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(Filing, 10-K, Myrexis, SEP 13, 2012, View Source [SID:1234505685])

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Lundbeck Canada Offers New Treatment Option for Relapsed Indolent B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

On September 15, 2012 Lundbeck reported that Treanda is approved in Canada in patients with symptomatic chronic lymphocytic leukemia (CLL) who have received no prior treatment and in relapsed indolent B-cell non-Hodgkin lymphoma (iNHL) who did not respond to or progressed during or shortly following treatment with a rituximab regimen (Press release Lundbeck, SEP 13, 2012, View Source [SID:1234500349]).

The SFJ Pharmaceuticals Group announces agreement with Pfizer to co-develop Dacomitnib as first-line treatment for patients with advances non-small cell cancer

On September 7, 2012 the SFJ Pharmaceuticals Group entered into a collaborative development agreement with Pfizer Inc. to conduct a Phase III clinical trial of Pfizer’s investigational pan-HER inhibitor, dacomitinib (PF-00299804) (Press release SFJ Pharmaceuticals, SEP 7, 2012, View Source [SID:1234500284]). The trial, which will be conducted across multiple sites in Asia and Europe, will evaluate dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR).
Under the terms of the agreement, SFJ will provide the funding and clinical development supervision to generate the clinical data necessary to support a registration dossier on dacomitinib for marketing authorization by regulatory authorities for the indication: First-line treatment of patients with locally advanced or metastatic NSCLC with EGFR activating mutations. If approved for this indication, SFJ will be eligible to receive milestone payments and earn-out payments.
This is the second collaborative agreement between SFJ and Pfizer. SFJ previously entered into an agreement with Pfizer to conduct a Phase 3 trial in Asia of Pfizer’s Inlyta (axitinib) for the adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy.

CRT, Astex Pharmaceuticals and The ICR announce Epigenetic Drug Discovery Collaboration

On September 7, 2012 CRT, Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics and The Institute of Cancer Research, London, reported they have initiated a collaboration to discover and develop drug candidates targeting an undisclosed epigenetic target in a blood cancer with high unmet medical need (Press release, Cancer Research Technology, SEP 7, 2012, View Source [SID1234523270]).

The collaboration combines Astex’s world-renowned fragment-based drug discovery platform and epigenetic* drug development experience with the expertise in blood cancer biology at The Institute of Cancer Research (ICR) and proven success in drug discovery at the Cancer Research UK Cancer Therapeutics Unit at the ICR.

Dysregulated epigenetic mechanisms are now understood to underlie a variety of cancer types, and have been successfully targeted by the first generation of epigenetic anticancer drugs**. In some cases, specific epigenetic mutational events can be linked to disease etiology, providing an opportunity to develop highly targeted personalised medicines and associated companion diagnostics that will ultimately improve survival and reduce side effects.

"We are delighted to be entering into this new collaboration with the ICR and CRT on a key epigenetics target," said Harren Jhoti, PhD, president of Astex Pharmaceuticals. "This new partnership builds on the highly successful collaboration which Astex entered into with the ICR and CRT in 2003 on another cancer target, PKB/Akt. That collaboration led to the discovery of two clinical candidates, the first of which, AZD5363, was taken into Phase I by our partner AstraZeneca in early 2011 and the second of which, AT13148, is being prepared to be taken into Phase 1 under our development partnership with Cancer Research UK. "

Professor Paul Workman, director of the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research, said: "ICR scientists are pioneers at unravelling blood cancer drug targets, which others have considered challenging to drug effectively. We have a very strong track record of designing drugs to attack challenging biological targets and bringing them into clinical trial, and given Astex’s complementary expertise, we are very excited about the potential of this collaboration."

Dr Phil L’Huillier, director of business management at CRT, said: "Putting in place this collaboration between the Cancer Research UK-funded drug discovery team at the ICR and Astex provides a powerful route to identify drug candidates for this promising new target.

"The deal will ensure that the research programme benefits from the necessary investment to progress the research to its full potential while building on the validation and assay development work that has been carried out at the ICR and funded by Cancer Research UK and others.

"We hope that this research will lead to the development of new drugs to ultimately improve survival for cancer patients."

ImmuNext Enters into a Strategic Partnership with Janssen, a subsidiary of Johnson and Johnson, to Develop Novel Immunotherapies for the Treatment of Cancer

On September 5, 2012 ImmuNext reported that it has entered into an agreement with Janssen Biotech, Inc., focused on the development of novel therapeutics that modulate the immune system for the treatment of cancer (Press release ImmuNext, SEP 5, 2012, http://immunext.com/news.php [SID:1234500867]).

Under the terms of the agreement, ImmuNext will grant Janssen a worldwide, exclusive license to develop and commercialize therapeutics that antagonize the V-region immunoglobulin-containing suppressor of T-cell activation (VISTA) signaling pathway. VISTA is a newly identified negative checkpoint regulator.

Potential payments to ImmuNext under the agreement include an upfront payment, plus payments for reaching certain development and commercial-based milestones, which could total more than $150 million. ImmuNext is also eligible to receive royalties on sales of products and sponsored research support.

ImmuNext and Janssen will engage in a collaborative effort to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway. Janssen will be responsible for clinical development and commercialization of all products under the agreement.

"VISTA is an exciting, novel, negative checkpoint regulator that we anticipate will be a key target for enhancing immunity to solid and liquid cancers," stated Randolph Noelle, Ph.D, ImmuNext’s chief scientific officer.

"We look forward to working with Janssen, a global leader in the field of oncology, to develop innovative immunotherapies to improve the lives of cancer patients," commented David DeLucia, ImmuNext’s chief executive officer.

The ImmuNext technology is based on discoveries made in Dr. Noelle’s labs at the Geisel School of Medicine at Dartmouth and King’s College, London.

ImmuNext was represented by transaction counsel Charles Hoyng, PhD, of Latham Watkins, intellectual property counsel Robin Teskin of Hunton Williams, business development consultant, Chris Krueger and corporate counsel MaryLiz Geffert of McLane, Graf, Raulerson & Middleton.