Special Focus: Recruiting the body in the war against cancer

DDNews checks in on the growing and promising activity around immuno-oncology

Jeffrey Bouley
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Special Focus on Cancer: Immuno-oncology
Recruiting the body in the war against cancer
 
DDNews checks in on the growing and promising activity around immuno-oncology
 
For a while, it was all the rage on Facebook to claim that the pharma industry was hiding the cure for cancer to keep people hooked on long-term therapies, as if there was some single silver bullet that could address the myriad types of cancers—and as if any company would pass on the opportunity for exclusively marketing a treatment that would redefine the very term “blockbuster drug.”
 
More recently, it seems my social media feeds more often feature posts and memes about how no one really needs pharma to treat cancer because with a few natural products and the right diet, our bodies will never see malignancies rear their ugly heads.
 
The notion that supplements and lifestyle choices alone will stave off disease, especially something as insidious as cancer, is a naive one, to be sure. But that doesn’t mean the basic idea isn’t a good one—that is, making the body do the work instead of trying to kill off tumor cells with a drug or some other kind of direct-acting therapeutic like radiation. After all, that is the core concept behind immuno-oncology—the idea that if we can get the body to recognize and mount a vigorous defense against cancerous cells, then we won’t need to rely as much on drugs to kill them.
 
And immuno-oncology has been taking off in recent years; it may be far from refined as a truly effective approach yet, but there is much promise.
 
Promising enough that GlobalData has visited this area of pharma and biotech several times in recent months with predictions and observations. For example, the research and consulting firm noted in May that cellular immunotherapies, which encompass dendritic cell therapy and chimeric antigen receptor T cell (CAR-T) therapy, will likely show promising results in combination treatments over the next few years, but maintained that they are unlikely to make a significant impact on the immuno-oncology market in the short term.
 
“Sales of cell therapies will be very low to 2024, especially when compared to checkpoint inhibitors. CAR-T cells, because of their high administration costs, are only primarily being developed in blood cancer populations, and GlobalData envisages that they will have overall low uptake and will be restricted to selected patients in large academic centers during the forecast period,” wrote GlobalData oncology and hematology analyst Dan Roberts. “However, the research being conducted into these kind of immunotherapies is indicative of an innovative and changing immuno-oncology arena that offers considerable opportunities in the long term.”
 
Roberts noted in a different report around the same time period that the total immuno-oncology market will be worth approximately $14 billion by 2019, rising to $34 billion by 2024, as the treatment of cancer patients undergoes drastic changes over the next decade. GlobalData feels that this will largely be driven by increased recognition of the potentially long and durable tumor responses of such therapies, which are similar to targeted therapies—in addition, such treatments have shown efficacy in a wide variety of indications and do not tend to be associated with the adverse side effects produced by something like chemotherapy, which tends to involves fatigue, neutropenia and/or alopecia.
 
Roberts noted that “Immuno-oncology products have demonstrated comparable respective efficacy and safety profiles, so their commercial success will largely rest on the speed with which they enter the market, their clinical and commercial positioning, target patient populations and the marketing power of the relevant pharmaceutical company.”
 
In other immuno-oncology prognostication, GlobalData noted in the spring that the termination of Celldex’s Phase 3 trial for its peptide-based vaccine therapy (Rintega) in newly-diagnosed glioblastoma patients was a blow to that treatment space that might very well see efforts increase to instead make drugs that combine peptide vaccines with immuno-oncology products.
 
Maxime Bourgognon, another oncology and hematology analyst at GlobalData, predicted recently that a combination immunotherapy from Merck KGaA and Pfizer—bringing together the checkpoint inhibitor avelumab and anti-angiogenesis tyrosine kinase inhibitor Inlyta—is likely to become an integral element of renal cell carcinoma treatment.
 
Leerink Partners analysts, for their part, took note of a new private company, Vor BioPharma, which is focused on CAR-T and was launched with technology licensed from Columbia University. Although Leerink sees the emergence of that company to be neutral to the market space right now, it did make note of the company’s desire to expand CAR-T use beyond B-cell cancers, which could be another sign of the broadening of immuno-oncology and some increasingly ambitious and creative thinking in the space.
 
And looking even more broadly at the market, Partners HealthCare announced its selections for the second annual “Disruptive Dozen,” in the spring, noting the 12 emerging technologies with the potential to revolutionize cancer care over the next decade. The first two technologies mentioned in the list were both immunotherapeutic in nature—cellular immunotherapy and immune modulators/vaccines.
 
