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You are here: Home / Archives for cancer

IMMUNO-ONCOLOGY: CHECKPOINTS

October 10, 2017 by The Antibody Society

The Antibody Society invites you to attend its annual meeting, Antibody Engineering & Therapeutics, on December 11-15, 2017 at the Manchester Grand Hyatt, San Diego, CA! In this summary, chairperson James Larrick, M.D., Ph.D., Managing Director and Chief Medical Officer, Panorama Research Institute and Velocity Pharmaceutical Development, discusses what you will learn at his session on immune-oncology checkpoints, which will be held on Friday December 15.

The management of cancer has dramatically changed over the past decade with the introduction of novel immunotherapies, chief among them inhibitors of checkpoint receptors — molecules whose function is to restrain the host immune response.  Antibodies inhibiting CTLA4 and PD1-PD-L1 have shown remarkable clinical benefit.  The field is evolving rapidly, with many clinical trials testing novel checkpoint inhibitors (e.g., anti-LAG3, anti-TIM3), alone, in combination, or with other targeted therapies. A sampling of novel approaches will be covered in this symposium.

This Friday morning (December 15, 2017) session will be led off by Mickey Hu (Panorama Institute of Molecular Medicine) who has developed a series of novel immunomodulatory drugs that suppress PD-L1 expression in tumor cells and inhibit the PD-L1/PD-1 checkpoint, resulting in the recruitment of natural killer (NK) cells into the tumor microenvironment that leads to tumor suppression. Efforts to combine immunomodulatory drugs with checkpoint blockades to overcome difficult-to-treat cancers with tolerable side effects will be described.

Clinical lead candidate antibodies often lack species cross-reactivity, necessitating the development of substitute antibodies for pre-clinical development in mice or monkeys. Next, Erik Hofman, (Argenx) will describe the use of the SIMPLE Antibody platform to generate functional human-mouse cross-reactive antibodies against several validated immune checkpoint proteins, including PD-1, VISTA and LAG-3.

Xin Lu (University of Notre Dame) will present data indicating that targeted therapy against myeloid-derived suppressor cells, using multikinase inhibitors such as cabozantinib and dactolisib, can synergize with immune checkpoint blockade antibodies (e.g., anti-CTLA4, anti-PD1) to eradicate metastatic castration-resistant prostate cancer.

A key feature of effective cancer immunotherapy relies on enhanced anti-tumor immune response and reduced suppressive effects. As natural cytokines are made to maintain a balance between activation and suppression, they are often unable to achieve desired therapeutic efficacy. Cheng-I Wang (Biomedical Sciences Institutes, ASTAR, Singapore) will describe a cytokine receptor agonist antibody that mimics IL-2’s immune stimulatory effects on CD8 T cells with minimal Treg activation.

Cow antibodies have unusually long CDR3 regions. Vaughn Smider (The Scripps Research Institute) has characterized the genetic and structural properties of these antibodies, and has identified novel antibodies against HIV and exhausted T-cell targets utilizing this approach.

The final speaker, Sarah Crome, (Princess Margaret Cancer Centre, University Health Network, Canada) will describe efforts to characterize a unique innate lymphoid cell (ILC) population that suppresses the expansion and function of tumor-associated T cells, and is associated with early recurrence in high-grade cancer. This regulatory ILC population has properties that overlap with NK cells and other defined ILCs, yet can be differentiated by a distinct gene expression signature. Studies defining molecular interactions that control regulatory ILC function and ways to target this population to enhance immunotherapy will be presented.

Interested in attending the meeting? Society members can save 15% on the registration fee!

