Month: June 2017

Almac Discovery and Debiopharm International SA Announce a Licensing Agreement for the Development of a Novel Wee-1 Inhibitor

On June 20, 2017 Almac Discovery (www.almacgroup.com/discovery), a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, and Debiopharm International SA (Debiopharm – www.debiopharm.com), a Switzerland based specialty pharma company, reported a collaboration to pursue the development of Almac Discovery’s Wee-1 kinase inhibitor program (Press release, Debiopharm, JUN 20, 2017, View Source [SID1234525171]).

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Under the terms of the license agreement, Almac Discovery has granted exclusive global rights to its Wee-1 patent families and related subject matter expertise to Debiopharm International SA. Almac Discovery is eligible to receive an upfront payment with further development and commercial milestone payments in addition to receiving royalties from Debiopharm.

The area of DNA damage response and cell cycle regulation has seen notable activity from the pharmaceutical industry recently, including some high profile drug approvals for cell cycle kinase inhibitors. Many cancer treatments such as radiation, antimetabolites, alkylating agents, DNA topoisomerase inhibitors and platinum compounds damage DNA in cells. The cellular response is to arrest the cell cycle temporarily to allow for DNA repair, hence reducing the efficacy of chemotherapy.

The Wee-1 kinase is a key regulator of a number of cell cycle checkpoints and inhibition of Wee1 can force arrested cells through the cell cycle leading to cell death. The Almac Discovery Wee-1 inhibitors exhibit good drug-like properties, high potency, excellent selectivity and demonstrate potent anti-proliferative activity in vitro and in vivo, both as single agents and in combination with genotoxics, in several cancer models.

"We are thrilled to pursue the outstanding work of Almac Discovery on this promising target." said Dr. Bertrand Ducrey, CEO of Debiopharm International SA, who added "Almac Discovery’s compelling expertise in medicinal chemistry and drug discovery is very complementary with Debiopharm business model and we look forward to developing these compounds to offer an innovative treatment for patients with high medical need."

Dr Stephen Barr, Managing Director & President, Almac Discovery commented "We are extremely pleased to announce this agreement with Debiopharm who have proven expertise and an impressive track record of developing drug candidates. The professionalism, dedication and commitment of their team is aligned perfectly with our own core values making them the number one choice to develop our Wee-1 inhibitor. Agreements of this nature enable both companies to continue to strive to improve human health worldwide and we look forward to working with them."

Merck Ventures Creates New Immuno-Oncology Company iOnctura

On June 20, 2017 Merck, a leading science and technology company, reported its corporate venture arm Merck Ventures created iOnctura SA, Geneva, Switzerland. This immuno-oncology spin-out company was formed around two assets from the Healthcare R&D portfolio of Merck and three assets from Cancer Research Technology (CRT) (Press release, Cancer Research Technology, 20 20, 2017, View Source [SID1234523165]). CRT is the commercial arm of Cancer Research UK, London, UK. Merck Ventures will manage the investment and will be represented on iOnctura’s board of directors.

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"Our goal is to modulate key culprits of immunosuppression in the tumor microenvironment to maximize the therapeutic potential of checkpoint inhibitors for patients," said Catherine Pickering, CEO and co-founder of iOnctura. "Through our key alliances with CRT and Merck, we are optimally positioned to explore novel combination therapies and advance them quickly to cancer patients."

iOnctura aims to develop a pipeline of selected assets that target and modulate mechanisms that drive immunosuppression in the tumor microenvironment (TME). Such immunosuppression has been shown to be one of the main causes behind a significant number of patients not responding to first generation checkpoint inhibitors. iOnctura, through its alliances with Merck and CRT, has already built a pipeline of promising programs and entered a research collaboration with CRT Discovery Laboratories. In exchange for the exclusive global option to license three immuno-oncology assets from CRT, iOnctura will provide CRT with an initial equity holding in the company and will make further payments for the achievement of late development and approval milestones as well as royalties on net sales. iOnctura has also secured access to future supply of avelumab, being co-developed and co-commercialized by Merck and Pfizer, which will enable acceleration into initial clinical proof of concept studies.

Stuart Farrow, CRT’s director of biology, said: "We’re delighted that these three potential new cancer treatments, partly developed by our drug discovery laboratories alongside leading Cancer Research UK-funded scientists, have been prioritized for further development through the formation of this new company. The ongoing support by our drug discovery laboratories will hopefully help build a strong development pipeline for iOnctura."

