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OncoSec Announces Technology Access Program Agreement with Jounce Therapeutics, Inc.

June 12, 2017 /PRNewswire/ — OncoSec Medical Incorporated ("OncoSec") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that they have engaged in a preclinical agreement through the OncoSec Technology Access Program (TAP) with Jounce Therapeutics, Inc., (NASDAQ:JNCE) Cambridge, MA, a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment.

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Under the agreement, Jounce can utilize OncoSec’s gene delivery technology to evaluate in vivo efficacy in murine models of intratumorally-delivered therapeutic candidates. The agreement includes the GENESIS research generator and proprietary applicators developed for research use.

"We are excited to provide a preclinical delivery solution to Jounce for early-stage research purposes and expand the data set from our delivery technologies through our Technology Access Program," said Punit Dhillon, CEO and President of OncoSec. "Through the establishment of these programs, OncoSec benefits from extensive, multi-party characterization and validation of our proprietary, state-of-the art electroporation technologies. We are pleased to be working with Jounce to help advance their preclinical programs with these technologies."

"OncoSec has developed a unique delivery technology that will enable us to rapidly assess potential candidates in preclinical models," said Debbie Law, Jounce’s Chief Scientific Officer. "We are delighted to be working with OncoSec and leveraging their technology to help us evaluate our preclinical immunotherapy programs."

About OncoSec Research Technologies and Technology Access Program:

The OncoSec GENESIS research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.)

TRACE technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS with TRACE has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.

Potential advantages of GENESIS with TRACE for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.

The OncoSec Technology Access Program makes OncoSec’s electroporation technologies available to collaborators for preclinical research. Devices are available for intratumoral, intradermal, and intramuscular delivery. For more information, please contact [email protected].

For SEC reporting purposes, the agreement between OncoSec and Jounce is non-material.

Mateon Therapeutics Provides Update on its Clinical Trial Programs and Milestones

On June 12, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported an update regarding the current status of all clinical trials of its investigational drugs (Press release, Mateon Therapeutics, JUN 12, 2017, View Source [SID1234519489]).

Company-sponsored studies:
FOCUS for platinum-resistant ovarian cancer
FOCUS is a phase 2/3 study in patients with platinum-resistant ovarian cancer, evaluating whether the addition of CA4P to the current standard-of-care (bevacizumab plus chemotherapy) improves progression-free survival. As of June 9, 2017, FOCUS has enrolled 57 patients in the United States, Germany and Belgium, with enrollment on-going at 37 sites. The second interim analysis, which will occur after the first 40 patients have been treated for at least two months or withdrawn from the study, remains on track to be completed in August 2017. Based on the number of patients enrolled and projected enrollment trends, the company expects the third interim analysis, representing 60 patients, to be completed in late September 2017.

OX1222 for acute myeloid leukemia
OX1222 is a dose-ascending phase 1b/2 clinical trial evaluating OXi4503 in combination with cytarabine in patients with recurrent/relapsed acute myeloid leukemia (AML). Mateon recently completed enrollment and treatment for the fourth cohort of 7.81 mg/m2 of OXi4503, and no dose limiting toxicities or significant safety issues were identified among the three patients. One patient treated in the fourth cohort experienced a significant AML blast reduction, with blast counts going from 89% upon enrollment to 7% following the first cycle of treatment. However, the patient subsequently experienced an unrelated adverse event and withdrew from the study approximately two weeks after the last dose of OXi4503 in the second cycle of treatment, prior to an additional blast measurement and accordingly did not meet the criteria for a complete remission. Three complete remissions were observed in the first three cohorts (19% overall in the clinical trial to date), each of which occurred after two cycles of treatment, and two complete remissions remain on-going at 12+ and 3+ months. Enrollment is on-going in the fifth cohort of 9.76 mg/m2 of OXi4503.

Investigator-sponsored studies:
PAZOFOS for recurrent ovarian cancer
The PAZOFOS study is a phase 1b/2 investigator-sponsored study being conducted in the U.K., evaluating the combination of CA4P and the TKI-inhibitor pazopanib for patients with advanced recurrent ovarian cancer. To date, the study has enrolled and treated 20 patients with CA4P and pazopanib in the phase 1b and phase 2 portions of the trial. The study sponsor, The Christie NHS Trust, has temporarily suspended enrollment in the trial in order to collect and review additional information on two recent serious adverse events – one patient in the study experienced hypertension and myocardial ischemia, and a second patient experienced chest pain. In both cases, the events were of short duration and the clinical symptoms resolved.

The label for pazopanib, which is not approved for the treatment of ovarian cancer in the U.S., contains warnings for cardiac dysfunction, arterial thrombotic events and hypertension. CA4P has been observed in most patients to cause an acute and transient increase in blood pressure following administration.

