On April 3, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with unmet needs in hematology and oncology, reported preclinical data for its novel oral Cdc7 inhibitor, SRA141, in a late-breaking poster being presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, Georgia (Press release, Sierra Oncology, APR 3, 2019, View Source [SID1234534995]).

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"Prior studies demonstrated that SRA141 potently and selectively inhibits Cdc7, resulting in robust anti-tumor efficacy in colorectal xenograft models, however, the compound’s exact mechanism of action has not been characterized previously. Our findings reveal a potentially novel mechanism of cytotoxicity for Cdc7 inhibitors that is distinct from other agents, and thus SRA141 may herald a new class of cancer therapeutic agents with a differentiated anti-tumor profile," said Dr. Eric J. Brown, Associate Professor of Cancer Biology at the Perelman School of Medicine of the University of Pennsylvania, and member of Sierra’s DNA damage response (DDR) Advisory Committee.

"SRA141 does not induce G1 cell cycle arrest or replication stress, thereby distinguishing it from other agents such as palbociclib or SRA737. Rather, SRA141 alters DNA replication dynamics and delays cell cycle progression, ultimately resulting in caspase-dependent cell death associated with mitotic accumulation. Promisingly, we believe we have shown for the first time that this mechanism appears to synergize with anti-apoptotic drugs, such as venetoclax, and dysregulators of mitosis, such as barasertib. This differentiated mechanism of action supports a potentially unique spectrum of clinical opportunities for SRA141 as both monotherapy and in combination with pro-apoptotic and mitotic disrupting agents," said Dr. Christian Hassig, Chief Scientific Officer, Sierra Oncology.

SRA141 AACR (Free AACR Whitepaper) Late-Breaking Poster:
Date/Time: Wednesday, April 3rd from 8:00 am to 12:00 pm ET
Session: Late-Breaking Research: Molecular and Cellular Biology / Genetics 2
Title: CDC7 kinase inhibition by SRA141 induces a potentially novel caspase-dependent tumor cell apoptosis associated with altered DNA replication and cell cycle dynamics.
Authors: Veena Jagannathan, Snezana Milutinovic, Ryan J. Hansen, Bryan Strouse, Christian Hassig and Eric J. Brown.
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41, Poster #5

The poster will be made available on the company’s website at www.sierraoncology.com.

About SRA141 targeting Cdc7
SRA141 is a novel, potent, orally bioavailable selective inhibitor of Cell division cycle 7 (Cdc7) kinase. Owing to its important role in DNA replication, and its overexpression in various neoplasms, Cdc7 is an attractive therapeutic target with emerging clinical validation in oncology.

Cdc7, together with its partner proteins Dbf4 or Drf1, is responsible for activating DNA replication origin firing during S-phase through phosphorylation and activation of the MCM2-7 helicase. Cdc7 also has functions within the DNA Damage Response (DDR) and mitosis. Over-expression of Cdc7 and its partner proteins is correlated with unfavorable clinical outcomes and poor survival in a broad range of solid tumors and hematological malignancies.

SRA141 has been shown to cause cancer cell death in a p53-independent manner and to induce tumor regression or stasis in a variety of in vivo cancer models, including complete and partial regressions in animal models of colorectal cancer.

An Investigational New Drug Application (IND) filing has been accepted by the U.S. Food and Drug Administration (FDA) for SRA141, and Sierra Oncology has prepared for a potential Phase 1/2 trial of the drug candidate in patients with advanced colorectal cancer. Sierra Oncology is currently evaluating the optimal timing to commence this trial within the context of its recently expanded portfolio.

Sierra Oncology retains the global commercialization rights to SRA141

On April 3, 2019 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, is reported changes to its senior executive team to help its focus on commercial development and execution of its pipeline of radiopharmaceutical products for the treatment of children and adults with cancer (Press release, Clarity Pharmaceuticals, APR 3, 2019, View Source [SID1234534941]).

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Dr Matt Harris, the current Managing Director of Clarity, will move to Chief Scientific Officer and remain on the Board of Directors, and Clarity’s current Chief Operating Officer, Dr Colin Biggin, will move to Acting Chief Executive Officer, whilst an international search, expected to take 6-9 months, for a CEO will begin.

Dr Biggin’s background in radiopharmaceutical development is extensive with over 15 years in the industry, including his experience at Algeta ASA (Algeta) where he worked in multiple roles from 2006 up to Algeta’s acquisition by Bayer for US$2.9 billion in 2014. Dr Biggin was among the first ten employees at Algeta and was responsible for providing scientific and project support across all departments, gaining broad expertise in Regulatory & Quality Assurance, Quality Control, Research and Clinical Development, Manufacturing and Commercial. He was significantly involved in the development and launch of Xofigo, Algeta’s lead radiopharmaceutical product targeting metastatic prostate cancer.

Dr Biggin gained his PhD in Environmental Radiochemistry and a BSc in Environmental Biogeochemistry from the University of Glasgow.

Dr Matt Harris has been integral to the successful development of the company from inception through to its early stage development and will continue his role on the Board of Directors and within the senior executive team as Chief Scientific Officer. These changes at the senior executive level will accommodate Clarity’s focus on moving from an early to a later stage clinical development company. This also coincides with the recent addition of Dr Robert Miller as Contract Chief Medical Officer and Dr Thomas Ramdahl to the Board of Directors, having all gained significant clinical and commercialisation experience through their involvement at Algeta.

