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MorphoSys to Present Clinical Data on Proprietary Programs at Upcoming ASCO Annual Meeting 2017

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.

Roche presents the first Phase I efficacy and safety data on CEA-TCB (CEA CD3 TCB), a novel T-cell bispecific antibody targeting solid tumours

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).

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.

LION BIOTECHNOLOGIES TO PRESENT NEW DATA FROM ONGOING LN-144 PHASE 2 CLINICAL TRIAL AT 2017 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING

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]).

"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

Syndax Announces Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Melanoma

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]).

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.

Immune Design Reports First Quarter 2017 Financial Results and Provides Corporate Update

On May 17, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the first quarter ended March 31, 2017 (Press release, Immune Design, MAY 17, 2017, View Source [SID1234519205]).

"During the first quarter of the year, we were pleased to complete enrollment in the first randomized studies for each of CMB305 and G100, an important milestone for Immune Design," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "We hope that the emerging biomarker and clinical data that we intend to present starting at ASCO (Free ASCO Whitepaper) and continuing throughout 2017, may form the initial foundation to support commercialization of novel and safe immunotherapies for selected cancer patients."

Recent Highlights

Product Development: Two Phase 2 randomized studies fully enrolled; multiple ASCO (Free ASCO Whitepaper) presentations; Orphan Drug status for G100 in follicular NHL

Antigen Specific Immunotherapy: CMB305 Program

CMB305, the novel, prime-boost NY-ESO-1 targeted immunotherapy, is being evaluated primarily in soft tissue sarcoma (STS) patients both as a monotherapy and in combination with an anti-PD-L1 antibody.
CMB305 monotherapy
Follow-up continues on the two enrolled monotherapy Phase 1 trials (25 CMB305 STS patients, and 23 STS patients treated with CMB305’s vector-only component, LV305).
Data from the CMB305 trial will be presented in two separate presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2017 (ASCO 2017):
Both clinical and translational data from at least 25 STS patients will be presented in an oral presentation entitled "Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS)"; and
An analysis of translational data indicating an association of baseline and immunotherapy (LV305 and CMB305)-induced NY-ESO-1 immune response with survival in patients with multiple tumor types, will be presented in a poster presentation entitled "Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1 immunity with survival in recurrent cancer patients."
CMB305 combination therapy with Tecentriq
Enrollment was completed by the end of Q1 in the randomized, 80-patient, Phase 2 study comparing CMB305 plus Tecentriq (atezolizumab) vs. atezolizumab alone, pursuant to a collaboration with Genentech.
Immune Design intends to submit early data from a pre-specified analysis of this Phase 2 study for presentation at the European Society for Medical Oncology 2017 Congress to be held in September 2017.
Antigen Agnostic Intratumoral Immunotherapy: G100 Program

G100, the novel, synthetic TLR4 agonist injected intratumorally, is being evaluated in an ongoing Phase 1 dose escalation and in a randomized Phase 2 trial in patients with low grade follicular non-Hodgkin lymphoma (FL).
G100 monotherapy (with low dose radiation (XRT)). Data from the fully enrolled Phase 1 dose escalation monotherapy portion of the trial (n=9) evaluating G100 with XRT will be presented at ASCO (Free ASCO Whitepaper) 2017 in a poster presentation entitled "Intratumoral G100 induces systemic immune responses and abscopal tumor regression in patients with follicular lymphoma."
G100 and XRT combination therapy with Keytruda:
Patient enrollment was completed by the end of Q1 in the randomized, 24-patient, Phase 2 study comparing G100 and XRT versus G100 and XRT with the systemic administration of the anti-PD-1 antibody, Keytruda (pembrolizumab), pursuant to a collaboration with Merck.
Immune Design intends to submit follow-up data from all patients in both the Phase 1 dose escalation and Phase 2 randomized portions of the study for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017.
The U.S. Food and Drug Administration recently granted Orphan Drug Designation for G100 for the treatment of FL. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.
Financial Results

First Quarter

Immune Design ended the first quarter of 2017 with $90.1 million in cash and cash equivalents, short-term investments, and other receivables compared to $110.4 million as of December 31, 2016. Net cash used in operations for the three months ended March 31, 2017 was $17.4 million.
Net loss and net loss per share for the first quarter of 2017 were $12.6 million and $0.50, respectively, compared to $12.3 million and $0.61, respectively, for the first quarter of 2016.
Revenue for the first quarter of 2017 was $5.5 million and was primarily attributable to $5.2 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration and $0.3 million in product sales to other third parties. Revenue for the first quarter of 2016 was $1.9 million and was primarily attributable to the Sanofi G103 collaboration.
Research and development expenses for the first quarter of 2017 were $14.0 million compared to $10.6 million for the same period in 2016. The $3.4 million increase was primarily attributable to continued advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.
General and administrative expenses for the first quarter of 2017 were $4.1 million, relatively consistent with general and administrative expenses of $3.9 million recorded in the first quarter of 2016.
Cash Guidance

Based on current expectations, Immune Design continues to expect to have cash to fund operations into the second half of 2018.