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Defying the “inevitable” development of type 1 diabetes

March 7, 2021 by The Antibody Society

Post written by Raquel Barroso Ferro, University of Aberdeen

Regular exogenous insulin injections, monitoring food and activity levels, increased risk of developing heart and kidney disease. These are some of the many challenges faced by people with type 1 diabetes (T1D), an autoimmune disease where the body’s own immune cells destroy its insulin-producing beta cells. This chronic condition affects over 540,000 children worldwide according to a leading UK charity, and is the second most common childhood disease in the US after asthma (1). Current estimates place a global increase in incidence of 2-5% every year (2), highlighting the increasing number of individuals having to physically, emotionally, and financially bear this burden and the need to develop therapeutics that can prevent, cure or improve the management of this condition.

Development of drugs that can delay the onset of T1D is ongoing. One such drug is teplizumab (hOKT3 γ1(Ala-Ala)), a humanized anti-CD3 monoclonal antibody that has been engineered to have reduced Fc receptor binding. Teplizumab works by modulating T cells, which are immune cells believed to be key players in the destruction of beta cells (3). Maintaining the remaining activity of the beta cells and enabling self-blood glucose control without the need for exogenous influence is critical to controlling the disease.

Results of a Phase 2 study (TrialNet TN10, NCT01030861) of teplizumab reported in 2019 were very promising (4). This randomized, blinded trial investigated if a single two-week course of treatment with teplizumab could delay or prevent the onset of T1D in high-risk individuals that were without a clinical diagnosis of T1D. The researchers observed that over the course of approximately 7 years (July 2011 to November 2018) teplizumab was able to delay the onset of T1D. Furthermore, this trial provided additional evidence of the importance of the T-cell mediated response for the onset of T1D, suggesting the value of using immunomodulation to affect disease development.

Sims et al. (5) extended the follow-up of participants in the original study, and have now reported that the effects persisted in the initial participants who received teplizumab. The median time to onset of T1D was more than double in participants who received teplizumab compared to those who received the placebo (~5 vs 2 years, respectively). Moreover, they observed improvements in beta cell function and, in some, a partial reversal in the decline of insulin secretion. Despite using a small cohort (total study enrolment = 76 participants) and a single 14-day course of drug, the results of this study form the foundation for exciting work in the future to actively prevent the onset of this lifelong condition whose prevalence only seems to be increasing.

A biologics license application for teplizumab for the delay or prevention of clinical T1D in at-risk individuals is undergoing priority review by the U.S. Food and Drug Administration, and their first action on the application is expected by July 2, 2021. The European Medicines Agency is evaluating a marketing authorization application for teplizumab.

References
1.       Menke et al. (2013). The prevalence of type 1 diabetes in the United States. Epidemiology 2013;24:773-774.
2.       Moobaseri et al. (2020).  Prevalence and incidence of type 1 diabetes in the world: a systematic review and meta-analysis. Health Promot Perspect. 2020; 10(2): 98–115. DOI: 10.34172/hpp.2020.18.
3.       Gaglia J, Kissler S. Anti-CD3 Antibody for the Prevention of Type 1 Diabetes: A Story of Perseverance. Biochemistry. 2019 Oct 8;58(40):4107-4111. doi: 10.1021/acs.biochem.9b00707.
4.       Herold et al. (2019). An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med 2019; 381:603-613. DOI:  10.1056/NEJMoa1902226.
5.       Sims et al. (2021).  Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. Science Translational Medicine. 13 (583); eabc8980. DOI: 10.1126/scitranslmed.abc8980.

Filed Under: Antibody therapeutic, Food and Drug Administration Tagged With: diabetes, teplizumab

Interns looking for Integrated Immunology Projects

March 6, 2021 by jpburckert

The Friedrich Alexander University in Erlangen (Germany) is looking for PIs working in the AIRR-seq space to take on intern students. The internship should be a short scientific project spanning 8 weeks to 6 months. The application process starts in March and the internship is expected to start in October to December. You can read more information about it at  https://www.iimmune.nat.fau.de/ . 

Interested PIs should send an email to Simon Schäfer of the AIRR-C Communications Sub-committee (simon.schaefer@fau.de) for further details.

The Comms SC is interested in helping to facilitate matchmaking between PIs and students to engage in AIRR internship exchanges and this is the first step in that process.

Please add your name to the list today!