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Filed Under: Antibody discovery, cancer, Meetings Tagged With: antibody therapeutics, cancer, immune checkpoints

First approval for durvalumab

May 4, 2017 by Janice Reichert

On May 1, 2017, the US Food and Drug Administration (FDA) granted an approval to the anti-PD-L1 antibody durvalumab (IMFINZI) for the treatment of patients with urothelial carcinoma, and FDA approved a complementary diagnostic, the VENTANA PD-L1 assay, for assessment of PD-L1 protein in suitably prepared urothelial carcinoma tissue. Durvalumab’s license application received accelerated approval, priority review, and Breakthrough Therapy Designation from FDA. The approval was based on one single-arm trial of 182 patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after prior platinum-containing chemotherapy. An ongoing clinical trial to confirm the clinical benefit of durvalumab must be completed to fulfill the conditions of the accelerated approval.
Durvalumab is the sixth antibody therapeutic to be granted a first marketing approval in any country so far in 2017, and the second human IgG1 anti-PD-L1 antibody therapeutic to be approved by FDA in 2017, following the approval of avelumab (Bavencio) for Merkel cell carcinoma in March 2017. It is also the second anti-PD-L1 antibody therapeutic to be granted an approval for urothelial carcinoma, following FDA’s approval of atezolizumab (Tecentriq) in May 2016.
The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. As of May 1, 2017, marketing applications for a total of 9 antibody therapeutics that have not been approved in any country are undergoing review in the EU or US. In addition, marketing applications for sarilumab, which is approved in Canada, and gemtuzumab ozogamicin, which was FDA approved in 2000 and subsequently withdrawn from the US market, are undergoing review in the EU and US.

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Filed Under: Ab news, Approvals, cancer, Food and Drug Administration Tagged With: approved antibodies, cancer, durvalumab, Food and Drug Administration

New antibodies for cancer start clinical testing

April 20, 2017 by Janice Reichert

During 2014-2016, the pharmaceutical industry initiated first-in-human studies for an average of ~80 antibody-based therapeutics per year, and over 60% of these were designed to be treatments for cancer. The safety and tolerability of drugs are evaluated in Phase 1 studies, but preliminary efficacy may also be evaluated if the studies include patients rather than healthy volunteers. The anti-cancer antibodies new to the clinical pipeline in 2017 include two (CX-072, KN035) that target the programmed death-1 receptor ligand (PD-L1), and one each (CBT-501, FLYSYN) that target programmed death-1 receptor (PD-1) and Fms-like tyrosine kinase (FLT3), respectively.

PD-1 and PD-L1 are immune-checkpoint proteins that are frequently selected as targets for antibody therapeutics. Currently, two anti-PD-1 antibodies (pembrolizumab (Keytruda®), nivolumab (Opdivo®)) and two anti-PD-L1 antibodies (atezolizumab (Tecentriq®), avelumab (Bavencio®)) are approved for marketing, and one anti-PD-L1 antibody (durvalumab) is undergoing regulatory review. An additional 19 antibody-based therapeutics that target either PD-1 or PD-L1 are in clinical studies, with most (63%) in Phase 1 studies. Among these 19 are three antibodies, CX-072, KN035 and CBT-501, that recently entered their first clinical study. Developed by CytomX Therapeutics, CX-072 is a Probody targeting PD-L1. The first-in-human study (NCT03013491) of CX-072 as monotherapy and in combination with ipilimumab or with vemurafenib in patients with advanced or recurrent solid tumors or lymphomas started in January 2017. Probody therapeutics are designed to be activated by tumor-specific proteases, and thus may have minimal off-target effects. KN035, comprising an anti-PD-L1 single domain antibody fused with an Fc, is being evaluated in two Phase 1 studies (NCT02827968, NCT03101488) that started in 2017. Sponsored by 3D Medicines (Sichuan) Co., Ltd, the NCT02827968 study will evaluate the safety and tolerability of KN035 in patients with advanced and metastatic solid tumors, and the NCT03101488 study will evaluate and characterize the tolerability and safety profile of single agent KN035 in Chinese adults with unresectable advanced carcinoma. Anti-PD-1 CBT-501 (genolimzumab, GB-226) is a humanized IgG4 antibody with low antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity activity. A Phase 1 dose-escalation study (NCT03053466) sponsored by CBT Pharmaceuticals, Inc. of CBT-501 in patients with select advanced or relapsed/recurrent solid tumors was started in Australia in March 2017.
Developed by the University of Tübingen and SYNIMMUNE GmbH, FLYSYN is a chimeric antibody that targets the extracellular domain of FLT3 and is optimized for enhanced ADCC. The Phase 1 NCT02789254 study, which was initiated in February 2017, will evaluate the safety, tolerability and preliminary efficacy of FLYSYN for the treatment of acute myeloid leukemia patients with minimal residual disease.

