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Selvita Announces First Patient Dosed in Phase 1b Study of CDK8 Inhibitor SEL120 in the Treatment of Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

On September 6, 2019 Selvita (WSE: SLV) reported that the first patient enrolled in the Phase 1b study of company’s selective CDK8 inhibitor, SEL120, has received the first dose. SEL120 is being initially investigated in the treatment of patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) (Press release, Selvita, SEP 6, 2019, View Source [SID1234539321]). This open-label, dose-escalation study is being conducted at multiple sites in the U.S. and evaluates the safety, tolerability and the preliminary activity of SEL120, as well as establishing a recommended dose for further clinical development.

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"CDK8 represents an important potential therapeutic target in cancer. SEL120, an orally available small molecule, is potentially the best in class CDK8 inhibitor and is the first in class to enter the clinical trials," commented Dr. Setareh Shamsili, Chief Medical Officer of Selvita.

"SEL120 has been identified through our in-house discovery platform with having differentiating characteristics, such as high selectivity, and has potential for development in a broad range of both hematological and solid malignancies. In preclinical studies, SEL120 has shown strong proof of concept for the treatment of AML, a disease where patients still face poor prognosis. We’re very grateful for the strategic support and advisory role that The Leukemia & Lymphoma Society (LLS) has played in bringing SEL120 into clinical development through its Therapy Acceleration Program (TAP). We expect to share the preliminary results of SEL120 study with the oncology community in 2020."

This Phase 1b study is a multicenter, sequential, modified 3+3 dose escalation study in adult patients with AML or HR-MDS who are refractory to treatment or have relapsed after previous therapies. Patients will be enrolled in the study independent of specific tumor mutational burden. The study will also assess pharmacokinetic and pharmacodynamic parameters of SEL120. Selvita is the sole sponsor of the Study.

About SEL120

SEL120 is an oral, selective inhibitor of CDK8, a kinase which is a part of the mediator complex and is essential for the activity of super-enhancers important to the regulation of RNA transcription. CDK8 kinase is implicated in the development of hematological malignancies and solid tumors. SEL120 was discovered with the Selvita discovery engine platform and is currently in clinical development for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. SEL120 has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. More information about TAP program is available at: View Source

ONCOCYTE ANNOUNCES DEFINITIVE AGREEMENT TO ACQUIRE RAZOR GENOMICS

On September 5, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel tests for the early diagnosis and management of lung cancer, reported that it has entered into a definitive agreement to acquire Razor Genomics (Press release, Oncocyte, SEP 5, 2019, View Source [SID1234551117]). An initial closing at which OncoCyte will acquire shares of Razor preferred stock representing 25% of the outstanding equity of Razor, is expected to close by the end of September, subject to customary and other closing conditions. OncoCyte will have the option to acquire the balance of the outstanding shares of Razor common stock from Razor’s shareholders (the "Purchase Option").

Razor’s CLIA-certified treatment stratification test (the "Razor test") has been rigorously validated to identify early-stage lung cancer patients who are at high-risk versus low-risk of death within five years following surgical resection. The Razor test enables the identification of lung cancer patients at high risk for recurrence and allows them to be treated at a time when their cancer can still be responsive to adjuvant chemotherapy. Importantly, the recent decision by Centers for Medicare and Medicaid Services Molecular Diagnostic Services Program ("CMS") to recommend coverage for the Razor test is a significant inflection point for OncoCyte and accelerates the path to becoming a commercial stage company.

"Notwithstanding recent advancements in treatment, lung cancer remains a leading cause of cancer death. Approximately 30% of patients with surgically removed early stage lung cancer recur and over half of those that recur die within five years of surgery," said Ron Andrews, Chief Executive Officer of OncoCyte. "The addition of the Razor treatment stratification test for patients diagnosed with early stage lung cancer is a perfect downstream complement to our proprietary DetermaVu liquid biopsy test that we are developing to help manage CT-identified lung nodules and thereby facilitate the early diagnosis of lung cancer. The Razor test enables us to address an adjacent critical decision point that physicians and patients face during the lung cancer treatment journey that today remains unmet. There are many such decision points along this care continuum, and this transaction is a significant step forward for OncoCyte as we work to build a comprehensive diagnostic content company serving the needs of lung cancer patients across disease stages, from early diagnosis all the way through recurrence monitoring and beyond."

"Importantly, the Razor test is extensively validated and has been published in prestigious medical journals such as Lancet and the Journal of the American Medical Association. CMS’s recent proposed positive coverage decision to provide reimbursement reflects the clinical utility of the test and, we believe, will drive broad test adoption. There remain many significant unmet needs in the detection and treatment of lung cancer, and we are poised to occupy a leading position in providing molecular tests that can improve outcomes for lung cancer patients," Mr. Andrews concluded.

In a published clinical utility study, the five-year disease-free survival rate was 92% for individuals identified as high risk by the Razor test and treated with chemotherapy, compared to 49% in untreated high-risk patients. Similarly, individuals identified as low risk by the Razor test had a 5-year disease free survival of 94% without the use of chemotherapy. In this study, the test demonstrated higher accuracy at discriminating between high and low risk patients than current National Comprehensive Cancer Network (NCCN) guideline criteria for risk assessment.

In another published survey of physicians who ordered the test, approximately one in three physicians changed their treatment decision based on the results of the Razor test.

"The current staging system for lung cancer is not adequate and misses high risk patients who could benefit from chemotherapy," noted Dr. David M. Jablons, Professor and Chief of General Thoracic Surgery at the University of California San Francisco Medical Center. "The Razor treatment stratification test has been shown to improve the identification of high-risk patients over conventional staging, and when given chemo, these high-risk patients had a profound improvement in survival. In fact, a new staging approach that incorporates the Razor test has now been published in Journal of Thoracic Oncology."