Following review of the data available for the patients in PAZOFOS, the company does not believe any changes or adjustments to Mateon’s FOCUS study are warranted. FOCUS has restrictive enrollment criteria for patients with pre-existing cardiovascular risk factors and specific algorithms for treatment of patients that experience blood pressure increases.

Neuroendocrine tumors
The Markey Cancer Center at the University of Kentucky recently began a phase 1 study evaluating the combination of CA4P and everolimus for the treatment of neuroendocrine tumors. In the first part of the study, patients are being treated with two different dosing regimens of CA4P in combination with everolimus to evaluate the safety of the drug combination and establish appropriate CA4P dosing levels.

"We are pleased that studies in both our core programs, the FOCUS study of CA4P for platinum-resistant ovarian cancer and Study OX1222 of OXi4503 for AML, are enrolling well and showing a good safety profile, as well as initial indications of efficacy," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "We are looking forward to data read outs from each of these studies later this summer."

"The investigator-sponsored PAZOFOS study, which uses CA4P with a different combination of drugs for recurrent ovarian cancer, also holds significant potential for patients and we’re hopeful that enrollment will resume soon," Dr. Schwieterman added.

AbbVie Announces New Data Evaluating Venetoclax in a Variety of Hematologic Malignancies at the 22nd European Hematology Association Congress

On June 12, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that data from multiple clinical trials evaluating venetoclax, a first-in-class oral B-cell lymphoma-2 (BCL-2) inhibitor, will be presented at the 22nd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, June 22-25, in Madrid (Press release, AbbVie, JUN 12, 2017, View Source [SID1234519487]). Investigational data will be presented from 15 studies evaluating venetoclax across some of the most common hematologic malignancies, including chronic lymphocytic leukemia, multiple myeloma, acute myeloid leukemia and non-Hodgkin lymphoma.

VENCLYXTO monotherapy is approved in the EU for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.1 VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

"AbbVie is committed to investigating the safety and efficacy of venetoclax. The data being presented at EHA (Free EHA Whitepaper) reinforce this commitment and underscore our mission to develop and deliver therapies that address unmet needs in a selected set of debilitating hematologic malignancies and have a remarkable impact on the lives of people affected by cancer," said Gary Gordon, M.D., Ph.D., vice president, oncology clinical development, AbbVie.

AbbVie abstracts:

Venetoclax in CLL

Venetoclax in relapsed/refractory chronic lymphocytic leukemia (CLL) with 17p deletion: outcome and correlation with minimal residual disease from the full population of the pivotal M13-982 trial; Stilgenbauer et al.; Abstract S771; Oral Presentation; Sunday, June 25, 2017; 8:30-8:45 a.m. CEST
Treatment and 17p deletion testing patterns in community practice for patients with chronic lymphocytic leukemia (CLL) in the United States; Kapustyan et al.; Abstract E1023; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Durability of responses on continuous therapy and following drug cessation in deep responders with venetoclax and rituximab; Anderson et al.; Abstract P247; Poster Presentation; Friday, June 23, 2017; 5:15-6:45 p.m. CEST
Attainment of complete remission is significantly associated with longer survival outcomes in relapsed/refractory (R/R) CLL: a meta-analysis; Ektare et al.; Abstract E1037; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Impact of venetoclax on the quality of life of CLL patients relapsed/refractory to B-cell receptor (BCR) signaling pathway inhibitor treatment; Wierda et al.; Abstract P728; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
Impact of venetoclax on the quality of life of patients with relapsed/refractory chronic lymphocytic leukemia: results of a Phase 2, open-label study of venetoclax (ABT-199/GDC-0199) monotherapy; Wierda et al.; Abstract E1466; ePOSTER; Friday, June 23, 2017 8:30 a.m. CEST
Reduced healthcare resource utilization in patients with chronic lymphocytic leukemia achieving complete remission to first-line therapy; Enschede et al.; Abstract E1035; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST
Progression-free survival (PFS) and overall survival (OS) in patients with chronic lymphocytic leukemia (CLL) — clinical benefits of achieving a deep response to first-line therapy; Samp et al.; Abstract PB1791; Publication; Thursday, May 18, 2017; 12:00 p.m. CEST

Venetoclax in AML

Safety and efficacy of venetoclax (VEN) in combination with decitabine or azacitidine in treatment-naive, elderly patients (>=65 years) with acute myeloid leukemia (AML); Pratz et al.; Abstract S472; Oral Presentation; Saturday, June 24, 2017; 4:15-4:30 p.m. CEST
Updated safety and efficacy results of Phase 1/2 study of venetoclax plus low-dose cytarabine in treatment-naive acute myeloid leukemia patients aged >=65 years and unfit for standard induction therapy; Wei et al.; Abstract S473; Oral Presentation; Saturday, June 24, 2017; 4:30-4:45 p.m. CEST

