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Spotlight Innovation Commences Part 2 of Phase I Cancer Trial

On March 10, 2017 Spotlight Innovation Inc. (OTCQB: STLT) reported that its subsidiary Celtic Biotech has begun Part 2 of its Phase I dose escalation safety study, Crotoxin in Patients with Advanced Cancer using an Intravenous Route of Administration (Press release, Spotlight Innovation, MAR 10, 2017, View Source [SID1234518077]). ImmunoClin Ltd., a company specializing in clinical development, is the contract research organization (CRO) overseeing the study conduct.

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Part 2 of the Phase I study uses a revised protocol designed to determine whether faster dose escalation can be attained in a shortened time frame without increased risk to patients. The trial is being conducted at the Department of Medical Oncology at Pitié-Salpêtrière Hospital in Paris under the direction of Principal Investigator Maria A. Gil-Delgado, MD, PhD. Dr. Gil-Delgado is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Noted French oncologist David Khayat, MD, PhD, FASCO, a Board Member of ASCO (Free ASCO Whitepaper), is serving as Principal Scientific Advisor.

John Krohn, Spotlight Innovation’s President and Chief Operating Officer, said, "Commencement of Part 2 of this study is a significant step in our cancer drug development program. Crotoxin is an important new potential treatment option for patients with advanced solid tumors, and we are pleased with our progress in the clinical trial process."

Oncology is one of four focus areas within Spotlight Innovation’s research and development pipeline; the others are chronic pain, Zika virus infection and spinal muscular atrophy (SMA).

Oncolytics Biotech® Inc. Announces 2016 Year-End Results

On March 10, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company) reported its financial results and operational highlights for the year ended December 31, 2016 (Filing, Q4/Annual, Oncolytics Biotech, 2016, MAR 10, 2017, View Source [SID1234518074]).

"It was a year of change for Oncolytics, highlighted by additional clinical data that saw our understanding of REOLYSIN’s mechanism of action evolve and grow," said Dr. Matt Coffey, President and CEO of Oncolytics. "Through this process, and with the help of our expanding senior team, we thoughtfully and deliberately put in place a plan that initially contemplates combinations with chemotherapy for late-stage clinical development, but will expand to include targeted immunotherapies over the longer term as we look to leverage the role of the immune system in patient treatment. In the coming months we will specifically define our first registration pathway. In the year ahead we expect data readouts from as many as five sponsored, randomized Phase 2 studies, including one in advanced or metastatic breast cancer."

Selected Highlights

Since January 1, 2016, selected highlights announced by the Company include:

Clinical Results

· An abstract submitted to the American Association of Cancer Research Annual Meeting by Canadian Cancer Trials Group ("CCTG") at Queen’s University in Kingston, Ontario covering results from IND 213, an open-label, randomized, non-blinded Phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer;
· A poster presentation by Dr. Kevin Kelly at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on the Phase 1b Study of REOLYSIN with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma, with preliminary data suggesting evidence of activity and that the treatment combination was well tolerated;
· Additional data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), which showed: a statistically significant improvement (p=0.0201) in progression free survival (PFS) for female patients with adenocarcinoma in the test arm versus the control arm, a strong trend to improved overall survival (OS) for female patients with adenocarcinoma in the test arm versus the control arm;
· Preliminary data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an overall response rate (ORR) of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)), and a trend to improvement in median OS in female patients (female patients in the test arm had median OS of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm);
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a doubling of patients surviving two years; 20% on the test arm versus 9% on the control arm;
· Treatment of the first patients in a Phase 1b study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor;

Corporate

· The appointment of Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO;
· The appointment of Andres Gutierrez, MD, PhD, with more than 25 years of senior clinical development expertise designing and implementing both early- and late-stage oncology clinical studies, to the role of Chief Medical Officer;
· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and

Financial

· At December 31, 2016, the Company reported $14.1 million in cash, cash equivalents and short-term investments. At March 9, 2017, the Company had approximately $11.3 million in cash, cash equivalents and short-term investments.

