TRILLIUM THERAPEUTICS APPOINTS JAN SKVARKA AS PRESIDENT AND CHIEF EXECUTIVE OFFICER REPORTS INDUCEMENT GRANT UNDER NASDAQ LISTING RULE 5635(C)(4)

On September 25, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the appointment of Mr. Jan Skvarka as President and Chief Executive Officer effective today (Press release, Trillium Therapeutics, SEP 25, 2019, View Source [SID1234539769]). Mr. Skvarka has also been appointed to the Board of Directors of the company.

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"We are delighted to welcome Mr. Skvarka to Trillium," said Robert L. Kirkman, M.D., Executive Chair of Trillium. "We are looking forward to his leadership as we continue to advance the clinical development of TTI-621, our novel CD47 immune checkpoint inhibitor. We believe his long experience in healthcare and finance will be invaluable as we position Trillium for the future."

Added Mr. Skvarka, "I am thrilled at the opportunity to join Trillium, which has positioned itself as a leading CD47-focused immuno-oncology company. TTI-621 is a unique and differentiated molecule that has shown promising results as a monotherapy in early-stage studies in both T- and B-cell lymphomas. I look forward to working with the Trillium team and Board of Directors to take this promising investigational therapy to the next stage of clinical development, and, ultimately, to patients."

Before joining Trillium, Mr. Skvarka was President and Chief Executive Officer of Tal Medical, a clinical-stage neuroscience company in Boston, Massachusetts, from 2014 until 2018. Prior to that he had a long career from 1999 to 2013 as a healthcare consultant at Bain & Company, Boston. He was a partner in the Bain Healthcare practice from 2007 until 2013, with a focus on pharmaceutical, biotechnology and medical technology companies. Earlier in his career he worked in the corporate finance arm of Price Waterhouse in London, UK and Vienna, Austria. Mr. Skvarka holds an MBA degree from Harvard Business School.

Inducement Grant under Nasdaq Listing Rule 5635(c)(4)

Effective September 25, 2019, the Board of Directors adopted the Trillium Therapeutics Inc. 2019 Inducement Stock Option Plan, or the 2019 Inducement Plan, under which Trillium may grant inducement equity awards outside of Trillium’s current stockholder-approved stock option and incentive plans.

The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Trillium (or following a bona fide period of non-employment) as an inducement material to such individual’s entering into employment with Trillium in accordance with Nasdaq Listing Rule 5635(c)(4).

In connection with the appointment of Mr. Skvarka as Chief Executive Officer, the Board of Directors has granted to Mr. Skvarka an option to purchase 1,800,000 common shares under the 2019 Inducement Plan at an exercise price equal to the closing market price of Trillium’s common shares on September 24, 2019. One quarter of the stock options vest 12 months after the date of grant and 1/48th of the remaining options vest each month for the following three years, subject to his continued service with Trillium on such vesting dates. Other terms of the stock option grant are as determined by the Board of Directors and set forth in the 2019 Inducement Plan and applicable award agreement covering such grant. The award is intended to qualify as an "employment inducement award" within the meaning of Nasdaq Listing Rule 5635(c)(4).

Spectrum Pharmaceuticals to Present Corporate Update at the 2019 Cantor Global Healthcare Conference on October 2nd

On September 25, 2019 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that an overview of the company’s business strategy and development-stage programs will be given at the 2019 Cantor Global Healthcare Conference being held in New York (Press release, Spectrum Pharmaceuticals, SEP 25, 2019, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-2019-cantor [SID1234539768]). The company presentation is on Wednesday, October 2, 2019 at 2:25 PM EDT.

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The presentations will be webcast live and may be accessed by visiting Spectrum’s website at View Source

Chi-Med Highlights Presentation of Clinical Data from the Successful SANET-ep Phase III Trial at ESMO Annual Meeting

On September 25, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will showcase data from its proprietary clinical programs at the 2019 European Society for Medical Oncology Congress ("ESMO") on September 27 to October 1, 2019 in Barcelona, Spain (Press release, Hutchison China MediTech, SEP 25, 2019, View Source [SID1234539767]).

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A key highlight will be the oral presentation of a Late-Breaking Abstract reporting efficacy and safety results from the positive Phase III trial in China of surufatinib in non-pancreatic neuroendocrine tumors ("NET"), known as SANET-ep. An interim analysis in June 2019 confirmed that the study met its primary endpoint of progression-free survival ("PFS"). As a result, the independent data monitoring committee ("IDMC") recommended the study be stopped, a year ahead of schedule, and preparations are now underway for the submission of a New Drug Application ("NDA") by the end of 2019 for this indication in China.

The Late-Breaking Abstract will be published on the ESMO (Free ESMO Whitepaper) website coincident with the its presentation; the details of which are as follows:

Title:

Efficacy and Safety of Surufatinib in Patients with Well-Differentiated Advanced Extrapancreatic Neuroendocrine Tumors: Results from the Randomized Phase III Study (SANET-ep)

Presenting Author:

Jianming Xu, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA

Abstract #:

LBA76

Date & Time:

Sunday, September 29, 2019, 16:30 CEST

Location:

Tarragona Auditorium (Hall 7), Fira de Barcelona Gran Via Conference Centre

A conference call and webcast for analysts and investors will be held on Monday September 30, 1 p.m. U.K. time (2 p.m. Barcelona time; 8 a.m. New York time; 8 p.m. Hong Kong time) to review the SANET-ep trial data presented on Sunday, September 29. Safety and tolerability data presented from an ongoing U.S. Phase Ib study of surufatinib in pancreatic NET patients who have progressed on Sutent or Afinitor treatment will also be discussed.

