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8-K – Current report

On August 31, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) (Bio-Path), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, reported the formation of its inaugural Scientific Advisory Board comprised of leading oncology experts (Filing, 8-K, Bio-Path Holdings, SEP 1, 2015, View Source [SID:1234507371]). Jorge Cortes, M.D., renowned leukemia expert from The University of Texas MD Anderson Cancer Center, will join as Chairman, where he will provide clinical and scientific guidance, and work with Bio-Path to identify and attract additional oncology thought leaders to join the Company’s growing Scientific Advisory Board. Amy P. Sing, M.D., a member of Bio-Path’s board of directors and Senior Director of Medical Affairs at Genomic Health, Inc., will also join as a founding member.

"We are honored to have attracted such esteemed oncology experts to join our Scientific Advisory Board," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "The creation of this board is a testament to the level of confidence in Bio-Path’s pipeline of nucleic acid therapies and lipid-based delivery technology. Dr. Sing and Dr. Cortes’ vast expertise in oncology and the treatment of blood cancers will be invaluable as Bio-Path continues clinical development of our lead candidate, Liposomal Grb-2. We look forward to benefitting from their contributions and expanding our board in the future."

Dr. Cortes joins Bio-Path’s Scientific Advisory Board as a well-established expert in oncology and hematology. He currently holds several positions at The University of Texas MD Anderson Cancer Center, including Jane and John Justin Distinguished Chair in Leukemia Research, Chief of the AML (acute myeloid leukemia) and CML (chronic myelogenous leukemia) sections, and Deputy Chair of the Department of Leukemia.

Over the course of his 25-year career specializing in leukemia research, Dr. Cortes has held several prestigious academic appointments at the University of Texas, including associate professor in the Department of Leukemia at the Graduate School of Biomedical Sciences and Chair of the CML section at the MD Anderson Cancer Center.

Dr. Cortes has also lent his experience as a consultant to leading pharmaceutical companies such as AstraZeneca on the development of prenyltransferase inhibitors, GlaxoSmithKline on the use of topotecan in MDS (myelodysplastic syndromes) and CMML (chronic myelomonocytic leukemia), and Rhône-Poulenc Rorer on the use of PEG-Asparaginase in adult ALL (acute lymphoblastic leukemia).
Dr. Cortes earned his M.D. from la Facultad de Medicina, Universidad Nacional Autónoma de México and a B.S. from el Centro Universitario México. He currently serves on the National CML Society’s Medical Advisory Board, as well as on numerous other executive committees and scientific advisory boards for organizations such as the Leukemia & Lymphoma Society and the International CML Foundation.

"As a hematologist and clinical researcher, I have dedicated my career to improving cancer outcomes and discovering better therapies for blood cancers such as AML and CML," said Dr. Cortes. "I have the utmost confidence in Bio-Path’s executive leadership and its novel liposomal Grb-2. I look forward to helping guide the Company as it makes meaningful strides in developing and strengthening its pipeline of products using liposomal delivery technology."

Dr. Sing joins the Scientific Advisory Board as a member of Bio-Path’s board of directors, where she has served since November 2014. She is the Senior Director of Medical Affairs at Genomic Health, Inc., a global health company focused on improving the quality of cancer treatment through a genomic-based approach. Dr. Sing has more than 20 years of experience working in the oncology space in various roles. Earlier in her career, she served as Senior Medical Director at Genentech, Inc., where she played an integral role in the Avastin program. Earlier, Dr. Sing served as the Senior Director of Medical and Regulatory Affairs at Seattle Genetics, at which she managed clinical programs for the company’s various antibody drug conjugates for the treatment of cancers.

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Dr. Sing earned an M.D. from the Stanford University School of Medicine, and conducted research at notable medical institutes, including the Dana Farber Cancer Institutes and Fred Hutchinson Cancer Research Center. She also holds a B.A. from Amherst College.

"Bio-Path has a unique and potentially best-in-class approach to treating cancer," said Dr. Sing. "I am honored to join the Scientific Advisory Board and am eager to lend my expertise as the Company continues its mission."

CytRx Announces Participation at FBR & Co. Second Annual Health Conference and Rodman & Renshaw 17th Annual Global Investment Conference

On September 1, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that Steven A. Kriegsman, Chairman and Chief Executive Officer, and David Haen, Vice President of Business Development and Investor Relations, will present a corporate overview at two significant investment conferences in September, 2015 that spotlight the biotechnology and healthcare industries: the FBR & Co. Second Annual Health Conference and the Rodman & Renshaw Annual Global Investment Conference (Press release, CytRx, SEP 1, 2015, View Source;p=RssLanding&cat=news&id=2084014 [SID:1234507368]).

