On January 21, 2015 Curis and Aurigene reported that they have entered into an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets (Press release Curis, JAN 21, 2015, View Source [SID:1234501360]). The collaboration provides for inclusion of multiple programs, with Curis having the option to exclusively license compounds once a development candidate is nominated within each respective program. The partnership draws from each company’s respective areas of expertise, with Aurigene having the responsibility for conducting all discovery and preclinical activities, including IND-enabling studies and providing Phase 1 clinical trial supply, and Curis having responsibility for all clinical development, regulatory and commercialization efforts worldwide, excluding India and Russia, for each program for which it exercises an option to obtain a license.

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The first two programs under the collaboration are an orally-available small molecule antagonist of programmed death ligand-1 (PD-L1) in the immuno-oncology field and an orally-available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) in the precision oncology field. Curis expects to exercise its option to obtain exclusive licenses to both programs and file IND applications for a development candidate from each in 2015.

"We are thrilled to partner with Aurigene in seeking to discover, develop and commercialize small molecule drug candidates generated from Aurigene’s novel technology and we believe that this collaboration represents a true transformation for Curis that positions the company for continued growth in the development and eventual commercialization of cancer drugs," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "The multi-year nature of our collaboration means that the parties have the potential to generate a steady pipeline of novel drug candidates in the coming years. Addressing immune checkpoint pathways is now a well validated strategy to treat human cancers and the ability to target PD-1/PD-L1 and other immune checkpoints with orally available small molecule drugs has the potential to be a distinct and major advancement for patients. Recent studies have also shown that alterations of the MYD88 gene lead to dysregulation of its downstream target IRAK4 in a number of hematologic malignancies, including Waldenström’s Macroglobulinemia and a subset of diffuse large B-cell lymphomas, making IRAK4 an attractive target for the treatment of these cancers. We look forward to advancing these programs into clinical development later this year."

Dr. Fattaey continued, "Aurigene has a long and well-established track record of generating targeted small molecule drug candidates with bio-pharmaceutical collaborators and we have significantly expanded our drug development capabilities as we advance our proprietary drug candidates in currently ongoing clinical studies. We believe that we are well-positioned to advance compounds from this collaboration into clinical development."

CSN Murthy, Chief Executive Officer of Aurigene, said, "We are excited to enter into this exclusive collaboration with Curis under which we intend to discover and develop a number of drug candidates from our chemistry innovations in the most exciting fields of cancer therapy. This unique collaboration is an opportunity for Aurigene to participate in advancing our discoveries into clinical development and beyond, and mutually align interests as provided for in our agreement. Our scientists at Aurigene have established a novel strategy to address immune checkpoint targets using small molecule chemical approaches, and have discovered a number of candidates that modulate these checkpoint pathways, including PD-1/PD-L1. We have established a large panel of preclinical tumor models in immunocompetent mice and can show significant in vivo anti-tumor activity using our small molecule PD-L1 antagonists. We are also in the late stages of selecting a candidate that is a potent and selective inhibitor of the IRAK4 kinase, demonstrating excellent in vivo activity in preclinical tumor models."

In connection with the transaction, Curis has issued to Aurigene approximately 17.1 million shares of its common stock, or 19.9% of its outstanding common stock immediately prior to the transaction, in partial consideration for the rights granted to Curis under the collaboration agreement. The shares issued to Aurigene are subject to a lock-up agreement until January 18, 2017, with a portion of the shares being released from the lock-up in four equal bi-annual installments between now and that date.

The agreement provides that the parties will collaborate exclusively in immuno-oncology for an initial period of approximately two years, with the option for Curis to extend the broad immuno-oncology exclusivity.

In addition Curis has agreed to make payments to Aurigene as follows:

for the first two programs: up to $52.5 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for additional indications, if any;
for the third and fourth programs: up to $50 million per program, including $42.5 million per program for approval and commercial milestones, plus specified approval milestone payments for additional indications, if any; and
for any program thereafter: up to $140.5 million per program, including $87.5 million per program in approval and commercial milestones, plus specified approval milestone payments for additional indications, if any.

Curis has agreed to pay Aurigene royalties on any net sales ranging from high single digits to 10% in territories where it successfully commercializes products and will also share in amounts that it receives from sublicensees depending upon the stage of development of the respective molecule.

