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the official website of the antibody society

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Two new antibody therapeutics enter regulatory review

February 5, 2020 by Janice Reichert

Biologics license applications (BLA) for tanezumab and dostarlimab have been submitted by Pfizer and GlaxoSmithKline, respectively.

Tanezumab is a humanized IgG2 antibody that selectively targets nerve growth factor. It has a novel mechanism compared to opioids and other analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), and, in studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence. FDA granted Fast Track designation for tanezumab for the treatment of osteoarthritis pain and chronic lower back pain. During a Q4 earnings conference call on January 28, 2020, Pfizer announced that it completed a marketing application submission for tanezumab in December 2019. This submission was done in close collaboration with the FDA, and it includes the 2.5 mg dose in moderate-to-severe osteoarthritis patients. A decision on the application may occur by the end of 2020. The submission was confirmed by development partner Eli Lilly. Tanezumab is also being evaluated in Phase 3 study of patients with cancer pain due to bone metastasis who are taking background opioid therapy.

Dostarlimab (TSR-042) is a humanized IgG4 antibody that binds with high affinity to the PD-1 receptor and effectively blocks its interaction with the ligands PD-L1 and PD-L2. Dostarlimab is being developed by Tesaro (a division of GlaxoSmithKline) for the treatment of solid tumors, including endometrial cancer that could be classified as microsatellite stable (MSS/75%) or microsatellite instability-high (MSI-H/25%). GlaxoSmithKline’s BLA is for dostarlimab as second-line treatment of recurrent endometrial cancer. Tesaro is also evaluating dostarlimab as a treatment for ovarian cancer in the Phase 3 FIRST study (NCT03602859). This study will compare platinum-based therapy with dostarlimab and niraparib versus standard of care platinum-based therapy as first-line treatment of Stage III or IV non-mucinous epithelial ovarian cancer.

Tanezumab and dostarlimab are now queued for a possible first approval in 2020 along with 13 other antibody therapeutics:

  1. Isatuximab, a humanized IgG1 targeting CD38 for multiple myeloma
  2. Inebilizumab, a humanized IgG1 targeting CD19 for neuromyelitis optica and neuromyelitis optica spectrum disorders
  3. Eptinezumab, a humanized IgG1 targeting CGRP for migraine prevention
  4. Leronlimab, a humanized IgG4 targeting CCR5 for HIV infection
  5. Sacituzumab govitecan, a humanized IgG1 antibody-drug conjugate targeting TROP-2 for  triple-negative breast cancer
  6. Satralizumab, a humanized IgG2 targeting IL-6R for neuromyelitis optica spectrum disorder
  7. Narsoplimab, a human IgG4 targeting MASP-2 for hematopoietic stem cell transplant-associated thrombotic microangiopathies
  8. Tafasitamab, a humanized IgG1 CD19 for diffuse large B-cell lymphoma
  9. REGNEB3, mixture of 3 human IgG1 targeting the Ebola virus for Ebola virus infection
  10. Naxitamab, a humanized IgG1 targeting GD2 for high-risk neuroblastoma and refractory osteomedullary disease
  11. Oportuzumab monatox, a humanized scFv immunotoxin targeting EpCAM for bladder cancer
  12. Belantamab mafodotin, a humanized IgG1 ADC targeting B-cell maturation antigen for multiple myeloma
  13. Margetuximab, a chimeric IgG1  targeting HER2 for HER2+ metastatic breast cancer

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. Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

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Filed Under: Antibody therapeutic, Food and Drug Administration, Regulatory review Tagged With: antibody therapeutics, approved antibodies, dostarlimab, Food and Drug Administration, tanezumab

First approval for teprotumumab-trbw (Tepezza)

January 21, 2020 by Janice Reichert

On January 21, 2020, the U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with 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. Teprotumumab, a human IgG1 antibody targeting insulin growth factor 1 receptor, was granted Fast Track, Breakthrough Therapy and Orphan Drug designations by the FDA. Positive data from both Phase 2 (NCT01868997) and Phase 3 (OPTIC, NCT03298867) studies were reported by Horizon Pharma. In the randomized, placebo-controlled OPTIC study, teprotumumab met the study’s primary endpoint, which was a responder rate of ≥ 2 mm reduction of proptosis (bulging) in the study eye (without deterioration in the fellow eye) at Week 24. Data from the OPTIC study showed that 82.9% of patients receiving teprotumumab were proptosis responders compared to 9.5% of patients receiving placebo at Week 24 (p<0.001). All secondary endpoints in the study were also met.

