Development pipeline

Tregalizumab (BT-061)

Tregalizumab (BT-061) is a humanised monoclonal anti-CD4 antibody that selectively activates regulatory T cells (Tregs).

Tregalizumab thus reinforces a natural function of the body to prevent excessive immune reactions. The antibody with this new mechanism of action is being developed for the treatment of autoimmune diseases.

Clinical development of tregalizumab in rheumatoid arthritis was discontinued, after BT-061 did not met primary end-point in a Phase 2b trial. Pre-clinical work is currently ongoing to evaluate the MoA in other diseases.

Press releases

Preliminary announcement of the publication of financia...

06.12.2017,

Biotest AG hereby announces that the following financial reports shall be disclosed : Report: Annual financial report Date of disclosure / German: March 22, 2018 Date of disclosure / English: March ... [More]

Preliminary announcement of the publication of quarterl...

06.12.2017,

Biotest AG hereby announces that the following financial reports shall be disclosed : Report: Quarterly financial report within the 1st half-year (Q1) Date of disclosure / German: May 15, 2018 Date ... [More]

Biotest supports a randomized multicenter controlled tr...

05.12.2017,

/PRESS RELEASEBiotest supports a randomized multicenter controlled trial in peritonitis (PEPPER trial) with Pentaglobin(R) lead by Aachen University- Trial investigates personalized treatment approach ... [More]

Biotest generates revenues of EUR 377.8 million in the ...

14.11.2017,

PRESS RELEASEBiotest generates revenues of EUR 377.8 million in the first nine months 2017- Successful regulatory inspection and approval of Biotest Next Level in August- Paul-Ehrlich Institute approv ... [More]

Tender Offer by Tiancheng (Germany) Pharmaceutical Hold...

07.11.2017,

/Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)Tender Offer by Tiancheng (Germany) Pharmaceutical Holdings AG / Tiancheng withdrawal of application of transa ... [More]

Biotest AG opens eighth plasma collection centre in Hun...

06.11.2017,

/PRESS RELEASEBiotest AG opens eighth plasma collection centre in Hungary- 17 plasma collection centres in Europe and- 22 in the USA to ensure long-term plasma supplyDreieich, 6 November 2017. Biotest ... [More]

Correction of a release from 24.10.2017, 10:28 CET/CEST...

26.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Release according to Article 26, Section 1 of the WpHG ...

24.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights X Acquisition/d ... [More]

Release according to Article 26, Section 1 of the WpHG ...

19.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights X Acquisition/d ... [More]

Release according to Article 26, Section 1 of the WpHG ...

18.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Correction of a release from 16.10.2017, 12:50 CET/CEST...

17.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Release according to Article 26, Section 1 of the WpHG ...

16.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Release according to Article 26, Section 1 of the WpHG ...

13.10.2017,

Notification of Major Holdings1. Details of issuer Biotest AG Landsteinerstraße 5 63303 Dreieich Germany 2. Reason for notification X Acquisition/disposal of shares with voting rights   Acquisit ... [More]

Biotest strengthens its position in the German haemophi...

11.10.2017,

/PRESS RELEASEBiotest strengthens its position in the German haemophilia market with the introduction of new patient support services- Biotest supports home treatment with a team of specialised nurses ... [More]

Biotest AG: Annual general meeting approves payout of d...

30.08.2017,

PRESS RELEASEBiotest AG: Annual general meeting approves payout of dividend- Dividend payout of EUR 0.05 per ordinary share and EUR 0.07 per preference shareDreieich/ Frankfurt a. M., 30 August 2017. ... [More]

Preliminary announcement of the publication of quarterl...

23.08.2017,

Biotest AG hereby announces that the following financial reports shall be disclosed for the business year 2017: Report: Quarterly financial report within the 2nd half-year (Q3) Date of disclosure / ... [More]

Biotest reported sales of EUR 247.1 million in the firs...

14.08.2017,

/PRESS RELEASEBiotest reported sales of EUR 247.1 million in the first half of 2017- Successful building inspection of the new building at Dreieich- Closing of the Public Takeover Offer is subject to ... [More]

Biotest takes over Cara Plasma s.r.o. with one plasma c...

19.07.2017,

PRESS RELEASEBiotest takes over Cara Plasma s.r.o. with one plasma collection centre in the Czech Republic- Long-term plasma supplier Cara Plasma was taken over by Biotest- Biotest has now 16 plasma c ... [More]

Biotest reaches 2nd milestone in Biotest Next Level exp...

22.06.2017,

Biotest reaches 2nd milestone in Biotest Next Level expansion project- Authorities grant building approval- Relocation activities of laboratories and offices for production start in June Dreieich ... [More]

Biotest AG shareholders accept voluntary public tender ...

14.06.2017,

PRESS RELEASEBiotest AG shareholders accept voluntary public tender offer by CREAT GroupDreieich, 14 June, 2017. The shareholders of Biotest AG have accepted the voluntary public tender offer by Tianc ... [More]

Publications

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Rharbaoui et al.:Therapeutic Potential of Anti-CD4 Mediated Regulatory T-cell Activation
[ Link ]

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ACR/ARHP Annual Scientific Meeting; November 14-19, 2014, Boston (USA)
PDF, 391.6 kB
[ Download ]

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ACR/ARHP Annual Scientific Meeting, November 9.-14.2012, Washington, D.C., (USA)
PDF, 372.84 kB
[ Download ]

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Helling et al.: A specific CD4 epitope bound by tregalizumab mediates activation of regulatory T cells by a unique signaling pathway. Immunol Cell Biol. 2014 Dec 16. doi: 10.1038/icb.2014.102.
[ Link ]

Clinical trials

Title

Indication

Status

 
Tregalizumab (Study 986) Rheumatoid arthritis Study completed

A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)

Link Clinicaltrial.gov
 
Tregalizumab (Study 979) Rheumatoid arthritis Study completed

A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061

Link clinicaltrials.gov
 
Tregalizumab (Study 971) Rheumatoid arthritis Study completed

A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis

Link clinicaltrialsregister.eu
 
Tregalizumab (Study 962) Rheumatoid arthritis Study completed

A randomised, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety, and tolerability of the study drug BT962 (humanised CD4 monoclonal antibody BT061 or placebo) in patients with chronic rheumatoid arthritis

 
Tregalizumab (Study 973) Plaque psoriasis Study completed

A Randomized, Placebo-controlled, Double-blind, Multicentre, Multiple Dose, Cohort Study With Escalating Doses to Evaluate the Safety and Efficacy of the Humanized Monoclonal Antibody BT061 Administered to Patients With Moderate to Severe Chronic Plaque Psoriasis

Link clinicaltrials.gov
 
Tregalizumab (Study 967) Plaque psoriasis Study completed

A randomised placebo-controlled double-blind dose escalation study to evaluate the efficacy, safety and pharmacokinetic properties of the humanised CD4 monoclonal antibody BT061 in patients with chronic plaque psoriasis

 
Tregalizumab (Study 985) Healthy volunteers Study completed

A prospective, open-label, randomized, monocenter, phase I study to investigate pharmacokinetic and pharmacodynamic properties of single SC doses of the humanized monoclonal antibody BT061

 
Tregalizumab (Study 961) Healthy volunteers Study completed

A prospective open-label single-dose study to investigate the safety and tolerability of low doses of the humanised CD4 monoclonal antibody BT061 in healthy volunteers