On January 27, 2016 Adicet Bio, Inc. ("Adicet"), a biopharmaceutical company focused on the development of next-generation cell immunotherapies, reported that it closed a $51 million Series A financing (Press release, Adicet Bio, JAN 27, 2016, View Source [SID:1234508891]). Adicet also announced the acquisition of Applied Immune Technologies, Ltd. ("AIT"), an Israel-based company that develops immunotherapies directed to the intracellular proteome.

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The financing was led by OrbiMed and also included Novartis Venture Fund and Pontifax.

"These significant financial resources will allow Adicet to progress its universal immune cell therapy ("uICT") platform technology and related products and advance AIT’s programs and product pipeline," said Aya Jakobovits, Ph.D., Founder, President and Chief Executive Officer of Adicet. "AIT’s technologies, capabilities, and intellectual property highly complement those of Adicet and position the combined company to become a leader in next-generation immunotherapy products for cancer and other indications."

Adicet was founded by Aya Jakobovits and OrbiMed. Previously, Dr. Jakobovits served as the President and founding CEO of Kite Pharma, Inc. Before joining Kite Pharma, she served as Executive Vice President, Head of Research and Development at Agensys, Inc., which became an affiliate of Astellas Pharma Inc. in a deal valued at up to $537 million. Before its acquisition, she served as Agensys’ Senior Vice President, Technology and Corporate Development and Chief Scientific Officer. Prior to Agensys, Dr. Jakobovits served as the Director, Discovery Research and Principal Scientist at Abgenix, Inc., which was spun out of Cell Genesys, Inc. and based on the XenoMouse technology developed under her leadership. Abgenix was acquired by Amgen Inc. for $2.2 billion.

AIT specializes in generating and developing T-Cell Receptor-Like ("TCRL") antibodies with high affinity and specificity to disease-specific intracellular peptides presented on the cell surface by the major histocompatibility complex ("MHC"). AIT also established Epitarget, a proprietary technology to identify and validate novel disease-specific peptide targets. AIT technology is based on work by Prof. Yoram Reiter, a world leader in the research of immunotherapies directed to the intracellular proteome. AIT will continue its operations in Israel as Adicet’s wholly-owned subsidiary.

Following the financing and acquisition, the Adicet Board of Directors will include Jonathan Silverstein and Carl Gordon, General Partners and Co-Heads of Global Private Equity at OrbiMed, Aya Jakobovits, Florent Gros, Managing Director at Novartis Venture Fund, and Erez Chimovits, Managing Director at OrbiMed Israel.

"We are excited to join forces again with Aya, a prominent figure in the field of immunotherapy with a track record of growing successful biotechnology companies," said Carl Gordon.

"We look forward to building a leading immunotherapy company," said Jonathan Silverstein. "The AIT acquisition expands Adicet’s platform technologies and its product pipeline."

About Applied Immune Technologies, Ltd.

Applied Immune Technologies Ltd. ("AIT") pioneered and advanced the generation and development of TCRLs for therapeutic and diagnostic applications in cancer, inflammation, autoimmune, and infectious diseases. AIT’s TCRLs are directed to disease-specific peptide-MHC complexes and are aimed at delivering potent payloads specifically to the diseased cells. AIT’s pipeline includes TCRLs directed to different disease indications. AIT also established a robust and proprietary technology for identification and validation of novel MHC-based targets. AIT was founded in 2006 by Prof. Yoram Reiter, Head of the Laboratory of Molecular Immunology at the Technion, Israel Institute of Technology, and Mira Peled-Kamar, Ph.D., AIT Chief Executive Officer. AIT is located in Haifa, Israel.

About Adicet Bio, Inc.

Adicet Bio, Inc. is a privately held, pre-clinical stage biotechnology company engaged in the design and development of cutting-edge immunotherapies for cancer and other disease indications, with a focus on novel universal immune cell therapies (uICT). Adicet Bio is located in Menlo Park, California.

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 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics,reported an update on the Phase 2 ALPINE clinical trial following a pre-planned January 23 interim efficacy assessment of the clinical trial by an independent data safety monitoring board (DSMB) (Press release, OncoMed, JAN 25, 2016, View Source [SID:1234508857]). The DSMB assessed data from 172 patients treated as of a January 6, 2016 data cutoff date.

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From a safety standpoint, the DSMB recommended that the study proceed to completion without modification. No unexpected safety findings emerged from its review.

However, the DSMB informed OncoMed of several findings regarding futility of the trial, notably:

A statistically significant worsening of response rate and progression-free survival (PFS) in the treatment arm in the overall intent-to-treat population, as well as a negative trend in each Notch biomarker subgroup
A strong trend to lack of benefit in the treatment arm for overall survival (OS), regardless of Notch biomarker levels, suggesting a low probability of achieving a statistically significant OS benefit based on analyses reviewed by the DSMB

Based on this information, OncoMed is in the process of unblinding the trial to carefully assess the current results and determine appropriate next steps for this fully enrolled trial. Eighteen patients remain on study drug treatment (tarextumab or placebo) between 172 and 527 days.

"The findings communicated by the DSMB suggest a low likelihood of a statistically significant benefit in overall survival in the tarextumab ALPINE pancreatic cancer trial," said Paul J. Hastings, Chairman and CEO. "Our aim is to quickly unblind the trial and work with our clinical sites and investigators to verify, analyze, interpret, and fully understand the data, including Notch biomarker subgroup trends, and determine next steps."

The Phase 2 ALPINE trial is a randomized, double-blinded, multicenter clinical trial designed to evaluate the efficacy of tarextumab in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. The ALPINE study completed enrollment of 177 patients in August 2015. The trial was designed to compare the overall survival of patients receiving tarextumab 15 mg/kg every two weeks versus placebo in combination with Abraxane plus gemcitabine. Secondary and exploratory endpoints, including progression-free survival and overall response rate, pharmacokinetics, safety and other biomarkers, are to be evaluated. Overall survival, progression-free survival and overall response rates will be assessed using a predictive biomarker for high tumor Notch3 expression. Increased Notch3 expression is estimated to occur in approximately 70 percent of pancreatic tumors and is associated with poor patient outcomes.

Conference Call Today

OncoMed management will host a conference call today beginning at 8:30 a.m. ET/5:30 a.m. PT to answer investor and analysts questions regarding the ALPINE Phase 2 program.

Analysts and investors can participate in the conference call by dialing 1-855-420-0692 (domestic) and 1-484-756-4194 (international) using the conference ID# 37742080. The web broadcast of the conference call will be available for replay through February 15, 2016 via a link in the Investor Relations section of the OncoMed website.

About Tarextumab (anti-Notch2/3, OMP-59R5)
Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied in two randomized Phase 2 clinical trials. The "ALPINE" study (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is assessing tarextumab with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients. The "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer) is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive-stage small cell lung cancer patients. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

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.