Author: [email protected]

(Press release, Apotex, OCT 13, 2014, View Source [SID:1234504499])

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Dynavax Initiates Phase 1/2 Study of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma

On October 13, 2014 Dynavax Technologies reported the initiation of a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor ("TLR") 9 agonist, in adults with untreated low-grade B-cell lymphoma (Press release Dynavax Technologies, OCT 13, 2014, View Source [SID:1234500825]). In this multicenter study (known as LYM-01), SD-101 is administered intratumorally in combination with localized low-dose radiation. The open-label, dose escalation and expansion design of LYM-01 is intended to accelerate dose optimization while simultaneously assessing the safety, tolerability and initial local and distant antitumor activity of SD-101.

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"Beginning LYM-01 is an important milestone in the maturation of Dynavax’s TLR-based cancer immunotherapy research and development efforts" said Eddie Gray, Dynavax CEO. "This study will provide a range of data that will be integral to our strategy for evaluating SD-101 both alone and in combination with other immuno-oncology agents, such as checkpoint inhibitors."

LYM-01 Study Design

LYM-01 is an open-label, single arm, multicenter, dose-escalation and expansion study designed to evaluate the safety and preliminary efficacy of localized low-dose radiation therapy and intratumoral SD-101 injection into a single target lesion. It will include up to 25 patients diagnosed with untreated low-grade B-cell lymphomas who do not require immediate systemic therapy and are appropriate candidates for "watch and wait." Treatment consists of local radiation given over 2 days followed by 5 weekly intratumoral injections of 1, 2, 4, or 8 mg of SD-101. The total duration of patient participation in this study is up to 2 years.

The primary objectives of LYM-01 are:

To assess safety and tolerability of escalating doses of SD-101 administered with low-dose radiation;
To evaluate the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and
To determine the maximum tolerated dose or optimal dose.

A key secondary objective of the study is assessment of the objective response to SD-101 in untreated lesions distant from the lesion in which SD-101 and radiation were administered. All tumor responses are assessed according to the Cheson criteria.

Pfizer Announces FDA Acceptance Of Palbociclib New Drug Application With Priority Review

On October 13, 2014 Pfizer reported that the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA) (Press release Pfizer, OCT 13, 2014, View Source [SID:1234500826]). This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015.

Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer.

"If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the U.S. who are living with metastatic breast cancer," said Garry Nicholson, president, Pfizer Oncology. "We look forward to continuing to work closely with the FDA through the review process."

Pfizer recently announced the initiation of a multi-center, open-label expanded access program (EAP) in the United States for palbociclib. Through the program, palbociclib is available to post-menopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer who are eligible for letrozole therapy and for whom enrolling in other palbociclib clinical trials is not an option. Healthcare professionals and patients can learn more about the palbociclib EAP by visiting www.clinicaltrials.gov (trial number: NCT02142868).

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Bristol-Myers Squibb, Pharmacyclics and Janssen Announce Clinical Collaboration to Evaluate OPDIVO® (nivolumab) and IMBRUVICA®(ibrutinib) in Non-Hodgkin Lymphoma

On October 13, 2014 Bristol-Myers Squibb, Pharmacyclics and Janssen Research & Development reported that they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO (nivolumab) in combination with IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen (Press release Bristol-Myers Squibb, OCT 13, 2014, View Source [SID:1234500823]). The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). Bristol-Myers Squibb has proposed the name OPDIVO (pronounced op-dee-voh), which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab.

OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies.

“Our collaboration to study OPDIVO in combination with IMBRUVICA is an innovative approach to accelerating Bristol-Myers Squibb’s progress in the study of immuno-oncology and hematologic malignancies, gaining further insight into promising areas of drug development and research,” stated Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “We look forward to working with Pharmacyclics and Janssen to evaluate the potential of these two therapies as options for patients with lymphomas.”

“We are excited about the opportunity to understand and evaluate the potential activity of IMBRUVICA and OPDIVO together, and the benefits this combination may offer patients,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “We look forward to working with Bristol-Myers Squibb and Pharmacyclics on this study as we continue to grow the body of knowledge about IMBRUVICA in different settings and patient populations.”

“This collaboration underscores our interest in exploring the use of IMBRUVICA in combination with other therapies to address a variety of histologies in which we believe IMBRUVICA can make a meaningful clinical difference,” said Bob Duggan, Chairman and CEO, Pharmacyclics. “We value our strategic collaboration with Janssen and look forward to extending our relationship to Bristol-Myers Squibb for this project as our companies collectively seek to advance treatment options for patients.”

The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.

Oxford BioMedica announces new process development and manufacturing collaboration which includes LentiVector® licence agreement

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."