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Xspray Pharma announces positive clinical data for its HyNap-dasatinib product candidate, HyNap-Dasa

On June 15, 2017 Xspray Pharma AB reported that its lead product candidate, HyNap-Dasa, demonstrated the ability to eliminate the clinically relevant pH dependent of dasatinib in a Phase I clinical trial (Press release, Xspray, JUN 15, 2017, View Source [SID1234523282]).

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Xspray Pharma AB is a clinical stage product development company that utilizes its innovative HyNap technology to develop improved and generic versions of marketed anti-cancer products. Xspray’s lead product candidate, HyNap-Dasa, is being developed as an improved version of a leading dasatinib product indicated for treatment of CML. HyNap-Dasa has the potential to reach the US market in 2020.

One of the drugs being marketed for treatment of CML – SPRYCEL – reported global sales in 2016 exceeding 1.8 billion USD of which US sales were close to 1 billion USD. As disclosed in SPRYCEL labelling, one of the challenges is that the uptake is dependent on the patient’s gastric acidity. Reduced gastric acidity (increased pH) dramatically decreases dasatinib´s solubility and absorption. Previous studies with acid reducing agents (ARAs) have shown that dasatinib’s absorption measured as area under the curve (AUC), decreased by 61% and 43% using leading ARAs famotidine and omeprazole, respectively. SPRYCEL is a trademark of Bristol-Meyers Squibb Company. Xspray Pharma AB is not affiliated with, sponsored by, or endorsed by Bristol-Meyers Squibb Company.

In the completed Phase I clinical trial in 16 healthy subjects, HyNap-Dasa given with or without the acid reducing agents omeprazole demonstrated bioequivalence by showing less than 2% difference in absorption measured as AUC.

Highlights from the clinical data include:

Absorption of dasatinib from HyNap-Dasa was equal before and after omeprazole treatment measured as area under the curve, AUC (AUC-ratio was 0.98 and C.I. 87 – 120%).
Dasatinib´s maximum concentration (Cmax) was equal before and after omeprazole treatment (Cmax-ratio was 0.98 and C.I. 81 – 128%).
The PK profile of HyNap-Dasa was shown not to be influenced by omeprazole treatment.

"We are extremely pleased with the clinical results obtained and believe that these data will support our further development of HyNap-Dasa as a product with clinically relevant benefits compared to available dasatinib products," stated Per Andersson, Chief Executive Officer. Mr. Andersson continued, "The results of this clinical trial also confirmed that our HyNap technology may not only address the food effect as shown in the previous clinical study with HyNap-Nilo (nilotinib) but also the important pH dependent absorption frequently encountered for orally administered PKI drugs in targeted cancer therapy."

Mikael von Euler, clinical advisor to Xspray, who has held leading clinical positions for 4 of today’s marketed PKIs at 3 different big pharma companies said: "I am impressed with the results of this study showing the ability of the HyNap technology to eliminate the clinically important drug-drug interaction between PKIs and omeprazole. There are currently 34 PKI anti-cancer products on the market, and more than 300 in clinical development. I believe HyNap formulations of PKIs have the potential to improve both present and upcoming products´ profiles improving safety and enhancing patients’ quality of life during this type of therapy."

Blaze Bioscience Announces Presentation of Tumor Paint BLZ-100 Clinical Data at Pediatric Neuro-Oncology Basic and Translational Research Conference

On June 15, 2017 Blaze Bioscience, Inc., the Tumor Paint Company, a biotechnology company dedicated to improving the lives of cancer patients, reported that clinical data from the company’s Phase 1 study of Tumor Paint BLZ-100 (tozuleristide) in pediatric brain cancer patients were presented at the 4 th Biennial Pediatric Neuro-Oncology Basic and Translational Research Conference in New York, NY (Press release, Blaze Bioscience, JUN 15, 2017, View Source [SID1234519593]).

The presentation, titled "Phase 1 safety, pharmacokinetic and imaging study of BLZ-100 Tumor Paint in pediatric brain tumor patients", was presented by the study’s principal investigator, Sarah Leary, M.D., pediatric oncologist at Seattle Children’s Hospital.

