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Oncolytics Biotech® to Present Clinical Findings of Pelareorep-Induced Immune Response in Breast Tumors at the ESMO Breast Cancer Virtual Meeting

On May 4, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract for an electronic-poster (ePoster) to be presented as part of the ESMO (Free ESMO Whitepaper) Breast Cancer Virtual Meeting on May 23 & 24, 2020 (Press release, Oncolytics Biotech, MAY 4, 2020, View Source [SID1234556966]). The abstract highlights preliminary data on viral replication and a pelareorep-induced adaptive immune response in tumors from the Company’s window-of-opportunity study, AWARE-1. The study combines the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq), followed by surgery in early-stage breast cancer.

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The abstract, A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer, was co-authored by Oncolytics Scientific Advisory Board member Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), as well as several others at institutions across North America and Europe.

The Abstract reported that pelareorep treated patients experienced productive and tumor cell-specific pelareorep replication, an increase in CD8+ T cells, and an upregulation of the immune-checkpoint marker PD-L1. Four of the six patients exhibited an increase in tumor-associated cellularity and tumor-infiltrating lymphocytes (CelTIL), the primary endpoint, which is significant as an increase in CelTIL is associated with a favorable response to treatment. Importantly, our biomarker of T cell clonality was found to correlate with changes in the tumor microenvironment and CelTIL.

Abstracts are available in the ESMO (Free ESMO Whitepaper) Breast Cancer Virtual Meeting program at View Source . The poster will be added to the Oncolytics corporate website shortly after the virtual presentation.

Abstract ID: 485
Presentation Number: 41P
Session Name: ePoster (ID 19)
Section: Biomarkers and translational research and precision medicine
Abstract Title: A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (REO-027, AWARE-1)
Session Date and Time: May 23, 6:00 am ET – 2:00 pm ET & May 24, 6:00 am ET – 1:30 pm ET

About AWARE-1

AWARE-1 is an open label window-of-opportunity study in early stage breast cancer enrolling 38 patients into five cohorts:

Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)
The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

About Breast Cancer

Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

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.

AC Immune Reports Q1 2020 Financial Results and Provides Business Update

On May 4, 2020 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, reported financial results for the first quarter ended March 31, 2020 and provided a business and 2020 research and development update (Press release, AC Immune, MAY 4, 2020, View Source [SID1234556965]).

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: "AC Immune has had a strong start to 2020. We received a second milestone payment and expanded our transformative agreement with Eli Lilly and Company, further reinforcing our position as one of the most influential biotechnology companies targeting neurodegenerative diseases.

"With increasing recognition that precision medicine is likely to be the best way to address the complexity of neurodegenerative disease (NDD) pathology, one of AC Immune’s key strengths is our diversified approach. New proof-of-concept data presented at this year’s AAT-AD/PDTM reflects that alongside programs advancing on well-established targets like Tau and Abeta, we are also focused on novel targets and mechanisms. Our TDP-43 and alpha-synuclein therapeutic and diagnostic programs are amongst the most advanced in the field, as it becomes clear that co-pathologies in AD and NDD are an important element in the route to a cure.

"We continue to believe that 2020 will be an important and eventful year for AC Immune and for the entire field of neurodegenerative diseases, despite the challenges posed by the Covid-19 pandemic. Our continued strong cash position of CHF 277.9 million provides a solid foundation with the Company being fully financed through at least Q1 2024. And we remain on track to meet multiple value-creating milestones this year, with five clinical readouts, including the first Phase 2 proof-of-concept data for semorinemab, an anti-Tau antibody, through our partnership with Genentech, a member of the Roche group."

Q1 2020 Research & Development Highlights:

Presented new preclinical data at the first ever online AAT-AD/PD Focus, describing proof-of-concept data for lead candidates in AC Immune’s therapeutic and diagnostic programs targeting TDP-43 and alpha-synuclein. These pathological proteins represent targets of increasing interest for the treatment of neurodegenerative diseases, and AC Immune’s programs are amongst the most advanced in the field
Dr. Juan Fortea, an internationally renowned neurologist with a specific focus in the emerging field of Down syndrome-related Alzheimer’s disease, joined AC Immune’s Clinical Advisory Board (CAB)
Received a second milestone payment of CHF 10 million from Lilly related to development progress in the small molecule Morphomer Tau aggregation inhibitor program. Under updated collaboration terms, AC Immune is now eligible for a new additional milestone payment of CHF 60 million within 60 days after dosing of the first patient in the first Phase 2 clinical trial of a Morphomer Tau in the United States or European Union. The amendment to the financial terms increases the total deal value by CHF 40 million to CHF 1.86 billion, up from CHF 1.82 billion
2020 Research & Development Outlook
The coming years will be transformational for the field of neuroscience and AC Immune is poised to make significant clinical contributions, capturing substantial interest and value in 2020 and beyond. The Company expects to deliver multiple near-term catalysts, including results from five clinical trials in 2020. The Company’s sustained growth is being fueled by its proprietary discovery platforms, SupraAntigen and Morphomer, and driven by its industry-leading strategy, summarized in AC Immune’s Roadmap to Successful Therapies for Neurodegenerative Diseases.

