On November 5, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, reported that Dr. Jorge Cortes, Deputy Chair of the Department of Leukemia at the University of Texas MD Anderson Cancer Center and Chair of Bio-Path’s Scientific Advisory Board, will present data from Bio-Path’s Phase I and Ib clinical trials of its lead product candidate BP-100-1.01 (Liposomal Grb-2 antisense) in the treatment of blood cancers during a poster session at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida (Filing, 8-K, Bio-Path Holdings, NOV 5, 2015, View Source [SID:1234508025]).

Details for the poster presentation are as follows:

Title: "Safety, Pharmacokinetics, and Efficacy of BP-100-1.01 (Liposomal Grb-2 Antisense Oligonucleotide) in Patients with Refractory or Relapsed Acute Myeloid Leukemia (AML), Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia (ALL), and Myelodysplastic Syndrome (MDS)"

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Date: Monday, December 7, 2015

Presentation Time: 6:00 p.m. – 8:00 p.m. Eastern Time

Location: Hall A, Orange County Convention Center

The poster will highlight results from Bio-Path’s Phase I and Ib clinical trials in patients with blood cancers, notably the complete remission (CR) of one patient with advanced acute myeloid leukemia (AML) who was treated with BP-100-1.01 in combination with low-dose cytarabine (LDAC) chemotherapy and another patient with chronic myelogenous leukemia (CML) who showed significant reduction (81 percent to 5 percent) in bone marrow blasts. The results suggest possible disease inhibition with BP-100-1.01 treatment.

The full abstract can be found at View Source

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On November 5, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported initial data from a Phase 1b/2 study of the company’s lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient (pazopanib) in patients with advanced recurrent ovarian cancer (Press release, OXiGENE, NOV 5, 2015, View Source [SID:1234508054]). The data are from the ongoing "PAZOFOS" study and were presented at the 19th International Meeting of the European Society of Gynaecological Oncology (ESGO) in Nice, France.

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"The initial results we’ve seen to date from the Phase 1b portion of PAZOFOS are encouraging and we expect to move into the phase 2 portion of the study in early 2016," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the trial. "We are excited about continuing our clinical evaluation of this complementary combination—a combination that utilizes the potential synergistic effects of CA4P and pazopanib and could offer a new treatment approach for patients with relapsed ovarian cancer."

Dr. Rustin reported that 12 patients have been enrolled in the phase 1b portion of the study. Nine of the patients were evaluated for objective response using RECIST criteria, showing two partial responses, five stable diseases and two progressive diseases. Eight of the ten patients with evaluable data demonstrated decreases in the tumor marker CA125, with three achieving a response according to CGIC criteria. Dr. Rustin also noted that four patients were still on treatment, and that the efficacy data are currently preliminary and unverified. Safety data showed that the combination of CA4P and pazopanib was generally well tolerated with no Grade 4-5 adverse events (AEs). The most commonly reported AEs were hypertension, fatigue, and pain. The Development Safety Update Report #1 submitted to the regulatory body stated that no definitive conclusions can be made regarding the benefit of treatment in the small subset of patients treated so far.

"The results seen thus far with CA4P combined with pazopanib broaden and strengthen the body of evidence indicating that CA4P can be effectively used as a component of combination therapy for patients with solid tumors," said William D. Schwieterman, MD, OXiGENE’s President and CEO. "We look forward to the continued results from this trial, and to advancing CA4P in combination with Avastin in phase 2/3 studies in platinum-resistant ovarian cancer and glioblastoma multiforme in 2016."

PAZOFOS is a randomized, controlled clinical study consisting of a phase 1b dose escalation portion (CA4P plus pazopanib) and a phase 2 portion comparing CA4P plus pazopanib versus pazopanib alone. The study is designed to enroll up to 128 patients at up to ten sites in the United Kingdom. The primary endpoint for the phase 2 portion is progression-free survival; secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.

PAZOFOS is sponsored by The Christie NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). CA4P and pazopanib are being provided by OXiGENE and GlaxoSmithKline/Novartis, respectively.

About CA4P

CA4P (also known as fosbretabulin) is a vascular disrupting agent and is OXiGENE’s lead investigational drug. CA4P exerts its anti-tumor effects by targeting an established tumor’s immature endothelial cells within the tumor’s blood vessels, compromising the tumor vasculature and leading to widespread ischemia and necrosis of the cells within the central core of the tumor. OXiGENE plans to advance CA4P in clinical development in combination with approved anti-angiogenic agents which prevent the growth of new tumor blood vessels. Following an extensive clinical review, OXiGENE recently announced its plans to focus on initiation of two late-stage clinical programs for CA4P in 2016. These planned programs combine CA4P with standard-of-care in platinum-resistant ovarian cancer and in glioblastoma multiforme. In addition to PAZOFOS, CA4P is also being evaluated in an ongoing study in neuroendocrine tumors.

