On May 17, 2018 Oncolytics Biotech Inc. (TSX:ONC) (OTCQX:ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported an investigator sponsored study (IST) supported by Merck Inc (Press release, Oncolytics Biotech, MAY 17, 2018, View Source [SID1234534183]). (Merck), Northwestern University (Northwestern) and Oncolytics. This study is an extension of the previously reported phase 1 study (REO 024) that will investigate pelareorep in combination with Merck’s anti-PD1 checkpoint inhibitor Keytruda, to treat second line pancreatic cancer patients. The study, run by the principal investigator of REO 024, Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

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"This study using Merck’s Keytruda is our second I-O combination in human trials after our multiple myeloma study in combination with Celgene’s Imnovid and Revlimid," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We’re very happy with Merck’s increased involvement in our pancreatic studies and believe combining pelareorep with Keytruda poses an exciting opportunity to lay additional groundwork towards our ultimate goal – to expand the use of check point inhibitors as anti-cancer agents by promoting an inflamed phenotype in the tumor, or turning cold tumors hot."

"REO 024, a phase 1b study combining pelareorep and Keytruda in second line pancreatic patients, was designed to evaluate safety and tolerability of the combination," said Dr. Mahalingam, Associate Professor of Medicine (Hematology and Oncology), Northwestern University Feinberg School of Medicine. "The results from that study demonstrated that the combination is safe, but also that there was early evidence of clinical activity, including one patient that had a partial response lasting 17.4 months and two with stable disease of 126 days and 277 days. This new phase two study will enroll patients with advanced pancreatic cancer failing front line chemotherapy and will primarily evaluate overall response rate of the combination therapy. The study will also provide important biomarker data determined by analysis of pre- and post-treatment biopsies and blood-based immune markers."

Final study design and other details will be announced upon enrollment of the first patient, expected in the third quarter 2018.

On May 17, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that two abstracts on its lead product candidate BPX-501 have been selected for presentation at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden on June 14-17, 2018 (Press release, Bellicum Pharmaceuticals, MAY 17, 2018, View Source [SID1234526757]).

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The presentations will include updated interim survival results from pediatric patients with primary immunodeficiencies (PIDs) and acute myelogenous leukemia (AML) who are undergoing a curative haplo-HSCT with BPX-501.

Oral Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Primary Immunodeficiencies Abstract: S871
Session Title: Stem cell transplantation – Clinical II
Date: Saturday, June 16
Time: 4:00 – 4:15 p.m. CEST

Poster Presentation Details

Title:Administration of BPX-501 Cells Following Alpha/Beta T-cell and B-cell-Depleted HLA‑Haploidentical HSCT (haplo-HSCT) in Children with Acute Myelogenous Leukemia Abstract: PS989
Session Title: Acute myeloid leukemia – Clinical
Date: Saturday, June 16
Time: 5:30 – 7:00 p.m. CEST

The BPX-501 clinical presentations at the conference will include updated information beyond that included in the abstracts currently available online on the EHA (Free EHA Whitepaper) conference website.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

On May 17, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that multiple abstracts from its robust clinical development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois, from June 1-5, 2018 (Press release, Seattle Genetics, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349592 [SID1234526775]).

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"The abstracts being presented at ASCO (Free ASCO Whitepaper) 2018 highlight the depth of our clinical program in multiple solid tumors and hematological malignancies," said Robert Lechleider, M.D., Senior Vice President, Clinical Development at Seattle Genetics. "Of note, an oral presentation will feature updated data from a phase 1 study of enfortumab vedotin for patients with metastatic urothelial cancer. Data from this study formed the basis of the recent FDA Breakthrough Therapy Designation for enfortumab vedotin. In addition, multiple posters featuring sub-analyses from the ECHELON-1 trial of ADCETRIS provide continued strong rationale for ADCETRIS combination use in the treatment of patients with frontline Stage 3 and 4 classical Hodgkin lymphoma."

The abstracts published in advance of the ASCO (Free ASCO Whitepaper) meeting were made available yesterday on the ASCO (Free ASCO Whitepaper) website at www.asco.org.

Urothelial Cancer

(Abstract #4504) "Updated results from the enfortumab vedotin phase 1 (EV-101) study in patients with metastatic urothelial cancer (mUC)"

Presenter: J. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center

Oral Abstract Session: Genitourinary (Nonprostate) Cancer

Date and Time: Sunday, June 3, 9:12 a.m.-9:24 a.m. CDT (session begins at 8:00 a.m.)

Location: Arie Crown Theater

(Abstract #TPS4590) "EV-201 Study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy"

Presenter: J. Rosenberg, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Genitourinary (Nonprostate) Cancer

Date and Time: Saturday, June 2, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #414a

Hodgkin Lymphoma

(Abstract #7534) "Improving outcomes with brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma"

Presenter: D. Straus, M.D., Memorial Sloan Kettering Cancer Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #171

(Abstract #7541) "Brentuximab vedotin (BV) plus chemotherapy in patients with newly diagnosed advanced stage Hodgkin lymphoma (HL): North American results"

Presenter: R. Ramchandren, M.D., Barbara Ann Karmanos Cancer Institute

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #178

(Abstract #7542) "Long-term follow-up of brentuximab vedotin +/- dacarbazine as first line therapy in elderly patients with Hodgkin lymphoma"

