On January 20, 2016) Immunocore Limited, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, viral infections and autoimmune disease, reported that it has started a Phase Ib/II combination trial for the treatment of metastatic cutaneous melanoma (Press release, Immunocore, JAN 20, 2016, View Source [SID1234518905]).

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 trial will evaluate IMCgp100, Immunocore’s lead ImmTAC (Immune Mobilising Monoclonal T-Cell Receptor Against Cancer), in combination with durvalumab and tremelimumab, the investigational immunotherapies of MedImmune, the global biologics research and development arm of AstraZeneca. The open label, four arm, randomized Phase Ib/II trial will explore IMCgp100 paired respectively with durvalumab and tremelimumab as well as investigating all three immunotherapy agents together. The primary goal of the combination trials will be to assess the safety and efficacy of the different combinations. Immunocore is responsible for conducting the trial.

Dr. Christina Coughlin, Chief Medical Officer of Immunocore commented: "This collaboration with MedImmune offers an excellent opportunity to explore how IMCgp100, together with durvalumab and tremelimumab respectively, could form the backbone of a set of best-in-class combinations for the treatment of patients with metastatic melanoma."
The companies announced the formation of this combination partnership in April 2015 and also have a pre-existing research collaboration and licensing agreement, announced in January 2014, to develop novel cancer therapies using Immunocore’s ImmTAC technology.

On January 20, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported that data from the Phase 2 Spruce trial evaluating the combination of apatorsen with carboplatin and pemetrexed in patients with untreated metastatic non-small cell lung cancer (NSCLC) did not reach the statistical significance required to demonstrate a progression-free survival (PFS) benefit (Filing, 8-K, OncoGenex Pharmaceuticals, JAN 20, 2016, View Source [SID:1234508826]).

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!

A potential PFS benefit was observed in patients with high baseline serum Hsp27 status when treated with apatorsen. The study is ongoing and overall survival results are expected in the second half of 2016.

Treatment and maintenance therapy with apatorsen was well tolerated. Adverse events were comparable between the arms and as expected for the study chemotherapy treatment.

"We look forward to following the Spruce study through overall survival this year to determine if apatorsen can provide a treatment benefit for this population of lung cancer patients," said principal investigator David Spigel, director, lung cancer research program and chief scientific officer for Sarah Cannon Research Institute. "Despite recent advances including exciting immunotherapies, patients with lung cancer still have a significant need for new treatment options that extend survival. Chemotherapy remains a standard of care and an important option for people with advanced disease."

Spruce is a placebo-controlled, double-blind, randomized trial sponsored and conducted by Sarah Cannon Research Institute. Approximately 155 patients with non-squamous NSCLC received either apatorsen plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy in the Spruce trial. In addition to PFS and OS, other analyses are being conducted to evaluate tumor response rates, safety, tolerability, and the effect of therapy on Hsp27 levels. Detailed results will be presented at an upcoming medical meeting.

"PFS can provide an early signal of activity in lung cancer trials, yet overall survival continues to be the benchmark for determining both clinical and regulatory significance," said Scott Cormack, President and CEO of OncoGenex. "Overall survival results from Spruce expected later this year will inform the future development of apatorsen in lung cancer. We plan to continue to evaluate a potential correlation between Hsp27 and survival benefit in this and other apatorsen trials."
Lung cancer is the most common cancer worldwide, with approximately 1.8 million new cases per year. It is the leading cause of cancer death among both men and women in the U.S., with approximately 160,000 Americans expected to die from the disease in 2016. Non-squamous histology NSCLC includes adenocarcinoma and large cell carcinoma and accounts for more than half of all diagnoses.

About Apatorsen and ORCA

Apatorsen (OGX-427) is designed to inhibit production of heat shock protein 27 (Hsp27), disable cancer cells’ defenses and overcome treatment resistance. Hsp27 is an intracellular protein that protects cancer cells by helping them survive, leading to resistance and more aggressive cancer phenotypes. Both the potential single-agent activity and synergistic activity of apatorsen with cancer treatments may increase the overall benefit of existing therapies and augment the durability of treatment outcomes, which could lead to increased patient survival.

The ORCA (Ongoing Studies Evaluating Treatment Resistance in Cancer) program encompasses clinical trials of apatorsen. Phase 2 clinical trials are underway in bladder, lung and prostate cancers. For more information on apatorsen and ORCA, please visit www.OncoGenex.com.

On January 20, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY)reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to venetoclax in combination with MabThera/Rituxan (rituximab) for the treatment of people with relapsed or refractory chronic lymphocytic leukaemia (CLL) (Press release, Hoffmann-La Roche , JAN 20, 2016, View Source [SID:1234508820]). Venetoclax is an investigational medicine being developed in partnership with AbbVie.

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 designation was based on results from the M13-365 study, which were presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2015 (abstract #830). Venetoclax was previously granted breakthrough therapy designation by the FDA in April 2015 for the treatment of people with previously treated (relapsed or refractory) CLL with 17p deletion.

Breakthrough therapy designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The combination of venetoclax and MabThera/Rituxan for the treatment of people with relapsed or refractory CLL is being further evaluated in the ongoing MURANO (GO28667) study.

About Venetoclax (RG7601, GDC-0199/ABT-199)
Venetoclax is an investigational small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signalling system that tells cancer cells to self-destruct. The BCL-2 protein is linked to the development of resistance in certain blood cancers and is expressed in chronic lymphocytic leukaemia (CLL) and non-Hodgkin’s lymphoma (NHL). In collaboration with AbbVie, venetoclax is being evaluated in a robust development program as a single agent or in combination with other medicines. There are ongoing Phase II and III studies for venetoclax in CLL, and Phase I and II studies are also ongoing in several other blood cancers, including indolent NHL, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukaemia (AML) and multiple myeloma (MM).

About Roche in haematology
For more than 20 years, Roche has been developing medicines that redefine treatment in haematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera/Rituxan (rituximab) and Gazyva/Gazyvaro (obinutuzumab), Roche’s pipeline of investigational haematology medicines includes an anti-PDL1 antibody (atezolizumab/MPDL3280A), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596), a small molecule antagonist of MDM2 (idasanutlin/RG7388) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (venetoclax/RG7601/GDC-0199/ABT-199). Roche’s dedication to developing novel molecules in haematology expands beyond oncology, with the development of the investigational haemophilia A treatment emicizumab (ACE910).