On May 23, 2018 Strata Oncology, a precision oncology platform company, reported the close of a $26 million USD Series B funding round (Press release, Strata Oncology, MAY 23, 2018, View Source [SID1234526890]). New investors Pfizer Ventures, Merck Global Health Innovation Fund, Deerfield Management and Renaissance Venture Capital Fund were joined by existing investors Arboretum Ventures and Baird Capital.

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Strata Oncology will use the new funding to:

Expand the Strata Precision Oncology Network, a group of leading health systems adopting Strata’s platform to systematize tumor molecular profiling and precision therapy trials.
Further develop the company’s clinical-genomic data and software solutions to streamline health system precision oncology workflows and catalyze new clinical research opportunities.
Submit the company’s tumor molecular profiling assay, StrataNGS, for approval by the US Food and Drug Administration. StrataNGS includes actionable DNA and RNA biomarkers and will be expanded to include tumor mutational load.
Launch the pan-cancer molecular analysis for cancer therapy (PATH) study, a Strata-sponsored master therapeutic protocol, to support rapid and cost-effective indication expansion studies for on-market pharma drugs.
"We are grateful to our early partners who have helped us demonstrate a new way forward in precision oncology," said Dan Rhodes, PhD, CEO of Strata Oncology, "And now with this funding, we’re eager to take our offerings to the next level so that we can further enable our health system partners and deliver a truly differentiated solution for pharma drug development."

"We believe that data is the future currency of healthcare," added Prem Tumkosit, Investment Principal at Merck Global Health Innovation Fund, "Strata’s platform will generate and leverage clinical-genomic data to drive precision trial enrollment and advance cancer care."

"We’ve been very impressed with Strata Oncology’s effort in building a comprehensive solution that meets the needs of both health systems and biopharma research," said Bill Burkoth, Executive Director at Pfizer Ventures. "We look forward to working with the company to achieve its goal of transforming precision oncology."

On May 23, 2018 Kronos Bio, Inc. (Kronos), a Two River portfolio company, reported the appointment of Norbert Bischofberger, Ph.D. as its President and Chief Executive Officer and completion of an $18 million seed financing (Press release, Kronos Bio, MAY 23, 2018, View Source [SID1234526872]). Prior to joining Kronos, Dr. Bischofberger was at Gilead Sciences for almost 30 years, where he most recently served as Executive Vice President, Research and Development and Chief Scientific Officer until April 2018.

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The financing was led by a number of industry leaders and venture capital funds, including Omega Funds, BellCo Capital, John Martin, Ph.D., Norbert Bischofberger, Ph.D., and Vida Ventures, LLC. As part of this financing, Drs. Bischofberger and Martin, as well as Rebecka Belldegrun, M.D., and Otello Stampacchia, Ph.D. joined the company’s Board of Directors.

Kronos is researching and developing first-in-class therapies against historically intractable targets. Its technology is based on over a decade of research by Kronos’ Scientific Founder, Angela Koehler, Ph.D., into high-throughput screening strategies for chemical modulators of transcription factors and other recalcitrant targets in oncology. By combining small molecule microarrays (SMM) with extensive know-how in biological assay development, Kronos’ technology platform enables high-throughput screens of chemical libraries against target proteins in a more physiologically-relevant context. This approach is ideally suited for rapid discovery of unique ligands that can be utilized in the generation of novel modulators or degraders of challenging targets such as transcription factors.

"Kronos’ technology creates the opportunity to fundamentally challenge the historic belief that certain targets should not be pursued," said Dr. John Martin. "Norbert is ideally positioned to shepherd this exciting technology into the next stage of development. I am thrilled to have the opportunity to work with Norbert again to accelerate the progress of this novel technology to generate lead compounds."

"The future of our industry belongs to companies who dare to be first," said Dr. Arie Belldegrun, Chairman of Kronos’ Board of Directors. "Angela’s innovative research combined with Norbert’s expertise and track record of success, provides Kronos the opportunity to discover first-in-class treatments for some of the most elusive targets in oncology."

