization of sitravatinib in Asia (excluding Japan), Australia and New Zealand
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Expected to accelerate development of sitravatinib in NSCLC as well as other key indications including bladder, renal and hepatocellular cancer

$86.7M public offering completed in November 2017; $150.8M of cash, cash equivalents and short-term investments as of December 31, 2017

Fourth Quarter and Full Year Financial Results
Cash, cash equivalents, and short-term investments were $150.8 million on December 31, 2017, as compared to $56.7 million on December 31, 2016.

Research and development expenses for the fourth quarter of 2017 were $15.2 million, compared to $16.0 million for the same period in 2016. Research and development expenses for the year ended December 31, 2017 were $58.1 million, compared to $68.5 million for the same period in 2016. The decrease in research and development expenses for both periods is primarily due to a reduction in glesatinib expenses and a reduction in share-based compensation expense. These decreases are partially offset by increases in expenses associated with our ongoing sitravatinib clinical trials.

General and administrative expenses for the fourth quarter of 2017 were $3.0 million, compared to $3.9 million for the same period in 2016. General and administrative expenses for the year ended December 31, 2017 were $13.5 million, compared to $15.3 million for the same period in 2016. The decrease in general and administrative expense for both periods is primarily due to a decrease in share-based compensation expense.

Net loss for the fourth quarter of 2017 was $17.9 million, or $0.67 per share basic and diluted, compared to net loss of $19.7 million, or $0.99 per share basic and diluted for the same period in 2016. Net loss for the year ended December 31, 2017 was $70.4 million, or $2.78 per share basic and diluted, compared to net loss of $83.1 million, or $4.20 per share basic and diluted for the same period in 2016.