On January 27, 2016 Cancer Research Technology (CRT) – the development and commercialisation arm of Cancer Research UK – reported to have entered into a license agreement with MSD, known as Merck in the US and Canada, to develop inhibitors of protein arginine methyltransferase 5 (PRMT5) (Press release, Cancer Research Technology, 27 27, 2016, View Source [SID1234523188]). These promising new drugs, which potentially have clinical applications in both cancer and non-cancer blood disorders, have been developed by the Australian Cooperative Research Centre (CRC) for Cancer Therapeutics (CTx) with support from the Wellcome Trust and CRT.​

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CRT has licensed rights to MSD on behalf of CTx – a Melbourne based CRC focused on the discovery and development of novel therapies for cancer. The programme is the result of initial research by Professor Stephen Jane at Monash University and collaboration between the CTx academic partners.

The PRMT5 protein is involved in many cellular processes including the epigenetic control of genes such as p53 – a gene that protects the cell against cancer-causing mutations and is faulty in nine out of ten cancers. High levels of PRMT5 protein are found in mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), melanoma, lung and breast cancers and are linked to poor survival.

In addition to applications for cancer, PRMT5 inhibitors switch on important genes in the development of blood, which could provide disease-modifying treatment options for patients with blood disorders like sickle cell disease and beta thalassemia.

Dr Ian Street, CTx chief scientific officer, said: "We are delighted to be working with CRT and MSD to progress the PRMT5 programme to the clinic. This is why CTx was established, to leverage cutting edge research developed by Australian scientists and ensure that this knowledge is translated for the benefit of patients."

Under the terms of the license, MSD will be responsible for research and development, including clinical development, and for worldwide commercialisation of products. As part of the research and development activities, MSD has entered into a research collaboration with CTx focusing on blood disorders, which MSD will fund.

CRT will receive an upfront payment of US$15 million (around £10.5 million) and is eligible to receive potential payments of up to US$0.5 billion (around £0.35 billion) for achievement of development, regulatory and commercialisation milestones. In addition, the agreement provides for royalties on sales. All payments will be shared between CRT, CTx and the Wellcome Trust with the majority being returned to CTx and its Australian research partners.

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted to have brought together the multiple parties involved in the discovery and optimisation of this multi-purpose target and to have established this major license agreement. The deal provides potentially significant financial returns, which CRT will invest into life-saving cancer research, and most importantly will hopefully bring promising new drugs to cancer patients as well as those suffering from blood disorders where there are no effective treatment options available."

Dr Warwick Tong, CTx chief executive, said: "This is a great result for Australian science and the CRC Programme as a whole and further demonstrates what can be achieved when science and commercialisation capabilities unite."

Dr Richard Seabrook, head of business development at the Wellcome Trust, said: "We’re excited to see that the support from our Seeding Drug Discovery Award is playing a key role in moving the project forward. We hope that in time the collaboration will lead to the development of effective new treatments for haemoglobin disorders such as sickle cell and beta thalassemia, both of which are associated with significant illness and early mortality."

On January 27, 2016 BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS, reported that the iNSITE 1 trial in non-small cell lung cancer (NSCLC) with squamous histology is fully enrolled and data is expected to be available by the end of the first quarter of 2016 (Press release, BIND Therapeutics, JAN 27, 2016, View Source [SID:1234508870]). In addition, the Company reported that the iNSITE 2 trial in patients with advanced cervical cancer and head and neck cancer has completed enrollment of at least 20 patients in each cohort in the first stage of the trial. A decision is expected on whether to advance to the second stage of the study for head and neck cancer by the end of the first quarter of 2016 and early in the second quarter of 2016 for the cervical cancer cohort. Lastly, the Company announced that enrollment is being discontinued in the cholangiocarcinoma and bladder cancer cohorts in the iNSITE 2 trial due to slower than anticipated enrollment.

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Additional information on the iNSITE 1 and iNSITE 2 studies can be found at: View Source

On January 26, 2016 Inivata Limited, a clinical cancer genomics company employing the precision of circulating tumour DNA ("ctDNA") analysis to improve personalized healthcare in oncology, reported the completion of a Series A fundraising of £31.5 Million ($45M) (Press release, Cancer Research Technology, JAN 26, 2016, View Source [SID1234523507]). Existing investors Imperial Innovations, Cambridge Innovation Capital, and Johnson & Johnson Innovation – JJDC, Inc. all participated in the round, as did new investor Woodford Patient Capital Trust.