Presenter: J. Friedburg, M.D., University of Rochester Medical Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #179

(Abstract #7539) "Brentuximab vedotin with chemotherapy for stage III or IV Hodgkin lymphoma (HL): Impact of cycle 2 PET result on modified progression-free survival (mPFS)"

Presenter: R. Chen, M.D., Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center

Poster Session: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #176

Breast Cancer

(Abstract #1015) "Clinical benefit of tucatinib after isolated brain progression: A retrospective pooled analysis of tucatinib phase 1b studies in HER2+ breast cancer"

Presenter: R. Murthy, M.D., University of Texas MD Anderson Cancer Center

Poster Session: Breast Cancer – Metastatic

Date and Time: Saturday, June 2, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #96

Discussed at Poster Discussion at Hall D1 on Saturday, June 2, 1:15 p.m.-2:30 p.m. CDT

Cervical Cancer

(Abstract #TPS5601) "A single-arm, phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF-ADC) in previously treated, recurrent or metastatic cervical cancer"

Presenter: R. Coleman, M.D., The University of Texas MD Anderson Cancer Center

Poster Session: Gynecologic Cancer

Date and Time: Monday, June 4, 1:15 p.m.-4:45 p.m. CDT

Location: Hall A, Poster Board #327b

Additional Cancers

(Abstract #3093) "SEA-CD40, a non-fucosylated CD40 agonist: Interim results from a phase 1 study in advanced solid tumors"

Presenter: J. Grilley-Olson, M.D., UNC Lineberger Comprehensive Cancer Center/University of North Carolina Chapel Hill

Poster Session: Developmental Therapeutics – Immunotherapy

Date and Time: Monday, June 4, 8:00 a.m.-11:30 a.m. CDT

Location: Hall A, Poster Board #307

On May 17, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it will present data at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), to be held June 14-17, 2018 in Stockholm, Sweden, showing that BL-8040, combined with high dose cytarabine (HiDAC), significantly enhanced overall survival of difficult-to-treat relapsed or refractory AML (r/r AML) patients in a Phase 2a clinical trial (Press release, BioLineRx, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349648 [SID1234526758]).

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The Phase 2a study consisted of 42 patients in two cohorts: dose-escalation (range 0.5-2.0 mg/kg) and dose-expansion at the selected dose of 1.5 mg/kg. Patients with r/r AML were treated daily with BL-8040 monotherapy for two days followed by combined administration of BL-8040 and HiDAC for 5 days for 1-2 cycles. Efficacy endpoints included response rate (CR/CRi), overall survival, duration of response and event free survival. BL-8040 in combination with HiDAC was safe and well tolerated at all BL-8040 dose levels (range 0.5-2.0 mg/kg). The response rate for all dosing levels was 29% and median overall survival was 9.1 months, compared with historical data on overall survival of 6.1 months for HiDAC alone. In patients receiving the dose selected for expansion (n=23), the response rate was 39% and median overall survival was 9.2 months with 1-year and 2-year survival rates of 31.6% and 21.1%, respectively. Furthermore, median overall survival for responding patients (CR/CRi) at the 1.5 mg/kg dose was 16.7 months, with 1- and 2-year survival rates of 50% and 37.5%, respectively.

"We are extremely encouraged with the overall survival data continuing to flow from this proof-of-concept study. The study included a very difficult-to-treat patient population, in which 81% were either refractory to one or two inductions, or experienced progression-free survival of less than 12 months after first-line therapy. These data continue to give us confidence in the AML space, where we have two important studies ongoing – a large, randomized controlled Phase 2b study in consolidation AML, and a Phase 1b/2 study in maintenance AML under our collaboration with Genentech," said Philip A. Serlin, Chief Executive Officer of BioLineRx.

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On May 17, 2018 SELLAS Life Sciences Group Inc., (Nasdaq:SLS) (SELLAS) reported that data from the Company’s ongoing Phase 1/2 study of galinpepimut-S (GPS) in combination with Bristol Myers Squibb’s nivolumab in patients with Wilms Tumor 1 + ovarian cancer will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1 – 5, 2018 in Chicago, Illinois (Press release, Sellas Life Sciences, MAY 17, 2018, View Source [SID1234526776]). Additionally, following the positive outcome in triple negative breast cancer patients (TNBC) from the Phase 2b trial for NeuVax, SELLAS will be conducting clinical and regulatory advisory board meetings at ASCO (Free ASCO Whitepaper) based on the independent Data Safety Monitoring Board recommendation to expeditiously seek regulatory guidance by the FDA for the development of NeuVax in TNBC.

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Clinical and immunological data from the ongoing Phase 1/2 GPS plus nivolumab trial evaluating GPS in patients with recurrent WT1+ ovarian cancer in second or greater clinical remission after salvage chemotherapy will be presented. Details for the presentation are as follows:

Title: A phase I study of concomitant galinpepimut-s (GPS) in combination with nivolumab (nivo) in patients (pts) with WT1+ ovarian cancer (OC) in second or third remission.
Presenter: Roisin E. O’Cearbhaill, M.D., Memorial Sloan Kettering Cancer Center
Abstract Number: 5553
Poster Session: Gynecologic Cancer
Date and Time: June 4, 2018, 1:15PM – 4:45PM CT
Location: McCormick Place, Hall A