2020 Clinical Readouts

Semorinemab, anti-Tau antibody: Phase 2 trial primary completion (estimated last patient, last visit) in prodromal/mild in Q2
ACI-24 anti-Abeta vaccine in Down syndrome (DS): Phase 1b full study reporting in H2
ACI-35.030 anti-pTau vaccine: Phase 1b/2a in AD interim analysis in Q2
ACI-3024 small molecule Morphomer Tau aggregation inhibitor: Phase 1 results in healthy volunteers in Q2; data disclosed by Lilly in H2 (expected)
ACI-24 in AD: Phase 2, 12-month interim analysis in H2
2020 Preclinical Milestones

Alpha-synuclein antibody: started investigational new drug (IND)-enabling studies for lead candidate in Q1 (achieved)
Anti-TDP-43 antibody: declare clinical lead and start IND-enabling studies in Q2
Alpha-synuclein small molecule: identify first biologically active small molecule in Q2
Alpha-synuclein imaging agent: advance third generation candidate to clinical stage in Q4
Neuroinflammation: declare lead candidates for small molecule and antibody programs in Q4
Update on Covid-19
AC Immune has always maintained a robust business continuity plan. During the Covid-19 outbreak, every provision is being made to protect the health of patients, staff and investigators, as well as the productivity and integrity of our clinical development. Importantly, the Company currently remains on track to deliver the five clinical readouts expected in 2020, owing largely to the fact that many of the Company’s key trials are already fully enrolled, and patient follow up is continuing virtually. AC Immune notes the following additional considerations related to Covid-19:

The 12-month interim data analysis for ACI-24 in AD will proceed as planned on a reduced patient data-set

Plans to initiate a Phase 2 study of ACI-24 in DS in the second half of 2020 are progressing and will be initiated in line with public health guidance at that time

Dosing of participants in the Phase 2 Colombian Alzheimer’s disease prevention initiative (API) study has been temporarily interrupted by the countrywide stay at home order. While the ultimate duration of the dosing interruption is not yet known, participants are receiving crenezumab or placebo for at least five years as part of the long-term prevention study, and we continue to expect data from the study in 2022
There are positive signs that countries, including Switzerland, are beginning to ease restrictions. AC Immune remains in continuous contact with its partners and other important stakeholders, including the Swiss government, trial investigators and contractors. At this stage the Company is not modifying guidance with respect to the multiple clinical and preclinical data readouts anticipated this year. AC Immune will keep the market apprised of any new developments or information that may impact clinical timelines.

Prof. Andrea Pfeifer, CEO of AC Immune SA, concluded: "With the support of our highly respected investors and partners as well as our strong balance sheet, AC Immune is in an excellent position to deliver on these exciting plans and make a significant difference for patients with neurodegenerative diseases."

Analysis of Financial Statements for the Three Months Ended March 31, 2020

Revenues: Revenues for the three months ended March 31, 2020 totaled CHF 12.4 million. This represents a CHF 62.6 million decrease compared to the three months ended March 31, 2019. The decrease predominantly relates to CHF 73.9 million recognized in the prior period associated with our license agreement with Lilly offset by a recognition of the CHF 10 million milestone payment and CHF 2.1 million for research and development activities performed in the current period
R&D Expenditures: R&D expenses increased by CHF 3.6 million to CHF 15.2 million for the three months ended March 31, 2020 compared to the prior period. Of this increase, CHF 2.4 million relates to increases in R&D expenses directly allocated to R&D programs such as a CHF 1.3 million increase related to scaling up activities for the Phase 2 clinical trial for ACI-24 in DS and a CHF 1.0 million increase for certain Phase 1 clinical activities completed for our lead MorphomerTM Tau compound. Additionally, personnel costs increased by CHF 0.6 million through the addition of 15 FTEs with remaining increases of CHF 0.6 million in regulatory and quality assurance and other unallocated research and development costs
G&A Expenses: For the three months ended March 31, 2020, G&A increased CHF 1.2 million to CHF 4.5 million. Increases were driven by the addition of seven FTEs as well as an increase in administrative and depreciation expenses
IFRS (Loss)/Income for the period: The Company recorded a net loss after taxes of CHF 7.7 million for the three months ended March 31, 2020, compared with net income after taxes of CHF 63.6 million for the prior period
Cash Position: The Company had a total cash balance of CHF 277.9 million, comprised of CHF 182.9 million in cash and cash equivalents and CHF 95 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. This decrease of CHF 10.7 million is principally due to the factors noted above in the income statement which resulted in a CHF 7.7 million net loss for the period and changes in our working capital. Further details are available in our Statements of Cash Flows on the accompanying Form 6-K

Kitov Pharma Company Presentation – May 2020

On May 4, 2020 Kitov Pharmaceuticals presented the Corporate Presentation (Presentation, Kitov Pharmaceuticals , MAY 4, 2020, View Source [SID1234556964]).

