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 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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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.

On March 8, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported on the development and commercial launch timeline of DetermaVu, its liquid biopsy lung cancer diagnostic test (Press release, BioTime, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337172 [SID1234524610]).

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As reported in November 2017, during the process of running initial samples for the Clinical Validation Study inconsistent analytic results were observed by OncoCyte’s technical team. OncoCyte determined that this was caused by a variance in the lots of consumables used in the sample-processing system that analyzes blood samples for markers that may indicate whether lung nodules found in patients are benign or suspicious. OncoCyte has been actively engaged with NanoString to more completely understand the issues that have delayed the DetermaVu validation study. The work with NanoString is ongoing. The work to date continues to support OncoCyte’s conclusion that the previous studies of DetermaVu were not impacted by this consumables issue and the positive results reported previously have not changed.

In addition to assessing the NanoString platform’s commercial applicability, OncoCyte is actively evaluating alternative assay platforms for use with its molecular biology diagnostic testing. OncoCyte is announcing the encouraging initial results of its initial clinical sample feasibility study on the Illumina Sequencing platform. The Illumina platform is a market-leading platform for molecular biology testing in the clinical Laboratory Developed Test (LDT) space. While further testing is needed, OncoCyte’s initial results indicate that the Illumina platform could provide consistent and robust support for the further clinical development studies that are necessary for the commercialization of DetermaVu.

Lyndal Hesterberg, OncoCyte’s Senior Vice President of Research and Development, stated, "The initial feasibility results on an established clinical platform may provide OncoCyte with an alternative path to clinical validation and commercial launch of the DetermaVu product in 2018. We will be pursuing the next steps to further assess the Illumina platform, along with other commercially established clinical molecular testing platforms, and we are encouraged by the results of this initial feasibility study."

OncoCyte has also identified ways that potentially may enhance the lung cancer signal identified by DetermaVu and has incorporated this approach into a revised algorithm. This revised algorithm was tested on about 60 clinical samples and resulted in accuracy (as measured by Area Under the Curve (AUC) data) equivalent or superior to previously reported results, although the error bar or potential range of results from this small sample set is wide and the results must be confirmed in a larger sample set.

Because of these developments, OncoCyte is extending its evaluation of the commercial molecular diagnostic platforms by doing a follow-on study utilizing a larger set of clinical samples. The Company expects to complete the process during the second quarter of 2018. After concluding this process, data will be available to determine which platform delivers the most accurate, consistent and robust test results while maintaining a reasonable cost of goods. The Company then intends to complete product development on the selected platform by carrying out an R&D Validation Study followed by an Analytical Validation Study. If these studies are successfully completed, OncoCyte intends to conduct a Clinical Validation Study. Clinical validation is the final step prior to commercial launch, which is still anticipated during 2018. OncoCyte has collected all the samples necessary for carrying out all these studies.

"The results from our recent evaluation of commercially available molecular testing platforms support our continued confidence in DetermaVu as a confirmatory test for the diagnosis of early stage lung cancer," commented William Annett, President and Chief Executive Officer.

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant.

DetermaVu is a trademark of OncoCyte Corporation.

On March 8th, 2018 Aurigene Discovery and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, reported plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India (Press release, Aurigene Discovery, MAR 8, 2018, View Source [SID1234624578]).

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This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc., a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial.

CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO (Free ESMO Whitepaper) 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses.

Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment.

"These results are consistent with the observations made in the preclinical setting and further affirm CA-170’s mechanism of action as an oral small molecule checkpoint inhibitor. Based on these initial clinical results, we are excited for the opportunity to expand testing of CA-170, possibly in earlier lines of treatment and in a greater number of immunotherapy treatment-naïve cancer patients," commented Mr. CSN Murthy, Chief Executive Officer of Aurigene. "Together with Curis, we have designed a Phase 2 trial, treating selected populations of patients of interest in the CA-170 program to be treated at major cancer centers in India. Aurigene’s decision to sponsor and fund this trial is further affirmation of our commitment to CA-170 and a reflection of the successful collaboration we have with Curis in multiple development programs. Aurigene has the commercial rights to the program in India and Russia in addition to milestones, royalties other commercial supply rights globally."

"We are pleased with these early results. Evidence of tumor shrinkage and multiple patients remaining on drug treatment for extended periods, along with signals for biomarkers of immune modulation in patient blood and tumor samples, tells us the program continues to move in the right direction. We plan to continue with the dose escalation and continued analysis of patient biopsy samples in the Phase 1 trial," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "We expect to provide additional updates at upcoming conferences including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November."

"The ability for cancer patients to administer a potential checkpoint inhibitor on their own as a once daily oral drug is a significant and unique opportunity in our field," added Adil Daud, M.D., investigator in the CA-170 Phase 1 trial and director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. "These initial clinical results are encouraging and merit continued development."