News

Elevar Therapeutics and Tanner Pharma Group Announce Global Named Patient Program to Provide Access to Apealea® (paclitaxel micellar)

SALT LAKE CITY, Utah and CHARLOTTE, N.C. USA, July 27, 2020 -- Elevar Therapeutics, Inc. (“Elevar”), a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer, and Tanner Pharma Group (“Tanner”), a global provider of integrated specialty access solutions, today announced a partnership that will

Elevar Therapeutics Appoints Mark Gelder, M.D. as Global Head of Medical Affairs

SALT LAKE CITY, May 26, 2020 Elevar Therapeutics, Inc., a late-stage biopharmaceutical company focused on developing and commercializing promising therapies to address unmet needs in cancer, today announced that Mark Gelder, M.D. has been named vice president of medical affairs, effective immediately. Dr. Gelder will build and

Elevar Therapeutics Acquires Global Rights to European Approved Apealea® from Oasmia Pharmaceutical

SALT LAKE CITY, USA, March 25, 2020 Elevar Therapeutics, Inc., a fast-growing biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, announced today an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea®, except in Nordics, Russia, and certain countries in

Elevar Therapeutics Announces Enrollment of the First Patient in a Pivotal Trial for the Treatment of Adenoid Cystic Cancer (ACC)

March 9, 2020 SALT LAKE CITY, USA. Elevar Therapeutics, a late stage biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, announced today the initiation of a pivotal trial for the treatment of adenoid cystic cancer (ACC) with the enrollment of the first

Elevar Therapeutics and Neopharma establish a JV for the Commercialization of Rivoceranib in MENA and India

October 3, 2019

October 3, 2019 SALT LAKE CITY, USA. Elevar Therapeutics and Abu Dhabi-based Neopharma have entered into an agreement to establish a joint venture in the United Arab Emirates. The 50:50 venture is planned to undertake a broad range of development and commercialization activities for rivoceranib in the Middle East, North

Elevar Announces Results from the ANGEL trial, a study of Monotherapy Rivoceranib (Apatinib) in Late-Stage Gastric Cancer Patients

September 29, 2019

September 29, 2019 SALT LAKE CITY, USA. Elevar Therapeutics announced data from the ANGEL trial, a randomized phase 3 study of rivoceranib (also known as apatinib) plus best supportive care in patients with gastric or gastroesophageal junction cancer who have failed at least 2 prior lines

Elevar Therapeutics Announces ANGEL Trial Podium Presentation at ESMO

September 20, 2019

September 20, 2019 SALT LAKE CITY, USA. Elevar Therapeutics announced that data from the ANGEL trial has been accepted for a podium presentation by the European Society for Professional Oncology at the annual meeting in Barcelona, Spain. The ANGEL trial is a randomized phase 3 study of rivoceranib (commonly known

Elevar Therapeutics Announces Appointment of New Member to the Board of Directors

September 16, 2019

SALT LAKE CITY, USA, September 16, 2019 Elevar Therapeutics is pleased to announce the addition of a new member to the Board of Directors, Paul Chen. “We are very excited to have Paul join our Board of Directors,” said Alex Kim, Elevar Therapeutics’ CEO, “Paul is a

Elevar Therapeutics’ Board of Directors Appoints Alex S. Kim as New CEO

September 3, 2019

SALT LAKE CITY, USA. The Board of Directors of Elevar Therapeutics has appointed Mr. Alex Kim to the position of Chief Executive Officer to succeed Dr. Sung Chul Kim as the head executive of the Company effective August 31, 2019. Dr. Sung Chul Kim, who is a co-founder,

LSK BioPharma Announces New Corporate Name: Elevar Therapeutics

September 3, 2019

SALT LAKE CITY, USA. LSK BioPharma is pleased to announce its new company name, Elevar Therapeutics, effective immediately. “In the last year the Company has made significant strides towards making rivoceranib available to patients worldwide,” said Alex Kim, Elevar Therapeutics’ Chief Executive Officer, “We would

Senior Data Manager

August 26, 2019

Job Title Senior Data Manager Job Status Full Time Job Summary This position provides tactical direction for data management activities across all projects in all phases of development. Supports high quality conduct of Data Management activities for Elevar Therapeutics projects, from program design via protocol development and study execution

Manager, Quality Assurance

Job Title Manager, Quality Assurance Job Status Full Time Job Summary The Manager of Quality Assurance position is responsible for oversite of the Quality Management System (QMS). This position provides support and guidance to ensure compliance with regulatory requirements as well as maintain and update information to those requirements. Job