(Filing, 10-Q, Merck & Co, NOV 5, 2015, View Source [SID:1234508052])

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On November 05, 2015 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel cancer stem cell (CSC) and immuno-oncology therapeutics, reported financial results for the quarter ended September 30, 2015 (Press release, OncoMed, NOV 5, 2015, View Source [SID:1234507972]). The company ended the third quarter with $175.2 million in cash, cash equivalents, and short term investments.

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"Our internally discovered research and development pipeline continues to advance, with both demcizumab and tarextumab in two randomized Phase 2 clinical trials each," said Paul J. Hastings, Chairman and Chief Executive Officer. "We now have seven product candidates in 17 clinical trials, and are advancing two additional immuno-oncology product candidates to IND filings."

Pipeline Update

Demcizumab (anti-DLL4, OMP-21M18)

Enrollment continues in the randomized Phase 2 YOSEMITE pancreatic cancer and Phase 2 DENALI non-small cell lung cancer (NSCLC) trials.

Planning advances for a Phase 1b trial testing combination of demcizumab with pembrolizumab (an anti-PD1 antibody). Participating institutions include Memorial Sloan Kettering Cancer Center, Columbia University, Royal Marsden Hospital.
Tarextumab (anti-Notch 2/3, OMP-59R5)

Completed enrollment in the randomized Phase 2 ALPINE pancreatic cancer trial in August. A readout of the trial data, including overall survival results from both intent-to-treat and Notch3 biomarker populations, is anticipated in the second half of 2016.
Enrollment continues in the randomized Phase 2 PINNACLE small cell lung cancer (SCLC) trial.

Presented Notch3 biomarker results at the World Congress on Lung Cancer in September highlighting the role of overexpression of Notch3 as a poor prognostic factor in SCLC patients and as a potential biomarker for tarextumab treatment. Updated survival data continued to suggest greater benefit of tarextumab in a dose-dependent fashion, with median overall survival not yet reached in patients with high Notch3 tumors receiving higher doses of tarextumab.

Wnt Pathway Programs

Reached an agreement with Bayer to enroll up to 24 additional subjects, including some subjects who will undergo serial tumor biopsies, in the Phase 1b clinical trial of vantictumab (anti-Fzd7, OMP-18R5) in breast cancer and the Phase 1b clinical trial of ipafricept (Fzd8-Fc, OMP-54F28) in ovarian cancer, to further elucidate the profile of these product candidates and generate additional data to inform Bayer’s opt-in decisions. Bayer has agreed to reimburse OncoMed for all out-of-pocket expenses to support this additional patient enrollment. Delivery of opt-in packages to Bayer for both vantictumab and ipafricept is now anticipated in late 2016/early 2017.

Brontictuzumab (anti-Notch1, OMP-52M51)

De-prioritized and discontinued the Phase 1a hematologic malignancy trial to focus on solid tumor indications in biomarker selected populations. Data will be presented at an upcoming medical meeting.

Data to be presented on November 8, 2015 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) Meeting in November in Boston show single-agent activity of brontictuzumab in Notch1 biomarker positive solid tumor subjects.

Advanced plans to clinically test brontictuzumab in combination with standard-of-care in solid tumor indications with a focus on patients whose tumors overexpress the active form of Notch1.
Anti-DLL4/VEGF (OMP-305B83) and Anti-RSPO3 (OMP-131R10)

Enrollment continues in Phase 1a study of anti-DLL4/VEGF bispecific in solid tumors.
Presented pre-clinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) of the immune mediated anti-cancer effects of OncoMed’s anti-DLL4/VEGF bispecific antibody.

Advance plans to study anti-DLL4/VEGF in Phase 1b in combination with standard-of-care.
Enrollment continues in Phase 1a/b study of anti-RSPO3 in solid tumors.

Immuno-oncology Research

Presented new data for GITRL-Fc showing potent single-agent anti-tumor activity and activity in combination with checkpoint inhibitors at the Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. OncoMed is advancing GITRL-Fc into IND-enabling studies with the goal of ultimately filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration.