Dr Biggin commented on his appointment: "I am looking forward to steering Clarity and the team as Acting CEO through this important stage of development when we are both expanding our clinical program, and preparing for extensive commercial growth of our theranostic platform. I have enjoyed working at Clarity and seeing the Company expand significantly in the last few years and am excited to apply the experience I gained at Algeta to lead Clarity to further success."

Clarity’s Executive Chairman, Dr Alan Taylor commented "The changes at the executive and Board level will prepare us for transitioning the Company to a new commercial stage of development. We want to bring the right expertise to successfully drive our clinical program and with Dr Thomas Ramdahl joining our Board recently, we are now building a Board and management team with people who have relevant clinical and commercial experience and a track record of successfully growing radiopharmaceutical companies."

Media Contact
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Executive Chairman

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On April 3, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that new interim data from Cohort 2 of the innovaTIL-01 (C-144-01) study and data from the ongoing innovaTIL-04 (C-145-04) study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place from May 31 to June 4, 2019, in Chicago. Details of the presentations are as follows:

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Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1
Authors: Amod Sarnaik et al.
Session: Developmental Immunotherapy and Tumor Immunobiology
Session Type: Poster Discussion Session
Abstract Number: 2518
Location: McCormick Place Convention Center
Date/Time: Poster display Saturday, June 1, 8:00 a.m. – 11:00 a.m. EDT; poster discussion 1:15 p.m. – 2:45 p.m. EDT

Title: Safety and efficacy of adoptive cell transfer using autologous tumor infiltrating lymphocytes (LN-145) for treatment of recurrent, metastatic, or persistent cervical carcinoma
Authors: Amir Jazaeri et al.
Session: Developmental Immunotherapy and Tumor Immunobiology
Session Type: Poster Session
Abstract Number: 2538
Location: McCormick Place Convention Center
Date/Time: Saturday, June 1, 8:00 a.m. – 11:00 a.m. EDT

On April 3, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO) reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Sangamo Therapeutics, APR 3, 2019, View Source [SID1234534996]). All of the shares are being offered by Sangamo. In addition, Sangamo expects to grant the underwriters of the offering a 30-day option to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering will be completed, or as to the actual size or terms of the offering.

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Sangamo anticipates using the net proceeds from the offering for working capital and other general corporate purposes, including support for its own and its partnered gene therapy, genome editing, cell therapy and gene regulation product candidates and research programs, its manufacturing facilities and other business development activities.

Cowen and Company, LLC, Wells Fargo Securities, LLC and Barclays Capital Inc. are acting as joint book-running managers for the offering.

A registration statement relating to the shares was previously filed with and became effective by rule of the Securities and Exchange Commission. The offering is being made solely by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the Securities and Exchange Commission and will be available on the Securities and Exchange Commission’s website located at View Source A copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806; or from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by telephone at (800) 326-5897 or email to [email protected]; or from Barclays Capital Inc., c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (888) 603-5847, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 April 3, 2019 Nerviano Medical Sciences reported two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in, Atlanta, Georgia, USA regarding preclinical efficacy and safety of NMS-P088, a potent FLT3, KIT and CSF-1R inhibitor with in vitro and in vivo activity also in presence of the gatekeeper mutation, and about the Identification and characterization of ATP-mimetic choline kinase inhibitors (Press release, Nerviano Medical Sciences, APR 3, 2019, View Source [SID1234535098]).

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During the event NMS researchers describes new data regarding NMS-P088 that is a potent and selective FLT3, KIT and CSF-1R inhibitor with in vitro and in vivo activity also in presence of the gatekeeper mutation. Based on NMS-P088 original kinase targets profile, including FLT3 and KIT gatekeeper resistance mutations as well as CSF1R, preclinical efficacy and safety, a Phase I/II clinical trial was started to potentially address unmet medical needs in AML and CMM.

The second presentation regards identification and characterization of ATP-mimetic choline kinase inhibitors. The chemical expansion of ATP-mimetic quinazoline class allowed identification of potent compounds, both in biochemical and in cellular assay, with selectivity against ChoKß and a panel of 60 tyrosine and serine/threonine kinases. Preliminary genomic analysis identified genes differentially expressed in sensitive versus resistant cell lines. Further studies are ongoing to confirm these genes as predictive biomarkers of sensitivity to compounds and to identify other sensitive cancer cell lines. A structure-based drug design optimization program is ongoing with the aim of further improving biological and ADME properties.

Both NMS-P088 and the new choline kinase inhibitors are the results of the Kinase platform in Nerviano Medical Sciences. It represents an integrated system of know-how, technologies and intellectual property developed over the years by the Campus and based on protein kinases as molecular targets. The use of this platform allows the Nerviano research Campus a conspicuous synergy in the efficient development of innovative anticancer drugs.

Presentation title: NMS-P088, a novel FLT3, KIT and CSF1R inhibitor, is a promising clinical candidate for AML and CMML treatment. Marina Ciomei et Al.
Meeting: American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting March 29 – Apr 3, 2019, Atlanta, Georgia, USA (Abs. 1324)

Presentation title: Identification and characterization of ATP-mimetic choline kinase inhibitors. Paola Gnocchi et al
Meeting: American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting March 29 – Apr 3, 2019, Atlanta, Georgia, USA (Abs. 4790)