Venetoclax in NHL/MM

A Phase 1 study evaluating the safety and pharmacokinetics of venetoclax in Japanese patients with non-Hodgkin lymphoma and multiple myeloma; Yamamoto et al.; Abstract E1139; ePOSTER; Friday, June 23, 2017; 8:30 a.m. CEST

Venetoclax in MM

A Phase 1b study of venetoclax combined with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma; Moreau et al.; Abstract s460; Oral Presentation; Saturday, June 24, 2017; 5:00-5:15 p.m. CEST
BCL2 expression is a potential predictive biomarker of response to venetoclax in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma; Ross et al.; Abstract P682; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST
Venetoclax as targeted therapy for relapsed/refractory multiple myeloma; Kumar et al.; Abstract P675; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST

Venetoclax in NHL

Venetoclax (VEN) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL); Davids et al.; Abstract P564; Poster Presentation; Saturday, June 24, 2017; 5:30-7:00 p.m. CEST

The EHA (Free EHA Whitepaper) 2017 Annual Congress abstracts are available at www.ehaweb.org.

Propanc Biopharma Makes Significant Progress with PCT Patent Application

On June 9, 2017 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or "the Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported significant progress with yet another Patent Cooperation Treaty (PCT) patent application within its intellectual property (IP) portfolio (Press release, Propanc, JUN 9, 2017, View Source [SID1234519486]).

The Company received a Written Opinion from an International Search Authority regarding the novelty, inventive step and industrial applicability of the invention claimed in the recent PCT application, filed in April, 2017. The PCT application titled "Composition of Proenzymes for Cancer Treatment" is directed to a composition comprising trypsinogen and chymotrypsinogen, targeting specific weight ratios and certain dosage levels for the Company’s lead product, PRP. The majority of claims were considered novel and a number of claims considered inventive, as determined by the Authorized Officer from the Australian Patent Office. Furthermore, it appears that the experimental data included in the application and the way it is presented adequately supports the pending claims. The PCT assists applicants in seeking patent protection internationally for their inventions and the Written Opinion can guide national patent offices with their patent granting decisions. By filing one international patent application under the PCT, applicants can simultaneously seek protection for an invention in over 150 countries.

"We continue to make significant progress with our IP portfolio and look forward to entering the national phase where we will seek to obtain jurisdiction in key countries and regions, globally," said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. "We remain committed to further establishing ourselves as the lead player in a new and exciting field of oncology, using proenzymes as a means to halt progression of cancer from solid tumors. Hence, we continue to work hard along with our partner research organizations and scientific experts to explore new opportunities to expand our portfolio, and to also discover new treatments methods and compounds which even further enhances the effects of PRP."

The Company’s lead product, PRP, is a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

XBiotech Announces Discontinuation of Phase III Study for Colorectal Cancer Based on Second Interim Analysis

On June 9, 2017 XBiotech Inc. (NASDAQ:XBIT) reported that an Independent Data Monitoring Committee (IDMC) has performed its second prospectively planned, unblinded analysis of the Phase 3 XCITE study for the Company’s novel candidate antibody therapy for the treatment of colorectal cancer (Press release, XBiotech, JUN 9, 2017, View Source [SID1234519485]). The IDMC had no safety concerns from the unblinded analysis. However, the committee recommended the early termination of the study since the findings were not sufficient to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis of less than or equal to p = 0.08.

John Simard, XBiotech President & CEO stated, "We are obviously disappointed with these findings. In the coming weeks, the Company plans to analyze the data extensively to further understand the primary and secondary endpoint data, as well as to identify populations that may have benefited from the therapy. These findings today will not affect our efforts to pursue approval of the therapy based on the successful completion of the European study, which demonstrated control of debilitating symptoms in colorectal cancer."

Patients enrolled in the XCITE study were randomized 2:1 to receive Xilonix or placebo plus, in each case, best supportive care. Advanced colorectal cancer patients were required to have previous failed regimens that included flouropyrimidines, oxaliplatin, irinotecan, and Cetuximab (or Panitumumab for patients with KRAS mutation). Patients were expected to continue in the study until there was evidence of radiographic progression. The patients were to be followed for up to 18 months in order to determine overall survival. The primary endpoint of this study was overall survival, with secondary endpoints including objective response rate, progression free survival, change in lean body mass and patient reported quality of life measures.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.