Filed Under: AIRR Community, Systems Immunology Tagged With: Adaptive Immune Receptor Repertoire Community, AIRR-seq, Systems Immunology

Triple-negative Breast Cancer Day, March 3, 2021

March 2, 2021 by Janice Reichert

On March 3rd each year, the global community affected by and working to treat triple-negative negative breast cancer (TNBC) comes together to raise awareness of this disease. Like all cancers, breast cancer is heterogenous. The triple-negative form of the disease is characterized by the absence of expression of the estrogen and progesterone receptors and lack of amplification of human epidermal growth factor receptor 2 (HER2) on tumor cells, which makes it particularly difficult to treat. Although only ~10-20% of all breast cancer cases, TNBC is particularly aggressive, and occurs more commonly in women younger than age 40, who are African-American, or who have a BRCA1 mutation. The 5-year survival rate is high (91%) if the disease is localized when first diagnosed, but decreases substantially (to 12%) if the tumor has already metastasized.

Due to the lack, or relatively small number, of relevant receptors, TNBC typically does not respond to hormonal therapeutics or agents targeting HER2. Chemotherapy has been the standard of care, although the benefits of this treatment are limited. Recently, however, three monoclonal antibody (mAb) therapies, atezolizumab (Tecentriq, Genentech Inc.), sacituzumab govitecan-hziy (TrodelvyTM, Immunomedics, Inc.), and pembrolizumab (KEYTRUDA, Merck & Co.) were approved by the US Food and Drug Administration (FDA) for TNBC. In addition, numerous other mAbs are in late-stage clinical study for this disease.

Atezolizumab is a humanized IgG1 mAb targeting programmed cell death protein 1 ligand (PD-L1) that was first approved by FDA for treatment of locally advanced or metastatic urothelial carcinoma in 2016. The Fc domain of atezolizumab was engineered by introducing an Asp to Ala change at position 298 in the CH2 domain of each heavy chain. Due to this alteration, the antibody devoid of N-linked oligosaccharides and does not have effector functions. On March 8, 2019, the FDA granted accelerated approval to atezolizumab in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Approval was based on the placebo-controlled Phase 3 IMpassion130 (NCT02425891) study of 902 patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease. In patients whose tumors express PD-L1, median progression-free survival was 7.4 months for patients receiving atezolizumab with paclitaxel protein-bound and 4.8 months for those receiving placebo with paclitaxel protein-bound. The objective response rate in patients with confirmed responses was 53% compared to 33% for the atezolizumab and the placebo-containing arms, respectively. Tecentriq is also approved in the European Union for treatment of TNBC.

Sacituzumab govitecan is an antibody-drug conjugate (ADC) comprising a humanized IgG1k antibody targeting TROP-2 fused to the active metabolite of irinotecan (SN-38). On April 22, 2020, FDA granted Trodelvy® an accelerated approval for adults patients with metastatic TNBC who received at least two therapies for metastatic disease. FDA’s approval was based on findings from the pivotal, single-arm clinical trial IMMU-132-01 (NCT01631552) that enrolled 108 previously treated patients with metastatic TNBC. The overall response rate was 33.3% and the median response duration was 7.7 months. Of the patients with a response to sacituzumab govitecan-hziy, 55.6% maintained their response for 6 or more months and 16.7% maintained their response for 12 or more month.

Pembrolizumab is a humanized IgG4 mAb targeting programmed cell death protein 1 (PD-1) that was first approved by FDA for treatment of melanoma in 2014. On November 13, 2020, FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. FDA’s approval was based on results from the Phase 3 KEYNOTE-355 study (NCT02819518) of patients with locally recurrent unresectable or metastatic TNBC, who had not been previously treated with chemotherapy in the metastatic setting. Median progression-free survival was 9.7 months in the pembrolizumab plus chemotherapy arm and 5.6 months in the placebo arm.

Other ADCs and antibodies that target PD-1 or its ligand (PD-L1) are undergoing evaluation in late-stage clinical study of TNBC patients, including the anti-HER2 ADC trastuzumab deruxtecan (Enhertu); anti-PD-L1 avelumab (Bavencio) and TQB2450; and anti-PD-1 serplulimab and toripalimab. More information about TNBC and antibody therapeutics for this disease can be found in these reviews:

Nagayama A, Vidula N, Ellisen L, Bardia A. Novel antibody-drug conjugates for triple negative breast cancer. Ther Adv Med Oncol. 2020 May 11;12:1758835920915980. doi: 10.1177/1758835920915980.

Won KA, et al. Triple‑negative breast cancer therapy: Current and future perspectives. Int J Oncol. 2020. PMID: 33174058.

Keep up to date on US and EU approvals all year by visiting our website!