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

2016 2015
As at December 31, $ $
Assets
Current assets
Cash and cash equivalents 12,034,282 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,406 340,059
Prepaid expenses 260,841 506,669
Total current assets 14,438,329 26,923,980

Non-current assets
Property and equipment 319,955 459,818
Total non-current assets 319,955 459,818

Total assets 14,758,284 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 4,068,664 2,709,492
Total current liabilities 4,068,664 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
December 31, 2016 – 121,258,222
December 31, 2015 – 118,151,622 262,321,825 261,324,692
Contributed surplus 26,643,044 26,277,966
Accumulated other comprehensive income 554,060 760,978
Accumulated deficit (278,829,309) (263,689,330)
Total shareholders’ equity 10,689,620 24,674,306
Total liabilities and equity 14,758,284 27,383,798

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

2016 2015 2014
For the years ending December 31, $ $ $

Expenses
Research and development 9,770,007 8,601,864 13,824,252
Operating 5,524,500 5,315,837 4,998,694
Loss before the following (15,294,507) (13,917,701) (18,822,946)
Interest 163,902 197,859 210,390
Loss before income taxes (15,130,605) (13,719,842) (18,612,556)
Income tax recovery (expense) (9,374) (3,153) (6,779)
Net loss (15,139,979) (13,722,995) (18,619,335)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (206,918) 480,935 200,345

Net comprehensive loss (15,346,897) (13,242,060) (18,418,990)
Basic and diluted loss per common share (0.13) (0.12) (0.21)

Weighted average number of shares (basic and diluted) 119,880,200 112,613,845 87,869,149

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366

Net loss and other comprehensive income — — — 200,345 (18,619,335) (18,418,990)
Issued, pursuant to Share Purchase Agreement 8,861,652 — — — — 8,861,652
Issued, pursuant to "At the Market" Agreement 1,468,668 — — — — 1,468,668
Expired warrants — (376,892) 376,892 — — —
Share based compensation — — 980,325 — — 980,325
Share issue costs (1,285,828) — — — — (1,285,828)
As at December 31, 2014 237,657,056 — 25,848,429 280,043 (249,966,335) 13,819,193

Net loss and other comprehensive income — — — 480,935 (13,722,995) (13,242,060)
Issued, pursuant to Share Purchase Agreement 4,371,687 — — — — 4,371,687
Issued, pursuant to "At the Market" Agreement 20,049,693 — — — — 20,049,693
Share based compensation — — 429,537 — — 429,537
Share issue costs (753,744) — — — — (753,744)
As at December 31, 2015 261,324,692 — 26,277,966 760,978 (263,689,330) 24,674,306

Net loss and other comprehensive income — — — (206,918) (15,139,979) (15,346,897)
Issued, pursuant to incentive share award plan 41,000 — (41,000) — — —
Issued, pursuant to "At the Market" Agreement 1,456,296 — — — — 1,456,296
Share based compensation — — 406,078 — — 406,078
Share issue costs (500,163) — — — — (500,163)
As at December 31, 2016 262,321,825 — 26,643,044 554,060 (278,829,309) 10,689,620

ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

2016 2015 2014
For the years ending December 31, $ $ $

Operating Activities
Net loss for the year (15,139,979) (13,722,995) (18,619,335)
Amortization – property and equipment 162,233 180,411 163,501
Share based compensation 406,078 429,537 980,325
Unrealized foreign exchange (gain) loss (139,810) (816,319) 242,542
Net change in non-cash working capital 2,233,865 (1,105,464) (2,443,988)
Cash used in operating activities (12,477,613) (15,034,830) (19,676,955)

Investing Activities
Acquisition of property and equipment (23,527) (108,268) (152,750)
Redemption (purchase) of short-term investments (27,823) (29,292) (30,041)
Cash used in investing activities (51,350) (137,560) (182,791)

Financing Activities
Proceeds from Share Purchase Agreement — 4,305,396 7,830,409
Proceeds from "At the Market" equity distribution agreement 956,133 19,362,240 1,214,083
Cash provided by financing activities 956,133 23,667,636 9,044,492
(Decrease) increase in cash (11,572,830) 8,495,246 (10,815,254)
Cash and cash equivalents, beginning of year 24,016,275 14,152,825 25,220,328
Impact of foreign exchange on cash and cash equivalents (409,163) 1,368,204 (252,249)
Cash and cash equivalents, end of year 12,034,282 24,016,275 14,152,825

To view the Company’s Fiscal 2016 Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s annual filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source

Bio-Path Holdings to Present Data at the 2017 AACR Annual Meeting

On March 10, 2017 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster presentation at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place from April 1-5, 2017 in Washington D.C. Dr. Ana Tari Ashizawa, Director of Research at Bio-Path, will present preclinical data of BP1002 (Liposomal Bcl2 antisense), the Company’s second drug candidate, for the treatment of aggressive non-Hodgkin’s lymphoma (Filing, 8-K, Bio-Path Holdings, MAR 10, 2017, View Source [SID1234518073]).