Regulatory Affairs – Senior Manager

Job Title Regulatory Affairs – Senior Manager Job Status Full Time Job Summary We are currently seeking a full-time, office-based Regulatory Affairs Senior Manager to join LSK BioPharma. This position will work with our clinical and product development teams to contribute to the preparation of regulatory submissions for our

Senior Manager Clinical, Quality Assurance (CQA)

Job Title Senior Manager Clinical, Quality Assurance (CQA) Job Status Full Time Job mmary Responsible for ensuring clinical processes within the Drug Development Group are conducted in accordance with corporate SOPs, guidelines and regulations. Develops, performs, and manages clinical quality assurance activities. Presides over clinical audits. Job Details Ensure that

LSK BioPharma Announces a New Board Member

SALT LAKE CITY, USA, July 23, 2019 LSK BioPharma is pleased to announce the addition of one new member to the Board of Directors: Wook Kim. He is currently a Managing Director of HLB and Next Science, a Korea-based company. He has over 20 years’ experience

Clinical Trial Manager (CTM)

Job Title Clinical Trial Manager (CTM) Job Status Full Time Job Summary The Clinical Trial Manager (CTM) manages at least one primary project, and depending on scope and phase of project, may support multiple projects. The CTM provides project management expertise throughout the development and implementation

LSK BioPharma and Jiangsu Hengrui Medicine Announce Enrollment of The First Patient in a Phase 3 Clinical Study of PD-1 Antibody SHR-1210 Plus Rivoceranib (Apatinib)

SALT LAKE CITY, USA, June 30, 2019 LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced the first patient has been enrolled in

LSK BioPharma Announces Preliminary Review of Top-Line Results from ANGEL Study

LSK BioPharma Announces Preliminary Review of Top-Line Results from ANGEL Study SALT LAKE CITY, USA, June 27, 2019 – LSK BioPharma (LSKB) has completed the unblinding and preliminary review of topline data from its ANGEL Study, a Phase III clinical trial for rivoceranib (apatinib) which enrolled 460

Clinical Trial Associate

Job Title Clinical Trial Associate (CTA) Job Status Full Time Job Summary The Clinical Trial Associate (CTA) supports at least one primary project, and depending on scope and phase of project, may support multiple projects. The CTA provides support to one or more Clinical Trial Managers (CTM). Interacts with

Senior Scientists, Clinical

Job Title Senior Scientists, Clinical Job Status Full Time Job Summary The senior clinical scientist will be a key player of a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex clinical data findings. This individual has the responsibility for influencing

Principal Medical Writer

Job Title Principal Medical Writer Job Status Full Time Job Summary The Principal Medical Writer is responsible for authoring documents, including clinical study reports (CSRs), protocols, investigator’s brochures, publications and other documents. This position is also expected to contribute to higher level submission documents. This position will be responsible

Business Development/Safety Project Management Associate

Business Development/Safety Project Management Associate. Work within the pharmaceutical industry practices and standards for new drug development and safety reporting. Organize aggregate safety data including adverse events, concomitant medications and lab data. Prepare and lead safety oversight meetings for global phase III trials and study

LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC)

SALT LAKE CITY, USA, and SHANGHAI, CHINA, April 8, 2019 -- LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced that the

LSKB Announces that the ANGEL Study Has Reached its Primary Completion Date

February 12, 2019

SALT LAKE CITY, USA, Feb 12, 2019 -- LSK BioPharma (LSKB, Company) announced that it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global Phase III clinical trial, which

LSK BioPharma Introduces New Location for Its Corporate Headquarters

February 2, 2019

SALT LAKE CITY, USA, Feb 2nd, 2019 – In order to accommodate rapid growth, LSK BioPharma (LSKB, Company) has relocated its corporate headquarters to 2825 E Cottonwood Pkwy, Suite 180, Salt Lake City, Utah 84121 USA. The new offices will house the company’s corporate development,

CMC Senior Director

November 21, 2018

Overview We are currently seeking a full-time, San Francisco office-based CMC Senior Director to join LSK BioPharma. This position will manage and guide our API and CMC activities for our small molecule drug substance and product programs from preclinical through commercial. If you want an exciting career

Regulatory Affairs Associate

November 9, 2018

JOB DESCRIPTION Responsible for compliance with applicable procedures. This position will play a key role in preparing US and international regulatory filings. Individual coordinates and supports technical and scientific regulatory activities, researches regulations and guidelines, and maintains and organizes key information sources. Individual works under general

LSKB Announces Completion of Enrollment for the ANGEL Study of Rivoceranib (Apatinib) in Gastric Cancer

