On May 17, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported the publication of abstracts for an open-label phase 1b trial in patients with metastatic adenocarcinoma of the pancreas (MAP) (REO 024) and an open-label, randomized, phase 2 study in metastatic castration resistant prostate cancer (mCRPC) (Press release, Oncolytics Biotech, MAY 17, 2017, View Source [SID1234519223]). Data from the studies will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2-6, in Chicago, IL.

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REO 024, a phase 1b study, was designed to assess the safety (primary endpoint) and dose-limiting toxicity of REOLYSIN in combination with pembrolizumab (KEYTRUDA) and chemotherapy in patients with histologically confirmed MAP who have failed, or did not tolerate, first-line treatment. The study enrolled 11 patients who were given REOLYSIN plus pembrolizumab, along with one of gemcitabine, 5-fluouracil or irinotecan. Grade 1 and 2 treatment emergent adverse events (TEAE) occurred in all patients and Grade 3 and 4 TEAE occurred in eight patients. Three of five efficacy evaluable patients showed a tumor response (secondary endpoint), with one having a partial response (six-month duration) and two having stable disease (lasting 126 and 221 days). Investigators noted that on-treatment biopsies revealed reovirus infection in cancer cells and immune infiltrates and concluded that the combination therapy showed manageable safety profiles and anti-tumour activity in previously treated MAP patients. The abstract, authored by Mahalingam et al, "A study of REOLYSIN in combination with Pembrolizumab and chemotherapy in patients (pts) with relapsed metastatic adenocarcinoma of the pancreas (MAP)," is now available on the ASCO (Free ASCO Whitepaper) annual meeting website.

"We continue to expand our library of clinical data and establish REOLYSIN as safe in combination with KEYTRUDA, a highly promising checkpoint inhibitor," said Dr. Andres Gutierrez, CMO of Oncolytics. "This is a major first step in supporting the adaptive immunity component of our clinical development plan, and it opens the door for additional collaborations with other checkpoint inhibitors as we advance the longer-term, immuno-oncology portion, of the clinical development plan. We look forward to announcing further developments for this program later in the year."

The phase 2 study in prostate cancer was an 85-patient trial designed and executed by the Canadian Cancer Trials Group (CCTG) (IND 209) to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with docetaxel/prednisone versus docetaxel/prednisone alone in patients with mCRPC. The study did not meet its primary endpoint of 12-week lack of progression, which was comparable in both the test and control arms, or the secondary endpoint of overall survival. The abstract reports significant differences at baseline, where more patients had poor prognostic factors for survival in the test arm versus the control arm. In addition, while the combination of REOLYSIN and docetaxel was tolerated, dose reductions were more common on the test arm with only 51 percent of the patients receiving 90% of the planned dose intensity of docetaxel, versus 76 percent on the control arm.

"In recent years, we and our collaborators have performed numerous phase 1b and phase 2 trials to better understand the anti-tumour mechanisms of REOLYSIN, to identify the best therapies to pair with REOLYSIN, and to identify the cancer indications for which REOLYSIN provides clear benefit," said Dr. Matt Coffey, President and CEO of Oncolytics. "Collectively, these findings reinforce our Clinical Development Plan. While these results themselves indicate that prostate cancer is likely not a viable tumor target, they do not impact our focus on the advancement of REOLYSIN into a phase 3 registration study in patients with metastatic breast cancer. We thank the investigators, staff and patients that participated in these trials that delivered very important data to guide the late stage development of REOLYSIN toward patient populations that can most benefit from its immune-oncology effects."

The abstract, authored by Eigl et al, "A randomized phase II study of pelareorep (REO) plus docetaxel vs. docetaxel alone in patients with metastatic castration resistant prostate cancer (mCRPC): Canadian Cancer Trials Group study IND 209," is now available on the ASCO (Free ASCO Whitepaper) annual meeting website.

On May 18, 2017 MorphoSys reported that it will Present Clinical Data on Proprietary Programs at Upcoming ASCO (Free ASCO Whitepaper) Annual Meeting 2017 (Press release, MorphoSys, MAY 17, 2017, View Source [SID1234519219]).

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Updates on Hemato-Oncological Programs MOR208 and MOR202 will be presented

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported the publication of four abstracts accepted for the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2017 in Chicago, Illinois, USA. The abstracts include first data from the phase 2 "L-MIND" combination study with MOR208 and lenalidomide in relapsed/refractory diffuse large B cell lymphoma (DLBCL) as well as data from a phase 1/2a study with MOR202 in patients with relapsed/refractory multiple myeloma. The MOR208 L-MIND abstract has also been selected for the poster discussion session "Targeting CD19 in Aggressive Lymphoma".

