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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;year=2015 [SID:1234507781]).

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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.

Palobiofarma signs licensing agreement to develop novel adenosine-based immuno-oncology treatments

On October 21, 2015 Palobiofarma reported that they have entered into a licensing agreement with Novartis (Press release, Palobiofarma, OCT 21, 2015, View Source [SID:1234507780]). Under the terms of the agreement Novartis will acquire exclusive global rights to develop, manufacture and commercialize Palobiofarma´s adenosine A2A receptor antagonist PBF-509, currently entering Phase I clinical trials in Non-Small Cell Lung Cancer. Additionally, Novartis will get access to several adenosine-related patents from Palobiofarma related to the role of adenosine in immunotherapy. Tumour cells have developed mechanisms to evade the immune system, including through the production of a natural molecule called adenosine. By stimulating A2A receptors, adenosine stops T-cells within the immune system from proliferating and reduces their ability to destroy cancer cells. Blocking A2A receptors can therefore promote the anti-cancer response of T-cells within in the tumour microenvironment. Palobiofarma will receive an upfront payment of $15 million USD and is eligible to receive near-term clinical, development and commercial milestones on successful projects as well up to double-digit tiered royalties on net sales.

Julio Castro, Chief Executive Officer of Palobiofarma, said: "We are delighted to collaborate with Novartis, a strong player in the immuno-oncology field. This agreement represents one of the best agreements ever signed in the history of the Spanish Biotechnology, and we are very proud of it. We have good reasons to believe that the current agreement is just the start of a successful research and development collaboration between the two companies".

Admune Therapeutics to be Acquired by Novartis

On October 21, 2015 Admune Therapeutics reported that it has agreed to the sale of Admune to Novartis (Press release, Admune, OCT 21, 2015, View Source [SID:1234507779]). The focus of the acquisition is Admune’s lead compound, Heterodimeric IL-15 (IL15:IL15Ra), a novel IL-15 agonist that may have broad applications for cancer immunotherapy. Admune will be integrated into Novartis’ rapidly expanding immune-oncology portfolio.
Admune’s IL-15 agonist is currently in phase I clinical trials for metastatic cancers at the National Cancer Institute of the National Institutes of Health. In pre-clinical studies, IL-15 therapies have been shown to activate lymphocyte cells including CD8+ T-cells and Natural Killer (NK) cells that play a critical role in stimulating the body’s immune system.

OPKO Health’s GeneDx business Presenting at National Society of Genetic Counselors Annual Meeting

On October 21, 2015 OPKO Health, Inc. (NYSE:OPK) reported that GeneDx, a business unit of OPKO will be presenting at the National Society of Genetic Counselors (NSGC) 34th Annual Education Conference in Pittsburgh, PA (Press release, Opko Health, OCT 21, 2015, View Source [SID:1234507760]). GeneDx staff and genetic counselors will participate at the conference as individual speakers, poster presenters and exhibitors. GeneDx is also sponsoring a networking reception with partners and colleagues. Details are below:

GeneDx BOOTH: #115

RSVP here for the Annual GeneDx Happy Hour
When: Thursday, October 22, at 8:00pm
Where: Il Tetto Rooftop Bar at Sienna Mercato

GeneDx Lunch Session and Presentation
Diagnostic Testing, Evolving Phenotypes, and Impact on Patient Care: A GeneDx Update on XomeDxXpress and Inherited Cancer Testing

When: Friday, October 23 at 11:45 pm
Where: Allegheny Grand Ballroom, Westin Hotel
Who: Sara Knapke, MS, CGC; Audra Bettinelli, MS, CGC; Stephanie DeWard, MS, CGC

GeneDx Individual Speaker Presentations
Pre‐Conference Symposium ‐ Diagnostic Exome Sequencing as the Standard of Care
When: Wednesday, October 21 at 9:00 am
Where: Room 315/316
Who: Jane Juusola, PhD, FACMG

