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aossa 1 juli 2020 11:48

Nieuwsverwachtingen?

www.iex.nl/Forum/Topic/1138751/BioPha...

aossa 1 juli 2020 11:59

Genmab Announces Very Favorable Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
Company Announcement
• Genmab and Seattle Genetics plan to discuss the results with the U.S. Food and Drug Administration (U.S. FDA)
• Full data to be presented at an upcoming medical meeting
Copenhagen, Denmark; June 29, 2020 – Genmab A/S (Nasdaq: GMAB) today announced very favorable topline results from the Phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer. Results from the trial showed a 24 percent confirmed objective response rate (ORR) by independent central review (95% Confidence Interval: 15.9% - 33.3%) with a median duration of response (DOR) of 8.3 months. The most common treatment-related adverse events (greater than or equal to 20 percent) included alopecia, epistaxis (nose bleeds), nausea, conjunctivitis, fatigue and dry eye. The data will be submitted for presentation at an upcoming medical meeting.
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor, which is expressed on cervical cancer and can promote tumor growth, angiogenesis and metastases.1 Standard therapies for previously treated recurrent and/or metastatic cervical cancer generally result in limited objective response rates of typically less than 15 percent with median overall survival ranging from 6.0 to 9.4 months, in an all-comers population.1-8 Tisotumab vedotin is being developed in collaboration with Seattle Genetics.
“After treatment with first-line chemotherapy regimens, there is a high unmet need for new effective and tolerable treatment options for women with advanced cervical cancer, regardless of biomarkers and histology,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “These promising topline data from innovaTV 204 will be the basis of further engagement with the U.S. FDA as we continue to progress and expand our tisotumab vedotin development program in solid tumors with our partner.”
Additional clinical trials of tisotumab vedotin are currently enrolling patients, including in combination with pembrolizumab, carboplatin or bevacizumab, and with a weekly dosing schedule in patients with locally advanced or metastatic cervical cancer. Tisotumab vedotin is also being evaluated in other tissue factor expressing tumor types, including ovarian and other solid tumors.
About innovaTV 204 Trial
The innovaTV 204 trial (also known as GCT1015-04 or innovaTV 204/GOG-3023/ENGOT-cx6) is an ongoing single-arm, global, multicenter study of tisotumab vedotin for patients with recurrent or metastatic cervical cancer who were previously treated with doublet chemotherapy with bevacizumab if eligible per local standards. Additionally, patients were eligible if they had received up to two prior lines of therapy in the metastatic setting. In the study operationalized by Genmab, 101 patients were treated with tisotumab vedotin at multiple centers in the U.S. and Europe. The primary endpoint of the trial was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by independent central review. Key secondary endpoints included duration of response, progression-free survival, overall survival, safety and tolerability.
The study was conducted by Genmab in collaboration with Seattle Genetics Inc., European Network of Gynaecological Oncological Trial Groups (ENGOT) and Gynecologic Oncology Group (GOG). For more information about the Phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

aossa 1 juli 2020 12:06

Koersdoel UBS: 2500DKK

demo44 8 juli 2020 13:56

Goed nieuws

FDA lifts partial hold on mid-stage study of ADC Therapeutics' camidanlumab tesirine
Jul. 6, 2020 8:10 AM ET|About: ADC Therapeutics SA (ADCT)|By: Douglas W. House, SA News Editor
The FDA has removed its partial clinical hold on a pivotal Phase 2 clinical trial evaluating ADC Therapeutics' (NYSE:ADCT) antibody-drug conjugate camidanlumab tesirine in patients with relapsed/refractory Hodgkin lymphoma.

The company says it "worked diligently" to provide responses to the agency's request for information but does disclose the specific nature of the request.

A partial clinical hold suspends recruitment but allows current participants to continue treatment.

Camidanlimab tesirine is comprised of a CD25-targeting monoclonal antibody in-licensed from Genmab A/S (NASDAQ:GMAB) linked to tesirine, the pyrrolobenzodiazepine (PBD) dimer payload.

Fredk 11 augustus 2020 22:37

Hoe verhoudt zich de Nasdaq koers t.o.v. de koers in Kopenhagen?

Dokter Bob 23 september 2020 15:08

Weet iemand wat de koersval vandaag triggerde?

[verwijderd] 23 september 2020 15:16

Check even draadje ; genmab “ de Deense parel “

twinkletown 23 september 2020 17:48

quote:
Dokter Bob schreef op 23 september 2020 15:08:
Weet iemand wat de koersval vandaag triggerde?

De ruzie met J&J zet koers Genmab onder druk. Koers van succesvol Deens-Nederlands biotechbedrijf daalde ruim 10%. Verlies voor een klein deel weer ingelopen.

twinkletown 23 september 2020 17:49

quote:
Dokter Bob schreef op 23 september 2020 15:08:
Weet iemand wat de koersval vandaag triggerde?

De ruzie met J&J zet koers Genmab onder druk. Koers van succesvol Deens-Nederlands biotechbedrijf daalde ruim 10%. Verlies voor een klein deel weer ingelopen tot -/-6%.

twinkletown 23 september 2020 17:50

quote:
Dokter Bob schreef op 23 september 2020 15:08:
Weet iemand wat de koersval vandaag triggerde?

De ruzie met J&J zet koers Genmab onder druk. Koers van succesvol Deens-Nederlands biotechbedrijf daalde ruim 10%. Verlies voor een deel weer ingelopen tot -/-6%.

twopence 25 november 2020 22:36

Morgen een run naar de uitgang?

Kojo 29 januari 2021 20:01

Ondertussen een mooie rit gemaakt. Nu een terugval met kansen om om terug in te stappen.

priscillaaaa 4 november 2021 21:30

Genmab Improves its 2021 Financial Guidance

Genmab’s projected revenue for 2021 primarily consists of DARZALEX royalties. Such royalties are based on Genmab’s revised estimate of DARZALEX 2021 net sales of USD 5.9–6.2 billion compared to Genmab’s previous estimate of USD 5.6-5.9 billion.

Goed nieuws, morgen opnieuw omhoog!

DeZwarteRidder 3 april 2024 13:15

Genmab neemt ProfoundBio over
03-04-2024 08:26 - Voor 1,8 miljard dollar in contanten.

(ABM FN-Dow Jones) Het Deense Genmab wil voor 1,8 miljard dollar ProfoundBio inlijven. Dit maakte Genmab woensdagochtend bekend.

Met deze acquisitie verwerft Genmab drie kandidaatmedicijnen, onder meer tegen eierstokkanker, en het technologische platform van Profoundbio.

De transactie heeft de goedkeuring van de commissarissen van beide ondernemingen en zal naar verwachting afgerond worden in de eerste helft van dit jaar.

Door: ABM Financial News.

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