"We are delighted to underscore our maturing proprietary development portfolio with new clinical data at the preeminent conference on clinical oncology. The data set will provide additional insight into the progress of our lead cancer compounds MOR208 and MOR202," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

List of abstracts relating to MorphoSys’s proprietary programs

Abstract #7514, poster board #276

L-MIND: MOR208 combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R-R DLBCL) – A single-arm phase 2 study

The poster presentation will include preliminary safety and efficacy results from the first patients enrolled in a clinical phase 2 study evaluating MOR208 in combination with lenalidomide in patients with relapsed/refractory (R-R) DLBCL. The poster will be presented during the session, "Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia," to be held on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall). The results will also be highlighted during a poster discussion session on June 5, 2017 (1:15 PM-2:30 PM CDT, room E354b).

Abstract #8024, poster board #350

MOR202 with low-dose dexamethasone (DEX) and in combination with pomalidomide/DEX and lenalidomide/DEX in relapsed or refractory multiple myeloma (RRMM): Interim analysis of a phase 1/2a dose-escalation study

The poster presentation will include matured efficacy and safety data with MOR202 alone as well as in combination with lenalidomide or pomalidomide, plus dexamethasone, for R-R multiple myeloma. The poster will be presented during the "Hematologic Malignancies – Plasma Cell Dyscrasia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).

Abstract #TPS7571, poster board #330b

B-MIND: MOR208 plus bendamustine (BEN) versus rituximab (RTX) plus BEN in patients with relapsed or refractory (R-R) diffuse large B-cell lymphoma (DLBCL): An open-label, randomized phase 2/3 trial

The poster presentation in the trial-in-progress format will include the design of the phase 2/3 B- MIND study, which will evaluate the treatment of MOR208 plus bendamustine compared to rituximab plus bendamustine in patients with R-R DLBCL who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (SCT). The poster will be presented in the "Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).

Abstract #TPS7567, poster board#328b

COSMOS: MOR208 plus idelalisib or venetoclax in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously treated with a Bruton’s tyrosine kinase inhibitor (BTKi) – A two-cohort phase 2 study

Patients with R/R CLL who discontinue treatment with the BTKi ibrutinib due to progression have a poor prognosis. The poster presentation in the trial-in-progress format will include the design of the COSMOS phase 2 study in patients with R/R CLL receiving a combination treatment of MOR208 with idelalisib or venetoclax. The poster will be presented in the "Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia" session on June 5, 2017 (8:00 AM-11:30 AM CDT, poster hall).

The full abstracts can be accessed online here.

On May 18, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from two Phase I studies evaluating the novel cancer immunotherapy CEA-TCB (RO6958688; RG7802), a molecule that binds T-cells and tumour cells simultaneously (Press release, Hoffmann-La Roche, MAY 17, 2017, View Source [SID1234519212]). CEA-TCB was studied in patients with carcinoembryonic antigen (CEA)-positive solid tumours, including microsatellite stable (MSS) metastatic colorectal cancers (mCRC) that overexpress CEA and progressed after at least two prior chemotherapy regimens.1 The studies demonstrated encouraging anti-tumour activity of CEA-TCB as a monotherapy, which was further enhanced in combination with TECENTRIQ (atezolizumab).

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In the monotherapy, out of 31 patients with mCRC treated with CEA-TCB doses of 60mg or above, 14 patients (45%) showed either partial response (n=2, 6%) or stable disease (n=12, 39%). For the combination, of 25 patients treated with doses of 5–160mg of CEA-TCB, 11 patients with MSS mCRC were treated at doses shown to induce tumour lesion inflammation (80 and 160 mg). Nine of these patients (82%) showed either a partial response (n=2, 18%) or stable disease (n=7, 64%) in this difficult-to-treat population.

CEA-TCB showed favourable pharmacokinetics and a manageable safety profile in both monotherapy and combination therapy with TECENTRIQ. Including all adverse events (AEs) in both studies, the majority of AEs were Grade 1–2, with 7.9% being Grade 3 or higher in the monotherapy trial and 8.1% being Grade 3 or higher in the combination trial. Two treatment-related AEs with severity greater than grade 3, (one Grade 4, one Grade 5), occurred in the monotherapy dose escalation at the highest dose level, which exceeded the maximum tolerated dose (MTD) in cycle 1. The results of these Phase I studies will be presented at the 2017 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting which takes place from 2–6 June in Chicago, IL, United States.1

"These early data in heavily pre-treated metastatic colorectal cancer are particularly encouraging because there is a critical need to improve outcomes for people living with this disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "CEA-TCB is currently being further investigated in Phase I clinical trials and has the potential to be combined with a wide variety of other agents. We look forward to continuing the development of this novel cancer immunotherapy across a range of CEA-positive cancers."