Advanced preclinical testing of an immuno-oncology antibody under the collaboration with Celgene with goal of achieving formal designation as a clinical development candidate in the collaboration by the end of 2015 followed by an IND filing in 2016.

Third Quarter 2015 Financial Results

Cash, cash equivalents and short-term investments totaled $175.2 million as of September 30, 2015, compared to $200.2 million as of June 30, 2015.

Revenues for the third quarter 2015 totaled $4.7 million, as compared to $19.0 million in the third quarter of 2014. Revenues were higher in the third quarter of 2014 primarily due to milestone revenues from the GlaxoSmithKline and Bayer collaborations achieved during that period.

Research and development (R&D) expenses for the third quarter 2015 were $24.7 million compared with $21.0 million for the same period in 2014. Increases in R&D expenditures in the three months ended September 30, 2015 were primarily attributable to increased personnel expenses, increased program costs associated with the advancement of demcizumab and tarextumab into randomized Phase 2 trials, as well as increased costs related to advancement of our anti-DLL4/VEGF and anti-RSPO3 programs into clinical development.

General and administrative (G&A) expenses for the quarter ended September 30, 2015 were $4.5 million, compared to $3.5 million for the same three-month period in 2014. The increased costs during the third quarter 2015 were attributable to higher employee-related costs, increased patent expenses, and financial expenses related to the June 2015 S-3 shelf registration filing.

Net loss for the third quarter 2015 was $24.5 million ($0.81 per share), compared to $5.5 million ($0.18 per share) for the same three-month period of 2014. The change in net loss for the third quarter of 2015 was primarily due to an increase in operational expenses and lower milestone revenues.

On November 5, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported that Great Ormond Street Hospital (GOSH) and University College London (UCL) will present encouraging data from a first in man clinical use of UCART19, at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando during the poster session (Press release, Cellectis, NOV 5, 2015, View Source [SID:1234507990]).

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GOSH has treated in June 2015 a young leukemia patient under a special license from the Medicines & Healthcare products Regulatory Agency(MHRA) with Cellectis’ TALEN gene edited allogeneic UCART19 product candidate because no other therapies were available for refractory relapsed Acute Lymphoblastic Leukemia (ALL) following mismatched allogeneic stem cell transplantation.

In response to an unsolicited request from Professor Waseem Qasim, Consultant Immunologist at GOSH and Professor of Cell and Gene Therapy at University College London (UCL) Institute of Child Health, Cellectis gave its approval for the use of its UCART19 product candidate and technologies under GOSH’s "Specials" license and responsibility, for the particular clinical needs of that individual patient.

Professor Qasim says: "The successful treatment of a patient with UCART19 cells represents a landmark in the use of new gene engineering technology. If replicated in other patients, it could represent a huge step forward in treating leukaemia and other cancers."

"We are very glad for this young patient to have benefited from our highly innovative TALEN gene edited allogeneic CAR T therapy UCART19. We expect to accelerate our clinical development of TALEN gene-edited allogeneic CAR-T therapies to further confirm this encouraging clinical proof of concept," said Doctor Mathieu Simon, MD, Executive Vice President, Chief Operating Officer at Cellectis.

"Our team aims to provide to patients, with unmet medical needs, access to the first allogeneic CAR-T therapy, UCART19 made with Cellectis’ TALEN gene-editing technologies," said Doctor André Choulika, Founder, Chairman and Chief Executive Officer of Cellectis. "Cellectis had, is and will invest significant amounts of energy and creativity to provide cancer patients with an accessible, cost-effective, off-the-shelf allogeneic CAR-T therapies across all geographies. UCART19 has been provided for to a patientwho could not undergo an autologousCAR-T therapy. Our goal is to make our product candidates accessible to anyone."

About UCART19
UCART19 is a potential best-in-class allogeneic engineered T-cell product for treatment of CD19 expressing hematologic malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Servier has an option under the collaboration agreement to acquire the exclusive rights to further develop and commercialize UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, "off the shelf" T-cell based medicinal product.

About Great Ormond Street Hospital (GOSH)
Great Ormond Street Hospital for Children NHS Trust is the country’s leading centre for treating sick children, with the widest range of specialists under one roof. With the UCL Institute of Child Health, they are the largest centre for paediatric research outside the US and play a key role in training children’s health specialists for the future.

About the UCL department of hematology
The UCL department of hematology is the major tertiary referral center in the UK for all types of hematological malignancies. They have assumed a global leadership position in stem cell transplantation and adoptive cell therapy for leukemia patients.