Of the cellular space, focused on CAR-T therapies, of course, Partners HealthCare noted: “While the field is early in its development, the response rate to many of the new CAR-T therapies has been unprecedented for patients who had stopped responding to all other cancer treatments. The latest research is investigating how best to use CAR-T cells with other immunotherapies. Combining checkpoint inhibitors, such as PD-1 inhibitors and anti-CTLA4 drugs, with CAR-T cells are strong possibilities. Going forward, cancer experts predict that CAR-Ts have the potential to become frontline cancer therapies by engineering the patient’s own immune system to fight their cancer and defeat it.”
 
As for immune modulators and vaccines, the read on that part of the market was that checkpoint inhibitor drugs that target the PD-1/PD-L1 pathway “have made a lasting impression on cancer outcomes during a rapid rise from benchtop to FDA approval ... Novel vaccines are also being developed that can generate antitumor responses by expanding the population of immune cells capable of fighting cancer. Vaccines are now being tested in a variety of malignancies and, once approved, will allow doctors to make significantly more progress against advanced cancer than they had been able to achieve in decades.”
 
Now that we’ve given you the 50,000-foot view of the immuno-oncology space, peruse this section to discover some of the specific news happening in discovery, research and development, preclinical efforts, clinical trials and business deals in recent months.
 

A look at early-stage pipeline news
 
Compugen discloses lead candidate for CGEN-15029 program, plus news from Bio-Path and Pierre Fabre
 
HOLON, Israel—This summer, Compugen Ltd., a leading predictive therapeutic discovery company, disclosed COM701 as the lead monoclonal antibody therapeutic candidate for the company’s CGEN-15029 target program. This antibody candidate is now undergoing preclinical development activities in preparation for advancement to clinical trials, with an anticipated IND filing next year. CGEN-15029 is one of multiple novel immune checkpoint targets discovered by the company through the use of its in-silico predictive discovery infrastructure.
 
“Selection of COM701 as our lead clinical candidate marks a new phase for Compugen, where we not only discover novel targets for immuno-oncology, but are now positioned to advance our discoveries into preclinical and clinical development on our own,” said Dr. Anat Cohen-Dayag, president and CEO of Compugen. “The rapid progress of the CGEN-15029 program, with extremely aggressive timelines from target discovery and validation to therapeutic antibody development, was made possible in large part by the identification of CGEN-15029’s binding partner and the expansion of the company’s immuno-oncology R&D infrastructure.
 
“In parallel to the CGEN-15029 program, Compugen is using this infrastructure to pursue additional novel immuno-oncology programs and is now positioned to advance them. In addition to the information disclosed today, the company intends to share further data with respect to the CGEN-15029 program and the status of its pipeline program in the coming months.”
 
COM701 was selected from among multiple candidate antibodies for CGEN-15029, which were generated through various antibody discovery technologies and screened at Compugen USA Inc., the company’s wholly-owned subsidiary in South San Francisco. This effort resulted in a collection of high affinity antibodies with the ability to block CGEN-15029 from binding to its ligand, and which demonstrated activation of T cells in functional studies.
 
The selected hybridoma lead antibody demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate antitumor immune responses.
 
COM701 was successfully humanized and has advanced into preclinical development. Cell line development has been initiated for this antibody candidate, and the company has entered into agreements for the manufacturing and respective analytics of the therapeutic antibody.
 
The CGEN-15029 target was predicted in silico and experimentally confirmed to be a receptor-like checkpoint protein expressed on immune cells, with restricted expression on T and natural killer immune cells, similar to PD-1.
 
Experimental validation systems established over the last two years have enabled Compugen to validate and advance multiple novel immuno-oncology targets, and have allowed Compugen’s scientists to show that this target is expressed in tumor-infiltrating T cells in various solid and hematologic cancer types. Overexpression of CGEN-15029 was shown to decrease T cell activation, whereas inhibition of CGEN-15029 by knocking down its gene resulted in increased T cell activation, indicating that this novel target is indeed an immune checkpoint protein.
 
Bio-Path teams up with university on immunotherapy for brain cancer
 
HOUSTON—Bio-Path Holdings Inc., a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid drugs, in July announced that it had entered into a sponsored research agreement with Thomas Jefferson University to investigate DNAbilize antisense DNA technology for the development of a brain cancer immunotherapy that works by activating the patient’s own immune system to fight their cancer.
 
