On July 11, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the third dose cohort in the Phase Ib/II SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) (Press release, 4SC, JUL 11, 2019, View Source [SID1234537482]).

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The SENSITIZE study is a dose escalation study of domatinostat in combination with the checkpoint inhibitor pembrolizumab – an anti-PD-1 antibody approved in the US and the EU as a cancer immunotherapy – to evaluate the safety and tolerability of the combination treatment. The study is being conducted in patients with advanced-stage melanoma who are non-responding or refractory to prior treatment with checkpoint inhibitors.

The combination of domatinostat and pembrolizumab was confirmed as safe and well tolerated by the SRC at this, the third and highest predefined dose cohort.

Frank Hermann, M.D., Chief Development Officer of 4SC, said: "The SENSITIZE study is a key study to evaluate the safety and tolerability of domatinostat in combination with checkpoint inhibitors such as pembrolizumab. We are pleased to see that the highest predefined dose of domatinostat in combination with checkpoint blockade was safe and well tolerated.

In addition, from the sequential biopsies taken in SENSITIZE, we will be able to generate important biological data on the patient’s tumor microenvironment to investigate and support our preclinical data and proposed immuno-modulatory mechanism of action for domatinostat. Data analysis is ongoing, and we intend to publish the clinical and translational data set at an upcoming scientific conference."

Jason Loveridge, Ph.D., CEO of 4SC, added: "Based on the positive safety and tolerability outcome of the first three dose cohorts we will expand the SENSITIZE study and initiate further two cohorts. Taken together, the data from all cohorts will give us important information on how to optimally combine domatinostat with checkpoint blockade and inform our planned clinical studies of domatinostat in other indications.

We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."

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8 April 2019, Domatinostat’s mode of action in Merkel cell carcinoma

6 February 2019, First patient enrolled in Phase II study EMERGE of domatinostat (4SC-202) in gastrointestinal cancer

27 December 2018, Positive safety review of 4SC’s Phase Ib/II SENSITIZE study of domatinostat (4SC-202) + pembrolizumab in melanoma

On July 11, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release second-quarter 2019 financial results before the market opens on Thursday, July 25, 2019, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, JUL 11, 2019, View Source [SID1234537481]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 6143018.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the West website three hours after the live call and will be available through Thursday, August 1, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 6143018.

On July 11, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported it has entered into common stock purchase agreements for up to $21 million with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor and current shareholder (Press release, Leap Therapeutics, JUL 11, 2019, View Source [SID1234537480]).

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Under a purchase agreement dated July 11, 2019, LPC agreed to purchase $1,000,000 of Leap’s registered common stock at a price of $1.75 per share (the "July 11 Purchase Agreement"). Net proceeds to the Company are approximately $950,000.

Under the terms of a separate common stock purchase agreement (the "Commitment Purchase Agreement"), Leap will have the option, but not the obligation, to sell to LPC up to an additional $20 million in shares of common stock in tranches over a twenty-four month period and once a registration statement relating to the transaction is declared effective. The price of shares sold will be based on the market prices prevailing at the time of each sale to LPC. There is no upper limit as to the price per share that LPC may pay for future stock issuances under the Commitment Purchase Agreement, and Leap will control the timing and amount of any future sales. LPC has no right to require any sales by Leap but is obligated to make purchases according to Leap’s direction. Leap intends to use the net proceeds from the transaction for general corporate purposes, extending its runway to execute its business development and clinical development strategy.

LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Leap’s common stock. In consideration for entering into the Commitment Purchase Agreement and in lieu of making a cash payment, Leap has issued 330,000 shares of common stock to LPC. Leap maintains the right to terminate the Commitment Purchase Agreement at any time, at its discretion, without any additional cost or penalty.

A description of the July 11 Purchase Agreement, the Commitment Purchase Agreement and the related registration rights agreement is set forth in Leap’s Current Report on Form 8-K filed today with the Securities and Exchange Commission ("SEC").

The shares issued under the July 11 Purchase Agreement are offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-223419) that was previously filed by Leap with the SEC on March 2, 2018 and was declared effective by the SEC on March 16, 2018. A prospectus supplement and the related prospectus will be filed with the SEC today and will be available, for free, on the SEC’s website at View Source

The securities issued as payment for the commitment fee and the securities that may be sold in the future under the Commitment Purchase Agreement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and have not been registered or qualified under any state securities laws, and therefore may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements, and registration or qualification and under applicable state securities or "Blue Sky" laws or an applicable exemption from such registration or qualification requirements.

offer to sell or a solicitation of an offer to buy 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.

On July 11, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that the U.S. Patent and Trademark Office (USPTO) has issued and the European Patent Office has granted new patents further protecting the Company’s lead drug candidate, tipifarnib, a potent and selective farnesyl transferase inhibitor (Press release, Kura Oncology, JUL 11, 2019, View Source [SID1234537479]). Tipifarnib is currently being studied in multiple solid tumor and hematologic indications, including a registration-directed clinical trial in HRAS mutant head and neck squamous cell carcinoma (HNSCC).