For more information, please refer to the Current Report on Form 8-K filed by Curis with the U.S. Securities & Exchange Commission on January 21, 2015.

On January 20, 2015 Celator Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary Acute Myeloid Leukemia (AML) (Press release Celator Pharmaceuticals, JAN 20, 2015, View Source [SID:1234501354]).

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The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designation facilitates meetings with FDA to discuss all aspects of development to support approval. It also provides the opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission. In addition, a Fast Track designated product could be eligible for priority review if supported by clinical data at the time of NDA submission.

"We are pleased that FDA has granted Fast Track status for CPX-351 for the treatment of elderly patients with secondary AML," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Our ongoing Phase 3 study in these patients has completed enrollment, and we expect induction response rate data to be available in the second quarter of this year, and to have overall survival data, the primary endpoint of the study, in the first quarter of 2016. If our Phase 3 study, comparing CPX-351 to the current standard of care, is successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process."

On January 20, 2015 Verastem reported on dosing of the first patient in a new clinical trial evaluating the combination of VS-5584, its dual mTORC1/2 and PI3K inhibitor, in combination with VS-6063, the Company’s lead focal adhesion kinase (FAK) inhibitor, in patients with relapsed mesothelioma (Press release Verastem, JAN 20, 2015, View Source;p=RssLanding&cat=news&id=2008677 [SID:1234501359]).

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The Phase 1 open-label, dose escalation and schedule finding study is designed to assess safety, pharmacokinetics, pharmacodynamics and initial observations of clinical activity. The study is expected to enroll up to 56 patients at clinical sites in the UK and US.

"We are very pleased to initiate the first ever Phase 1 trial combining a dual mTORC1/2 and PI3K inhibitor (VS-5584) with a FAK inhibitor (VS-6063)," said Udai Banerji, MD, PhD, FRCP, Reader in Molecular Cancer Pharmacology and Honorary Consultant in Medical Oncology at The Royal Marsden Hospital and The Institute of Cancer Research London. "This study builds on robust synergy data from pre-clinical mesothelioma models presented by Verastem at the recent iMiG meeting. The trial is enrolling patients with relapsed mesothelioma: a patient population in dire need of new treatment options."

"Mesothelioma is a devastating disease and Verastem is committed to the development of new treatment options," said Dr. Joanna Horobin, Chief Medical Officer of Verastem. "This is the third study we have initiated with VS-6063 in patients with mesothelioma. We are very pleased with the progress of the multinational COMMAND study evaluating VS-6063 as a switch maintenance therapy following frontline chemotherapy in patients with malignant pleural mesothelioma. As reported in October at the 2014 iMIG, we are encouraged by the biomarker response and intriguing tumor shrinkage observed after 12 days of single agent VS-6063 administration in patients with untreated mesothelioma, prior to planned surgery. In this new study of VS-6063 in combination with VS-5584, building on the synergy seen in pre-clinical models, we hope to extend the potential benefit to patients with mesothelioma that has relapsed following initial therapy."

VS-5584 is currently in a Phase 1 study in advanced solid tumors where the compound has been generally well tolerated and preliminary activity has been observed, including in mesothelioma. Some patients have been on study for over 6 months and the maximum tolerated dose of VS-5584 has not been reached.

The combination clinical trial is supported by preclinical work demonstrating the synergistic activity of VS‐6063 and VS‐5584 in mesothelioma models in vitro and in vivo. In this preclinical research, the combination of VS‐6063 and VS‐5584 displayed synergistic reduction in cell viability based on multiple combination analysis models. When tested in vivo for reduction of mesothelioma tumor growth, VS‐6063 and VS‐5584 were each active as single agents and demonstrated synergistic antitumor efficacy when used in combination.

On January 20, 2015 European biotechnology company Valneva SE ("Valneva") and UK company BliNK Therapeutics Ltd ("BliNK Therapeutics") reported the closing of the transaction creating BliNK Biomedical SAS, a private company specialised in the discovery of innovative monoclonal antibodies as announced on December 11th, 2014 (Press release, Cancer Research Technology, JAN 20, 2015, View Source [SID1234523212]).