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Filed Under: Antibody therapeutic, Breast cancer, Food and Drug Administration Tagged With: antibody therapeutics, approved antibodies, Breast cancer, Food and Drug Administration

A newly certified AIRR-compliant software tool: The Immcantation Framework

February 26, 2021 by jpburckert

The AIRR Community is excited to announce that the Immcantation Framework has been certified as compliant with the AIRR-C v1.0 standard for AIRR-Seq software tools.

In an effort to enable rigorous and reproducible immune repertoire research at the largest scale possible, the AIRR-C Software Working Group has established a standard to validate software tools using the AIRR-C Standards and meeting a series of interoperability and quality criteria. Developers interested in certifying their tools should complete the checklist and submit it to the AIRR-C Software Working Group for evaluation and ratification by its members.

More details can be found at the website AIRR Software WG – Guidance for AIRR Software Tools.

All compliant tools will be issued a badge and listed on the website AIRR Software WG – List of Tools Certified as Compliant.

Filed Under: AIRR Community Tagged With: Adaptive Immune Receptor Repertoire Community

Rare Disease Day, February 28, 2021

February 23, 2021 by Janice Reichert

On or about the last day of February each year, the rare disease community comes together to raise awareness of these conditions. In the US, any disease affecting fewer than 200,000 people (1 per ~1,650 people) is considered rare, while a disease is defined as rare in Europe when it affects fewer than 1 in 2,000 people. There are more than 7,000 rare diseases, and these collectively affect ~ 25-30 million Americans. Information about specific rare diseases can be found in the National Organization for Rare Disorders’ Rare Disorders Database and the National Institutes of Health’s Genetic and Rare Diseases Information Center.

In the US, the Orphan Drug Act passed by Congress in 1983 incentivizes the development of drugs to treat rare diseases. Similar programs in Europe, Japan, as well as other countries, also allow other regulatory agencies to grant ‘orphan drug’ designations.  Hundreds of drugs have been approved for the treatment of rare diseases, including numerous antibody therapeutics, although substantial medical need still remains. Antibody therapeutics recently approved for rare diseases include:

  • Caplacizumab (Cablivi), a treatment for acquired thrombotic thrombocytopenic purpura, which is a rare blood clotting disorder.
  • Crizanlizumab (Adakveo), indicated to reduce the frequency of vaso-occlusive crisis, which is a painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells.
  • Teprotumumab (Tepezza), indicated for thyroid eye disease, which is associated with an outward bulging of the eye that can cause eye pain, double vision, light sensitivity or difficulty closing the eye.
  • Inebilizumab (Uplizna) and satralizumab (Enspryng), treatments for neuromyelitis optica spectrum disorder, which is a rare autoimmune disorder of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis.
  • Evinacumab (Evkeeza), a treatment for homozygous familial hypercholesterolemia, which is a genetic condition that causes severely high cholesterol.
  • Ansuvimab (Ebanga) and the triple antibody cocktail of atoltivimab, maftivimab, and odesivimab (Inmazeb) for the treatment for Zaire ebolavirus (Ebolavirus) infection.
  • Naxitamab (DANYELZA®) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.

More information about these antibody therapeutics, including target, format and year of approval, can be found here.

Other antibody therapeutics for rare diseases are in late-stage clinical studies and may be approved soon, including:

  • Garetosmab, which is undergoing evaluation as a treatment for fibrodysplasia ossificans progressive (FOP), an ultra-rare genetic disorder characterized by the progressive replacement of soft tissue, such as muscles, tendons, and ligaments, by bone, a process known as heterotopic ossification. Regeneron plans regulatory submission(s) for garetosmab for FOP in 2021.
  • Mirvetuximab soravtansine, which is undergoing evaluation as a treatment for ovarian cancer. ImmunoGen anticipates the submission of a biologics license application for accelerated approval of mirvetuximab soravtansine for ovarian cancer during the second half of 2021.
  • KN046, which is undergoing evaluation as a treatment for thymic carcinoma. Alphamab Oncology has announced that the Phase 2 clinical trial (NCT04469725) of KN046 to treat thymic carcinoma will support their plan to submit marketing applications for KN046 to China’s National Medical Products Administration and the US Food and Drug Administration in 2021.

More information about antibody therapeutics in late-stage studies can be found in ‘Antibodies to Watch in 2021‘.

Keep up to date on US and EU approvals all year by visiting our website!

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Filed Under: Antibody therapeutic, Rare diseases Tagged With: antibody therapeutics, rare diseases

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