The Phase 1 experience in pediatric brain cancer patients with the investigational product BLZ-100 (tozuleristide) through the dose escalation phase of the study was presented. This investigational agent has the potential to aid surgeons in achieving maximal safe surgical resection, an essential component of pediatric brain cancer treatment. Dr. Leary provided details on the safety and clinical proof of principle data for BLZ-100 to detect pediatric brain tumors in real time during surgery in 15 patients from the 5 dose escalation cohorts. BLZ-100 was well tolerated in the dose levels studied with tumor fluorescence observed in a majority of evaluated tumors. Data supported dose selection for the ongoing dose expansion phase of the study in which is currently open to enrollment.

"We are continually inspired by our pediatric patients and their families, and aim to provide the best outcomes possible for these children," said Dr. Leary. "Successful surgery is a foundation of treatment and extent of resection is the single best predictor of survival in pediatric patients with brain tumors. I believe BLZ-100 as an aid to surgery has tremendous potential and look forward to further clinical testing in the pediatric population."

"The results to date from the ongoing Phase 1 study are very encouraging," said Heather Franklin, Blaze Bioscience President and CEO. "Current treatment for pediatric brain cancer all too often has a devastating impact on subsequent childhood development. Disease symptoms in conjunction with harsh treatment options such as radiation therapy and chemotherapy have lasting negative effects on a developing body. We are dedicated to improving pediatric brain cancer surgery to achieve better survival and quality of life for children with brain cancer."

About the Phase 1 pediatric brain cancer study

The open-label Phase 1 dose escalation and expansion study is evaluating BLZ-100 in pediatric subjects with primary central nervous system tumors. The study is being conducted at Seattle Children’s Hospital under the direction of principal investigator Sarah Leary, M.D. The dose escalation part of the study has enrolled 15 pediatric patients at five pre-specified dose levels to evaluate safety and tolerability of BLZ-100 and provide clinical proof of principle data for BLZ-100 to detect tumors in pediatric subjects. The dose expansion part of the study is ongoing.

Further information on this clinical trial can be found at: View Source

About BLZ-100

BLZ-100 (tozuleristide) is the first product candidate from Blaze’s Tumor Paint platform and consists of an Optide (optimized peptide) and a fluorescent dye, which emits light in the near-infrared range. Tumor Paint products are
2 designed to provide real-time, high-resolution intraoperative visualization of cancer cells, potentially enabling more precise, complete resection of cancer throughout surgery. Preclinical utility of Tumor Paint technology has been demonstrated in a wide range of cancer types. BLZ-100, an investigational agent, is in Phase 1 clinical studies to evaluate the safety and imaging characteristics of BLZ-100 in solid tumors. BLZ-100 has achieved clinical proof of concept in brain, breast and skin cancers. Additional potential applications of BLZ-100 include prostate, lung, colorectal and other solid tumor cancers. More details about on-going trials are available at www.blazebioscience.com or www.clinicaltrials.gov.

BeiGene Presents Updated Phase 1 Data on BTK Inhibitor BGB-3111 in Patients with Waldenström’s Macroglobulinemia at the 14th International Conference on Malignant Lymphoma

On June 15, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported updated data from an ongoing Phase 1 study of Bruton’s tyrosine kinase (BTK) inhibitor BGB-3111 in patients with Waldenström’s macroglobulinemia (WM) at the 14th International Conference on Malignant Lymphoma (14-ICML) in Lugano, Switzerland (Press release, BeiGene, JUN 15, 2017, View Source [SID1234519560]). The updated Phase 1 data continue to demonstrate that BGB-3111 is well tolerated, with a very good partial response (VGPR) rate of 43% and with an overall response rate (ORR) of 90% in 42 efficacy-evaluable patients with a median follow-up time of 12.3 months.

"The updated data continue to suggest that BGB-3111 is well tolerated in WM. Particularly notable is the VGPR rate of over 40% in an evaluable population of 42 patients. In addition, responses to BGB-3111 appear to deepen with time and to occur in patients both with and without MYD88 mutations. The rates of adverse event-related discontinuation and disease progression remain very low," commented Judith Trotman, MBChB, FRACP, FRCPA, Director of Clinical Research in Haematology at the Concord Repatriation General Hospital, Clinical Associate Professor of Medicine at the University of Sydney, and the lead author of the abstract.