October 29, 2018

SALT LAKE CITY, USA, Oct 29th, 2018 -- LSK BioPharma (LSKB, Company) announced that it has completed patient enrollment in its pivotal Phase 3 trial, ANGEL, which is evaluating the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC

Director Clinical Strategic Development

October 26, 2018

Director Clinical Strategic Development LSK Biopharma South San Francisco, CA Director Clinical Strategic Development (CSD) provides critical expertise and leadership in the design and planning of integrated development plans for multiple disease indications. CSD drives adoption of innovative approaches and strategic thinking in program and study designs. CSD

LSK BioPharma and Jiangsu Hengrui Medicine Announce Global Clinical Collaboration to Evaluate the Combination of Anti-Angiogenesis and Immuno-Oncology Therapy for Patients with Advanced Hepatocellular Carcinoma (HCC)

October 21, 2018

SALT LAKE CITY, USA, and SHANGHAI, CHINA, October 21, 2018 -- LSK BioPharma (or “LSKB”), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or “Hengrui”), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, today announced that the

LSKB Announces MFDS Approval to Initiate a Phase I/IIa Combination Study of Rivoceranib and Paclitaxel at Asan Medical Center (South Korea)

October 1, 2018

SALT LAKE CITY, USA, Oct 1st, 2018 -- LSK BioPharma (LSKB, Company) announced that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a Phase I/IIa study protocol to investigate the combination of rivoceranib and paclitaxel, “A Phase I/IIa Study to Evaluate

Senior Clinical Study Manager

Ensure that global regulated clinical studies are compliant and that clinical trials are conducted with company goals, SOPs, Ethics, ICH GCP and global regulatory guidelines. Provide operations management for the planning, execution and reporting of Phase III global clinical trials. Work within the pharmaceutical industry

LSKB Announces that Enrollment has Opened at Huntsman Cancer Institute for the APPEASE Study combining Rivoceranib and Pembrolizumab

SALT LAKE CITY, USA, June 19, 2018 -- LSK BioPharma (LSKB, Company) announced that enrollment has opened for the APPEASE study, “A phase 1/2 open label study of the safety and efficacy of apatinib [rivoceranib] administered to patients with advanced malignancies to improve sensitivity to

Preclinical/DMPK Research Associate

Position Scope and Summary LSK BioPharma is searching for a qualified candidate to join our preclinical product development team in South San Francisco. The position will be responsible for planning and monitoring preclinical and DMPK-related projects performed by LSK BioPharma’s vendors/contractors. Roles and Responsibilities Oversee and monitor

CMC Product Manager

Overview We are currently seeking a full-time, office-based CMC Product Manager to join LSK Biopharma. This position will manage and guide our CMC activities for our small molecule drug substance and product programs from preclinical through commercial. If you want an exciting career where you use

Regulatory Affairs – Submissions Project Senior Manager/Director

Overview We are currently seeking a full-time, office-based Regulatory Affairs Manager/Director to join LSK Biopharma. This position will work with our clinical and product development teams to contribute to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major

LSKB TO REPORT NON-CLINICAL RIVOCERANIB (APATINIB) COMBINATION WITH IMMUNOTHERAPY

SALT LAKE CITY, April 16, 2018 – LSK BioPharma (LSKB) today will present a poster at the American Association for Cancer Research (AACR) Annual Meeting in Chicago. The poster discloses nonclinical data suggesting a synergistic combination of rivoceranib (apatinib) with anti-PD-1 therapy. The combination significantly

Part Time Contract – Senior CRA position

News, Uncategorized

Position has been filled. Responsibilities and Duties Essential Duties & Responsibilities: Primary contact for the site, supervise and monitor clinical trials to ensure adherence to ICH-GCP standards, study protocol, SOPs and regulations. Ensure proper adherence to protocol, Informed consent procedures, source data verification, compliance to safety

LSKB Announces Official Nonproprietary Naming of Apatinib (YN968D1): RIVOCERANIB

January 2, 2018

SALT LAKE CITY, USA, JANUARY 2, 2018. LSKB announced that it has adopted the nonproprietary/generic name “rivoceranib” (pronounced riv” oh ser’ an ib) for its small molecule angiogenesis inhibitor commonly known as apatinib and YN968D1. “Rivoceranib” has been approved as the nonproprietary name by the

LSKB Announces Enrollment of the First Patient in its Apatinib-Nivolumab Combination Study

