(Press release, NantBioScience, SEP 15, 2014, View Source [SID:1234503331])

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(Press release, NantBioScience, SEP 15, 2014, View Source [SID:1234503306])

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!


SignalRx Presents at AACR Conference on its Dual Kinase-Epigenetic Inhibitors for Treating Cancer

On September 15, 2014 SignalRX Pharmaceuticals Inc., focused on developing more effective oncology drugs though molecular design imparting multiple target inhibition, reported the presentation of scientific data on the Company’s proprietary dual inhibitor program in oncology (Press release, SignalRx, SEPT 15, 2014, View Source [SID1234527331]). The presentation by Dr. Donald Durden, MD, PhD, founder and CEO of SignalRx was made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Targeting the PI3K-mTOR Network in Cancer at the Sheraton Philadelphia Downtown Hotel, Philadelphia, Pennsylvania.

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The presentation highlighted the discovery and early development of patented new molecules such as SF2523 that inhibit kinase targets such as PI3 kinase (PI3K) while also blocking epigenetic targets such as bromodomain proteins. SignalRx presented in vivo evidence of efficacy without toxicity in mouse cancer models with SF2523 alleviating potential theoretical safety concerns arising from inhibiting multiple key nodal cancer targets with one drug.

The ability to safely simultaneously inhibit multiple key targets is highly sought after in cancer treatment to maximize efficacy and prevent resistance. Replacing several combinations of drugs with one drug hitting multiple targets is also being driven by exploding oncology drug costs to patients and to the health care system. SignalRx compounds are being developed as next generation PI3K inhibitors and it has now been shown that they also potently inhibit certain bromodomain proteins such as BRD4. SF2523 is a lead dual inhibitor compound and has been demonstrated to: 1) inhibit proliferation across 18 different cancer cell lines; 2) induce apoptosis in neuroblastoma cells, renal cell carcinoma cells, multiple brain cancer cell lines including patient-derived samples; 3) block angiogenic signaling and blood vessel production in vivo; 4) inhibit cancer stem cells in breast and human medulloblastoma patient cells; 5) exhibit potent antitumor efficacy and anti-metastatic effects without toxicity in renal cell carcinoma xenograft models, neuroblastoma mouse models, orthotopic pancreatic cancer model and Lewis lung cancer models.

Bromodomain proteins bind to acetylated lysine groups on chromatin and promote gene transcription. SignalRx’s compounds act as acetyl lysine mimetics and prevent the bromodomain protein from binding to chromatin. This mechanism of action is distinct from the compound’s PI3K inhibition where the inhibitors bind in the ATP catalytic site of the kinase. This allows for the first time simultaneous control of both the PI3K pathway and the transcription of certain genes mediated by bromodomain proteins. An example of the utility of this approach to solve unmet medical needs is to block the tumor suppressor gene MYC which is a driver in many cancers including CLL and multiple myeloma and for which small molecule inhibitors have been elusive. Inhibition of PI3K increases the cellular degradation of MYC protein while BRD4 inhibition decreases the transcription (production) of MYC protein. Use of SignalRx’s dual PI3K/BRD4 inhibitors provides a unique and effective approach to block the action of MYC via two orthogonal mechanisms demonstrated with lead compound SF2523 to be efficacious without toxicity in mouse models.

These new compounds are broadly covered by composition-of-matter U.S. Patent No. 8,557,807 entitled "Thienopyranones as kinase inhibitors" issued October 15, 2013. Additional information on preparation and structure-activity-relationships of these compounds were recently published in the Journal of Medicinal Chemistry (February 14th 2013 issue, volume 56, pages 1922-1939).

"The discovery of SF2523 which inhibits both PI3K and BRD4 represents a major step forward in designing anticancer agents to be as effective as possible" said Donald L. Durden, MD, PhD,. "Additionally, the problem of early stage clinical trial evaluation of multiple combinations is solved by this approach by consolidating at least two of the combination partners into one drug. Moreover, because two separate drugs will always suffer from differing cell penetration, metabolism, and pharmacokinetics our approach of one molecule hitting two critical targets in the same cell is the only way to ensure that desired simultaneous blockage of multiple key signaling pathways is achieved in vivo."

TG Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA for Its First Phase 3 Clinical Trial of TG-1101 (ublituximab) in Combination With Imbruvica(R) (ibrutinib) for Patients With Previously Treated Chronic Lymphocytic Leukemia

On September 15, 2014 TG Therapeutics reported that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design, endpoints and statistical analysis approach of a Phase 3 clinical trial for TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, in combination with Imbruvica (ibrutinib) for the treatment of Chronic Lymphocytic Leukemia (CLL) in patients with high risk cytogenetics (Press release TG Therapeutics, SEP 15, 2014, View Source [SID:1234500747]). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval.