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Filed Under: cancer, Clinical pipeline Tagged With: antibody therapeutics, cancer, Phase 1

Avelumab granted first approval

March 23, 2017 by Janice Reichert

On March 23, 2017, avelumab (Bavencio), an anti-PD-L1 human IgG1 mAb, was approved by the Food and Drug Administration (FDA) for treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, which is a rare form of skin cancer. Avelumab was granted an accelerated approval, which FDA can grant for drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Under such an approval, additional clinical trials are required to confirm the clinical benefit. The biologics license application was granted Priority review and Breakthrough Therapy designation by FDA. Avelumab was granted a US orphan drug designation for Merkel cell carcinoma, which is diagnosed in ~ 1,600 people in the US every year. A marketing application for avelumab is undergoing evaluation by the European Medicines Agency, which also granted avelumab an orphan drug designation. The marketing applications for avelumab are based on data from the Phase 2 JAVELIN Merkel 200 study (NCT02155647), which demonstrated meaningful tumor responses in patients with metastatic disease that progressed after prior chemotherapy. Avelumab is also undergoing evaluation in Phase 3 studies of patients with other types of cancers, including non-small cell lung, renal cell, ovarian, gastric, breast and urothelial cancers.

The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. As of March 23, 2017, marketing applications for a total of 11 antibody therapeutics that have not been approved in any country are undergoing review in the EU or US. In addition, marketing applications for sarilumab, which is approved in Canada, and gemtuzumab ozogamicin, which was FDA approved in 2000 and subsequently withdrawn from the US market, are undergoing review in the EU and US.

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Membership is free for students and employees of the Society’s corporate sponsors.

Filed Under: Approvals, Food and Drug Administration, Orphan drug Tagged With: approved antibodies, cancer, Food and Drug Administration

First approval for olaratumab, a new antibody therapeutic for sarcoma

October 20, 2016 by Janice Reichert

Antibody impressionOlaratumab (Lartruvo®) was granted an accelerated approval for treatment, with doxorubicin, of adults with soft tissue sarcoma by the US Food and Drug Administration on October 19, 2016. This new monoclonal antibody (mAb) therapeutic targets platelet-derived growth factor receptor-α. The approval was granted in part based on results of a clinical study that compared administration of doxorubicin alone with the combination of olaratumab with doxorubicin. In this study, median overall survival was 14.7 vs. 26.5 months for patients who received doxorubicin alone vs. those who received the combination of drugs. Olaratuzumab’s application was granted numerous FDA designations intended to facilitate the development of new drugs, especially those for serious or life-threatening diseases, including Fast Track and Breakthrough Therapy designations, and priority review. The product also received orphan drug designations in both the US and European Union (EU). On September 15, 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a conditional marketing authorization for olaratumab for the treatment of advanced soft tissue sarcoma. A decision by the European Commission is pending.

Olaratumab is the 5th new antibody therapeutic to be granted a first approval in 2016. Of the applications for 9 new mAb therapeutics currently undergoing regulatory review in the US or EU (i.e., mAbs not previously approved for any indication in these regions), 4 have FDA action dates known to occur in late October-December 2016. The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the US or EU. Please log in to access the table, located in the Members Only section.

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Filed Under: Ab news, Approvals, European Medicines Agency, Food and Drug Administration, Orphan drug Tagged With: antibody therapeutics, approved antibodies, cancer, European Medicines Agency, Food and Drug Administration, sarcoma

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