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Oncolytics Biotech ® Presents Positive Clinical Biomarker Data at the American Association for Cancer Research Annual Meeting 2019

On April 2, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 which is taking place March 30 through April 3 in Atlanta, Georgia (Press release, Oncolytics Biotech, APR 2, 2019, View Source [SID1234534909]).

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The poster, entitled, "Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma," describes analysis of patient samples from REO 024; a study of pelareorep and Keytruda in combination with chemotherapy in patients with advanced (second-line) pancreatic cancer.

"We are thrilled with the rates of disease control observed in this study evaluating pelareorep and Keytruda in combination with chemotherapy in patients with advanced second-line pancreatic cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The data presented at AACR (Free AACR Whitepaper) now demonstrate that the degree of T cell clonality, examined in patients from REO 024, has the potential to serve as a predictive and prognostic biomarker of pelareorep therapy. Providing physicians with a simple blood test to understand which patients are likely to respond to treatment is invaluable, allowing the medical community to target the right treatment to the right patient. We look forward to utilizing this new biomarker as we move forward with all of our current clinical programs with checkpoint inhibitors including trials for multiple myeloma, our ongoing phase 2 second-line pancreatic cancer study, and of course, our breast cancer program."

Dr. Rita Laeufle, Chief Medical Officer of Oncolytics Biotech, said, "These data provide additional insight into the underlying biology that drives the efficacy of pelareorep therapy when combined with a checkpoint inhibitor and chemotherapy. We see that treatment with pelareorep can educate or prime the immune system early on during treatment. This priming occurs after pelareorep but before Keytruda, highlighting the synergy of these agents given that checkpoint inhibitors need a primed immune system that recognizes cancer cells in order to work. Importantly, the extent of early priming measured before the addition of Keytruda, is what most strongly correlates to overall survival. We believe these biological changes are intimately tied to pelareorep’s mechanism of action and serve as a biomarker with utility across multiple cancer types."

Key data and conclusions:

Patients treated with pelareorep in combination with chemotherapy and pembrolizumab showed changes in their T cell repertories with high turnover and significant expansion during treatment
These post-treatment expanded T cell populations, are "new" clones not present at baseline, suggesting effective priming of the immune system
Higher T cell clonality at baseline correlates with longer progression free survival (HR=0.05, p=0.01) and overall survival (HR=0.12, p=0.01) demonstrating the predictive value of the assay
Enhanced T cell clonality after the first cycle of treatment correlates with improved overall survival (HR=0.08, p=0.01) and serves as an on-treatment prognostic biomarker
Early expanded T cell clones, detected at day 8 of treatment (prior to pembrolizumab), most strongly correlate with survival time which suggests that early versus late clonal expansion may be elicited by pelareorep treatment
T cell clonality has significant potential as a predictive and prognostic on-treatment biomarker to pelareorep therapy
The poster was authored by Dr. Grey Wilkinson, a translational scientist at Oncolytics Biotech, and his colleagues, in collaboration with Northwestern University, UT Health San Antonio and Adaptive Biotechnologies. The poster can be found on the Posters & Publications page of Oncolytics’ website, View Source

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.

IDERA PHARMACEUTICALS PRESENTS ILLUMINATE-101 DATA DEMONSTRATING TILSOTOLIMOD ACTIVATES INNATE AND ADAPTIVE IMMUNITY AS MONOTHERAPY IN PATIENTS WITH REFRACTORY SOLID TUMORS AT THE AMERICAN ASSOCIATION FOR CANCER RESEARCH (AACR) 2019 ANNUAL MEETING

On April 2, 2019 Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development, and ultimately the commercialization, of therapeutic drugs for both oncology and rare disease indications, reported clinical and translational data from the ILLUMINATE-101 Phase 1 study which explored the role of investigational tilsotolimod as monotherapy in patients with various refractory solid tumors (Press release, Idera Pharmaceuticals, APR 2, 2019, View Source [SID1234534908]). Data will be presented at the AACR (Free AACR Whitepaper) 2019 Annual Meeting being held in Atlanta, GA.

In the poster presentation entitled, "Activation of Innate and Adaptive Immunity Using Intratumoral Tilsotolimod (IMO-2125) as Monotherapy in Patients with Refractory Solid Tumors: a Phase 1b Study (ILLUMINATE-101)" (abstract number 4062), Hani Babiker, M.D., Assistant Professor of Medicine and Associate Director of the Phase 1 Program at the University of Arizona Cancer Center, presented results from this study.

"Tilsotolimod’s therapeutic mission is to alter the immune conditions within the tumor microenvironment to help provide more favorable conditions for checkpoint inhibitors to help achieve successful outcomes for patients," stated Dr. Babiker. "We typically would not expect to see substantial tumor reduction with tilsotolimod monotherapy; however, it is highly encouraging to see the number and duration of stable diseases, including some with tumor reductions, from this study across a wide spectrum of difficult-to-treat refractory solid tumor types. The finding from this study bodes well for both the ILLUMINATE-301 Phase 3 trial and the upcoming ILLUMINATE-206 trial of tilsotolimod in combination with ipilimumab and nivolumab in multiple planned tumor types, including those that have not responded favorably to immunotherapy to date."

The poster will be presented on Tuesday, April 2, 2019 during the Biomarkers and Immune Monitoring poster session from 1:00 PM to 5:00 PM at the Georgia World Congress Center, Exhibit Hall B.