Full details of the Phase 3 clinical trial will be released at the launch of the study, which is expected to occur before the end of the year. In this randomized controlled trial, patients will receive either TG-1101 plus ibrutinib or ibrutinib alone. The trial will enroll approximately 330 patients, with approximately the first two-thirds of the patients included in the ORR assessment. As per the SPA, the Company plans to use the ORR data from the trial as the basis for submission of a Biologics License Application (BLA) for accelerated approval for TG-1101. All patients will then be followed for PFS assessment, which is designed to support full approval.

Additionally, the Company reported that enrollment into the CLL cohort of its ongoing combination Phase 2 study of TG-1101 plus ibrutinib is now closed. The Company expects it will have over 30 CLL patients evaluable for safety and efficacy available for presentation at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) this December.

Dr. Jeff Sharman, Medical Director of Hematology Research for the US Oncology Network, and currently the lead investigator on the Company’s Phase 2 combination trial of TG-1101 plus ibrutinib, will be the Study Chair for this Phase 3 trial. Dr. Sharman commented, “We have been very pleased with the safety and activity profile of the combination seen thus far in our Phase 1/2 trial, and are excited to lead this important clinical trial. Combining a glycoengineered anti-CD20 monoclonal antibody with ibrutinib has the potential to materially increase the number of patients benefitting from treatment with ibrutinib therapy. The Phase 2 trial has enrolled very quickly throughout our clinical research network with patients, physicians, and nurses recognizing the benefits of this study.”

Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated, “The TG-1101 SPA agreement is a major milestone for us as it represents the first clearly defined development and regulatory pathway for the approval of TG-1101 for the treatment of CLL. As we’ve mentioned previously, reaching agreement with the FDA on this combination trial with ORR as a primary endpoint for accelerated approval was our number one priority. We are thrilled to get this first SPA in place earlier than anticipated, which puts us in an excellent position to build out the remainder of our registration program for both TG-1101 and TGR-1202. We would like to thank the FDA for its invaluable guidance throughout this process. The speed at which the FDA reviewed the submission demonstrates a real commitment to drive novel medicines to the patients who need them as rapidly as possible.” Mr. Weiss continued, “We look forward to launching this trial by year end and are excited to continue to work with Dr. Sharman, the entire US Oncology team, and all investigators, who have been instrumental in our development of this important combination.”

Merck Discontinues Clinical Development Program of Tecemotide as a Monotherapy in Stage III Non-Small Cell Lung Cancer

On September 12, 2014 Merck reported that its biopharmaceutical division Merck Serono will discontinue the clinical development program of its investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) as a monotherapy in Stage III non-small cell lung cancer (NSCLC) (Press release Merck KGaA, SEP 12, 2014, View Source [SID:1234500739]).

Luciano Rossetti, Global Head of Research & Development at Merck Serono, said: “While the data from the exploratory subgroup analysis in the START trial1 generated a reasonable hypothesis to warrant additional study, the results of the recent trial in Japanese patients decreased the probability of current studies to reach their goals. Therefore, we have decided to discontinue the development of tecemotide as a monotherapy in NSCLC in order to refocus our efforts on other promising candidates in our pipeline, like our anti-PD-L1 antibody MSB0010718C. Merck Serono remains committed to developing new treatment options for patients with difficult-to-treat cancers.”

The company’s decision to discontinue the current clinical program in NSCLC, which includes the Phase III START2 and INSPIRE studies, follows recent results from a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled Phase I/II study in Japanese patients with Stage III unresectable, locally advanced NSCLC who had received concurrent or sequential chemoradiotherapy (CRT), with a minimum of two cycles of platinum-based chemotherapy and radiation dose ≥50 Gy. Of the patients included in the Phase II part of the study, the majority had received concurrent CRT. The results indicate that no effect has been observed for either the primary endpoint, overall survival (OS), or for any of the secondary endpoints (progression-free survival [PFS], time to progression [TTP] and time to treatment failure). An analysis of the reported adverse events has not identified a clinically meaningful difference in the frequency between treatment groups. Although the trial was not powered to demonstrate a statistically significant difference in benefit between the two arms, Merck Serono made the recommendation to stop the investigational treatment for patients in the EMR 63325-009 study in Japan.

Merck Serono has made the decision to discontinue all other Merck Serono-sponsored clinical trials with tecemotide in NSCLC worldwide. Those patients on active treatment with tecemotide can undergo an individual assessment by their treating physician and apply to receive further treatment outside of the studies. The company will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with Merck’s agreements with the sponsors of these studies.

Merck Serono continues to evaluate a number of investigational compounds for difficult-to-treat cancers, and remains committed to improving the lives of cancer patients and their families.