10-Q – Quarterly report [Sections 13 or 15(d)]

Leap Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Leap Therapeutics, 2017, AUG 11, 2017, View Source [SID1234521978]).

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!

Biotecnol and CRUK to Trial New Immuno-Oncology Treatment for Advanced Solid Tumours

On August 10, 2017 Biotecnol LImited and Cancer Research UK (CRUK), reported that an experimental immuno-oncology treatment will move into early phase clinical trials for patients with advanced solid tumours, including lung cancers, under a collaboration agreement between Cancer Research UK and Biotecnol Limited (Press release, Biotecnol, AUG 10, 2017, View Source [SID1234570282]).

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!

Cancer Research UK will support the early clinical development of the company’s promising first-in-class drug called Tb535H.

The drug is the first to emerge from Biotecnol’s novel antibody development platform, Trisoma. It is directed against the 5T4/WAIF1 tumour antigen, a protein found on many different solid tumours and is thought to contribute to the spread of cancer cells.

Tb535H recruits the patient’s T-cells –killer cells of the immune-system – and directs them to attack tumours. This highly targeted approach uses the patient’s own immune system to fight cancer.

The WAIF1 antigen was discovered by scientists at the Cancer Research UK Manchester Institute. It could be a valuable target in many different cancer types, but the initial focus in this trial will be to treat cancers with high unmet-need.This includes thoracic cancers such as mesothelioma, small-cell lung carcinoma (SCLC) and non-small cell lung cancer (NSCLC), for which survival remains very low, and renal cell carcinoma.

Under the agreement, Biotecnol and Cancer Research UK’s Centre for Drug Development will collaborate to take forward Tb535H through a Biotecnol-sponsored first-in-man Phase I clinical trial, using Cancer Research UK’s drug development expertise in return for shareholdings in Biotecnol.

Pedro de Noronha Pissarra, chief executive officer of Biotecnol said: "We’re very proud to work with Cancer Research UK on the development of advanced clinical trial approaches in this competitive and highly promising field of immuno-oncology.

"The collaboration is important for Biotecnol’s strategy of working with top cancer institutions in the immune-oncology field which will accelerate the development of cutting-edge therapeutic approaches to fight cancer."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "It’s hugely exciting to be able to accelerate the development of a drug that could change outcomes for patients with many different types of cancer.

"In particular we urgently need new ways to improve treatment for lung cancer, which causes more than one in five of all cancer deaths in the UK.

"Without this collaboration it might have been years before this treatment reached patients so we‘re pleased to work with Biotecnol to elevate their novel drug development platform."

TG Therapeutics, Inc. Announces Successful Outcome from the First Pre-Planned Interim Analysis by Independent DSMB of the DLBCL Cohort in the UNITY-NHL Phase 2b Trial

On August 10, 2017 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the independent Data Safety Monitoring Board (DSMB) of the UNITY-NHL Phase 2b registration directed trial has successfully completed the first pre-specified interim analysis to evaluate the Overall Response Rate (ORR) in the cohort enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) that are not eligible for high-dose chemotherapy or transplant (Press release, TG Therapeutics, AUG 10, 2017, View Source [SID1234520157]). Upon review of the available ORR data, based on pre-specified efficacy thresholds of ORR, the DSMB recommended the Company cease enrollment into the single agent TGR-1202 arm, while continuing enrollment into the TG-1101 + TGR-1202 arm which has demonstrated an acceptable level of efficacy to warrant continued evaluation. Per the UNITY-NHL protocol, the single agent TGR-1202 arm will be replaced by an arm evaluating the triple combination arm of TG-1101, TGR-1202, and bendamustine.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "The DLBCL cohort in our UNITY-NHL trial was designed to evaluate the contribution of TGR-1202 in our combination ‘U2’ regimen. We are extremely pleased that the DSMB has recommended continued enrollment in the U2 arm, while allowing us to proceed with replacing the single agent TGR-1202 arm with the triple combination of TG-1101, TGR-1202, and bendamustine (also referred to as U2 + Benda) as planned. As recently presented, the triplet combination of U2 + Benda was highly active, with a 50% ORR in patients with refractory DLBCL and a 100% ORR in relapsed DLBCL patients. We have long believed that patients with aggressive DLBCL in particular are best treated with combination therapy rather than single agents and are pleased to see our UNITY-NHL study advancing to the next level."

ABOUT UNITY-NHL PHASE 2b TRIAL

UNITY-NHL is a global Phase 2bclinical trial evaluating TG-1101 and TGR-1202, ("U2"), in patients with various types of B-cell lymphoma. The trial consists of three independent cohorts enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), and Marginal Zone Lymphoma (MZL). The study is evaluating the U2 combination and the combination of U2 + bendamustine in patients with DLBCL; TGR-1202 monotherapy and in the U2 combination in patients with FL and SLL; and TGR-1202 monotherapy in patients with MZL.

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!


10-Q – Quarterly report [Sections 13 or 15(d)]

AnaptysBio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AnaptysBio, 2018, AUG 10, 2017, View Source [SID1234527557]).

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!

10-Q – Quarterly report [Sections 13 or 15(d)]

Sophiris Bio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Sophiris Bio, AUG 10, 2017, View Source [SID1234520159]).

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!