On October 10, 2014 Oxford BioMedica reported that it has signed further contracts with Novartis which build on the collaboration with Novartis announced in May 2013 (Press release Oxford BioMedica, OCT 10, 2014, View Source [SID:1234500821]).

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Under the terms of the new agreement, Novartis will pay $14 million upfront including a $4.3 million equity subscription for a non-exclusive worldwide development and commercialisation licence in oncology under the Group’s LentiVector platform. OXB will manufacture lentiviral vectors expressing CTL019/CART-019. The manufacturing contract has an initial three year term. Additionally, OXB has granted Novartis an exclusive licence for the worldwide development and commercialisation of all Chimeric Antigen Receptor (CAR) T cell products arising from the process development collaboration.

According to the terms of the deal, OXB is eligible to receive up to $90 million from Novartis over the next three years. This amount includes the upfront licence payment, the equity investment, manufacturing and process development services and various performance incentives. The equity investment comprises 70,807,500 ordinary shares at 3.8p, the average middle market price for the 10 business days prior to 7 October 2014. OXB will also receive undisclosed royalties on potential future sales of CTL019 and other CAR T cell products covered by the agreement.

Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said:

"We are delighted to sign a second agreement with Novartis. Oxford BioMedica now has a breadth of leading capabilities in gene and cell therapy under-pinned by a dominant LentiVector patent estate (licensed to multiple companies), and a state-of-the-art GMP manufacturing facility. Today’s commitment from Novartis, including their equity investment, strongly endorses this. Our team has demonstrated its ability to solve complex gene and cell therapy manufacturing challenges, and to develop the state-of-the-art analytics essential for such programmes.

"Oxford BioMedica aims to help facilitate access to life changing treatments for many more patients with a variety of clinical indications and is now strongly positioned to deliver significant value-creating results against its strong asset base."

On October 9, 2014 Takeda reported that the U.S. Food and Drug Administration (FDA) has approved VELCADE (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL) (Press release Takeda, OCT 9, 2014, View Source [SID:1234500832]). VELCADE is the first treatment in the United States to be approved for use in previously untreated patients with MCL. This approval extends the utility of VELCADE beyond relapsed or refractory mantle cell lymphoma, for which it has been approved since 2006.

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"Mantle cell lymphoma is a subtype of non-Hodgkin lymphoma that is usually a clinically aggressive malignancy, and it is a challenging disease to treat in part due to a relatively high risk of relapse," said Andrew Evens, DO, MSc, Director, Tufts Cancer Center; Chief, Division of Hematology/Oncology; Director, Lymphoma Program. "There are several new targeted drugs approved by the FDA for patients with relapsed or refractory disease, but up to this point, there had been none approved for the treatment of patients with previously untreated disease. VELCADE, when used in the VcR-CAP regimen, VELCADE, rituximab, cyclophosphamide, doxorubicin and prednisone, has demonstrated improved outcomes for patients, making it an important advance for the treatment of newly-diagnosed patients with mantle cell lymphoma."

This approval is based on the results of an international, randomized, head-to-head Phase 3 study that showed that previously untreated patients receiving a VELCADE-containing combination (VcR-CAP) experienced a 59 percent relative improvement in the study’s primary endpoint of progression-free survival (PFS) compared to those who were administered the standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) regimen (median 25 vs. 14 months; Hazard Ratio [HR] 0.63; P < 0.001) at a median follow up of 40 months. An Independent Review Committee (IRC) assessed the primary efficacy endpoint of PFS. The complete response (CR) rate for patients receiving VcR-CAP vs. R-CHOP was 44 percent vs. 34 percent.

"We are delighted VELCADE has received approval in previously untreated mantle cell lymphoma. The VELCADE-combination delivered an 11-month median advantage in progression-free survival as compared to a current standard of care," said Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Clinical Research, Takeda Pharmaceuticals International Co. "Since 2006, VELCADE has proven to be an important therapy for the treatment of relapsed or refractory mantle cell lymphoma, and it can now be used as an initial treatment for all patients with mantle cell lymphoma."

