On June 13, 2016 The Multiple Myeloma Research Foundation (MMRF), a leader in precision medicine, reported that its founder, Kathy Giusti, whom Fortune recently named as one of three business leaders who are disrupting medicine, has been appointed faculty co-chair of the Kraft Precision Medicine Accelerator at Harvard Business School (HBS) (Press release, Multiple Myeloma Research Foundation, JUN 13, 2016, View Source [SID:1234513283]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Giusti, an alumna of HBS, will lead the Harvard Business School Kraft Precision Medicine Accelerator with HBS faculty member and co-chair Richard Hamermesh under the umbrella of the School’s Health Care Initiative. She will continue to act as a member of the MMRF Board of Directors and take an active role in the organization’s leadership.

The HBS Kraft Precision Medicine Accelerator is made possible by a $20M endowment from the Kraft Family Foundation, under the leadership of foundation President, Robert K. Kraft. The Kraft family, through its family foundation, is committed to giving back to the community. The foundation’s primary mission includes supporting education, healthcare, science, and the needs of underserved individuals.

"Precision medicine has the potential to revolutionize the way we prevent, diagnose, treat, and, ultimately, cure cancer and other devastating diseases. I look forward just as much to sharing the MMRF model as I do to learning best practices from other world-class organizations focused on this promising approach," said Ms. Giusti, who is also a multiple myeloma patient.

"The promise of precision medicine will only be realized if we abandon a siloed approach to research and work collaboratively toward a greater good – two approaches Kathy Giusti has embraced and advocated in her nearly two decades of service to the cancer community. I am certain her vision and leadership of the HBS/Kraft Precision Medicine Accelerator will greatly improve the lives of people with cancer and other diseases," said Robert Kraft.

The mission of the HBS/Kraft Precision Medicine Accelerator is to speed innovation and medical breakthroughs in precision medicine, the process by which genomic information and other unique characteristics of a person’s disease are used to predict which treatments will be most effective. The Accelerator will convene best-in-class leaders from the business, medical, scientific, and technological communities to identify and solve challenges slowing the advancement of precision medicine, disseminate best practices and models to overcome these challenges, and, ultimately, enable the faster commercialization of high-impact innovations.

"Many of the biggest challenges in advancing breakthroughs promised by precision medicine are business challenges—how to best develop and commercialize medical solutions for public benefit, and how to optimally share data, for example. HBS is uniquely positioned to address these challenges by drawing on the ingenuity and expertise of our faculty, alumni, and students, and by convening the leaders who can develop innovative new models," said HBS Dean Nitin Nohria.

On June 13, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the initiation of a second investigational Phase I site for MVT-5873 (HuMab-5B1) with Sarah Cannon Research Institute through its network of research sites (Press release, MabVax, JUN 13, 2016, View Source [SID:1234513257]). The product is for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. In addition to the Sarah Cannon Research Institute at Tennessee Oncology site in Nashville, Tenn., patient enrollment in the Phase I trial is underway within Sarah Cannon Research Institute at Florida Cancer Specialists in Sarasota, Fla.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase I trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard-of-care chemotherapy regimen in patients with metastatic pancreatic cancer. The first group of patients are being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient group will establish the safety and recommended dose of the antibody when administered with standard-of-care chemotherapy. Lead investigators at Sarah Cannon’s research sites are Todd M. Bauer, MD, associate director of drug development in Nashville, and Judy Wang, MD, associate director of drug development in Sarasota.

"We are very excited to engage with Sarah Cannon’s world-class clinical research organization and are highly encouraged by progress with patient enrollment to date," said David Hansen, MabVax President and CEO. "Pancreatic cancer is very difficult to treat and patients with advanced disease have few therapeutic options. We are delighted to be working with site staff at these research sites to evaluate MVT-5873 as a potential new therapeutic option for these patients."

About HuMab-5B1:

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

On June 13, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the presentation of data by Onconova collaborators from the U.S. and Europe from the ongoing Phase 2 clinical trial of oral rigosertib in combination with azacitidine in patients with either first- or second-line higher-risk myelodysplastic syndromes (HR-MDS) at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark, which took place June 9 — 11, 2016 (Press release, Onconova, JUN 13, 2016, View Source [SID:1234513246]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The results of this study are being finalized to initiate end of Phase 2 discussions with U.S. and European regulatory agencies to define the next steps in the development plan for this combination therapy. These interim results were initially presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2015.

"We are encouraged by the interim overall response rate results of this Phase 2 trial, which demonstrated that 23 of 30 patients, or 77%, responded to treatment, and anticipate further updates to the data set," stated Steve Fruchtman, M.D., Chief Medical Officer of Onconova. "Of note, 84% of HMA-naïve patients responded to this novel combination. We look forward to discussing these results, and the longer-term follow-up from this study, with U.S. and European regulatory agencies in order to define the next step of development for this combination therapy."

A full copy of the EHA (Free EHA Whitepaper) poster entitled, "Results from Phase I/II Study of the Combination of Oral Rigosertib and Azacitidine in Patients with Myelodysplastic Syndromes (MDS)," may be accessed by visiting "Posters" in the Investors and Media section of Onconova’s website at www.onconova.com.