In the ILLUMINATE-101 study, patients with histologically or cytologically confirmed diagnosis of metastatic refractory solid tumors were enrolled into 4 ascending dose cohorts to receive tilsotolimod (8mg, 16mg, 23mg and 32mg) injected into a single lesion. Tumor biopsies of injected and distant lesions were obtained at baseline and at 24 hours and 6 weeks after commencing treatment.

ILLUMINATE-101 FINDINGS
Safety Data

No dose limiting toxicities or treatment-related adverse events were observed;
No treatment-emergent adverse events (TEAEs) leading to treatment or study discontinuation or death occurred; and
The most common grade 3/4 TEAEs were anemia, hyponatremia, pain, sepsis (n=3 each), fatigue and thrombocytopenia (n=2 each).
Efficacy Data

Of 29 evaluable patients, 13 (45%) had a RECIST v1.1 disease assessment of stable disease (SD), with a disease control rate of 45%;
Of the 13 patients with SD, 5 (38%) had maximum tumor shrinkage >10% below baseline;
Duration of SD ranged from 1.3 to 9.7+ months from start of treatment, with 3 patients ongoing; and
No correlations between dose and efficacy were observed.
Translational Data

Fresh flow cytometry in 2 of 3 analyzed patients showed HLA-DR (MHC Class II) upregulation at 24 hours compared with pre-treatment; and
Robust activation and upregulation of type I IFN pathway was observed across analyzed tumor types, demonstrated by increased IRF7, IFIT1, and IFIT2 gene expression, and early increases in type I IFN signaling.
"The findings from ILLUMINATE-101 further strengthen the body of clinical evidence showing that tilsotolimod alters the immune landscape within the tumor microenvironment, setting the stage for potentially higher response rates when combined with other immune-oncology agents," stated Joanna Horobin, M.B. Ch.B, Idera’s Senior Vice President, Chief Medical Officer. "This approach appears to induce upregulation of antigen presentation regardless of tumor type which increases our confidence as we initiate the ILLUMINATE-206 trial (NCT03865082) initially focused on treating patients with squamous cell carcinoma of the head and neck (SCCHN) and microsatellite stable colorectal cancer (MSS-CRC)."

A copy of the poster presentation is available on Idera’s corporate website at View Source

About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the US Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, work for some but not all, as many patients’ immune response is missing or weak and thus they do not benefit from checkpoint therapy. Intratumoral injections with tilsotolimod are designed to selectively enable the tumor-specific T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

https://ir.canfite.com/press-releases/detail/850

On April 2, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with certain institutional investors to receive gross proceeds of approximately $3.2 million (Press release, Can-Fite BioPharma, APR 2, 2019, View Source [SID1234534907])

STARTPRODUCTCLEAR|

In connection with the offering, the Company will issue 4,923,078 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $0.65 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $0.86 per ADS, will be immediately exercisable and will expire five years from the issuance date. The closing of the offering is expected to take place on or about April 4, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to the offering of such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Agenus Begins Dosing with Next-Gen Anti-CTLA-4 Antibody

On April 2, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies1, reported that the first patient was dosed in the clinical trial of its next-generation anti-CTLA-4 antibody (AGEN1181) (Press release, Agenus, APR 2, 2019, View Source [SID1234534906]). AGEN1181, a novel ‘Fc engineered’ antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete cells that block the activity of these cancer killing cells.

The first patient in the trial was dosed by Dr. Steven J. O’Day, M.D., Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer. Dr. O’Day’s pivotal work has led to the approvals of commercial antibodies targeting CTLA-4 and PD-1. "AGEN1181 represents an important next-generation breakthrough with its potential for enhanced immune activation and tumor fighting abilities," said Dr. O’Day. "The pre-clinical data so far suggest that AGEN1181 may bring superior benefit compared to first generation anti-CTLA-4 antibodies and may be an optimal partner for combinations. I am thrilled to be working with this compound."

"AGEN1181 is a product of Agenus’ innovation engine that has been key to rapidly delivering new discoveries to patients," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1181 was developed based on a new mechanism of action discovered by our scientists. In addition to this monotherapy trial, we plan to pursue combination studies with AGEN1181 soon. Besides AGEN1181, additional important discoveries from our innovation engine are also advancing towards the clinic this year."

The Phase 1, open-label, multicenter study is designed to assess the maximum tolerated dose of AGEN1181 in subjects with advanced solid tumors. It will also evaluate the safety, tolerability, PK, and PD profiles and immunogenicity of this antibody. The outcome will determine the recommended phase II dose of AGEN1181.

AGEN1181 was developed based on a discovery made by Agenus scientists, that involves modification of a key region of an antibody, known as the "Fc region", to design next-generation, ‘Fc engineered’ antibodies that may significantly enhance functionality and antitumor immunity. To learn more about AGEN1181 and its potential advantages over first-generation anti-CTLA-4 antibodies, please see Agenus’ Newsletter here.

Savara To Present at the H.C. Wainwright Global Life Sciences Conference in London

On April 2, 2019 Savara Inc. (NASDAQ:SVRA), an orphan lung disease company, reported that Rob Neville, Chief Executive Officer, will present at the H.C. Wainwright Global Life Sciences conference on Tuesday, April 9, 2019 at 1:50 PM GMT / 8:50 AM EST (Press release, Savara, APR 2, 2019, View Source [SID1234534904]). The conference will be held at the JW Marriott Grosvenor House London.

Interested parties can access a live audio webcast on the Investors page of the Savara website at www.savarapharma.com/investors/events-presentations/. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure sufficient time for any software download that may be required for the webcast. An archived presentation will be available on Savara’s website for 30 days.