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Novartis broadens immuno-oncology pipeline with acquisition of Admune Therapeutics and licensing agreements with XOMA and Palobiofarma

On October 21, 2015 Novartis reported that it is broadening its portfolio of cancer immunotherapies with the acquisition of Admune Therapeutics and licensing agreements with Palobiofarma and XOMA Corporation (Press release, Novartis, OCT 21, 2015, View Source [SID:1234507745]).

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With four candidates currently in clinical trials and five more agents expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body’s immune system to combat cancers that includes novel checkpoint inhibitors, chimeric antigen receptor T-cell (CART) technology, myeloid cell targeting agents, and STING agonists. Currently Novartis’ myeloid cell targeting program (MCS-110) and checkpoint inhibitors targeting PD-1 (PDR001), LAG-3 (LAG525), are in phase 1 clinical trials. The CART program (CTL019) is in phase 2 clinical trials. The anti-TIM-3 program (MGB453) is expected to enter the clinic by the end of 2015 and a STING agonist (MIW815), through collaboration with Aduro Biotech, and GITR agonist are progressing toward first-in-human clinical trials in 2016.

The acquisition of Admune adds an IL-15 agonist program currently in phase I clinical trials for metastatic cancer. The licensing agreement with Palobiofarma gives Novartis development and commercialization rights to PBF-509, an adenosine receptor antagonist currently in phase I clinical trials for non-small cell lung cancer. The agreement with XOMA gives Novartis development and commercialization rights to XOMA’s TGF-beta antibody programs. All three programs will be explored as monotherapies and in combination with therapies in Novartis’ immuno-oncology and targeted therapy portfolios.

"The first wave of immuno-oncology therapies has demonstrated the impact this approach can have in treating certain types of tumors, " said Mark Fishman, President of the Novartis Institutes for BioMedical Research. "To realize its full potential requires exploration of the complex system of biological pathways in the tumor microenvironment with agents that can stimulate the immune system to attack a wider variety of tumors."

In pre-clinical studies, IL-15 therapies have been shown to activate CD8+, CD4+ memory T cells and Natural Killer (NK) cells that play a critical role in stimulating the immune system. Adenosine and TGFß both drive immune suppression in the tumor microenvironment, which allows cancer cells to escape immune surveillance, making inhibition of these two pathways an attractive next-generation immuno-oncology approach.

Synta Announces Termination for Futility of Ganetespib Phase 3 GALAXY-2 Trial in Lung Cancer

On October 20, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) treported that the Company has decided to terminate the Phase 3 GALAXY-2 trial of ganetespib and docetaxel in the second-line treatment of patients with advanced non-small cell lung adenocarcinoma (Press release, Synta Pharmaceuticals, OCT 20, 2015, View Source;p=RssLanding&cat=news&id=2098806 [SID:1234507747]). Based on the review of a pre-planned interim analysis, the study’s Independent Data Monitoring Committee (IDMC) concluded that the addition of ganetespib to docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to docetaxel alone. The IDMC noted that the combination of ganetespib and docetaxel was generally well tolerated in the study, with an adverse event profile consistent with previous studies combining these agents.

GALAXY-2 is a Phase 3 global, randomized, multi-center trial. Synta continues to support enrollment in four additional large, randomized, multi-center investigator-sponsored studies, including: the GANNET53 trial of ganetespib and paclitaxel in ovarian cancer; the AML LI-1 trial of ganetespib with low dose cytarabine (Ara-C) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS); the AML18 trial of ganetespib with standard DA (daunorubicin and Ara-C) in AML and high-risk MDS; and the I-SPY 2 TRIAL of ganetespib and standard chemotherapy in women with newly diagnosed, locally advanced breast cancer.

"This disappointing outcome underscores the challenges of treating lung cancer in the second-line setting and determining the precise population for whom ganetespib may be most effective," said Chen Schor, President and Chief Executive Officer of Synta. "We thank the patients, caregivers and investigators who participated in GALAXY-2."

Mr. Schor continued: "Despite the outcome of this trial, and pending discussions with the relevant investigators, we will continue to support ongoing investigator-sponsored studies while we determine the appropriate path forward for ganetespib. We also look forward to advancing candidates from our HDC platform into the clinic. With the significant cash reserves we have in hand, our pipeline, our scientific internal leadership and network of advisors, we expect to undertake a comprehensive review of our strategy going forward."

Upon formal acceptance of the IDMC’s recommendation, Synta will communicate with regulatory authorities, and will notify study investigators that treatment with ganetespib should be discontinued in the GALAXY-2 trial.

Lancet Oncology Commission Calls for Expanding Global Access to Radiotherapy

On October 20, 2015 Varian Medical Systems reported that increasing access to radiotherapy worldwide through greater investment could save millions of lives, according to The Lancet Oncology Commission’s report presented at the 2015 European Cancer Congress in Vienna, Austria, and published in The Lancet Oncology (Press release, InfiMed, OCT 20, 2015, View Source [SID:1234507742]).1 The Commission’s results were presented here yesterday at the 2015 annual meeting of the American Society for Radiation Oncology (ASTRO).

Patient receives a radiotherapy treatment for cancer.
The Commission found that up to 60% of all cancer patients worldwide will need radiotherapy at some point in their treatment, but a lack of investment in radiotherapy services has severely limited access to radiotherapy treatments worldwide, especially in low-income and middle-income countries (LMIC).

LMIC have 80% of the global cancer burden but only 5% of the resources for cancer control, and in low-income countries, 90% of the population lack access to radiotherapy. Even in high income countries the numbers of radiotherapy facilities, equipment, and trained staff are inadequate.

