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Evotec completes acquisition of Cyprotex PLC

On December 15, 2016 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported the successful closing of the acquisition of 100% shares in Cyprotex PLC ("Cyprotex", AIM: CRX-GB), a specialist pre-clinical contract research organisation in ADME-Tox and DMPK headquartered in the UK (Press release, Evotec, DEC 15, 2016, View Source [SID1234517081]). The proposed acquisition was announced in detail on 26 October 2016.

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Following a scheme of arrangement regulated by the UK takeover code, all shares of Cyprotex have been acquired by and transferred to Evotec AG effective 14 December 2016 and the shares will this morning be cancelled from AIM. Evotec is paying £ 55.7 m (EUR 66.3 m; at an assumed £/EUR exchange rate of 1.19) in cash for the acquisition of all 26.1 million issued and to be issued Cyprotex shares and the funding of company debt mainly in the context of loan notes. The offer of 1.60 £ per Cyprotex share reflects a 9.4% premium to the VWAP of the past 30 trading days at AIM prior to the offer on 26 October 2016. MCF Corporate Finance, led by Ian Henderson, acted as Evotec’s exclusive financial adviser throughout the acquisition process.

Cyprotex, headquartered in the UK, was founded in 1999 and is publicly traded on AIM (CRX). The company currently has 136 employees working from sites at Macclesfield and Alderley Park, both of which are located near Manchester in the UK, and at Watertown, MA, and Kalamazoo, MI, in the USA. Cyprotex will continue to operate and serve its loyal client base in all currently existing segments under its brand name "Cyprotex" whilst employees and capabilities will be integrated into Evotec’s global drug discovery group, thereby leveraging both companies’ extensive partner networks and identifying further commercial synergies.

Dr Mario Polywka, Chief Operating Officer of Evotec, commented: "We are pleased the acquisition has closed and we can now approach the exciting phase of welcoming Cyprotex’ employees and clients to our global drug discovery services platform. The addition of the market’s most industrialised ADME-Tox platform and proven expertise in in vitro ADME screening, mechanistic and high-content toxicology screening and predictive modelling to our offering substantially improves our ability to provide our alliance partners with access to the most comprehensive drug discovery platform. Cyprotex’ proven technology platform and its expert and dedicated employees perfectly augment Evotec’s business strategy and offering."

Dr Werner Lanthaler, Chief Executive Officer of Evotec, added: "The highest quality and completeness of our drug discovery platform is key to improve the efficiency in the process for our partners. With Cyprotex we make here an important next step. We warmly welcome the Cyprotex employees to the Evotec Group and look forward to working with them."

Evotec confirms its liquidity guidance for 2016. The Company expects liquidity to be at a similar level to the prior year, excluding any potential cash outflow for M&A or similar transactions. Based on current estimates, it is expected that the Cyprotex business will add approx. EUR 18-20 m in revenues in 2017 and will be accretive to Evotec’s 2017 EBITDA.

Cancer Research UK AND Bicycle Therapeutics have collaborated to trial new therapy for advanced solid tumours

On December 15, 2016 Cancer Research UK, Cancer Research Technology (CRT), and Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported an agreement to trial a first-in-class drug for cancers of high unmet need (Press release, Cancer Research Technology, 15 15, 2016, View Source [SID1234523174]).

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Cancer Research UK’s Centre for Drug Development (CDD) will sponsor and fund a Phase Ia and Phase Ib clinical trial for a drug called BT1718, a Bicycle Drug Conjugate (BDC) being developed by Bicycle Therapeutics, in patients with advanced solid tumours. BT1718 targets Membrane Type 1 Matrix Metalloproteinase (MT1-MTP) which is highly expressed in many solid tumours, including triple negative breast cancer and non-small cell lung cancer.

Dr. Udai Banaji, Principal Investigator for the Phase I trial, said: "I’m very excited to be involved in the first clinical study of BT1718. Based on the impressive pre-clinical data, I look forward to evaluating the clinical utility of BT1718, the first of a new class of agents that specifically targets tumour cells using a bicyclic peptide linked to an anticancer agent."