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. Information about other antibody therapeutics that may enter regulatory review in 2020 can be found in ‘Antibodies to watch in 2020’.

Like this post but not a member? Please join!

Filed Under: Ab news, Antibody therapeutic, Approvals, Food and Drug Administration Tagged With: antibody therapeutics, approved antibodies, Food and Drug Administration, teprotumumab

New AIRR-C Diagnostics Working Group initiated

January 18, 2020 by jpburckert

The idea of a Diagnostics WG originated in May at the AIRR-C IV meeting in Genoa, Italy. The three initiators, Florian Rubelt (Roche Sequencing Solutions), Nicolas Schwab (UK Münster) and Christopher Gooley (Microsoft Research), felt that it was time for AIRR-based diagnostics to make their way into the clinic. The transition from an academic environment to a clinical setting creates new challenges, which will be of high interest within the AIRR Community and beyond. The AIRR-Community has a unique advantage to connect people from academia and industry from around the world and provides a great basis to identify and address these new challenges in the AIRR field. 

A group of interested participants held an ad hoc session at the Genoa meeting and at this point the AIRR-C Diagnostics Interim Working Group has held 9 calls with over 30 participants. Early discussions have revolved around identifying the set of tasks and the format of the group. 

A first agreed-upon product is a commentary about AIRR-based diagnostics. This initial commentary manuscript is meant to introduce AIRR-based diagnostics and the potential future opportunities to a clinical audience. The group has also ran a survey to identify the background and interests of the group. One outcome of the survey was to identify bottlenecks and challenges bringing AIRR based diagnostics to the clinic.

Currently, the AIRR-C Diagnostics interim working group is led by Florian Rubelt, Nicholas Schwab and Christopher Gooley and has more than 60 members.

For more information and updates please refer to the AIRR-C Diagnostics Interim Working Group website.

If you are interested in joining, please contact diagnostics@airrc.antibodysociety.org

Filed Under: AIRR Community, Meetings, New articles Tagged With: Adaptive Immune Receptor Repertoire Community, diagnostics, Meetings, working groups

“Antibodies to Watch in 2020” is now online!

December 19, 2019 by Janice Reichert

This 2020 installment of the annual ‘Antibodies to Watch’ series documents the antibody therapeutics approved in 2019 and in regulatory review in the United States or European Union, as well as those in late-stage clinical studies, as of November 2019*.  At this time, a total of 5 novel antibody therapeutics (romosozumab, risankizumab, polatuzumab vedotin, brolucizumab, and crizanlizumab) had been granted a first approval in either the US or EU, and marketing applications for 13 novel antibody therapeutics (eptinezumab, teprotumumab, enfortumab vedotin, isatuximab, [fam-]trastuzumab deruxtecan, inebilizumab, leronlimab, sacituzumab govitecan, satralizumab, narsoplimab, tafasitamab, REGNEB3 and naxituximab) were undergoing review in these regions, which represent the major markets for antibody therapeutics. Also as of November 2019, 79 novel antibodies were undergoing evaluation in late-stage clinical studies. Of the 79 antibodies, 39 were undergoing evaluation in late-stage studies for non-cancer indications, with 2 of these (ublituximab, pamrevlumab) also in late-stage studies for cancer indications. Companies developing 7 (tanezumab, aducanumab, evinacumab, etrolizumab, sutimlimab, anifrolumab, and teplizumab) of the 39 drugs have indicated that they may submit a marketing application in either the US or EU in 2020. Of the 79 antibodies in late-stage studies, 40 were undergoing evaluation as treatments for cancer, and potentially 9 of these (belantamab mafodotin, oportuzumab monatox, margetuximab, dostarlimab, spartalizumab, 131I-omburtamab, loncastuximab tesirine, balstilimab, and zalifrelimab) may enter regulatory review in late 2019 or in 2020. Overall, the biopharmaceutical industry’s clinical pipeline of antibody therapeutics is robust, and should provide a continuous supply of innovative products for patients in the future.