Radiotherapy is important for managing most cancers, such as breast, lung, prostate, head and neck, and cervical cancers, which account for more than two-fifths of cases worldwide. In their report, the Commission details how a persistent underinvestment in radiotherapy globally has diminished access, and describes the substantial health and economic benefits of investing in radiotherapy.

With the number of new cancer cases expected to rise to 24.6 million by 2035, the Commission claims that increasing access to radiotherapy services in LMIC by scaling up radiotherapy capacity from current levels could lead to a saving of 27 million life years by 2035, over the lifetime of patients who receive this treatment.

In addition to saving human lives, providing full access to radiotherapy through investment could reduce the economic burden of cancer worldwide, which was $2 trillion in 2010. By 2035, full access to radiotherapy for all patients in LMIC could be achieved for as little as $97 billion, with economic benefits ranging from $278 billion to $365 billion over the next 20 years.

The Commission called for a long-term commitment to cancer care and treatment through the following actions:

80% of countries should have cancer plans that include radiotherapy by 2020.
By 2025, radiotherapy treatment capacity should be increased by 25% from 2015 capacity.
Each LMIC should have at least once cancer center by 2020.
LMIC should train 7,500 radiation oncologists; 20,000 radiation technologists; and 6,000 medical physicists by 2025.
LMIC should invest $46 billion by 2025 to establish radiotherapy infrastructure and training.
80% of LMIC should include radiotherapy services as part of their universal health coverage by 2020.
"The Lancet Commission has done an impressive job of demonstrating how increasing access to life-saving radiotherapy treatment makes sense not only for the health and well-being of our world community but economically as well," said Dow R. Wilson, president and CEO of Varian Medical Systems. "Congratulations on this important study, which will, we hope, lead to cancer programs that can help save lives around the world."

Nimbus Therapeutics Announces Global License Agreement with Genentech

On October 20, 2015 Nimbus Therapeutics, a biotechnology company focused on harnessing the power of computational chemistry to design breakthroughs for serious, underserved diseases, reported an exclusive worldwide license agreement with Genentech, a member of the Roche Group, to discover and develop small molecule inhibitors of interleukin-1 receptor-associated kinase 4 (IRAK4) (Press release, Nimbus Therapeutics, OCT 20, 2015, View Source [SID1234527306]).

Under the terms of the agreement, Nimbus will receive an undisclosed upfront payment and is eligible to receive milestone payments based on achievement of certain predetermined milestones. In addition, Nimbus is eligible to receive royalties on sales of certain products resulting from the license agreement. Genentech will be responsible for all preclinical and clinical development, manufacturing and commercialization. Financial terms have not been disclosed.

"With its expertise, capabilities and global reach, Genentech is the best partner to rapidly advance these promising candidates to the clinic and, ultimately, bring new treatments to patients," said Don Nicholson, Chief Executive Officer of Nimbus.

"Genentech is dedicated to bringing forth treatments for patients with serious and life-threatening diseases," said James Sabry, Senior Vice President and Global Head of Genentech Partnering. "Nimbus’ unique approach to drug discovery will enhance our research and development programs for immunological disorders."

Oncolytics Biotech® Inc. Announces Phase 1b Study in Advanced Pancreatic Cancer

On October 20, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) reported that, following submission to the U.S. Food and Drug Administration ("FDA") for review, the Investigational New Drug Application containing the protocol titled "A Phase Ib study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN (pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma" is now active (Press release, Oncolytics Biotech, OCT 20, 2015, View Source [SID:1234507741]).

"This is the first study examining the effects of REOLYSIN in combination with a checkpoint inhibitor in human patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "It builds on our previous clinical work in pancreatic cancer as well as findings from multiple clinical and preclinical studies indicating that REOLYSIN can upregulate PD-1 and PD-L1."

The study will enroll patients 18 years or older with histologically confirmed advanced or metastatic pancreatic adenocarcinoma who have failed, or did not tolerate, first line treatment. It is an open-label Phase Ib trial designed to determine the safety and dose-limiting toxicities of REOLYSIN and chemotherapy (gemcitabine or irinotecan or fluorouracil, at the treating physician’s preference) in combination with pembrolizumab. Secondary endpoints include overall response rate and progression free survival by immune-related response criteria; overall survival; and effects of REOLYSIN and pembrolizumab when administered in combination as determined by analysis of pre- and post-treatment treatment biopsies and blood based immune markers. Following an initial six to nine patient safety run-in, up to an additional 15 patients may be enrolled for further evaluation of safety and efficacy.

Oncolytics has previously conducted other clinical studies in pancreatic cancer. Mostly notably, in July 2015, the Company reported final data from a Phase 2 single-arm clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar) in chemotherapy-naïve patients with advanced or metastatic pancreatic cancer (REO 017). The reported data suggested that this drug combination, when compared to gemcitabine alone (as seen in historical data), can increase median overall survival, as well as generate an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates. The Company has received Orphan Drug Designation from the FDA and the European Medicines Agency for the use of REOLYSIN in the treatment of pancreatic cancer.

About Pancreatic Cancer
The American Cancer Society estimates that 48,960 Americans will be diagnosed with pancreatic cancer and an estimated 40,560 Americans will die from the disease in 2015. Approximately 44,539 patients are affected with pancreatic cancer at any time in the United States. The prognosis for patients diagnosed with pancreatic cancer, regardless of stage, is generally poor; the relative five-year survival rate for all stages combined is approximately seven percent.