Details for the poster presentation are as follows:

Date: Wednesday, April 5, 2017
Presentation Time: 8:00 am – 12:00 pm Eastern Time
Location: Walter E. Washington Convention Center
Session: Gene and Vector Based Therapy, Section 3
Abstract: 5091
Title: "Activity of Bcl-2 antisense therapeutic in aggressive non-Hodgkin’s lymphoma" (Link to abstract)

Endocyte and Seattle Children’s Research Institute to Collaborate on Endocyte’s Small Molecule Drug Conjugate Bi-Specific Adaptor Molecules for CAR T-cell Therapies

On March 10, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported their plan to collaborate with Seattle Children’s Research Institute and Dr. Michael Jensen for the development of Endocyte’s SMDC platform in the chimeric antigen receptor T-cell (CAR T-cell) immunotherapy setting through the use of Endocyte’s proprietary SMDC bi-specific adaptor molecules (Press release, Endocyte, MAR 10, 2017, View Source [SID1234518070]).

The aim of the research collaboration is to join Endocyte’s SMDC bi-specific adaptor technology with the CAR T-cell immunotherapy research efforts at the Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute, to move these potentially enabling technologies more quickly to patients in the clinic. Dr. Jensen, a recognized leader in the field of CAR T-cell research, is the director of Ben Towne Center for Childhood Cancer Research and the Janet and Jim Sinegal Endowed Chair in Pediatric Solid Tumor Research at Seattle Children’s Research Institute, and a professor of hematology-oncology at the University of Washington School of Medicine.

"This partnership brings together Dr. Jensen’s expertise in the discovery and development of CAR T-cell therapies and Endocyte’s SMDC platform, with the aim of improving the efficacy and safety of CAR T-cell therapies and enabling them in solid tumor indications," said Mike Sherman, president and CEO of Endocyte. "Together, Seattle Children’s Research Institute and Endocyte hope to make a meaningful difference in shaping the future of CAR T-cell therapies and offering an important new treatment option to cancer patients."

"This collaborative project with Endocyte represents a next-generation CAR T-cell therapeutic platform with exciting opportunities to target solid tumors," said Dr. Michael Jensen. "We have been impressed with the potential of Endocyte’s bi-specific adaptor molecules, which enable the engineering of a single universal CAR T-cell that binds with very high affinity, potentially allowing us to address several key challenges of current therapies in this novel area of development."

Research and development activities under the collaboration will be led by Dr. Michael Jensen and Dr. Phil Low, chief scientific officer at Endocyte and professor of chemistry and director of the Center for Drug Discovery at Purdue University.

About Endocyte’s SMDC Bi-Specific Adaptors

Endocyte’s SMDC bi-specific adaptors represent a novel approach that makes possible the engineering of a single universal CAR T-cell, designed to bind with high affinity to fluorescein isothiocyanate (FITC). This universal CAR T-cell can be specifically directed to cancer cells through the administration of a tumor targeted FITC-containing SMDC, known as a bi-specific adaptor, that acts to bridge the universal CAR T-cell with the cancer cells to cause localized T-cell activation. This technology may address or mitigate several challenges of current CAR T-cell therapies, such as i) the inability to control the rate of cytokine release and tumor lysis, ii) the absence of an "off switch" that can terminate cytotoxic activity when tumor eradication is complete, and iii) a requirement to generate a different CAR T-cell for each unique tumor antigen.

TRILLIUM REPORTS ANNUAL 2016 FINANCIAL AND OPERATING RESULTS

On March 10, 2017 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported a corporate update and reported financial results for the year ended December 31, 2016 (Filing, Q4/Annual, Trillium Therapeutics, 2016, MAR 10, 2017, View Source [SID1234518068]).