*Note on key updates through December 20, 2019: 1) the US Food and Drug Administration granted accelerated approval to [fam-]trastuzumab deruxtecan (Enhertu) on December 20, 2019; 2) the US Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev) on December 18, 2019, bringing the total number of novel antibody therapeutics granted a first approval in either the US or EU during 2019 to 7; 3) the European Commission approved romosozumab on December 9, 2019; 4) the European Medicines Agency issued a positive opinion for brolucizumab; 5) Sesen Bio initiated a rolling biologics license application (BLA) on December 6, 2019; 6) GlaxoSmithKline submitted a BLA for belantamab mafodotin; 7) Macrogenics submitted a BLA for margetuximab; and 8) the status of the Phase 3 study (NCT04128696) of GSK3359609 in patients with head and neck squamous cell carcinoma was updated to recruiting from not yet recruiting.

Filed Under: Ab news, Uncategorized Tagged With: antibody therapeutics, approved antibodies, European Medicines Agency, Food and Drug Administration

Antibody Engineering & Therapeutics, December 2019

December 17, 2019 by Janice Reichert

Thank you for joining us at The Antibody Society’s annual Antibody Engineering & Therapeutics meeting held December 9-13, 2019 in San Diego. The meeting was a great opportunity for Society members to connect with industry and academic scientists and executives from around the world, and learn about advances in antibody discovery and development.

As always, The Antibody Society’s members designed the scientific program and acted as session Chairs. The meeting featured sessions on Antibody Libraries, Selection, Screening and Engineering; Bioinformatics and Computational Tools for Antibody Optimization and Engineering; Clinical Data and Lessons from Cancer Immunotherapy; Systems Immunology for Target Discovery; and Targeting Subcellular Trafficking Pathways to Generate Antibody Therapeutics.

AE&T Student/Postdoc Poster Competition

The Society sponsored a poster competition for students and postdocs, with winners receiving complimentary registration, support for travel expenses, and an opportunity to present at the conference. Congratulations to the winners:

Timothy Czajka, University of New York at Albany. Poster title: RIP-Off: An Intrabody-based Strategy to Neutralize Ricin and other Ribosome-Inactivating Protein (RIP) Toxins.

Kamal Joshi, PhD., Genentech. Poster title: Toward Deeper Understanding of Bispecific Antibodies

“Thank you again to the Antibody Society for this recognition and opportunity to speak here.  This is my third time attending the Antibody Engineering and Therapeutics conference and each time I’ve learned more than I could possibly remember and return to the lab with a huge surge of excitement and several new ideas that I’d like to apply to my own project.  I’m honored to be able to present my own research this year alongside so many fascinating talks and to be able to engage with many different experts in the field.  I would also like to thank my advisor, Nicholas Mantis, and Anne Messer for their help with my research and encouragement to attend and apply for this award.” Timothy Czajka

 

“It is an honor to receive this award. I would like to thank the judges for conferring this recognition on my work. I would also like to thank the Antibody Society, of course for funding my trip here but more importantly for organizing these fantastic meetings and providing a solid platform for the exchange of the latest information on antibody research and development benefiting all including early stage career scientists like me. It’s a real treat coming back to this meeting every time. Not only do I learn what is ongoing in the field, this meeting also provides me the opportunity to network with fellow scientists and facilitate connections. So again, thank you to the Antibody Society for this award. Thank you all.” Kamal Joshi, Ph.D.

 

Moments at Antibody Engineering & Therapeutics

The Antibody Society’s T shirts were hot items
Poster award winner Kamal Joshi
Poster award winner Timothy Czajka

At The Antibody Society’s booth
At the Society’s booth v2
At the Antibody Society’s booth v3

Incoming President Paul Carter with outgoing President Kerry Chester
Specifica presentation
Antibody Solutions

At the Ablexis / AlivaMab booth
At the OmniAb booth
At Trianni’s booth

At ImmunoPrecise’s booth
At the Twist Bioscience booth
At Aldevron’s booth

Our fabulous conference managers
Chiara Capobianco on the harp
View of San Diego, Dec 2019

 

We look forward to seeing you at AE&T in December 2020!

All Society members receive discounts on registration to Antibody Engineering & Therapeutics (US), as well as registration at many antibody-related meetings.

Filed Under: Meetings Tagged With: antibody engineering, antibody therapeutics

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