"We are very pleased to update our Phase 1 data of BGB-3111 in patients with WM. The high rate of VGPRs observed to date may result in part from BGB-3111’s ability to completely and sustainably occupy BTK in both circulating and nodal lymphocytes. The VGPR rate also further supports the continued evaluation of BGB-3111 in its global, head-to-head Phase 3 study against ibrutinib in WM," commented Jane Huang, MD, Chief Medical Officer, Hematology at BeiGene.

Summary of Results from the Ongoing Phase 1 Study

The multi-center, open-label Phase 1 trial of BGB-3111 as monotherapy in B-cell malignancies is being conducted in Australia, New Zealand, South Korea, and the United States and consists of a dose-escalation phase and a dose-expansion phase in disease-specific cohorts, which include treatment naïve and relapsed/refractory WM. The ongoing dose-expansion phase is testing doses of 160 mg twice a day (BID) or 320 mg once a day (QD). As of March 31, 2017, 48 patients with WM were enrolled in the study. Responses were determined according to the modified Sixth International Workshop on WM (IWWM) criteria.

BGB-3111 was shown to be well tolerated with no discontinuation for BGB-3111-related toxicity to date. Adverse events (AEs) were generally mild in severity and self-limited. The most frequent AEs (>10%) of any attribution among 48 patients evaluable for safety were petechiae/purpura/contusion (35%), upper respiratory tract infection (31%), constipation (25%), diarrhea (19%), epistaxis (19%), nausea (17%), cough (15%), anemia (15%), headache (15%), neutropenia (13%), and rash (13%), all of which were grade 1 or 2 in severity except for grade 3 or 4 anemia and neutropenia (8% each) as well as grade 3 or 4 diarrhea and headache (2% each). Five serious AEs were assessed to be possibly related to BGB-3111; these included one case each of hemothorax, atrial fibrillation, colitis, febrile neutropenia, and headache. Among AEs of special interest, there were a total of three cases of atrial fibrillation (all grade 1 or 2), and one case of serious hemorrhage (hemothorax), defined as grade 3 or higher hemorrhage or central nervous system hemorrhage of any grade. Three events led to treatment discontinuation: one case each of bronchiectasis, prostate adenocarcinoma, and adenocarcinoma of pylorus.

At the time of the data cutoff, 42 patients were evaluable for response. Patients not evaluable for efficacy included two patients with less than 12 weeks of follow-up, three patients with IgM < 500mg/dl at baseline, and one patient with inaccurate baseline IgM due to cryoprotein. At a median follow-up of 12.3 months (4.4–30.5 months), the ORR was 90% (38/42 patients) and the major response rate was 76% (32/42 patients), with VGPRs in 43% (18/42) of patients and partial responses in 33% (14/42) of patients. There were two cases of disease progression.

Investor Call and Webcast Information

BeiGene will host an investor call and webcast to discuss the data presented at 14-ICML and its development program.

Date & Time: Friday, June 16, 2017, 2:00 PM CEST (8:00 AM EDT, 8:00 PM China Standard Time)

Dial-in Numbers: 1-845-675-0437 or 1-866-519-4004 (US), 400-620-8038 or 800-819-0121 (China), +852 30186771 (Hong Kong), or +65 67135090 (International)

Conference ID Number: 33044427

A live webcast and replay will be available on BeiGene’s investor website View Source The dial-in replay will be available approximately two hours after the conference and will be available for two days following the event. It can be accessed by dialing 1-646-254-3697 (US), 400-632-2162 (China), +852 30512780 (Hong Kong), or +61 2 8199 0299 (International).

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK (Bruton’s Tyrosine Kinase). BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays, higher exposure than ibrutinib based on their respective Phase 1 experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.

Moleculin Announces Intent to Expand Annamycin Planned Clinical Trial to Include Sites in Poland

On June 15, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has asked its contract research organization (CRO), Theradex Systems, Inc., to expand its engagement to include clinical sites in Poland for Moleculin’s planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, JUN 15, 2017, View Source [SID1234519558]).