CEA-TCB uses a novel 2-to-1 molecular design. It is engineered to bind simultaneously with one arm to CD3 on T-cells and with two arms to CEA on tumour cells, bringing T-cells into close proximity to the cancer cells. This leads to T-cell activation and subsequent tumour cell killing.

A summary of the Phase I results to be presented at ASCO (Free ASCO Whitepaper) are provided below.
Study 1: 80 patients (MSS mCRC: 70) treated; 31 available for efficacy evaluation at data cut-off
Study 2: 45 patients (MSS mCRC: 35) treated; 25 available for efficacy evaluation at data cut-off

About metastatic colorectal cancer
Colorectal cancer (CRC) is the third most common cancer in men (746,000 cases, 10.0% of the total) and the second in women (614,000 cases, 9.2% of the total) worldwide.2 Almost 55% of the cases occur in more developed regions. Incidence rates vary 10-fold in both sexes worldwide.2 The global burden of CRC is expected to increase by 60% to more than 2.2 million new cases and 1.1 million deaths by 2030.3
About CEA-TCB
CEA-TCB is a novel T-cell bispecific antibody being investigated for the treatment of carcinoembryonic antigen (CEA)-expressing solid tumours. As CEA is overexpressed in a variety of cancers, including colorectal cancer (CRC), CEA-TCB has the potential to work in a broad range of solid tumours. CEA-TCB uses a novel 2-to-1 molecular design. It is engineered to bind simultaneously with one arm to CD3 on T-cells and with two arms to CEA on tumour cells, bringing T-cells into close proximity to the cancer cells. This leads to T-cell activation and subsequent tumour cell killing.

On May 17, 2017 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that new interim data from the first cohort of its ongoing Phase 2 study of LN-144 for the treatment of metastatic melanoma will be presented at the upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL from June 2-6, 2017 (Press release, Lion Biotechnologies, MAY 17, 2017, View Source [SID1234519207]).

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"We are very encouraged by this data as we have now demonstrated that we can manufacture TIL at our contract manufacturing organization partners and dose patients at multiple clinical sites with consistent results compared to available literature. The patients enrolled in this study are more treatment experienced than those enrolled in most of the previously published TIL clinical studies. The enrolled patients disclosed in the abstract have advanced metastatic melanoma, all refractory to both anti-PD-1 and CTLA-4 with a median of 3 prior therapies," said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Lion Biotechnologies. "We will be reporting data from additional patients in the current cohort at the conference as well."

Poster Title: Efficacy of Single Administration of Tumor Infiltrating Lymphocytes (TIL) in Heavily Pre-treated Metastatic Melanoma Patients Following Checkpoint Therapy
Poster Session Title: Developmental Therapeutics — Immunotherapy
Poster Board Number: 140
Date & Time: Monday, June 5, 2017 from 8:00 a.m. to 11:00 a.m. CT (9:00 a.m. to 12:00 p.m. ET)
Abstract Number: 3045
Location: Hall A
First author: Amod Sarnaik, MD

The data in the published abstract is from nine patients in cohort one who were infused as of January 31, 2017. These advanced metastatic melanoma patients are a median age of 56 and all had prior anti-PD1 as well as anti-CTLA4 therapy and 67 percent had received three or more prior therapies. The results show:

33% objective response rate
Responses were observed in patients with tumors carrying wild type or BRAF mutations
Eight of nine patients received all six doses of IL-2 per protocol
The most common (≥3 patients) non-hematologic grade 3-4 TEAE was hypophosphatemia
No neurotoxicity of grade 3 or higher was reported
There were no deaths or discontinuations due to SAEs related to study treatment
The accepted abstract is available online on ASCO (Free ASCO Whitepaper)’s website at View Source

On May 17, 2017 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, reported results from the melanoma cohort of the ongoing Phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, which will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2017 in Chicago, Illinois (Press release, Syndax, MAY 17, 2017, View Source [SID1234519206]).