December 27, 2017

SALT LAKE CITY, USA, December 27, 2017 -- LSK BioPharma (LSKB, Company) announced that it has enrolled the first patient in a clinical trial studying the combination of apatinib with the immuno-oncology drug nivolumab. This study (designated LSK-AM107) is an open-labeled, single-center, Phase 1 study

LSKB Announces Enrollment of the First Patients in the US and Europe for its Ongoing Apatinib Phase 3 Clinical Trial in Advanced or Metastatic Gastric Cancer

December 20, 2017

SALT LAKE CITY, USA, December 20, 2017 -- LSK BioPharma (LSKB, Company) has enrolled the first US and European patients in its ongoing, multinational Phase 3 ANGEL Study; a pivotal study assessing the safety and efficacy of apatinib in patients with advanced or metastatic gastric

LSKB Announces its Clinical Initiative to Study the Safety and Efficacy of Combining Apatinib with Immunotherapy

December 10, 2017

SALT LAKE CITY, USA, December 10, 2017 -- LSK BioPharma (LSKB, Company) announced a new initiative to study the safety and efficacy of cancer therapies combining apatinib with immunotherapy. The first clinical study, designated LSK-AM107, will take place at the Cancer Center of Southern California

LSKB is hiring a Senior Clinical Research Associate

November 29, 2017

Responsibilities and Duties Essential Duties & Responsibilities: Assist protocol, IB and CRF development Provide monitoring guidance Plan and assist study start-up activities such as the creation of Site Initiation Presentations, CRF Completion Guidelines and various study tracking and management documents Perform pre-site selection, site initiation, interim,

LSKB is hiring a Global Clinical Project Manager

September 8, 2017

Position Summary: This position functions as a Clinical Project Manager for global late stage clinical trials within LSK BioPharma (South San Francisco) or within LSK Global CRO (Seoul) as the relevant study/project requires. The Global Clinical Trials Manager (GCTM) works primarily with CRO and other

The US FDA grants Apatinib Orphan Drug Designation for Treatment of Gastric Cancer

SALT LAKE CITY, USA, June 19 2017 -- LSK BioPharma (LSKB, Company) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to apatinib for the treatment of gastric cancer. Apatinib, which has been approved and is marketed in China for patients with

LSK BioPharma to Attend and Present at the ASCO 2017 Annual Meeting

SALT LAKE CITY, USA, June 1 2017 -- LSK Biopharma (LSKB Company) will be attending the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA from June 2-6. The Company will be meeting with leading oncologists and key opinion leaders from across the

LSK BioPharma Announces Starting of Site Initiation Visits in the U.S. for its Phase 3 Gastric Cancer Trial Studying Apatinib

SALT LAKE CITY, USA, May 16, 2017 – LSK BioPharma (LSKB, Company) announced today that it has started Site Initiation Visits (SIVs) for clinical sites in the United States for its global apatinib phase 3 gastric cancer trial. The Company has already initiated sites in

LSK BioPharma Announces Approval to Initiate a Phase 2 Clinical Trial in Colorectal Cancer in South Korea

SALT LAKE CITY, USA, May 8, 2017 – LSK BioPharma (LSKB, Company) announced today that it has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a phase 2 clinical trial of apatinib, the Company’s proprietary angiogenesis inhibitor, in colorectal

LSK BioPharma Announces Enrollment of First Patient in Phase 3 Apatinib Trial in Gastric Cancer

SALT LAKE CITY, USA, March 13, 2017 – LSK BioPharma (LSKB, Company) announced today enrollment of the first patient in a global, multicenter phase 3 trial to evaluate apatinib in patients with advanced or metastatic gastric cancer. This first patient was enrolled at ASAN Medical Center

LSK BioPharma’s Apatinib Receives Orphan Drug Designation in the European Union

SALT LAKE CITY, USA, March 1, 2017 – LSK BioPharma (LSKB, Company) today announced that it has received notification that the European Commission has designated apatinib as an orphan medicinal product for the treatment of gastric cancer in the European Union. Further to the development

LSK BIOPHARMA RECEIVES APPROVAL TO INITIATE PHASE 3 FROM KOREA’S MFDS, EXPECTS FIRST-PATIENT-ENROLLED IN GLOBAL PHASE 3 SHORTLY

January 6, 2017

SALT LAKE CITY, January 6, 2017 – LSK BioPharma (LSKB) today announced that it received approval for its apatinib phase 3 protocol under the Korean Ministry of Food and Drug Safety (MFDS). South Korea will be a part of the global phase 3 gastric cancer