"2016 marked a year of significant clinical progress with our lead drug candidate TTI-621, which completed Phase 1a dose escalation and advanced into Phase 1b cohort expansion in patients with advanced hematologic malignancies. Late in the year, we also initiated a Phase 1 clinical trial of TTI-621 in solid tumors. These studies will provide data that will guide us in designing the optimal commercial development path for TTI-621. Both trials are recruiting well, and we remain on track to provide updates later this year," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "The TTI-621 program momentum continues in 2017. Recent pharmacology data from the Phase 1 a/b trial expand on our preliminary findings and suggest that with weekly dosing we are achieving biologically relevant drug levels."

Corporate Update:

•
Trillium recently presented additional pharmacology data from its ongoing Phase 1a/1b trial of TTI-621, demonstrating well-tolerated drug levels that exceed those necessary for anti-tumor activity in preclinical models. Specifically, the following scientific findings were highlighted at the February ASCO (Free ASCO Whitepaper)-SITC Conference :

o
Receptor occupancy increases with multiple infusions of TTI-621, conferring robust CD47 blockade on circulating leukemic cells;

o
Increases in cytokines associated with macrophage activation suggest rapid engagement of the innate immune system;

o
Transient thrombocytopenia due to target mediated clearance is attenuated subsequent to the first infusion of TTI-621, and

o
Weekly infusions lead to a longer half-life and accumulation of circulating drug, overcoming the platelet antigen sink.

2016 Highlights:

•
Initiated and completed the Phase 1a dose escalation phase of a first-in-human clinical trial of TTI-621 in patients with relapsed or refractory lymphoma, and began enrollment in the Phase 1b dose expansion cohorts in patients with advanced hematologic malignancies. Two additional expansion cohorts were added, including combination therapy of TTI-621 and rituximab in patients with CD20-positive malignancies.

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•
Presented data from the TTI-621 hematologic malignancy Phase 1a trial at the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing one partial response and decreased tumor volume and/or reduced metabolic activity over extended intervals of continued dosing in several patients.

•
Filed a second Investigational New Drug application with the FDA and initiated in January 2017, a Phase 1 trial with intratumoral injection of TTI-621 in patients with percutaneously accessible solid tumors and mycosis fungoides. This study could lead to a more thorough understanding of the mechanism of action of TTI-621 and could provide insight into the tumor micro-environment before, during and after treatment.

•
Significantly expanded its preclinical oncology pipeline with the acquisition of Fluorinov Pharma Inc., a discovery engine with a demonstrated ability to generate high quality preclinical development candidates. This proprietary medicinal chemistry platform uses fluorine chemistry, which permits the creation of new chemical entities from validated drugs and drug candidates with improved pharmacological properties, potentially leading to increased safety and efficacy.

2016 Financial Results
(Amounts in Canadian dollars)

As of December 31, 2016, Trillium had cash of $50.5 million. For the year ended December 31, 2016, the company used $22.9 million of cash for operations; $9.6 million for the acquisition of Fluorinov Pharma Inc; and used $3.0 million for capital purchases related to its new office and laboratory facility.

Net loss for the year ended December 31, 2016 of $31.7 million was higher than the loss of $14.7 million for the year ended December 31, 2015. The net loss was higher due mainly to increased research and development program expenses of $11.7 million, higher intangible asset amortization of $3.3 million related mainly to the acquisition of Fluorinov intangible assets, and a net foreign currency loss in 2016 of $2.0 million from holding US denominated cash with a weakening US dollar, compared to a foreign currency gain in the comparable 2015 period of $6.1 million. This was partially offset by the recognition of a deferred tax recovery in relation to the acquisition of Fluorinov of $3.7 million.

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Selected Consolidated Financial Information:

Consolidated statements of loss and comprehensive loss

Year ended Year ended
Amounts in Canadian dollars December 31, 2016 December 31, 2015
Research and development expenses 29,788,795 18,050,091
General and administrative expenses 3,932,910 3,184,347
Net finance costs (income) 1,691,680 (6,510,241 )
Net loss and comprehensive loss for the year 31,733,085 14,733,699
Basic and diluted loss per common share (4.06 ) (2.22 )

Consolidated Statements of Financial Position

As at As at
Amounts in Canadian dollars December 31, 2016 December 31, 2015
Cash 50,472,971 86,770,542
Total assets 66,622,691 90,039,468
Total equity 58,119,519 85,803,868