Dr. D. Craig Hooper, of the Sidney Kimmel Cancer Center at Thomas Jefferson University (and the principal investigator of the study)  previously evaluated Bio-Path’s DNAbilize liposomal delivery and antisense technology in preclinical studies that demonstrated efficacy, suggesting the potential for a systemic antisense immunotherapy for brain cancers. The objective of the collaboration is to demonstrate that DNAbilize delivered systemically would have an effect in redirecting the immune system to fight a patient’s own cancer.
 
“Brain cancers, such as glioblastoma, are very aggressive and with median survival of about 15 months, novel treatments are urgently needed,” said Peter Nielsen, president and CEO of Bio-Path. “We are excited to continue our work with Dr. Hooper to further demonstrate the potential of DNAbilize to safely and systemically deliver a brain cancer immunotherapy. We are entering the immunotherapy market with a unique approach to triggering the immune system to fight a patient’s cancer. This collaboration offers a significant development opportunity for Bio-Path that has the potential to create a second technology platform of immunotherapy products.”
 
Pierre Fabre advancing ADCs in oncology
 
CASTRES, France—This June, Pierre Fabre Pharmaceuticals announced a research project in translational medicine on a proprietary drug target in oncology. The collaboration includes Dr. David L. Rimm, as professor of pathology at Yale School of Medicine, and the Pierre Fabre Pharmaceuticals R&D Translational Medicine department headed by Dr. Alexandre Passioukov.
 
This collaboration focuses on a precision medicine approach to develop a first-in-class antibody-drug conjugate (ADC) identified by the Pierre Fabre Pharmaceuticals teams. Both partners will work on the translational aspects of the project to enable the progression of this drug candidate into clinical trial.
 
“We are delighted to be collaborating with Yale, a world-class university and medical center. This international collaboration reinforces our R&D organization’s commitment to work with the best teams in our areas of strategic interest and will reinforce our ability to bring new oncology treatment to patients in the most effective manner,” said Laurent Audoly, head of research and development at Pierre Fabre.
 

What’s happening in animal models and human trials
 
Aduro announces key data for multiple myeloma, plus news from Heptares, VAXIMM,  Immune Design and Immunovaccine
 
BERKELEY, Calif.—In the spring, Aduro Biotech Inc. announced the publication of a pivotal paper elucidating the roles of B cell maturation antigen (BCMA) and its ligand A proliferation-inducing ligand (APRIL) in multiple myeloma, highlighting the potential of its proprietary monoclonal antibody (mAb) BION-1301 targeting APRIL. The authors demonstrated through in-vivo and in-vitro preclinical studies that the APRIL/BCMA ligand/receptor pair drives multiple myeloma tumor growth and survival and activates immunosuppressive mechanisms that allow the tumor to thrive. Importantly, the studies demonstrated that BION-1301 halts tumor growth and overcomes drug resistance to chemotherapeutic agents lenalidomide and bortezomib in preclinical models.
 
The study, entitled “APRIL and BCMA promote human multiple myeloma growth, chemoresistance, and immunosuppression in the bone marrow microenvironment,” was published by Dr. Kenneth Anderson and Dr. Yu-Tzu Tai of the Dana-Farber Cancer Institute and appears in the journal Blood.
 
“For the first time, we have identified several different molecular mechanisms by which APRIL activates BCMA to promote multiple myeloma progression in vivo,” said Anderson, program director of the Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics at Dana-Farber and Kraft Family Professor of Medicine at Harvard Medical School. “Understanding the mechanism of tumor progression and resistance allowed us to test a novel approach to potentially combat disease advancement by using an anti-APRIL antibody. BION-1301 blocks the APRIL-induced signal cascade at a critical juncture and represents a new potential mechanism to both achieve disease response and restore immune function, even in patients with myeloma resistant to current therapies.”
 
The researchers also identified a novel and important role for APRIL and BCMA to induce immune suppression in multiple myeloma. They further developed a comprehensive understanding of APRIL as a strong driver of multiple features of tumor development even in the presence of protective bone marrow myeloid cells such as osteoclasts, macrophages and dendritic cells. In contrast, introducing an anti-APRIL mAb blocked interaction with both BCMA and a second TNF receptor TACI to inhibit multiple myeloma tumor growth, adhesion to bone marrow cells and immune suppression. In addition, the introduction of BION-1301 allowed tumor cells to be susceptible to standard chemotherapy regimens of lenalidomide and bortezomib.
 