LSKB TO REPORT PHASE 2 APATINIB CLINICAL DATA AT 2016 ESMO CONGRESS

September 22, 2016

SALT LAKE CITY, September 21, 2016 – LSK BioPharma (LSKB) announced that it will release data from its phase 2 apatinib clinical trial in a poster at the 2016 ESMO Congress in Copenhagen, Denmark October 7-11, 2016. This data comes from patients that were enrolled in

LSK BIOPHARMA RECEIVES ADVICE FROM CHMP SUPPORTING ITS PLAN TO ENROLL EUROPEAN PATIENTS IN GLOBAL PHASE 3

September 22, 2016

SALT LAKE CITY, September 21, 2016 – LSK BioPharma (LSKB) today announced receiving advice from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) supporting its plan to recruit European patients in its global phase 3 clinical trial. “We are very encouraged

LSK BioPharma Announces Successful Outcome from End-of-Phase 2 meeting with FDA

FDA meeting clears pathway to initiation of pivotal phase 3 study SALT LAKE CITY, July 26, 2016 -- LSK BioPharma (LSKB) today announced the successful completion and positive outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for apatinib, an

LSKB seeks to hire a Business Development Associate

Position Summary: Responsible for assisting with the planning and implementation of business development activities (out-license and in-license research, valuations/models and other value driving documentation, competitive and prospective client research, and relationship building) and participating in developing infrastructure to support current and future drug development. Act as

LSK BioPharma has landed in California!

LSK BioPharma is pleased to announce the opening of its west coast office in San Bruno, California at 1001 Bayhill Dr. on the 2nd Floor. This office will handle business development for LSKB’s products and product development partnerships in Asia.

LSKB seeks to hire a Project Manager Associate

LSKB is a privately-held biopharmaceutical company based in Salt Lake City, Utah. We are opening an office in the Bay Area. The Company specializes in the early clinical development of promising therapies for unmet medical needs in cancer. LSKB is developing two exciting drug candidates;

Apatinib End-of-Phase 2 meeting scheduled with US FDA

LSKB has scheduled an End-of-Phase 2 meeting with US FDA on July 20, 2016 to discuss clinical development plans for apatinib. The FDA guidance from this meeting will assist LSKB in finalizing the design of a pivotal Phase 3 study in patients with gastric cancer

LSKB Attending Bio International Convention in San Francisco

LSKB is attending Bio International Convention June 6-9th in San Francisco at the Moscone Center - We are discussing product license and co-development opportunities. Schedule a meeting with us through the bio partnering system, or send us a message at alexkim@lskbiopharma.com.

LSKB Attending ASCO 2016 annual meeting

LSKB is attending ASCO in Chicago at the McCormick Center June 2-7th. We will be meeting with key leading oncologists from across the globe to discuss late stage development of apatinib mesylate in gastric cancer, colorectal cancer, and hepatocellular carcinoma. Contact arlo.mcginn@lskbiopharma.com for more information.

LSKB Attending Bio Europe Spring in Stockholm

LSKB is attending Bio Europe Spring in Stockholm - schedule a meeting with us through the partnering system, or send us a message at alexkim@lskbiopharma.com

LSK BioPharma and LSK Global PS Announce a Strategic Alliance for Global Clinical Trials

LSK BioPharma (LSKB), which is currently developing two promising cancer drugs, announced that it has entered into a strategic alliance with the largest CRO in Korea, LSK Global PS. The strategic alliance will initially focus on the clinical development of apatinib, a drug which has

LSK BioPharma and Huntsman Cancer Institute Announce an Exclusive License Agreement for HCI-1401, a BTK inhibitor for treatment of B-cell malignancies and other diseases

Salt Lake City– LSK BioPharma (LSKB) and the University of Utah’s Huntsman Cancer Institute (HCI) today announced an exclusive license agreement for LSKB to develop and commercialize HCI-1401, an orally bioavailable, small molecule, irreversible inhibitor of Bruton’s tyrosine kinase (BTK). “BTK inhibitors are an exciting

LSK BioPharma at ASCO 2015

Dr. Sunil Sharma and Dr. Yoon Koo Kang in front of the Apatinib poster at ASCO 2015. Read The Abstract

LSKB announces initiation of a US clinical trial studying the dose escalation and safety of apatinib mesylate (YN968D1) in solid tumor cancers

Clinical Studies, News, Pharmaceutical Developments, Research

Salt Lake City, UT, June 6, 2012 - LSK BioPartners today announced the initiation of a Phase 1/2A dose escalation and safety trial of apatinib mesylate (YN968D1) with the enrollment of the first three patients of the first dose cohort. This is the first clinical