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The Company recently reported that the first cohort of 13 melanoma patients who had progressed on or after prior immune checkpoint inhibitor therapy in ENCORE 601 met the pre-specified objective response criteria, with a minimum of 2 patients demonstrating a confirmed or unconfirmed objective response, to advance into the second stage of the trial. Data from the first cohort of patients indicate that 4 patients achieved an objective response (ORR) by irRECIST criteria (3 patients had a confirmed response; 1 patient had an unconfirmed response; 31% ORR, 95% CI: 9 — 61%). Of the 4 responders, 2 patients had stable disease (SD) and 2 patients had progressive disease (PD) as best response to their prior anti-PD-1 therapy prior to progressing, with a median duration on prior anti-PD-1 therapy of 4.9 months (range 2.7-12.5). Three patients remain on treatment, without progression, as of the data cutoff, 1 with a partial response (PR), and 2 with SD.

"This is important data showing that with the addition of entinostat, meaningful responses can occur in patients who have progressed on an anti-PD-1 or anti-PD-1/anti-CTLA-4 regimen. This is an area of very high unmet medical need," noted Jedd D. Wolchok, M.D., Ph.D., Chief of Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, and member of the Syndax Scientific Advisory Board.

ENCORE 601 (NCT02437136) is a Phase 1b/2 trial evaluating the efficacy and safety of entinostat in combination with KEYTRUDA in melanoma patients whose disease had progressed despite prior treatment with anti-PD-1/PD-L1 therapies. Responses were seen both in patients who had, as well as those who had not, received prior treatment with YERVOY (ipilimumab) in combination with an anti-PD-1 therapy, either (OPDIVO (nivolumab) or KEYTRUDA). Of note, 1 patient with a confirmed PR converted from a PD-L1 negative, non-inflamed gene signature in a pre-treatment tumor biopsy to PD-L1 positive, inflamed gene signature post-treatment with the entinostat-KEYTRUDA combination. Correlative analyses of peripheral blood and tumor tissue biomarkers across the entire patient cohort are ongoing. The combination of entinostat and KEYTRUDA also appears to have a manageable toxicity profile, with 8 patients having a treatment emergent adverse event with severity of Grade ≥ 3, and with 1 patient discontinuing treatment due to an adverse event (transaminitis that was deemed to be likely related to KEYTRUDA).

"Treatment options for advanced or metastatic melanoma have greatly improved with the recent regulatory approvals of several immunotherapies, including the anti-PD-1 inhibitor KEYTRUDA. However, viable treatment options for melanoma patients progressing on anti-PD-1 therapy, with or without prior YERVOY, remain an area of unmet need, as a majority of patients will progress on or following treatment with these agents. We look forward to results from the expansion cohort of 21 additional patients, enrollment of which is expected to complete in the third quarter," said Briggs Morrison, M.D., Chief Executive Officer of Syndax. "The early efficacy signal we have observed in both melanoma and NSCLC suggests that entinostat may re-sensitize a broad range of tumors after they have progressed on prior treatment with immune checkpoint therapies, and adds to the rationale supporting our trials in CRC, TNBC, and ovarian cancer."

Baseline demographic data in the first cohort of 13 melanoma patients included: Median age of 62; ECOG status of 0 (62% of patients) or 1 (38% of patients), PD-L1 expression negative (31%) or positive (46%) with 23% not evaluable; visceral metastases (46%); all patients had disease progression on or after prior treatment with a PD-1 antagonist, either KEYTRUDA therapy (54%) or OPDIVO therapy (46%); prior YERVOY therapy (62%); and prior B-Raf inhibitor therapy (15%).

The data announced today will be presented as part of a poster presentation at the upcoming ASCO (Free ASCO Whitepaper) meeting:

Title: ENCORE 601: A phase II study of entinostat (ENT) in combination with pembrolizumab (PEMBRO) in patients with melanoma
First Author: Melissa Lynne Johnson, M.D., Sarah Cannon Research Institute
Abstract Number: 9529
Poster Session: Melanoma/Skin Cancers
Poster Board: 137
Date and Time: Saturday, June 3, 2017, 1:15-4:45 PM CT

In addition to the melanoma cohort, ENCORE 601 is evaluating the safety, tolerability and efficacy of entinostat given in combination with KEYTRUDA in three additional cohorts: Patients with non-small cell lung cancer (NSCLC) who have not previously received a PD-1 antagonist (cohort 1); patients with NSCLC who have progressed on a PD-1 antagonist (cohort 2); and microsatellite stable colorectal cancer who have not previously been treated with a PD-1 antagonist (cohort 4). As previously announced, cohort 2 has met the pre-specified objective response threshold to advance into the second stage of the Phase 2 trial and enrollment has been reopened. A decision on whether to advance cohort 1 is expected this quarter.