“Current therapies for patients with multiple myeloma have significantly improved patient survival; however, a need for new treatments exists as drug resistance develops in the majority of the cases,” said Dr. Andrea van Elsas, chief scientific officer of Aduro Biotech Europe. “With the recent elucidation of the important role of the tumor microenvironment, we believe that blocking APRIL using our proprietary monoclonal anti-APRIL antibody BION-1301 could allow for a highly targeted immunotherapy approach to treat multiple myeloma, particularly when added to standard-of-care chemotherapy. Based on these promising preclinical data, we intend to initiate a clinical trial of BION-1301 next year.”
 
Heptares milestone triggered by start of immuno-oncology trial
 
LONDON—Heptares Therapeutics, a wholly-owned subsidiary of Sosei Group Corp. marked July with the announcement that it had been notified by its partner AstraZeneca that the first subject has been dosed with immuno-oncology candidate HTL1071 (AZD4635) in a Phase 1 clinical study, triggering a $10-million payment from AstraZeneca.
 
The first-in-human study is being conducted by AstraZeneca in approximately 50 patients with advanced solid malignancies and with non-small cell lung cancer. The primary objective is to determine the maximum tolerated dose (MTD) of HTL1071 alone and in combination with durvalumab (MEDI4736), an investigational human monoclonal antibody directed against PDL1. Pending the determination of the MTD, a Phase 2 trial is planned to investigate further the safety, tolerability, pharmacokinetics and anti-tumour activity of the selected doses.
 
HTL1071 is an orally available, small-molecule adenosine A2A receptor antagonist, and the lead candidate in a portfolio of A2A antagonists discovered by Heptares using its proprietary structure-based drug design platform. This portfolio was licensed to AstraZeneca in August 2015 for development and commercialization across a range of cancers, with an associated R&D collaboration designed to discover further A2A antagonists for development in cancer immunotherapy.
 
“The production of adenosine is a recently identified mechanism employed by tumor cells to suppress T cell activity and evade destruction. The initiation of this first clinical study in the A2A antagonist immuno-oncology programme with AstraZeneca is an important milestone for Heptares and we are excited to see how the results from preclinical studies translate into potential new medicines for cancer patients,” said Tim Tasker, Heptares’ chief medical officer. “This is the second program in our partnered pipeline to progress into the clinic, the first being the M1 agonist program licensed to Allergan, in which two novel compounds are undergoing clinical studies as potential new medicines for cognitive impairment in Alzheimer’s disease and other neurological indications.”
 
Susan Galbraith, vice president and head of oncology in AstraZeneca’s Innovative Medicines and Early Development Unit, said: “Immuno-oncology is one of four key oncology platforms for AstraZeneca. In building our immuno-oncology portfolio, we believe that blocking adenosine A2A receptor could enhance the efficacy of immune checkpoint inhibition via PDL1, CTLA4 and enhance the activity of CD73 inhibition. This innovative approach could help drive an immune attack on cancers, creating novel treatments with the potential to transform the lives of patients.”
 
VAXIMM initiates Phase 1 translational study in glioblastoma
 
BASEL, Switzerland & MANNHEIM, Germany—VAXIMM AG, a Swiss/German biotech company focused on developing oral T cell immunotherapies, launched a Phase 1 clinical trial that was set to initially enroll six patients with operable recurrence of a glioblastoma and which is being conducted at the University Hospital in Heidelberg, Germany.
 
All patients in the study must have recurrence of their disease following at least one prior treatment that must have included radiochemotherapy with temozolomide, and they must be candidates for routine reoperation with a safe option for delaying surgery for four to five weeks. Patients will receive four doses of oral VXM01 four to five weeks before surgery, and two safety magnetic resonance images at three weeks and one week prior to reoperation. Following surgery, patients may receive optional VXM01 administrations every four weeks up to week 48.
 
The primary objectives of the study are safety and tolerability. The trial will also investigate a number of pharmacodynamic endpoints and clinical response. A special focus of the study is the measurement of the VXM01-related cytotoxic T cell response, the assessment of immune cell infiltration and of changes in the vascularization and the PD-1/PD-L1 status of the tumor, as a response to the treatment.
 