Dr. Bischofberger was part of the early formation of Gilead Sciences. He joined the company in 1990 and served as Executive Vice President for Research and Development from 1999 to 2018 and Chief Scientific Officer from 2007 to 2018. Prior to joining Gilead, Dr. Bischofberger was a Senior Scientist in Genentech’s DNA Synthesis Group from 1986 until 1990. He received a Ph.D. in organic chemistry from Zurich’s Eidgenössische Technische Hochschule and performed postdoctoral research in steroid chemistry at Syntex. Dr. Bischofberger also performed additional research in organic chemistry and applied enzymology in Professor George Whiteside’s lab at Harvard University in Cambridge, Massachusetts.

"The science behind Kronos is compelling. At its core, it focuses on solutions, not limitations. It is some of the most exciting technology I’ve come across and it opens a new door for applied chemistry to solve some of the greatest challenges we face in the industry today," said Dr. Norbert Bischofberger. "When I started at Gilead, we had approximately 25 employees. I am excited to apply the wisdom and experience I’ve gained and return to my roots in early stage biotechnology."

Kronos is currently advancing two preclinical programs built upon hits identified from the SMM platform, targeting MYC and the Androgen Receptor (AR). The MYC family of transcription factors are master regulators of cell proliferation and differentiation, and MYC expression is dysregulated in a large proportion of human cancers. Kronos is currently pursuing lead compounds that have demonstrated activity in multiple MYC-driven cancer models. The Androgen Receptor (AR) is a primary driver of disease progression in prostate cancer. Kronos is progressing multiple hit series that target AR and its splice variants and have been shown to reduce viability and AR expression in treatment-resistant cell lines.

"While we can lay the framework in an academic setting, the speed with which progress can be made with the right team of commercial scientists is greatly accelerated. This next stage of development will uncover the real therapeutic potential of this research for patients," said Dr. Angela Koehler, Assistant Professor, Koch Institute for Integrative Cancer Research at Massachusetts Institute of Technology (MIT) and a Scientific Founder of Kronos. "I am thrilled to have the opportunity to work closely with Norbert and together advance our research to benefit patients with intractable cancers."

On May 23, 2018 Lava Therapeutics ("LAVA") reported it has raised EUR 16 million in its first major institutional financing round from an investor syndicate led by Gilde Healthcare and Versant Ventures with additional support from US-based MRL Ventures Fund (MRLV), joining founder investors Lupus Ventures and Biox Biosciences (Press release, Lava Therapeutics, MAY 23, 2018, View Source [SID1234526871]). The funding will support development of LAVA’s proprietary pipeline of bispecific gamma-delta (γδ) T cell engagers for the treatment of cancer. LAVA also announced the appointment of Paul Parren, PhD, as Executive Vice President and Head of Research & Development. Dr. Parren joins the company as an internationally recognized antibody drug innovator and developer.

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As part of the financing, LAVA established a Supervisory Board including Stefan Luzi, PhD of Gilde Healthcare, Guido Magni, MD, PhD, of Versant Ventures and Reza Halse, PhD of MRLV. They join Erik van den Berg, who will serve as Chairman of the Board, and biotech entrepreneur Jan van der Hoeven.

"The quality of the investors and the size of this financing underscores the potential of LAVA’s approach and its commitment to establishing itself as a leader in the T cell engager field with our vision centered on creating a new standard for potent and safe cancer treatments," said Mr. van den Berg. "The arrival of Paul Parren further validates the technology and LAVA’s dedication to developing a differentiated product pipeline."

"LAVA’s differentiated T-cell engager platform has the potential to target oncology settings of high unmet need. Based on cutting edge Dutch science, LAVA fits very well in Gilde Healthcare’s portfolio which includes first- and best-in-class therapeutics throughout Europe and the US," said Dr. Luzi from Gilde Healthcare.