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The newly issued U.S. patents are as follows:

U.S. Patent No. 10,335,404 includes multiple claims directed to a method of treating patients with HRAS mutant HNSCC consisting of administering any farnesyl transferase inhibitor; and

U.S. Patent No. 10,292,979 includes multiple claims directed to the use of tipifarnib as a method of treating patients with HRAS mutant non-small cell lung carcinoma (NSCLC).
In addition, the newly granted European patent is as follows:

European Patent No. 3277842 includes multiple claims directed to the use of tipifarnib as a method of treating patients with HRAS mutant HNSCC.
Each of the patents has an expiration date of August 2036, excluding any possible patent term extension.

"Along with advancing the development of tipifarnib in multiple, biomarker-defined patient populations, securing robust intellectual property protection to provide commercial exclusivity in major commercial markets is an important part of our overall corporate strategy," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "In this regard, we are pleased to announce new U.S. and European patents that cover the treatment of HRAS mutant HNSCC and NSCLC patients as well as the issuance of a first U.S. patent that extends our patent exclusivity to the use of any farnesyl transferase inhibitor for the treatment of HRAS mutant HNSCC patients. We believe these patents strengthen our competitive advantage as we continue to advance the development of tipifarnib, and we intend to continue to aggressively pursue additional intellectual property protection, both in the U.S. and abroad."

Kura’s intellectual property estate comprises multiple patent families with issued or pending claims related to the use of tipifarnib as well as claims directed to the use of any farnesyl transferase inhibitor in biomarker-defined patient populations. In 2018, the USPTO issued separate patents for tipifarnib as a method of treating patients with certain CXCL12-expressing cancers and as a method of treating patients with angioimmunoblastic T-cell lymphoma, an aggressive form of T-cell lymphoma often characterized by high levels of CXCL12 expression. The newly issued patents further expand protection for tipifarnib, with counterpart patents beginning to issue in foreign countries.

On July 11, 2019 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the second quarter of fiscal year 2019, and updated its 2019 revenue guidance (Press release, Illumina, JUL 11, 2019, View Source [SID1234537477]).

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Subject to quarter-end closing adjustments, the Company expects to report second quarter revenue of approximately $835 million, compared to $830 million in the second quarter of 2018.

The Company’s second quarter results were impacted by the following:

Approximately $30 million lower revenue than expected associated with population genomics initiatives, including a sizeable sequencing systems and consumables purchase that did not close as expected in the second half of June, which is now expected to close later in 2019.

Approximately $10 million lower revenue than expected associated with ongoing weakness in the direct-to-consumer (DTC) market, primarily impacting array services.

Approximately $10 million lower revenue than expected associated with Illumina’s non-high-throughput sequencing systems and consumables. While lighter than anticipated, NextSeq system and consumables shipments grew both sequentially and year-over-year, and average pull-through per NextSeq system was within Illumina’s target range.

NovaSeq consumable volume growth of 40% sequentially, and more than 100% year-over-year, with particularly strong growth in the S4 and S1 flow cells. NovaSeq system shipments were ahead of expectations in the second quarter, excluding the multi-system population genomics transaction referenced above.

"We are obviously disappointed with our second quarter financial results. Our preliminary analysis suggests that these challenges are transitory and do not reflect a macro change to the fundamentals of our business," said Francis deSouza, President and CEO. "Despite our shortfall this quarter, we remain as enthusiastic about the long-term growth prospects for our markets as we have ever been, and are committed to setting the industry’s bar for consistency and execution in the dynamic and rapidly growing world of genomics."

Financial outlook and guidance

Reflecting on the Company’s experience in 2019 so far, Illumina now expects fiscal year revenue growth of approximately 6%, primarily associated with lower near-term expectations in DTC, a more conservative assumption about the speed with which certain population genomics initiatives ramp, and lower non-high-throughput systems and consumables, including a delay in a partner program that is now expected to ramp in 2020.

Illumina now expects sequencing business revenue to grow approximately 10%, which includes sequencing consumables growth of approximately 15%, and sequencing service and other to be slightly down year-over-year.

The Company expects array business revenue to be down approximately 14% year-over-year, primarily reflecting ongoing DTC weakness.

Illumina continues to expect NovaSeq pull-through per system to be higher than the approximately $1 million per system reported for 2018.

The Company continues to expect 2019 NovaSeq system shipments to be flat to slightly up compared to 2018.

The Company will share additional guidance, including full year earnings per share guidance, on its upcoming quarterly conference call. In light of the Company’s lower revenue growth expectations for 2019, Illumina is taking immediate action to adjust operating expenses for the remainder of the year.
Quarterly conference call information
The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Monday, July 29, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (844) 647-5490, or 1 (615) 247-0295 outside North America, both with conference ID 3469888.