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

Biotest increases revenues in the first quarter 2018 by...

15.05.2018,

PRESS RELEASEBiotest increases revenues in the first quarter 2018 by 34%- Guidance confirmed- Q1 EBIT totalled to EUR -3.0 million after EUR-33.2 million in Q1 2017Dreieich, 15 May 2018. In the first ... [More]

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

15.05.2018,

PRESS RELEASEBiotest AG: Annual general meeting approves payout of dividend- Dividend payout of EUR 0.04 per preference shareDreieich/ Frankfurt a. M., 15 May 2018. At the annual general meeting (AGM) ... [More]

New data from Biotest's monoclonal antibody-drug-conjug...

03.05.2018,

PRESS RELEASENew data from Biotest's monoclonal antibody-drug-conjugate (ADC) BT-062 in the therapy of solid tumors- Good tolerability and signs of efficacy in phase I/IIa clinical study- Very good ef ... [More]

Biotest reaches 2017 profit guidance

22.03.2018,

PRESS RELEASEBiotest reaches 2017 profit guidance- Adjusted EBIT stable- Five new plasmapheresis centres opened in Europe- Biotest Next Level: building acceptance obtained and successful "Good Manufac ... [More]

First patient with acquired fibrinogen deficiency treat...

15.03.2018,

PRESS RELEASEFirst patient with acquired fibrinogen deficiency treated in clinical phase III study of Biotest AG - Important milestone reached in the clinical development programme of fibrinogen conce ... [More]

Biotest supports a large international registry study t...

13.03.2018,

PRESS RELEASE Biotest supports a large international registry study to record data on use of Pentaglobin(R) in patients with severe bacterial infections- High medical need due to high mortality a ... [More]

Biotest reaches FY 2017 EBIT guidance

27.02.2018,

Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)Biotest reaches FY 2017 EBIT guidanceDreieich, 27 February 2018. According to preliminary and unaudited figures ... [More]

Tiancheng intends to enter into a domination and profit...

08.02.2018,

Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)Tiancheng intends to enter into a domination and profit and loss transfer agreement with Biotest AGDreieich, 8 ... [More]

Release according to Article 40, Section 1 of the WpHG ...

02.02.2018,

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 40, Section 1 of the WpHG ...

01.02.2018,

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]

Creat takeover of Biotest closed

31.01.2018,

/PRESS RELEASE Creat takeover of Biotest closed- Transfer of tendered shares completed- Majority shareholding (approx. 90% of Biotest AG's ordinary shares and voting share capital) of Creat in Bi ... [More]

Biotest AG opens second plasma collection centre in Cze...

24.01.2018,

/PRESS RELEASEBiotest AG opens second plasma collection centre in Czech Republic- 19 plasma collection centres in Europe to ensure long-term plasma supplyDreieich, 24 January 2018. Biotest received an ... [More]

All conditions met for Creat takeover of Biotest

19.01.2018,

/Ad-hoc RELEASEAnnouncement according to Article 17 European Market Abuse Regulation (MAR)All conditions met for Creat takeover of BiotestDreieich, 19. January 2018. Biotest AG disclosed today that fo ... [More]

Release according to Article 40, Section 1 of the WpHG ...

11.01.2018,

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]

Trimodulin: concept for phase III study successfully co...

20.12.2017,

/PRESS RELEASETrimodulin: concept for phase III study successfully coordinated with the authorities- Clinical concept of the Phase III study is supported by the regulatory authorities- Optimized produ ... [More]

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]

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