Concurrent Paper Session (Clinical Care: Pediatrics & Adult Track) ‐ The Clinical Utility of a Multi‐Gene Panel for Neuromuscular Disorders (#1311)
When: Saturday, October 24 at 3:15 pm
Where: Room 315/316
Who: Meg Bradbury, MS, CGC, MSHS

GeneDx Poster Presentations
NOTE: Odd Numbered Posters: Thursday, October 22, 2015 2:00 pm – 3:00 pm
Even Numbered Posters: Friday, October 23, 2015 1:15 pm – 2:15 pm

Poster# 64
Comparing Yields and Referral Criteria for the Lynch/Colorectal High Risk Panel and the Colorectal Cancer Panel
Anna McGill, MS, LCGC

Poster# 78
Yield of Genetic Testing for Hereditary Cancer Among Male Patients
Kristin Theobald, MS, LCGC

Poster# 153
Genetic Testing Strategies for Patients With Epilepsy and Neurodevelopmental Disorders
Amy Decker, MS, CGC

Poster# 154
Mutations in SPATA5 Are Associated With a Novel Autosomal Recessive Disorder of Microcephaly, Intellectual Disability, Seizures and Hearing Loss
Stephanie DeWard, MS, CGC

Poster# 169
Whole Exome Sequencing Identifies the First PANX1 Germline Mutation in an Individual with Intellectual Disability, Hearing Loss, Endocrine Dysfunction and Skeletal Abnormalities
Kara Levine, MS, CGC

Poster# 192
De Novo Pathogenic Variants in DDX3X Are a Novel Cause of Intellectual Disability in Females
Leah Williams, MS, CGC

Poster# 194
Whole Exome Sequencing Identifies POGZ Mutations as a Cause of Neurodevelopmental Disorders and Microcephaly
Nora Alexander, MS, CGC

Poster# 218
Mutations in ARID2 Are Associated with Syndromic Intellectual Disabilities
Rebecca Willaert, MS, CGC

Poster# 268
Compound Heterozygosity of Two MECP2 Deletions with Paternal Inheritance of a Late-Truncating Mutation in a Female With Atypical Rett Syndrome
Dana Stolar, MS, CGC

OXiGENE Announces Initiation of Phase 1b/2 Clinical Trial of OXi4503 in Acute Myeloid Leukemia

On October 21, 2015 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that it has initiated a phase 1b/2 clinical trial (Study OX1222) of its investigational drug OXi4503 for treatment of acute myeloid leukemia (AML) (Press release, OXiGENE, OCT 21, 2015, View Source [SID:1234507758]). OXi4503, which has shown significant activity in preclinical studies of AML, is a novel VDA that is designed to reduce blood flow to tumors and to prevent cancer cells from replicating.

Study OX1222 is a continuation and expansion of a phase 1 single site clinical trial of OXi4503 conducted by the University of Florida (UF) with support from the Leukemia & Lymphoma Society. OXiGENE is expanding upon the UF study to speed collection of additional safety and efficacy data and to obtain clinical data for OXi4503 in combination with cytarabine, which is an approved treatment for AML.

"OXi4503 is a promising new investigational drug for patients with Myelodysplastic Syndromes and Acute Myeloid Leukemia," stated Christopher R. Cogle, M.D., Associate Professor of Medicine, University of Florida, and the principal investigator of the study. "Blood vessels are hiding spots for these diseases. OXi4503 is a first-in-class drug that rouses sleeping leukemia cells from vascular beds and primes leukemia cells to cytarabine chemotherapy."

The American Cancer Society estimates that there are approximately 21,000 patients diagnosed with AML each year.

About Study OX1222

Study OX1222 is currently enrolling patients with relapsed or refractory AML or with Myelodysplastic Syndromes (MDS), and will study the safety and efficacy of OXi4503 administered weekly. The study is designed to enroll up to 27 patients in phase 1b and up to 78 patients in phase 2 stage. The objectives of the study are to determine the maximum tolerated dose of OXi4503 both as a single agent and as part of combination therapy with intermediate-dose cytarabine chemotherapy, and to collect efficacy data as determined by the overall response rate. Data from both the open-label monotherapy and combination stages of the study are expected in 2016.