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

Disclaimer:

Statements in this "Document" describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

On May 23, 2018 Varian (NYSE: VAR) reported that Gary Bischoping, chief financial officer, and J. Michael Bruff, senior vice president of investor relations, will present at the Jefferies Global Healthcare Conference in New York City, scheduled for 11:30 a.m. ET on June 6, 2018 (Press release, Varian Medical Systems, MAY 23, 2018, View Source [SID1234526868]).

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Information about the webcast of the company’s presentation will be available through a link on the company website at www.varian.com/inv­estors.

On May 23, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, notably against rare or resistant forms of cancer, reported that Judith Greciet, the Company’s Chief Executive Officer, will present at the 25th BIO International Convention (Press release, Onxeo, MAY 23, 2018, View Source [SID1234526866]). The conference is being held on June 4-7, 2018, in Boston, MA.

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The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). It is attended by more than 1,100 biotechnology and pharmaceutical companies, academic institutions, state biotechnology centers and related organizations across the United States and from over 30 countries worldwide.

Onxeo corporate presentation:

Date: June 4th, 2018

Time: 3 pm EST / 9 pm CEST

Location: Theater 2 – Boston Convention & Exhibition Center: 415 Summer St., Boston, MA

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