Merck Ventures, the strategic venture investment arm of Merck, is providing the initial seed funding to iOnctura. Hakan Goker, Senior Investment Director at Merck Ventures, and Keno Gutierrez will represent Merck Ventures on iOnctura’s board of directors.

Merck Ventures Creates New Immuno-Oncology Company iOnctura

On June 20, 2017 Merck, a leading science and technology company, reported its corporate venture arm Merck Ventures created iOnctura SA, Geneva, Switzerland (Press release, iOnctura, JUN 20, 2017, View Source [SID1234519625]). This immuno-oncology spin-out company was formed around two assets from the Healthcare R&D portfolio of Merck and three assets from Cancer Research Technology (CRT). CRT is the commercial arm of Cancer Research UK, London, UK. Merck Ventures will manage the investment and will be represented on iOnctura’s board of directors.

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"Our goal is to modulate key culprits of immunosuppression in the tumor microenvironment to maximize the therapeutic potential of checkpoint inhibitors for patients," said Catherine Pickering, CEO and co-founder of iOnctura. "Through our key alliances with CRT and Merck, we are optimally positioned to explore novel combination therapies and advance them quickly to cancer patients."

iOnctura aims to develop a pipeline of selected assets that target and modulate mechanisms that drive immunosuppression in the tumor microenvironment (TME). Such immunosuppression has been shown to be one of the main causes behind a significant number of patients not responding to first generation checkpoint inhibitors. iOnctura, through its alliances with Merck and CRT, has already built a pipeline of promising programs and entered a research collaboration with CRT Discovery Laboratories. In exchange for the exclusive global option to license three immuno-oncology assets from CRT, iOnctura will provide CRT with an initial equity holding in the company and will make further payments for the achievement of late development and approval milestones as well as royalties on net sales. iOnctura has also secured access to future supply of avelumab, being co-developed and co-commercialized by Merck and Pfizer, which will enable acceleration into initial clinical proof of concept studies.

Stuart Farrow, CRT’s director of biology, said: "We’re delighted that these three potential new cancer treatments, partly developed by our drug discovery laboratories alongside leading Cancer Research UK-funded scientists, have been prioritized for further development through the formation of this new company. The ongoing support by our drug discovery laboratories will hopefully help build a strong development pipeline for iOnctura."

Merck Ventures, the strategic venture investment arm of Merck, is providing the initial seed funding to iOnctura. Hakan Goker, Senior Investment Director at Merck Ventures, and Keno Guttierrez will represent Merck Ventures on iOnctura’s board of directors.

Celyad reports promising early results at first dose level of the solid arm of the THINK trial

On June 19, 2017 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered CAR-T cell therapies, reported promising early clinical results at the 3-month follow-up of the first dose-level in the solid tumor arm of the THINK trial (THerapeutic Immunotherapy with CAR-T NKR-2) (Press release, Celyad, JUN 20, 2017, View Source [SID1234519620]).

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At the first 3 x 108 cell dose-level administered to a total of three patients with metastatic cancer, the two colorectal cancer (mCRC) patients, who were progressing after at least two prior chemotherapy regimens, achieved a confirmed Stable Disease (SD) according to RECIST criteria at three months. According to recent studies conducted on similar patient populations, median progression free survival in these patients under standard of care is between 1.9 and 3.2 months. The third patient, a refractory pancreatic patient, was in progression at the same time point. No toxicity signals were observed in any of the patients.

Christian Homsy, CEO of Celyad comments: "We are pleased to have observed these encouraging preliminary results in such a late stage population. Despite being dosed only at a tenth of the expected efficacious dose based on animal experiments, the results show a stabilization of the disease. We look forward to the next stages of the trial."

Dr. Frédéric Lehmann, Vice President Clinical Development and Medical Affairs at Celyad adds: "These early results in the two heavily pre-treated mCRC patients are encouraging, considering the dismal clinical outcome of the existing standard of care for this refractory patient population. Based on these preliminary results, we look forward to progressing our clinical development plan, including higher doses and longer follow-up in the THINK study, as well at starting the SHRINK (CAR-T NKR-2 cells in combination with chemotherapy) and LINK (loco-regional administration) clinical trials shortly."

Patients in the second dose of the solid tumor arm (1 x 109) are currently being enrolled and treated. CAR-T NKR-2 cells have so far showed a safety profile that could allow an outpatient clinical approach.

The hematological cancer dose escalation arm, including relapsing/refractory Acute Myeloid Leukemia (AML) and Multiple Myeloma (MM) patients, is progressing. The first dose patients have been registered and are being treated with no toxicity signals to date.