The open-label, multicenter, prospective study evaluated the efficacy and safety of VcR-CAP vs. R-CHOP in 487 patients with previously untreated MCL who were ineligible or not considered for a bone marrow transplant. VELCADE (1.3 mg/m2) is administered intravenously in combination with intravenous rituximab, cyclophosphamide, doxorubicin and oral prednisone (VcR-CAP) for six 3-week treatment cycles. VELCADE is administered first followed by rituximab. VELCADE is administered twice weekly for two weeks (days 1, 4, 8 and 11) followed by a 10‑day rest period on days 12‑21. For patients with a response first documented at cycle 6, two additional VcR-CAP cycles are recommended. At least 72 hours should elapse between consecutive doses of VELCADE.

The most common adverse reactions occurring in ≥20 percent of patients receiving the VcR-CAP regimen were neutropenia, leukopenia, anemia, thrombocytopenia, lymphopenia, peripheral neuropathy, pyrexia, nausea and diarrhea. Infections were reported for 31 percent of patients in the VcR-CAP arm and 23 percent of the patients in the R-CHOP arm including pneumonia (8 percent versus 5 percent). Adverse reactions leading to discontinuation occurred in 8 percent of patients in the VcR-CAP arm and 6 percent of patients in the R-CHOP arm. In the VcR-CAP group, the most commonly reported adverse reaction leading to discontinuation was peripheral sensory neuropathy (1 percent; 3 patients).

On October 9, 2014 Cyclacel Pharmaceuticals reported that the independent Data and Safety Monitoring Board (DSMB) for the Company’s Phase 3 SEAMLESS study in acute myeloid leukemia (AML) has completed its fourth planned safety review and recommended that the study should continue as planned without any modifications (Press release Cyclacel, OCT 9, 2014, View Source [SID:1234500809]). The DSMB reviewed available data from 317 randomized patients with at least 60 days of follow-up and noted that no safety or efficacy concerns were identified.

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"This is the fourth consecutive review for which the DSMB recommended that the SEAMLESS study should continue as planned," said Judy H. Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are encouraged by the DSMB’s recommendation based on their review of available data from US and European sites participating in SEAMLESS. We now have over 100 US and European sites open and expect completion of enrollment to occur in the next few months. In addition to SEAMLESS, we are conducting feasibility assessment of our Phase 2b randomized study of sapacitabine in older patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents."

SEAMLESS is a Phase 3, randomized, registration-directed study of oral sapacitabine capsules in elderly (70 years or older) patients with AML who are unfit for or have refused intensive chemotherapy. The primary endpoint is overall survival. SEAMLESS is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The DSMB will perform an interim analysis for futility once half of the required events have been observed.

(Press release, Intensity Therapeutics, OCT 9, 2014, View Source [SID:1234503398])

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On October 9, 2014 Vernalis plc reported that it has licensed worldwide rights in vipadenant (V2006), a small molecule A2A receptor antagonist, to RedoxTherapies Inc (Redox) (Press release, Vernalis, OCT 9, 2014, View Source [SID:1234513891]). Vipadenant has the potential to disrupt an immunosuppressive mechanism of tumor protection, generating improved efficacy for immunotherapies of certain cancers when used in combination.

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Redox is a private, Boston-based start-up company that is the exclusive licensee of National Institute of Health (USA) intellectual property in the field of using extracellular adenosine receptor inhibitors in combination with immuno-oncology therapies.

The detailed financial terms of the Licence Agreement with Redox are not disclosed, but Vernalis can earn milestones and royalties on successful clinical, regulatory and commercial advancement.

Commenting on the new relationship, Ian Garland, CEO of Vernalis said "We look forward to having Redox as a partner and to the progress of vipadenant into clinical studies in this exciting new setting for the potential benefit of cancer patients worldwide".