FBR & Co. Second Annual Health Conference
This conference will be held on Wednesday, September 9th at the Four Seasons Hotel in Boston, Massachusetts. The Conference will feature more than 60 companies in the biotech, biopharma, managed care, pharmaceutical and clinical lab sectors.

Rodman & Renshaw 17th Annual Global Investment Conference
CytRx will present its corporate overview on Thursday, September 10th at 11:40 AM in the St. Regis Hotel in New York. More than 300 companies will be participating in specialized tracks devoted to Biotechnology / Healthcare, Metals & Mining, Technology, Cleantech, and Growth.

A live and archived webcast of the presentation will be available on the Company’s website at View Source

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood / brain barrier.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

Varian Puts Research Tools in the Cloud to Speed Development of Next Generation Cancer Treatment Technologies

On September 1, 2015 Varian Medical Systems (NYSE: VAR) reported it has added a new cloud-based toolkit to the company’s OncoPeer interactive online forum, making development tools available for research that has the potential to lead to next generation cancer treatment technologies (Press release, InfiMed, SEP 1, 2015, View Source [SID:1234507366]).

Varian’s new Developer Cloud houses digital tools like information about TrueBeam Developer Mode, and cloud-based applications for managing Developer Mode and simulating treatments. It is part of the company’s overall objective to empower research-oriented clinical teams to accelerate the development of new treatment techniques and processes designed to improve outcomes for cancer patients.

"When Varian introduced the TrueBeam platform in 2010, we included Developer Mode, an optional non-clinical development tool for researchers to use in pioneering and prototyping new treatment techniques," said Corey Zankowski, vice president of products and strategic portfolio management. "Many important advances have been enabled by the use of this and other Varian development tools. Developer Cloud was created to aggregate these developer tools in one place so researchers can easily access what they need. Researchers can also use the OncoPeer forum to engage in discussions with other users of the research tools, to share best practices."

In a separate development, the OncoPeer online forum, first launched last March in select geographic areas, is now accessible to Varian customers worldwide. Since March, users have established discussion groups on topics like oncology analytics, knowledge-based treatment planning, treatment planning using Eclipse software, and the physics of radiotherapy. One discussion group focuses on how to use Varian’s ARIA information system to manage a medical oncology department. Other groups share information about Varian treatment delivery platforms.

"OncoPeer is a place for customers to find others who use Varian technology and learn from one another," said Sukhveer Singh, vice president, Varian Oncology Continuum Solutions. "With the addition of the Developer Cloud, OncoPeer is now a resource for the research community as well."

Varian held an online seminar about Navigating OncoPeer last May. Interested clinicians can view a replay of the webcast at this registration website. Customers can access OncoPeer at www.oncopeer.com (registration required).

ZIOPHARM Announces Cancer Research Publication of Study Demonstrating Preferential Targeting of Solid Tumor Cells by Modified CAR T Cells

On September 1, 2015 ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer immuno-therapies, reported the publication of a preclinical study in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), demonstrating the preferential targeting of solid tumor cells over healthy cells using engineered chimeric antigen receptor (CAR) T cells (Press release, Ziopharm, SEP 1, 2015, View Source [SID:1234507370]). The article, titled "Tuning sensitivity of CAR to EGFR density limits recognition of normal tissue while maintaining potent anti-tumor activity," is available online first at cancerres.aacrjournals.org, and was highlighted in a press release today by AACR (Free AACR Whitepaper).

Abnormally-expressed antigens on tumors, such as epidermal growth factor receptor (EGFR) on aggressive brain tumors such as glioblastoma, can be overexpressed relative to lower, basal levels on normal tissues. Taking advantage of this observation, researchers at The University of Texas MD Anderson Cancer Center tuned the binding affinity of CARs to activate T cells based on the density of EGFR expression. The approach was based on the clinical toxicity exhibited by the EGFR-specific antibodies cetuximab and nimotuzumab, which recognize overlapping epitopes and exhibit different kinetics of binding to EGFR. The lower affinity of nimotuzumab has been credited with absence of adverse events relative to cetuximab.

Researchers engineered high-affinity cetux-CAR T cells and low-affinity nimo-CAR T cells, which were tested in vitro on cancer cells with high levels of EGFR, and normal cells with low levels of EGFR. It was found that, while the cetux-CAR T cells killed both cancer and normal cells, the nimo-CAR T cells were selectively activated only in response to cancer cells.