The trial will be co-managed by Cancer Research UK and Bicycle Therapeutics. Under the terms of the agreement, Bicycle retains the right to further advance the BT1718 programme, and can license the results of the trial for an undisclosed amount split between cash and equity, success based milestones and royalty payments to Cancer Research UK.

Dr Kevin Lee, chief executive officer of Bicycle Therapeutics, said: "Through this important collaboration we aim to advance BT1718 through Phase I trials, generating a robust dataset to drive the programme forward. We’re excited to have developed this innovative relationship with Cancer Research UK that allows us access to their extensive network of collaborators and world class expertise to fully explore the potential of this new and transformative class of treatment for cancer patients."

Dr Nigel Blackburn, Cancer Research UK’s, director of drug development, said: "Finding new ways to target difficult-to-treat cancers is a crucially important area of research and a priority for Cancer Research UK. Through this collaboration, we hope we can speed up the development of therapies for patients who urgently need new treatment options."

NOXXON PHARMA SIGNS CLINICAL IMMUNO-ONCOLOGY COLLABORATION AGREEMENT WITH MSD TO STUDY NOX-A12 COMBINED WITH KEYTRUDA® (PEMBROLIZUMAB) IN PANCREATIC AND COLORECTAL CANCER

On December 15, 2016 NOXXON Pharma N.V. (Paris:ALNOX) reported the signature of a collaboration agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), under which the two companies will collaborate in a phase 1/2 clinical trial of NOXXON’s anti-CXCL12 agent, NOX-A12, and MSD’s anti-PD-1 inhibitor, Keytruda (pembrolizumab), in patients with metastatic solid tumors that do not usually respond to checkpoint inhibitor monotherapy (Press release, NOXXON, DEC 15, 2016, View Source [SID1234517085]).

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The goal of the two-part, open-label phase 1/2 study is to evaluate pharmacodynamic effects and safety of NOX-A12 as a monotherapy in addition to safety and efficacy of NOX-A12 in combination with Keytruda in patients with metastatic colorectal and pancreatic cancer. A total of twenty patients will be recruited, ten of each cancer type. NOXXON will be the sponsor of the study, which will be conducted in Europe.

The design of the clinical trial was a collaborative effort between NOXXON and MSD. Part 1 of the study, in which patients will receive NOX-A12 monotherapy for up to two weeks, will evaluate immune infiltrate changes within the tumor microenvironment induced by CXCL12 inhibition with NOX-A12 by comparing pre- and post-treatment biopsy specimens as well as the safety and tolerability of NOX-A12 in patients with metastatic (stage IV) colorectal and pancreatic cancer. Part 2 of the study, in which NOX-A12 is to be combined with Keytruda, will assess the safety and tolerability of the combination in addition to the efficacy of treatment.

NOX-A12, which inhibits the key tumor microenvironment chemokine CXCL12, may be a key partner for a wide range of IO (immuno-oncology) agents. NOXXON has generated promising pre-clinical and clinical data, including recent animal data showing synergy with a checkpoint inhibitor, as well as recent phase 2a trials in multiple myeloma and a second hematological cancer that showed a safety profile that supports further development and first signs of efficacy. NOXXON believes that its planned clinical study will position the drug to be combined with multiple classes of IO approaches including those acting on or through T cells and/or NK cells.

Under the collaboration agreement, MSD will provide Keytruda to NOXXON for the conduct of the trial and has approved the trial design. Multiple paths for further development of the combination in pivotal clinical trials are envisioned in this agreement, although the agreement grants no commercial rights to either party for the other party’s compound. Additional details were not disclosed.