On June 13, 2016 Sunesis Pharmaceuticals (NASDAQ:SNSS) reported the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) (Press release, Sunesis, JUN 13, 2016, View Source;p=RssLanding&cat=news&id=2177015 [SID:1234513244]). The results were presented Saturday in an oral session titled "New Compounds in AML Treatment" at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark. The presentation (abstract S505, Bella Center, Hall A3), titled "Phase I/ll study of vosaroxin and decitabine in newly diagnosed older patients with acute myeloid leukemia and high-risk myelodysplastic syndrome," is available at www.sunesis.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Older patients diagnosed with AML and MDS have limited treatment options and exceedingly poor outcomes," said Naval Daver, M.D., Assistant Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a study investigator. "At the optimized induction dose of 70 mg/m2 of vosaroxin, the combination of vosaroxin and decitabine demonstrates a compelling CR/CRp/CRi rate of 76% and a median overall survival of 16.1 months. This response rate and survival are significantly better than seen with single-agent decitabine among similar patients at our institution. This outcome was achieved with <5% induction mortality and good tolerability. In this vosaroxin-decitabine cohort, 23 of 41 patients remain alive."

Daniel Swisher, CEO of Sunesis, added: "We believe these results warrant further exploration in a larger outcome study, with plans currently under review to conduct a multicenter clinical trial comparing vosaroxin plus decitabine and vosaroxin plus cytarabine to the 7+3 regimen in patients with AML."

To date, 63 patients (56 AML, 7 high-risk MDS) with a median age of 69 years (range 60-78) have been enrolled in the trial. All 63 patients have completed at least 2 treatment rounds, rendering them evaluable for response; with a 75% overall response rate, 49% (31 patients) achieved complete remission (CR), 17% (11 patients) achieved CR with incomplete platelet recovery (CRp), and 8% (5 patients) achieved CR with incomplete peripheral blood count recovery (CRi). The therapy was well-tolerated, with the main therapy related grade 3 or higher toxicities being mucositis in 11 (17%) patients.

Initially for the first 22 patients in the study, the selected induction dose of vosaroxin was 90 mg/m2. Thereafter to reduce the incidence of mucositis, the induction dose was reduced to 70 mg/m2 for the next 41 patients. The lower dose of vosaroxin in combination with decitabine was associated with reduced early mortality and an improved overall response rate and OS, as follows:

Induction
Dose
(vosaroxin) N Median
OS 8-week
Mortality Overall
Response Need >1 Cycle to
Response
90 mg/m2 22 5.5 27 % 73 % 19 %
70 mg/m2 41 16.1 5 % 76 % 42 %

Sunesis also announced that follow-up data from the company’s VALOR trial was presented as an e-poster during the EHA (Free EHA Whitepaper) meeting. The poster (abstract E930, Bella Center, E-Poster Screens), titled "Characterization of patients with relapsed or refractory AML in continued follow-up after treatment with vosaroxin/cytarabine vs placebo/cytarabine in the VALOR trial," shows that, as of January 22, 2016, 83 of 711 patients enrolled in VALOR remain alive (46/356 in the vosaroxin/cytarabine arm, 37/355 in the placebo/cytarabine arm) and in follow up, which has reached a median of 40 months. In patients ≥60 years, more than twice as many patients were alive in the vosaroxin/cytarabine arm (23 vs. 10 patients).

All but seven patients in this follow up underwent allogeneic hematopoietic stem cell transplant (HCT). Of note, the non-HCT survivors were all in the vosaroxin/cytarabine treatment arm (68-71 years old, 2 primary refractory and 5 early relapsed).

Mr. Swisher added: "We are encouraged by the long-term benefit seen in the VALOR follow-up and also the potential for vosaroxin and cytarabine to provide long-term benefit in older patients who need more options."

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

On June 13, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that data from its 1404 and PyLTM prostate cancer imaging programs will be presented at the upcoming Society of Nuclear Medicine and Molecular Imaging 2016 Annual Meeting, taking place from June 11 — 15, 2016 in San Diego, California (Press release, Progenics Pharmaceuticals, JUN 13, 2016, View Source [SID:1234513241]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The details of the presentations are included below.

1404 Tc-99m Diagnostic Imaging Agent

Title: SPECT/CT Imaging of Prostatic PSMA Expression with Tc99m trofolastat chloride in Healthy Volunteers
Date and Time: June 13th from 3:00 — 4:30 p.m. PT
Poster Number: 1546
Session: Meet the Author Poster Session I: Prostate/GU Posters

PyL F-18 Diagnostic Imaging Agent

Title: Normal Organ Uptake Variability on PSMA-Targeted 18F-DCFPyL PET/CT
Date and Time: June 14th at 4:54 p.m. PT
Poster Number: 519
Session: SS76: Prostate/GU: Prostate and Other Malignancies

Title: Application of 18F-labeled PSMA-imaging using [18F]DCFPyL at very low PSA-values may allow curative treatment in recurrent prostate cancer
Date and Time: June 15th at 8:24 a.m. PT
Poster Number: 561
Session: SS82: Prostate/GU: PSMA Imaging in Advanced Disease

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of >95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as [18F]DCFPyL) is a clinical-stage, fluorinated PSMA-targeted PET imaging agent for prostate cancer that was discovered and developed at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine. A proof-of-concept study published in the April 2015 issue of the Journal of Molecular Imaging and Biology demonstrated that PET imaging with PyL showed high levels of PyL uptake in sites of putative metastatic disease and primary tumors, suggesting the potential for high sensitivity and specificity in detecting prostate cancer.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 180,890 new cases of prostate cancer will be diagnosed and about 26,120 men will die of the disease and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.