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The new company is owned by Valneva, Kurma Biofund I (founding investor of BliNK Therapeutics), funds managed by Idinvest Partners, Cancer Research Technology (CRT) and BliNK Therapeutics’ founders.

BliNK Therapeutics’ technology has been developed by Facundo Batista, Head of the Lymphocyte Interaction Laboratory at Cancer Research UK’s London Research Institute.

On January 20, 2015 BioInvent International (OMXS: BINV) reported an agreement with Cancer Research UK, Cancer Research Technology (CRT), the charity’s development and commercialisation arm, and Leukaemia & Lymphoma Research (LLR) to take its investigational drug, BI-1206, into a collaborative phase I/II trial for patients with chronic lymphocytic leukaemia (CLL) and non-Hodgkin lymphoma (NHL) (Press release, Cancer Research Technology, JAN 20, 2015, View Source [SID1234523213]).

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The first in man study will be funded and conducted by Cancer Research UK, CRT and LLR. BioInvent has been granted the option to take up an exclusive license to the study data, subject to payment of milestones and royalties to Cancer Research Technology.

BI-1206 is a fully-human anti-CD32b antagonistic antibody that in addition to directly killing tumour cells is thought to work by maintaining CD20 antibodies on the cell membrane of cancer cells, preventing them from becoming resistant to the current state-of-the-art treatment, rituximab.

The antibody has shown promise both in combination with CD20 antibodies and as a single agent in chronic lymphocytic lymphoma (CLL) and other types of NHL, in an extensive package of preclinical studies carried out by Leukaemia & Lymphoma Research-funded scientists at the University of Southampton. The potential development opportunity for BI-1206 may extend well beyond NHL.

The open label Phase I/ll study will enroll between 50 and 60 patients who will receive either BI-1206 alone or BI-1206 in combination with rituximab. The study will primarily enroll CLL patients but smaller cohorts of patients with other types of NHL, such as mantle cell lymphoma, follicular lymphoma and diffuse large B-cell lymphoma, may also be recruited. The study is expected to commence in the second half of 2015.

Each year in the UK approximately 12,800 people are diagnosed with NHL and 3,200 people are diagnosed with CLL. In Europe and North America around 157,000 people are diagnosed with NHL yearly and approximately 35,000 people are diagnosed with CLL.*

Michael Oredsson, CEO of BioInvent, said: "We are very pleased that Cancer Research UK and Leukaemia & Lymphoma Research have chosen to conduct and fund the BI-1206 Phase I/ll trial. Cancer Research UK is one of the world’s leading cancer research charities with in-house clinical, regulatory and medical capabilities and an established network of clinical cancer centres and leading clinicians in the UK. This agreement provides BioInvent with an ideal resource to execute the first-in-man study for BI-1206 whilst preserving the commercial value in the project."

Professor Chris Bunce, Research Director at Leukaemia & Lymphoma Research, said "Monoclonal antibodies have boosted survival rates for many types of lymphoma and leukaemia in recent years, but patient responses remain varied. BI-1206 has shown great promise in reducing treatment resistance in the laboratory. Leukaemia & Lymphoma Research has funded research into this treatment at the University of Southampton since 2008 and we’re very excited that through this partnership patients could benefit from it soon."

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said "BI-1206 has performed well in preclinical studies making it an ideal candidate for our Clinical Development Partnerships program, which helps industry run trials of potential new cancer treatments that would otherwise never progress beyond the lab. There is a real need for new blood cancer drugs that help boost the effectiveness of conventional chemotherapy drugs, as many patients cannot tolerate or become resistant to these treatments over time. Consequently, we look forward to seeing the results of this trial."

BI-1206 will be developed under Cancer Research UK’s Clinical Development Partnerships (CDP) program, a joint initiative between Cancer Research UK’s Centre For Drug Development (CDD) and CRT, to develop promising anti-cancer agents, which pharmaceutical companies do not have the resources to progress through early phase clinical trials.

It is the first drug to be entered into a new partnership through which Cancer Research UK and Leukaemia & Lymphoma Research will be jointly funding early phase clinical trials for patients with blood cancers.

Cancer Research UK’s CDD will manage and sponsor the study through the Experimental Cancer Medicine Centre (ECMC) network, with Leukaemia & Lymphoma Research providing the majority of the funding.