Principal Transaction Terms:

Upon closing, OncoCyte will make a cash payment of $10 million for an initial 25% equity interest in the form of Razor preferred stock. OncoCyte will pay an additional $1 million milestone resulting from the positive CMS coverage decision recently received.

In addition, the selling shareholders of Razor are eligible to receive an additional $10 million in cash and $5 million of OncoCyte common stock, or shares of common stock and cash in certain circumstances, for all remaining shares of Razor upon the achievement of certain clinical trial milestones. Upon achievement of a clinical trial milestone, Razor’s shareholders are eligible to receive up to $3 million of OncoCyte common stock, or shares of common stock and cash in certain circumstances, and upon the achievement of an additional CMS coverage milestone, Razor’s parent company is entitled to receive a $4 million cash payment from OncoCyte.

Razor will reserve $4 million of the initial $10 million payment from our purchase of the preferred stock for use in financing a supplemental clinical trial of the Razor test. OncoCyte has agreed to pay future clinical trial costs in excess of that $4 million reserve, subject to ceilings under a clinical trial budget.

Conference Call Information:

OncoCyte management will host a conference call and webcast today, September 5, at 10:00am ET. To access the call and webcast, please use the information below:

Dial in (US): 877-407-9716

Dial-in (International): 201-493-6779

Webcast: View Source

Pfenex Earns $11 Million Development Milestone under its Development and License Agreement with Jazz Pharmaceuticals

On September 5, 2019 Pfenex Inc. (NYSE American: PFNX) reported that it has earned an $11 million development milestone under its development and license agreement with Jazz Pharmaceuticals (Press release, Pfenex, SEP 5, 2019, View Source [SID1234539335]). The milestone is associated with process development activities for PF745, a recombinant crisantaspase with half-life extension technology.

"We are very pleased with our progress on PF745 and we believe the Jazz collaboration overall further validates the versatility of our proprietary protein expression platform and the quality of our development capabilities," said Eef Schimmelpennink, Chief Executive Officer of Pfenex. "Similarly, we are appreciative of the progress recently reported by Jazz on PF743 (JZP-458) with the completion of the Phase 1 study and announcement of plans to initiate a Phase 2/3 study later in 2019."

Under the terms of the development and license agreement, Pfenex is eligible to receive an aggregate total of up to $224.5 million in development and sales milestone fees, of which $177.5 million is still eligible to be received by Pfenex. Of this $177.5 million, $18.5 million are development milestones, $34 million are regulatory milestones, and $125 million are sales milestones. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration.

Dr. Henry Ji to Participate in Multiple Investment Conferences in September 2019 to Provide Corporate Updates

On September 5, 2019 Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will participate in multiple investment conferences in September 2019 (Press release, Sorrento Therapeutics, SEP 5, 2019, http://investors.sorrentotherapeutics.com/news-releases/news-release-details/dr-henry-ji-participate-multiple-investment-conferences [SID1234539331]). Dr. Ji will provide corporate updates to investors, focusing on the core clinical pipeline progress for Sorrento Therapeutics immuno-oncology and pain programs.

Details of the upcoming events:

Bio Century Newsmakers in the Biotech Industry
Date: Friday, September 6th
Time: 10:40 AM Eastern Time
Location: Millennium Broadway Hotel
Times SquareRoom 404/405, NY
Webcast: View Source

21st Annual Global Investment Conference Sponsored by H.C. Wainwright
Date: Tuesday, September 10th
Time: 10:50 AM Eastern Time
Location: Lotte New York Palace, Holmes II (4th Floor), NY
Webcast:View Source

Rambam Foundation Healthcare Conference
Topic: Off the shelf cellular therapies
Date: Tuesday, September 10th
Time: 12:30 PM Eastern Time
Location: The Mansion: 107 E 16th NY

Agilent Technologies Announces Pricing of $500 Million of Senior Notes

On September 5, 2019 Agilent Technologies, Inc. (NYSE: A) reported the pricing of an underwritten, registered public offering of a series of its senior notes in an aggregate principal amount of $500 million (Press release, Agilent, SEP 5, 2019, https://www.agilent.com/about/newsroom/presrel/2019/05sep-gp19020.html [SID1234539330]). The offering is being conducted under an automatic shelf registration statement on file with the Securities and Exchange Commission. The notes will mature in September 2029 and will bear interest at an annual rate of 2.750 percent. The offering is expected to close on September 16, 2019, subject to customary closing conditions.

The estimated net proceeds of the offering are expected to be approximately $492.8 million. Agilent intends to use the net proceeds from the offering and cash on hand to fund the redemption of its outstanding 5.00% senior notes due 2020.

Barclays Capital Inc., J.P. Morgan Securities LLC and MUFG Securities Americas Inc. are acting as joint book-running managers.

Copies of the prospectus supplement and the accompanying prospectus relating to the offering can be obtained from:

Barclays Capital Inc.
745 Seventh Avenue
New York, NY 10019
Telephone: (888) 603-5847

J.P. Morgan Securities LLC
383 Madison Avenue
New York, NY 10179
Telephone: (212) 834-4533

MUFG Securities Americas Inc.
1221 Avenue of the Americas, 6th Floor
New York, NY 10020-1001
Telephone: (877) 649-6848

Electronic copies of the prospectus supplement and accompanying prospectus are or will be available for free by visiting EDGAR on the Securities and Exchange Commission website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.