"By engaging and re-directing in-vivo gamma delta T cells against tumors, LAVA’s approach represents an innovative and unique platform technology capable of exploiting the immune system, with multiple potential applications in the therapy of solid and liquid cancers. We are enthusiastic about working with LAVA’s team to move this exciting technology forward," said Dr. Magni from Versant Ventures.

Paul Parren joins Lava Therapeutics with 30 years of experience in antibody science and drug development. For the past 16 years he served as Genmab’s Head of Preclinical Development and Research, translating antibody biology successfully into immunotherapies from discovery to the clinic, including approved therapeutic antibodies ofatumumab and daratumumab, as well as establishing validated antibody platform technologies. Dr. Parren is a Professor of Molecular Immunology at the Leiden University Medical Center in Leiden, the Netherlands, board member of The Antibody Society and was an Associate Professor at The Scripps Research Institute in La Jolla, California. He holds a PhD in Molecular Immunology from the University of Amsterdam.

"The opportunity at LAVA is to develop a novel pipeline of targeted biologic therapeutics to safely channel the immune system’s response towards tumors. I am looking forward to working with the LAVA team to build an organization that brings the exciting γδ T cell engager platform to its fullest potential and rapidly translate it to the clinic," added Dr. Parren.

To date, the company has demonstrated proof of principle for the platform, building on the scientific discoveries of the research team headed by Dr. Hans van der Vliet, medical oncologist at the Department of Medical Oncology of the VU University Medical Center and Cancer Center Amsterdam and CSO of Lava Therapeutics. LAVA will use the EUR 16 million investment to further develop and validate its bispecific γδ T cell engager platform, broaden its pipeline and to develop a lead candidate for clinical testing.

About γδ T cells
γδ T cells are a potent class of proinflammatory immune effector cells and one of two main categories of T lymphocytes. γδ T cells provide effective tumor immunosurveillance and anti-tumor immune responses against a wide variety of both solid and hematological malignancies. Human γδ T cells are classified based on their receptor Vδ chain, with Vγ9Vδ2 T cells being the predominant population in human peripheral blood. Vγ9Vδ2 T cells are endowed with specific reactivity to small phosphorylated metabolite antigens (termed phosphoantigens) that are expressed by tumor cells at higher levels and respond to signals from tumors leading to tumor-infiltration, interferon-γ secretion and tumor cell killing in addition to acting as antigen-presenting cells, priming the adaptive immune system.

On May 23, 2018 RenovoRx, Inc., a medical technology company developing an innovative catheter-based approach to treating pancreatic cancer, reported a $10 million financing round of which the company closed $7 million in an initial tranche (Press release, Renovorx, MAY 23, 2018, View Source [SID1234526870]). The round is led by Boston Scientific and joined by new investors including btov Partners and existing investors Astia Angels, the Angels’ Forum, the Halo Fund III, L.P., Golden Seeds, and Acorn Campus Taiwan.

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RenovoRx is developing a new approach to treating solid tumors – the RenovoCath System, a novel drug-device combination designed to deliver chemotherapy directly to tumors. The financing will be used to support ongoing product development and clinical trials of RenovoCath for the treatment of patients with locally advanced pancreatic cancer.

Pancreatic cancer is one of the deadliest types of cancer. Despite several FDA-approved treatments, it is projected to become the second-leading cause of cancer-related death in the United States around 20201, in part due to challenges in diagnosing and treating the disease. Pancreatic cancer is often not detected until it is advanced and considered inoperable. Standard treatments are often ineffective because they cannot be delivered directly to the tumor and are unable to penetrate the tumor tissue.

Based upon early studies of people with locally advanced pancreatic cancer and the potential to address a significant unmet need, the FDA recently granted RenovoCath an Orphan Drug Designation and approved an Investigational New Drug (IND) application for the company to advance directly to a pivotal Phase III clinical study.