Participating in the call will be Dr. James Yao, Chair of GI Oncology at MD Anderson Cancer Center and one of the lead investigators for our ongoing Phase I/Ib surufatinib study in NET, as well as members of the Chi-Med management team. Dial-in details for the conference call will be available prior to the event at www.chi-med.com/event-information, and a replay will also be available shortly after.

Details of the abstract for the U.S. Phase Ib trial of surufatinib in pancreatic NET patients are as follows:

Title:

Safety and Tolerability of Surufatinib in Western Patients with Solid Tumors

Presenting Author:

Erika P. Hamilton, Director, Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute

Abstract # & Link:

1393P

Date & Time:

Sunday, September 29, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

Other Clinical Data Abstracts

Fruquintinib in the U.S. and Europe: Safety and tolerability of fruquintinib in Western patients with solid tumors will be presented. Fruquintinib is currently in planning for a Phase III registration study in the U.S. and Europe in metastatic colorectal cancer ("CRC") patients who are resistant to or intolerant of prior treatment with Stivarga or Lonsurf. In China, fruquintinib is currently sold under the brand name Elunate, and is for the treatment of patients with metastatic CRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type).

Title:

Phase 1 Trial of Fruquintinib in Patients with Advanced Solid Tumors: Results of the Dose Escalation Phase

Presenting Author:

Andrea Wang-Gillam, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine

Abstract #:

467P

Date & Time:

Saturday, September 28, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

Chi-Med retains all rights to surufatinib worldwide. It retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.

Trials-in-Progress Abstracts

Title:

A Phase 1 Study of HMPL-523, a Selective Oral Anti-Spleen Tyrosine Kinase Inhibitor, in Patients with Relapsed or Refractory Lymphoma

Lead Author:

Nathan Fowler, Associate Professor, Department of Lymphoma/Myeloma, the University of Texas MD Anderson Cancer Center

Abstract #:

1106TiP

Date & Time:

Saturday, September 28, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

Title:

A Phase 1 Study of HMPL-689, a Selective Oral Phosphoinositide 3-Kinase-Delta Inhibitor, in Patients with Relapsed or Refractory Lymphoma

Lead Author:

Jonathan B. Cohen, Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine

Abstract #:

1107TiP

Date & Time:

Saturday, September 28, 2019, 12:00 CEST

Location:

Hall 4, Fira de Barcelona Gran Via Conference Centre

About SANET-ep

SANET-ep is a randomized, double-blind, placebo-controlled, multi-center, Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. In June 2019, an interim analysis was conducted, leading to the IDMC determination that the study met the pre-defined primary endpoint of PFS and should be stopped early. Preparations for an NDA submission are now underway for this indication in China. In this study, patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors for whom there is no effective therapy are randomized at a 2:1 ratio to receive either 300 mg of surufatinib orally daily or placebo, on a 28-day treatment cycle. The primary endpoint of the study is to evaluate the PFS, with secondary endpoints including objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), overall survival (OS), safety, and tolerability. Additional details may be found at clinicaltrials.gov, using identifier NCT02588170.

BioLineRx Announces Dosing of First Patient in Part 2 of Phase 1/2a Clinical Study for AGI-134, a Novel Immunotherapy for Treatment of Solid Tumors

On September 25, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported dosing of the first patient in part 2 of the Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, multi-arm mechanism that targets patient-specific tumor neoantigens (Press release, BioLineRx, SEP 25, 2019, View Source [SID1234539766]). In the dose-escalation part of the study completed earlier this month, AGI-134 was found to be safe and well tolerated, with no serious drug-related adverse events or dose-limiting toxicities reported.

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"Following the successful completion of part 1 of the study and determination of the recommended dose, we are pleased to announce the initiation of part 2 of the Phase 1/2a study of AGI-134, our second lead oncology product," said Philip Serlin, Chief Executive Officer of BioLineRx. "In preclinical trials, AGI-134 led to regression of established primary tumors, prevented growth of secondary tumors, and triggered a vaccine effect that may prevent the development of future metastases. We are looking forward to initial results from part 2 of the study expected by year-end 2020."

The ongoing Phase 1/2a study is a multicenter, open-label study expected to take place at approximately 15 sites in the US, UK and Israel. The objectives of the study are to evaluate the safety and tolerability of AGI-134 at doses up to the recommended dose in multiple solid tumor types, to evaluate a wide array of biomarkers, and to validate AGI-134’s mechanism of action. Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters.

About AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

Oncolytics Biotech(R) Announces Upcoming Presentation at the 12th Annual International Oncolytics Virus Conference

On September 25, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will have an oral presentation at the 12th Annual International Oncolytic Virus Conference (Press release, Oncolytics Biotech, SEP 25, 2019, View Source [SID1234539764]). The conference takes place at the Mayo Civic Center in Rochester, Minnesota, from October 9 – 12.

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The presentation, "Systemic administration of oncolytic reovirus, pelareorep, a metanalysis on the efficiency of tumor delivery", by Grey Wilkinson, PhD, Scientist of Translational Medicine at Oncolytics Biotech, will examine the efficiency of viral delivery and replication in tumor tissue across several clinical studies. It will highlight the potential for treating a variety of cancer indications with intravenously delivered pelareorep and how this delivery method allows for immunological priming for combination immunotherapy.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.