“This concept has paradigm-changing potential for data-driven development in immunotherapy. Today, the primary goal for brain tumor immunotherapy is to understand its treatment successes and limitations and to prepare for larger, more sophisticated trials,” explained Dr. Wolfgang Wick, chairman of the Department of Neurology at Heidelberg University Hospital and principal investigator of the study. “The current trial offers a window to immunotherapy treatment through a clear molecular readout and potential design insights for a new, larger study.”
 
Prof. Andreas Unterberg, Chairman, Department of Neurosurgery, Heidelberg University Hospital, commented: “I am pleased that the first patient in this study has undergone a successful reoperation. Given the deadly nature of glioblastoma, we are in urgent need of treatments that will help to prevent the recurrence of disease. Vaccination with the oral immunotherapy VXM01 has the potential to be a potent tool in helping to slow or stop the recurrence of the cancer, and I look forward to seeing the results from this study.”
 
VXM01 is an oral T cell immunotherapy that targets the tumor-specific vasculature and certain immune-suppressive cells. It is based on a live attenuated, orally available, bacterial vaccine strain, which is modified to carry vascular endothelium growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient’s immune system to activate VEGFR2-specific, cytotoxic T cells (killer cells). These immune killer cells then actively destroy cells in the tumor vasculature leading to an increased infiltration of various immune cells into the tumor.
 
In preclinical studies, a murine analog VXM01 vaccine showed broad antitumor activity in different tumor types. This activity was linked to a VEGFR2-specific T cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration.
 
Clinical collaboration for neoantigen cancer immunotherapy
 
SEATTLE & EMERYVILLE Calif—Immune Design, a clinical-stage immunotherapy company focused on oncology, and Gritstone Oncology, a private cancer immunotherapy company developing next-generation, personalized cancer therapeutics, this summer announced a clinical collaboration for development of novel, personalized immunotherapies combining both companies’ leading technologies.
 
The collaboration will involve the application of Immune Design’s ZVex discovery platform with Gritstone’s proprietary genomics and proteomics platform for identification of patient-specific tumor antigens to develop neoantigen-based immunotherapies. Immune Design and Gritstone will be jointly responsible for development activities, with an initial likely focus in non-small cell lung cancer. The first clinical trial is expected to commence in 2017.
 
“The emerging tumor neoantigen field holds great potential for the successful application of cancer immunotherapies, and we are pleased to be working with Gritstone, a company that we believe is a pioneer in the field,” said Dr. Carlos Paya, president and CEO of Immune Design. “Having validated our two platforms in clinical trials targeting conserved tumor antigens, we believe their application to patient-specific tumor antigens is a natural next step.”
 
For the first trial of their technologies, the companies are evaluating combining the Gritstone and Immune Design neoantigen vaccine with a checkpoint inhibitor, to optimize the vaccine-induced immune response at several levels and maximize the likelihood of clinical efficacy.
 
“We are excited to work with Immune Design and their novel immunotherapy approach,” said Dr. Andrew Allen, co-founder, president and CEO of Gritstone Oncology. “There is good evidence that viral vectors are one of the most effective means of generating high titer CD8+ T cells that recognize encoded antigens, and so this is a logical move for our company, as our neoantigen prediction platform starts to deliver immune targets for individual patients with lung cancer.”
 
Developing patient-specific neoepitope immunotherapies
 
HALIFAX, Nova Scotia—Immunovaccine Inc.,  a clinical stage vaccine and immunotherapy company, announced this spring the launch of its DPX-NEO program to develop neoepitope immunotherapies to further expand the immuno-oncology applications for its DepoVax-based vaccines. As its first official partnership for this program, Immunovaccine will collaborate with experts in this field at UConn Health on a preclinical study to evaluate the immunologic and antitumor activity of patient-specific neoepitopes.
 
Epitopes are the part of the biological molecule that are the targets of an immune response. Neoepitopes are the mutated proteins produced by a patient’s own tumors.
 
“Neoepitopes are emerging as a very strong option to advance personalized cancer medicine, as they have tremendous potential to effect cancer treatments that provide truly individualized immunotherapies,” said Frederic Ors, Immunovaccine’s CEO. “Our novel DepoVax platform, with its unique mechanism of action and cost-effective, scalable manufacturing capabilities, is ideally positioned to become an enabling technology in this exciting field.”
 