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"Since Inivata’s seed funding sixteen months ago, the market has seen an explosion of interest and funding in liquid biopsy research. With our early presence in Cambridge, UK and our imminent presence in the USA, we are well-placed to be forerunners in the practical application of liquid biopsy for clinical oncologists," said Michael Stocum, Chief Executive Officer of Inivata. "We are grateful to our existing investors for their continued strong support of Inivata and very pleased to welcome Woodford Patient Capital Trust to augment what is already a very strong investor base. Our mission is to partner with oncologists to revolutionize cancer treatments and outcomes for their patients – part of a new landscape of personalized healthcare."

The new funds will be used to accelerate clinical studies to validate Inivata’s technology platform based on enhanced TAm-Seq, and commercialize the company’s first products. Inivata’s platform will initially be applied across a spectrum of solid tumors, including lung, breast and colon cancer to demonstrate the integration of genomic information with clinically actionable decision-making, thereby defining a personalized approach to cancer care.

"Inivata has advanced significantly since inception and is poised to become a leader in the rapidly-growing field of ctDNA analysis," said Rob Woodman, Director of Healthcare Investments at Imperial Innovations. "This fundraising reflects the great progress the company has made in developing innovative molecular profiling and monitoring products that will have real impact on patient care, and will help strengthen the platform for the company to roll these products out."

Inivata’s proprietary technology represents a new generation of non-invasive molecular profiling from a simple blood draw that is poised to impact the major aspects of a patient’s care including diagnosis, prognosis, treatment stratification and response monitoring. The test, which allows precise analysis of cancer-related mutations present in ctDNA, is designed to provide oncologists with clinically actionable genomic information to guide therapy selection, monitor treatment progress and, importantly, detect new mutations as they emerge. The genomic analysis of ctDNA has the potential to transform cancer care and resolve many of the limitations inherent in current tissue-based testing protocols that are highly invasive and are not amenable to serial monitoring in routine practice. Inivata’s platform is based on pioneering research from the Rosenfeld Lab at the Cancer Research UK Cambridge Institute (CRUK-CI) and to date, Inivata has demonstrated putative clinical utility of enhanced TAm-Seq through published clinical work presented at multiple cancer conferences in the fall of 2015.

"We have been impressed with the results thus far from Inivata’s initial clinical studies that highlight the sensitivity and accuracy of the Company’s ctDNA platform. Inivata is already working with a strong network of clinicians in both Europe and the United States and this new funding will allow the company to accelerate its clinical validation and commercialization efforts," said Robert Tansley of Cambridge Innovation Capital.

On January 25, 2016 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported that it has entered into a clinical research collaboration in immuno­oncology with Merck (NYSE: M RK), known as MSD outside the United States and Canada (Press release, Affimed Therapeutics, JAN 25, 2016, View Source [SID:SID1234515606]). Under the terms of the agreement, Affimed will fund and conduct a Phase 1b clinical trial to investigate the combination of Merck’s anti -­ PD -­ 1 therapy, KEYTRUDA (pembrolizumab), with Affimed’s proprietary drug candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with the marketed antibody -­ drug -­ conjugate Adcetris TM (brentuximab vedotin). Merck will supply Affimed with KEYTRUDA for the clinical trial. The purpose of the study is to establish a dosing regimen for this combination therapy and assess its safety and efficacy. Affimed is on track to initiate the study in the first half of 2016.

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AFM13 is a bispecific antibody targeting CD30, an antigen specifically expressed in a variety of T -­ and B -­ cell lymphomas and targeting CD16A, an antigen expressed on natural killer (NK -­ ) cells, which are important for the activation of the innate immune system and the subsequent killing of tumor cells. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD -­ 1 and its ligands, PD -­ L1 a nd PD -­ L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
In patient -­ derived xenograft models, AFM13, in combination with an anti­PD­1 antibody, demonstrated impressive synergy, with up to 90 percent of the tumor eradicated. In this preclinical work, conducted at Stanford University, it was also shown that both NK­ and T­cells infiltrated the tumors and that cytokine levels, including notably interferon­gamma, were elevated.
"Our development strategy is to combine our NK­cell engagers with other immunotherapies that could enhance their efficacy through the uptake of both NK -­ cells and T­cells, and the collaboration with Merck is an important step in executing this strategy," said Dr. Adi Hoess, CEO of Affimed.