The THINK trial, conducted in the US and in Europe, includes two stages: a dose escalation and an extension stage.
The dose escalation is being conducted in parallel in solid cancers (colorectal, pancreatic, ovarian, triple negative breast and bladder) and in hematologic (AML and MM) cancer groups, while the extension phase will evaluate in parallel each tumor type independently. The dose escalation design includes three dose levels adjusted to body weight: up to 3×108, 1×109 and 3×109 NKR-2 CAR T-cells. At each dose, the patients receive three successive administrations, two weeks apart, of NKR-2 CAR T-cells at the specified dose.

NKR-2 CAR T-cell therapy was designed to act as a targeted therapy with short term persistence and multiple injections in order to provide a better controlled and more predictable safety profile. The primary objective is to avoid uncontrolled in vivo cell expansion and long-term persistence thereby replacing this paradigm with well controlled pharmacokinetics.

Cell and Gene Therapy Catapult Announces Cell Medica Acquisition of WT1 T-cell Therapy

On June 20, 2017 The Cell and Gene Therapy Catapult (CGT Catapult) reported the sale of its subsidiary, Catapult Therapy TCR Ltd, to Cell Medica (Press release, UCLB, JUN 20, 2017, View Source [SID1234519619]). The CGT Catapult, through Catapult Therapy TCR Ltd, has been developing and conducting phase I/II clinical trials of a gene-modified T cell therapy that actively targets several blood cancers and multiple solid tumours. Financial terms were not disclosed.

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Catapult Therapy TCR Ltd is a joint venture company set up by the CGT Catapult, UCL Business (UCLB) and Imperial Innovations which focused on the development of a gene-modified WT1 TCR T cell therapy for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) that are known to overexpress the antigen WT1. It represents a promising novel treatment approach in a therapeutic area where prognosis is often poor and therapeutic options limited. Early development work on this therapy conducted at UCL and Imperial was funded by the UK charity Bloodwise. The WT1 antigen is also present on a large variety of solid tumours, giving this treatment very broad therapeutic potential.

The acquisition of Catapult Therapy TCR Ltd by Cell Medica will enable and accelerate the further development and commercialisation of this innovative treatment in one of the most promising areas of cancer immunotherapy. The optimisation and development of next-generation T cells will be conducted by Cell Medica and CGT Catapult and manufacturing will take place at CGT Catapult’s large-scale cell and gene therapy manufacturing centre located at the Stevenage BioScience Catalyst in Hertfordshire, following a grant awarded earlier this year by Innovate UK.

"We are pleased that Cell Medica has acquired the WT1 T-cell immunotherapy," said Keith Thompson, Chief Executive Officer, Cell and Gene Therapy Catapult. "With their complementary technologies, they will take over the development of this exciting new therapy. The next generation product developed in our manufacturing centre underlines our ability to support the localisation of cell manufacturing processes in the UK. It reflects the CGT Catapult’s mission to work with academia and industry in bringing forward important new technologies that can be industrialised and turned into the advanced medicines of the future, building new industries."

"Immuno-oncology is an expanding discipline representing the next generation of cancer treatments, and WT1 has shown excellent results so far. We are delighted to have created this opportunity with our academic partners UCLB and Imperial Innovations."

Gregg Sando, Chief Executive Officer, Cell Medica, said: "The acquisition of the WT1-TCR cell therapy leverages the investment we made in 2016 for exclusive rights to the Dominant TCR technology. Our objective is to show how we can enhance any existing TCR cell therapy with the Dominant TCR technology to create a more effective treatment for patients with solid tumours who otherwise have a very poor prognosis. We are also looking forward to an important collaboration with CGT Catapult to initiate manufacturing at the Stevenage GMP facility where we will work together on scale-up strategies for commercial production."

Catapult Therapy TCR Ltd academic partners highlighted the relevance of T-cell immunotherapy to future cancer therapy options.

"Gene-modified T cells targeting WT1 have enormous potential to transform the lives of cancer patients, and the expertise of UCL Professors Hans Stauss and Emma Morris have enabled this innovative treatment to evolve," said Cengiz Tarhan, Managing Director, UCL Business. "Cell Medica is excellently placed to further develop this novel treatment approach."

Tony Hickson, Managing Director, Imperial Innovations Limited, said: "This project provides a case study of two leading UK universities working together alongside a Catapult to translate their high quality research outputs into clinical stage advanced therapeutics."