"There are significant challenges in treating pancreatic cancer and our aim is to overcome these barriers by using a catheter-based, targeted approach to delivering chemotherapy. This funding, along with our FDA Orphan Drug Designation and approval of our IND are three important milestones in bringing this new therapy option to patients," said Shaun R. Bagai, CEO of RenovoRx. "We are excited to begin enrollment in our pivotal Phase III trial of the RenovoCath System and advance this technology in an area of significant patient need."

RenovoCath is a dual-balloon infusion catheter that reaches pancreatic tumors using a proprietary, catheter-based approach to deliver chemotherapy directly to the tumor inside the pancreas, without the need to identify blood vessels locally at the treatment site. An early feasibility study using this targeted approach suggested an improved survival benefit for people with advanced pancreatic cancer compared to historical controls.

Enrollment has begun in a randomized, Phase III study designed to compare intra-arterial chemotherapy via RenovoCath to systemic chemotherapy in approximately 300 patients with locally advanced pancreatic cancer at up to 20 sites across the United States. The primary endpoint is overall survival (OS) with secondary endpoints including safety and quality of life.

On May 23, 2018 Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC. (Churchill) reported that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration (FDA) for YONSA (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Sun Pharma, 23 23, 2018, View Source [SID1234526869]).

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Churchill is eligible to receive upfront and sales-linked milestone payments, and royalties on sales from Sun Pharma pursuant to an agreement between the two companies to commercialize YONSA in the U.S.

"We are pleased to add YONSA to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies," said Abhay Gandhi, CEO – North America, Sun Pharma.

YONSA in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the U.S.

About YONSA (abiraterone acetate) tablets

YONSA is a CYP17 inhibitor which uses proprietary SoluMatrix Fine Particle Technology to create a micronized (smaller particle size) formulation of abiraterone acetate tablets – for the treatment of metastatic castration-resistant prostate cancer, in combination with methylprednisolone. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis.

INDICATION

YONSA (abiraterone acetate) in combination with methylprednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Important Administration Instructions

To avoid substitution errors and overdose, be aware that YONSA tablets may have different dosing and food effects than other abiraterone acetate products. Patients receiving YONSA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

YONSA can cause fetal harm and potential loss of pregnancy.

WARNINGS AND PRECAUTIONS

Hypertension, Hypokalemia, and Fluid Retention Due to Mineralocorticoid Excess: YONSA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with YONSA.

Closely monitor patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, such as those with heart failure, recent myocardial infarction, cardiovascular disease, or ventricular arrhythmia. The safety of YONSA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials.

Adrenocortical Insufficiency (AI): AI was reported in patients receiving abiraterone acetate in combination with corticosteroid, following an interruption of daily steroids and/or with concurrent infection or stress. Monitor patients for symptoms and signs of AI, particularly if patients are withdrawn from corticosteroids, have corticosteroid dose reductions, or experience unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with YONSA. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity: In postmarketing experience, there have been abiraterone acetate-associated severe hepatic toxicity, including fulminant hepatitis, acute liver failure and deaths. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with YONSA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced YONSA dose of 125 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt YONSA treatment and closely monitor liver function.

Re-treatment with YONSA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.

Permanently discontinue treatment with abiraterone acetate for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

The safety of YONSA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

ADVERSE REACTIONS

The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

DRUG INTERACTIONS:

Based on in vitro data, YONSA is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during YONSA treatment. If a strong CYP3A4 inducer must be co-administered, increase the YONSA dosing frequency only during the co-administration period.

Abiraterone is an inhibitor of the hepatic drug-metabolizing enzymes CYP2D6 and CYP2C8.

Avoid coadministration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug.

In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with an abiraterone acetate single dose equivalent to YONSA 500 mg. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with abiraterone acetate.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential: Advise male patients with female partners of reproductive potential to use effective contraception.
Do not use YONSA in patients with baseline severe hepatic impairment (Child-Pugh Class C).
Please see Full Prescribing Information for YONSA at www.YonsaRx.com/Yonsa-pi

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