Getting down to business in immuno-oncology
 
Celyad and Ono enter into license agreement, plus news of  deals between Celgene and Agios and also AbbVie and argenx
 
MONT-SAINT-GUIBERT, Belgium—Celyad, which touts itself as “a leader in the discovery and development of cell therapies,” announced in July an exclusive license agreement with Japanese immuno-oncology company Ono Pharmaceutical Co. Ltd. for the development and commercialization of Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This license agreement opens new markets to Celyad and expands the global footprint of its NKR-2 T cell cancer immunotherapy treatment and potentially for other disease conditions.
 
Celyad will receive an upfront payment equivalent to about $12.5 million and is eligible for as much as around $299 million in development and commercial milestones. Celyad will also receive double-digit royalties based on net sales of the licensed product in Ono’s territories.
 
Under the terms of the agreement, Celyad will continue developing its allogeneic NKR-2 T-cell immunotherapy in the European Union and in U.S. territories, and Ono will be responsible for future development and commercialization in its own territories (Japan, Korea and Taiwan). Both companies will also explore the opportunity to collaborate to collectively run global registration trials and combination trials. In addition, Celyad granted to Ono an exclusive option to license for development and commercialization of its autologous NKR-2 T cell product in the above Ono territories.
 
Georges Rawadi, vice president of business development for Celyad, said: “Celyad surrounds itself with the best immuno-oncology experts in the world to develop its NKR T-cell platform. This is why we have entered this agreement with Ono. Through this commercial license agreement, Celyad aims to expand the clinical and commercial potential of its allogeneic NKR-2 T cell immunotherapies worldwide.”
 
New collaboration in metabolic immuno-oncology
 
CAMBRIDGE, Mass. & SUMMIT, N.J.—Agios Pharmaceuticals Inc. and Celgene Corp. recently announced an agreement creating a new global strategic collaboration focused on metabolic immuno-oncology, an emerging field of cancer research focused on altering the metabolic state of immune cells to enhance the body’s immune response to cancer.
 
The goal of the collaboration is to discover, develop and commercialize novel therapies based on Agios’ innovative cellular metabolism research platform. Agios will receive an upfront cash payment of $200 million plus the potential for additional payments if certain development and regulatory milestones are achieved.
 
“The immune system’s ability to attack tumors is highly regulated by cellular metabolism. This emerging discipline of metabolic immuno-oncology has great potential to provide novel insights and targets for cancer immunotherapy in solid and hematologic malignancies,” said Dr. Rob Hershberg, chief scientific officer at Celgene. “This strategic agreement combines Agios’ scientific leadership in cellular metabolism with Celgene’s expertise and growing efforts in immuno-oncology and builds upon the extremely productive partnership and working relationship that exist between our two companies.”
 
At the same time, the companies modified certain rights from their 2010 collaboration. First, Agios, which previously held U.S. rights for AG-120, gained global development and commercialization rights to the program from Celgene. Second, the companies agreed that rights to two cancer metabolism programs discovered under the 2010 Agreement, including a program focused on methylthioadenosine phosphorylase deleted cancers, will advance under a restructured research collaboration. Following the expiration of the discovery phase of the 2010 agreement on April 14, 2016, all other cancer metabolism programs discovered at Agios will remain wholly owned by Agios.
 
AbbVie strikes $685M deal to boost immuno-oncology pipeline
 
NORTH CHICAGO, Ill. & GHENT, Belgium--Belgian biotech argenx in spring secured a $685-million licensing deal with AbbVie for an immuno-oncology candidate still in preclinical development. For $40 million up front and potential payments for preclinical objectives and other milestones, AbbVie gains rights to ARGX-115, an antibody targeting a membrane protein called GARP. Said protein is believed to contribute to the immuno-suppressive effects of regulatory T cells.
 
“ARGX-115 has been developed in collaboration with an outstanding team of academics at the de Duve Institute/Université Catholique de Louvain through our Innovative Access Program, which gives argenx rights to novel, exciting targets in our areas of therapeutic focus. We believe ARGX-115 has the potential to advance immuno-oncology by selectively targeting tumor immune escape pathways,” said Tim van Hauwermeiren, CEO of argenx. “We are proud to develop and commercialize ARGX-115 through collaboration with AbbVie, a global leader in oncology. In addition to the attractive financial elements of this transaction, our shared interest in the commercial potential of ARGX-115, including the right to co-promote the drug in Europe, makes this a highly strategic collaboration for argenx.”

Jeffrey Bouley

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