CymaBay Therapeutics to Report First Quarter 2020 Financial Results on Monday, May 11

On May 4, 2020 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Monday, May 11, 2020 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2020 and to provide a business update (Press release, CymaBay Therapeutics, MAY 4, 2020, View Source [SID1234556963]).

Conference Call Details
To access the live conference call, please dial 855-327-6837 from the U.S. and Canada, or 631-891-4304 internationally, Conference ID# 10009543. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

Aduro Biotech Provides Business Update and Reports First Quarter 2020 Financial Results

On May 4, 2020 Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, reported financial results for the first quarter ended March 31, 2020 (Press release, Aduro Biotech, MAY 4, 2020, View Source [SID1234556962]).

"We ended the first quarter of 2020 with a cash position of $205.9 million, which enables us to continue supporting the development of our STING and APRIL programs into 2023. We are currently focused on activating clinical trial sites and enrolling patients for Part 3 of our Phase 1 study of BION-1301 in IgA nephropathy and driving enrollment of patients in our Phase 2 study of ADU-S100 in combination with pembrolizumab in squamous cell carcinoma of the head and neck (SCCHN)," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "Despite the challenges associated with the current COVID-19 pandemic, our Board and leadership team remain committed to supporting the safety of our employees while moving our STING and APRIL clinical programs forward."

Recent Highlights

Announced corporate restructuring to reduce operating expenses and extend cash runway into 2023.

Received a $10 million development milestone payment from license partner, Merck & Co., Inc. (known as MSD outside the United States and Canada) (Merck). The payment was received as a result of Merck’s initiation of a Phase 2 clinical trial of MK-5890, the anti-CD27 agonist antibody licensed to Merck in 2014, in patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) that have been previously treated with anti-PD-L1 therapy.

Announced an update on clinical trial timelines and business operations in light of the COVID-19 global pandemic.

We expect delays in activating additional sites and enrolling patients into Part 3 of the Phase 1 clinical trial of BION-1301 in IgA nephropathy. As a result, our ability to report data in IgA nephropathy patients will likely be delayed until the first half of 2021.

Despite some delays in additional site activation and patient enrollment and anticipated delays in patient follow-up and data analysis, we expect to present interim data for the ongoing Phase 2 clinical trial evaluating ADU-S100 and pembrolizumab in SCCHN in the second half of 2020.

We are continuing preparations to initiate a Phase 1 clinical trial evaluating ADU-S100 as an intravesical monotherapy for non-muscle invasive bladder cancer in the second half of 2020. However, study start-up activities may be delayed.

Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $205.9 million at March 31, 2020, compared to $213.6 million at December 31, 2019.

Revenue – Revenue was $14.0 million for the first quarter of 2020 compared to $3.9 million for the same period in 2019. The increase in revenue for the quarter was primarily due to recognition of the $10.0 million development milestone payment received under our license and research agreement with Merck.

Expenses –

Research and development expenses were $15.8 million for the first quarter of 2020 compared to $17.5 million for the same period in 2019. The quarter to date costs decreased primarily due to lower costs related to our programs that are winding down partially offset by higher costs as a result of focused spending towards our STING and APRIL programs. The decrease was also attributable to lower compensation and related personnel costs as well as stock-based compensation as compared to 2019.

General and administrative expenses were $7.8 million for the first quarter of 2020 compared to $8.2 million for the same period in 2019. The quarter to date costs decreased primarily due to lower personnel and stock-based compensation expense, as compared to 2019.

Restructuring and related expense was $4.3 million for the first quarter of 2020 compared to $3.0 million for the same period in 2019. The 2020 restructuring and related expenses consisted of severance and employee retention costs as well as the impairment of property and equipment associated with the planned closure of the Oss facility as part of the January 2020 restructuring plan. The $3.0 million restructuring and related expense recorded in 2019, which includes employee severance and retention payments, related to the January 2019 strategic reset.

Net Loss – Net loss for the first quarter of 2020 was $7.6 million or $0.09 per share compared to net loss of $23.4 million or $0.29 per share for the same period in 2019. In addition to the factors described above, the net loss was offset by approximately $5.7 million of income tax benefit related to an income tax refund resulting from the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The income tax refund is expected to be received in the second half of 2020.