Aram Mangasarian, PhD, Chief Executive Officer of NOXXON commented: "This collaboration with MSD allows us to initiate a clinical trial of NOX-A12 in patients with metastatic solid tumors with the advice and support of one of the key players in the immuno-oncology space. We are pleased that MSD shares our interest in the potential of the CXCL12 pathway to modulate the tumor microenvironment to increase the efficacy of checkpoint therapy."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Cellectis Announces Recombinant DNA Advisory Committee’s (RAC) Unanimous Approval of UCART123 Phase 1 Study Protocols in AML and BPDCN

On December 15, 2016 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported the National Institute of Health’s Recombinant DNA Advisory Committee (RAC)’s unanimous approval of two Phase 1 study protocols for Cellectis’ UCART123, the Company’s most advanced, wholly owned TALEN gene edited product candidate in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) (Press release, Cellectis, DEC 15, 2016, View Source [SID1234517084]).

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Cellectis will host a conference call in the next coming days. The details will be communicated shortly.

The RAC hearing was held on December 14, 2016 during a session dedicated to UCART projects and TALEN based gene editing. This was the first time that allogeneic CAR T-cell programs gene edited with TALEN technology were presented during a RAC hearing.

Cellectis expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) by the end of 2016 and, pending FDA clearance, plans to initiate Phase 1 clinical trials in the first half of 2017. These programs will be the first therapeutic applications of a gene edited allogeneic "off-the-shelf" product candidate in the U.S.

UCART123 is a gene edited T-cell product candidate that targets CD123, an antigen that is located on CD123-expressing leukemic cells in AML, as well as in leukemic and other tumoral cells in BPDCN.

AML is a devastating clonal hematopoietic stem cell neoplasm that is characterized by uncontrolled proliferation and accumulation of leukemic blasts in bone marrow, peripheral blood and, occasionally, in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

The clinical research at Weill Cornell will be led by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is primarily a disease of bone marrow and blood cells but also often affects skin and lymph nodes.

The UCART123 clinical program at MD Anderson will be led by Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine and Professor Naveen Pemmaraju, MD, Assistant Professor.

Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production can be industrialized and standardized with defined pharmaceutical release criteria.

About RAC

The Recombinant DNA Advisory Committee (RAC) is a federal advisory committee that provides recommendations to the NIH Director related to basic and clinical research involving recombinant or synthetic nucleic acid molecules. The NIH, through the RAC, reviews the most innovative clinical study protocols involving a gene therapy product.

Aptevo Therapeutics Amends Collaboration Agreement with MorphoSys AG for Novel Immunotherapeutic, MOR209/ES414

On December 15, 2016 Aptevo Therapeutics Inc. (Nasdaq:APVO) a biotechnology company focused on developing novel oncology and hematology therapeutics, reported that it has amended the terms of its collaboration agreement with MorphoSys AG, originally executed in August 2014, for the joint worldwide development and commercialization of MOR209/ES414, a novel bispecific immuno-oncology therapeutic currently being evaluated in a Phase 1 clinical study for the treatment of metastatic castration-resistant prostate cancer (mCRPC.) (Press release, Aptevo Therapeutics, DEC 15, 2016, View Source [SID1234517083]).

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Aptevo and MorphoSys agreed to modify their collaboration agreement to, among other things, adjust the allocation of certain manufacturing and development costs and extend MorphoSys’ convenience termination rights. Under the amendment, the timeframe for a one-time right to terminate the collaboration agreement by MorphoSys has been extended from December 31, 2016 to June 30, 2017, or after review of clinical data from the first 6 patients enrolled and dosed in the MOR209/ES414 Phase I clinical trial. In addition, the companies have agreed that Aptevo will be responsible for 75% of the development costs of the program through June 30, 2017 with MorphoSys responsible for the remaining 25%, after which time the cost-sharing ratio shifts to 49% for Aptevo and 51% for MorphoSys through 2018, and subsequently 36% for Aptevo and 64% for MorphoSys in 2019 and thereafter.

"Bispecific antibodies represent an emerging new class of protein therapeutics that holds promise as an important new immunotherapeutic approach to cancer treatment," commented Marvin L. White, President and Chief Executive Officer of Aptevo. "We are pleased to have the opportunity to collaborate with MorphoSys on the development of MOR209/ES414 and look forward to the results of the ongoing Phase I dose escalation study."