The researchers then tested the two populations of genetically modified T cells in mice bearing human brain cancer cells expressing high levels of EGFR and found that both cetux- and nimo-CAR T cells were equally effective in inhibiting tumor growth. However, the cetux-CAR T cells caused significant toxicity to the mice, leading to death in some, whereas the infused nimo-CAR T cells were found to be safe. The researchers further tested both CAR T cells in mice bearing cells that had low levels of EGFR (to mimic normal human cells), and found that unlike cetux-CAR T cells, the nimo-CAR T cells did not impact the growth of these cells.

"Translating the remarkable effects of adoptive CAR T-cells from liquid to solid tumors can be challenging, as many solid tumor targets are found on healthy cells, creating the opportunity for toxicity," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and an author of the publication. "By targeting the density of tumor antigens, we have demonstrated an approach for preferentially killing cancer cells over healthy cells. In this case, the weakness of the nimo-CAR affinity is its apparent strength."

ZIOPHARM is developing various immuno-oncology programs, including CAR-T, TCR and natural killer (NK) adoptive cell based therapies, in collaboration with the MD Anderson Cancer Center and its partner Intrexon Corporation (NYSE:XON).

8-K – Current report

On September 1, 2015 Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage cancer immunotherapy company, reported that it has enrolled the first patient in a Phase 1b clinical trial investigating the combination of its HS-110 therapeutic vaccine and the Bristol-Myers Squibb PD-1 inhibitor nivolumab (Opdivo) in non-small cell lung cancer (NSCLC) (Filing, 8-K, Heat Biologics, SEP 1, 2015, View Source [SID:1234507369]). HS-110 is the Company’s first product candidate in a series of proprietary ImPACT based immunotherapies designed to stimulate patient’s own T-cells to attack cancer. Additionally, as the FDA approval of nivolumab and anticipated approval of other checkpoint inhibitors is dramatically changing the standard of care in lung cancer treatment, Heat is winding down its ongoing Phase 2 trial with HS-110, which does not include a checkpoint inhibitor combination, to instead focus on combinations with checkpoint inhibitors.

This multicenter trial is evaluating the safety and efficacy of HS-110 in combination with nivolumab in patients with NSCLC whose cancers have progressed after first-line therapy. Primary and secondary trial endpoints include safety and tolerability, immune response, overall response rate and progression-free survival.

"Checkpoint inhibitors such as nivolumab are rapidly becoming standard of care in the treatment of NSCLC and many other types of cancer," stated Jeff Wolf, CEO of Heat Biologics. "Substantial evidence is emerging regarding the benefits of combining checkpoint inhibitors and therapeutic vaccines. Heat had previously reported synergy between ImPACT and anti-PD-1 therapy. This important clinical study is among the first trials to explore the combination of a checkpoint inhibitor and therapeutic vaccine in NSCLC and will enable us to more fully evaluate this combination with other checkpoint inhibitors, such as Merck’s pembrolizumab, as they become available."

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"We reported earlier this year, in a clinical trial for HS-410 for bladder cancer, that patients with low levels of tumor-infiltrating lymphocytes (TILs) at baseline appeared to respond better," said Taylor Schreiber, M.D., Ph.D., Heat’s Chief Scientific Officer. "This is consistent with emerging clinical evidence demonstrating that while responses to checkpoint inhibitor therapy are biased toward patients with pre-existing TILs, the optimal patient population for therapeutic vaccines in conjunction with checkpoint inhibitors may in fact be the checkpoint unresponsive (and TIL negative) population. Currently, only 20% to 30% of NSCLC patients respond to nivolumab. This trial will specifically investigate whether HS-110 can broaden the base of patients who respond to nivolumab and other checkpoint inhibitors."

"This trial is expected to initially enroll 18 patients, and is designed to accommodate rapid cohort expansion as positive clinical data emerge," stated Melissa Price, Ph.D., Heat’s VP of Product Development. "We will be working with Yale Cancer Center’s Translational Immuno-Oncology Laboratory on the analysis of the TILs biomarker data for patient selection. We expect to release top-line objective response rate and 6-month progression free survival (PFS) data on these first 18 patients by the end of 2016, which should enable us to reach a clinical readout for HS-110 with a checkpoint-focused clinical trial, on the same schedule that we had forecasted for our previous trial. Our expectations around the timing of an HS-110 registration-directed study in NSCLC remain unchanged."

Nivolumab (Opdivo) was approved by the US Food and Drug Administration (FDA) for the treatment of NSCLC in March 2015 and is marketed by Bristol-Myers Squibb. Another anti-PD-1 drug candidate, Merck’s pembrolizumab (KEYTRUDA) is currently under FDA Priority Review for NSCLC.