"We have been working on ways to increase our rate of patient accrual once we start our planned clinical trial for Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin, "and we have identified several promising sites in Poland. By expanding our engagement with Theradex, we help ensure tight coordination of clinical activity between the US and Poland."

Mr. Klemp continued: "If our IND is permitted, which must happen for clinical trials to begin, we intend to hit the ground running, and we believe Poland improves that capability. AML patients in Poland have less access to clinical trials than those in the US, which should make it easier for us to recruit relapsed or refractory AML patients who have received a fewer number of prior failed treatments and, as a result, may be less resistant to future treatments, and/or whose general health is less severely compromised. Work is already under way to identify a lead European Principal Investigator and to recruit the most appropriate clinical sites for the expansion."

TG Therapeutics, Inc. Announces Follow-Up Data from the Triple Combination of TG-1101, TGR-1202, and Bendamustine in Patients with DLBCL and FL at the 14th International Conference on Malignant Lymphoma

On June 15, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported updated clinical data from its Phase I/Ib trial of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with TGR-1202 (umbralisib), the Company’s oral, next generation PI3K delta inhibitor, and bendamustine, in patients with Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) (Press release, TG Therapeutics, JUN 15, 2017, View Source [SID1234519555]). Data from this trial was presented today during a poster session at the 14th International Conference on Malignant Lymphoma (ICML).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "Relapsed and refractory DLBCL remains one of the most difficult to treat lymphoid malignancies, with a uniformly poor prognosis, particularly for patients with refractory disease who are not eligible for high-dose chemotherapy or stem-cell transplantation." Mr. Weiss continued, "The data presented today by Dr. Lunning supports our belief that the combination of TG-1101 (ublituximab) and TGR-1202 (umbralisib), our ‘U2 regimen’, with bendamustine is a highly active and well tolerated treatment for patients with aggressive lymphomas. We are excited to be able to rapidly bring this combination forward in the DLBCL arm of our randomized registration-directed UNITY-NHL program and hope to be enrolling patients into this cohort before the end of the summer."

Dr. Matthew Lunning, of the University of Nebraska Medical Center, stated, "I am extremely pleased with the durable responses seen with this novel triplet regimen, especially in patients with aggressive DLBCL who may not have been candidates for more intensive chemotherapy, transplantation, or CAR-T therapy, due to poor performance status or need for urgent therapy, a truly unmet medical need. Many patients had high-risk molecular features and some have obtained sustained responses. In addition to being highly active, the triplet regimen of U2-benda was very well tolerated, with a low incidence of Grade 3 or greater adverse events, particularly those that have been associated with the PI3K-delta class. I look forward to the possibility of testing this regimen earlier in relapsed and refractory DLBCL and am excited to see it advance into registration directed studies."

Highlights from today’s presentation include the following:

Poster Presentation: Combination of TGR-1202, Ublituximab, and Bendamustine is safe and highly active in patients with advanced DLBCL and Follicular Lymphoma (Abstract 277)

This poster presentation includes data from patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) treated with the triple combination of TG-1101 (ublituximab), TGR-1202 (umbralisib) and bendamustine. Thirty-three patients were evaluable for safety of which 24 were evaluable for efficacy (9 patients were note evaluable; 7 were too early to evaluate and 2 patients were off study prior to an efficacy assessment: 1 non-related adverse event (AE) and 1 investigator decision). The triple combination appears well tolerated with no discontinuations for a treatment related AE. No events of pneumonitis and no Grade 3/4 transaminitis were reported. Twenty-one patients (64%) were refractory to prior treatment. Mean time on study was approximately 6 months.

Efficacy highlights from this poster include:

100% (4 of 4) ORR, including a 50% CR rate, observed in patients with relapsed DLBCL
50% (6 of 12) ORR, including a 42% CR rate, observed in patients with refractory DLBCL with durable CR and PR responses observed (PR on-going for > 16+ months)
88% (7 of 8) ORR, including a 50% CR rate, observed in patients with relapsed or refractory FL
PRESENTATION DETAILS:

The above referenced presentation is now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.