"AFM13, a first­in­class NK­cell engager, has shown an acceptable safety profile and preliminary antitumor activity in the first­in­human Phase 1 study . Additionally, preclinical studies indicate that a combination with an anti PD­1 therapy could act synergistically and rep resent an additional future treatment option for patients." "Evaluating the potential for innovative combination therapies through strategic collaborations in difficult­to­treat tumor types continues to be an important part of our clinical development program for KEYTRUDA," said Dr. Eric Rubin, vice president and therapeutic area head, oncology early -­ stage development, Merck Research Laboratories . "In partnering with companies such as Affimed, we continue our efforts to bring forward new scientific breakthroughs for patients with Hodgkin lymphoma and the field of immuno-oncology overall."

The agreement is between Affimed and Merck, through a subsidiary. The collaboration agreement includes a provision for the potential expansion of the collaboration to include a subsequent Phase 3 clinical trial. Additional details were not disclosed.

On January 25, 2016 Athenex reported that it has received United States Food and Drug Administration (US FDA) allowance to proceed in the clinic with its proprietary oral form of Docetaxel (Press release, Athenex, JAN 25, 2016, View Source [SID1234517498]). This allowance to proceed represents Athenex’s sixth successful oncology investigational new drug (IND) application by the US FDA (5 oral anticancer drugs, one ointment) and the third such clinical drug candidate in Athenex’s oral absorption platform. Docetaxel is an established and effective high potency anti-cancer drug. Athenex has developed an oral form, called Oradoxel. The Athenex oncology oral absorption technology is based on a proprietary P-glycoprotein (Pgp) pump inhibitor ("Orascovery" platform) licensed exclusively from our business partner, Hanmi Pharmaceuticals, in 2011 for all major worldwide territories except Korea and Japan that were retained by Hanmi Pharmaceuticals. Athenex currently has the oral forms of paclitaxel and irinotecan in later stage clinical studies, which showed promising profiles in earlier clinical evaluations.

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Douglas Kramer, MD, Athenex Vice President of Clinical Development and Regulatory Affairs stated "Our team submitted to the FDA a comprehensive IND package for Oradoxel of over 35,000 pages, including information on our oral absorption platform. Our Pgp pump inhibitor has been demonstrated to enhance the oral absorption of well-known oncology drugs that today are only available to patients as intravenous medicines. We are excited for the possibilities to make a difference in helping more cancer patients."

Gerald Fetterly, PhD, Athenex Vice President of Clinical Pharmacology added "We have learned in the clinic that converting existing intravenous high potency oncology drugs into oral forms opens the door to optimizing a wide array of patient dosing regimens which cannot be achieved with IV. Oral forms of dosing allow the patients to be exposed over a longer period of time to the potent active pharmaceutical ingredients and clinical studies have shown expected pharmacokinetic blood levels of exposure; leading to good clinical efficacy with less adverse side effects compared with the intravenous counterparts."

Athenex Chairman and CEO Johnson YN Lau, MBBS, MD, FRCP, commented, "I want to congratulate both our Athenex Hong Kong team and the Athenex US team, and thank our collaborators on this project on achieving this important successful regulatory milestone. The Oradoxel project was initially developed by the Athenex Hong Kong team in the Henry Cheng Research Laboratory for Drug Development, Department of Applied Biology and Chemical Technology (ABCT), The Hong Kong Polytechnic University and this project was also partially supported by a SERAP matching grant from the Hong Kong Innovation and Technology Commission. Hong Kong should be congratulated as an innovator of important drug development science for cancer patients globally. This accomplishment also reinforces the successful execution of our business strategy creating a medical technology bridge between China and the United States."

In addition to its primary territories, Athenex is also developing Oraxol and Oratecan with Hanmi Pharmaceuticals, the originator of the Orascovery platform, in Korea and Japan, with PharmaEssentia in Taiwan and Singapore, and with ZenRx in New Zealand and Australia.