Active Biotech - Rebound alter Schwede?!
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| Eröffnet am: | 31.07.15 17:47 | von: Balu4u | Anzahl Beiträge: | 84 |
| Neuester Beitrag: | 14.11.24 21:56 | von: RichyBerlin | Leser gesamt: | 35.525 |
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Projected future milestones:
2021 H1
Naptumomab
• Safety readout and start of MTD (maximum tolerated dose) cohort of phase 1b study
2021 H2
Tasquinimod
• Safety readout and MTD expansion for single agent tasquinimod
• Start of combination study with tasquinimod and IRd
Laquinimod
• Start of oral Proof-of-principle phase 2 study
• Start of phase 1 topical eye formulation study
Naptumomab
• Start of phase 2 study in ”cold tumors” in combination with durvalumab
• Start of phase 2 study in Non-Small Cell Lung Cancer in combination with docetaxel
2022 H1
Tasquinimod
• Safety readout of combination study with tasquinimod and IRd Naptumomab
• Readout of MTD cohort of the phase 1b study regarding safety and preliminary effect
2022 H2
Tasquinimod
• Preliminary response readout of single agent tasquinimod
• Start of expansion cohort of combination study
Laquinimod
• Safety readout of phase 1 topical eye formulation study
2023
Tasquinimod
• Start of phase 2b study of single agent tasquinimod
Laquinimod
• Proof-of-principle readout of oral phase 2 study
Naptumomab
• Readout of phase 2 studies ”cold tumors” in combination with durvalumab
• Readout phase 2 study in Non-Small Cell Lung Cancer in combination with docetaxel
“I am very pleased with the progress we have achieved across our development projects since our new research focus was announced earlier this year, and we have a busy schedule ahead of us in the next coming years. The proposed rights issue of SEK 75 million which we announced recently will be used for advancing our prioritized project activities,” said Active Biotech’s CEO Helén Tuvesson."
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(News von gestern)
https://www.activebiotech.com/en/rights-issue-2021/
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https://www.activebiotech.com/en/...ive-milestone-payment-from-neotx/
NEWS
December 11, 2020
Active Biotech Receive Milestone Payment From Neotx
Active Biotech AB (publ) today announce a milestone payment of USD 750 000 from the partner NeoTX Therapeutics (NeoTX) under the terms of license agreement on the immunotherapy naptumomab.
Based on preclinical data and the previous clinical experience of naptumomab, a phase Ib/II study in patients with advanced solid tumors was initiated by NeoTX, in cooperation with AstraZeneca, in 2019. The study is currently ongoing, and the results from the dose escalation part of the study are expected early next year. NeoTX plans to expand the clinical program in the combination of naptumomab and durvalumab with focus on indications in so-called “cold tumors” with poor response to checkpoint inhibition alone, as well as evalutate further combination strategies such as the combination with docetaxel.
About the agreement
In 2016, Active Biotech and NeoTX entered into a partnership for the development and commercialization of naptumomab in cancer indications. Under the terms of the agreement, Active Biotech has granted NeoTX exclusive rights to develop and commercialize naptumomab worldwide in cancer indications. The total deal value amounts to USD 71 million and is contingent upon achievement of clinical, regulatory and commercial milestones whereof Active Biotech has received so far USD 250 000. In addition, NeoTX will pay Active Biotech progressive, double-digit royalties on its net sales of naptumomab.
...
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https://www.activebiotech.com/wp-content/uploads/...tation-201214.pdf
Bewertung; 3,-SKR (0,30 €)..
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"ACTIVE BIOTECH ENTERS INTO A MANUFACTURING AGREEMENT WITH FAMAR HEALTH CARE SERVICES FOR NEW FORMULATION OF LAQUINIMOD
February 4, 2021 15:00 (CET)
Active Biotech AB (publ) (NASDAQ STOCKHOLM: ACTI) today announced it has reached a manufacturing agreement with Famar Health Care Services Madrid SAU (“Famar”), a European provider of pharmaceutical manufacturing and development services. Famar will deliver clinical trial material of the newly developed eye-drop formulation of laquinimod.
The new formulation is developed by Active Biotech together with Leukocare AG, a biotechnology company from Munich, Germany, specialized in pharmaceutical formulation development. The formulation will be studied for the treatment of non-infectious non-anterior uveitis, which is an orphan disease and a serious, sight-threatening condition.
The agreement with Famar includes clinical trial material for dosing in clinical Phase I and II studies for the treatment of ophthalmic disorders. Famar R&D will provide process development, scale-up, supply of material for pre-clinical local tolerance studies and clinical grade material for use in the clinical studies.
The project has been initiated, and Active Biotech is aiming to start a clinical safety study in H2 2021. Active Biotech also plans to initiate a proof-of-principle study with oral laquinimod in uveitis patients in 2021..."
https://www.activebiotech.com/en/media/pressreleases/?id=2170025
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Active Biotech and NeoTX announce FDA Clearance of IND for Phase II Clinical Trial of Naptumomab
Phase IIa trial in non-small cell lung cancer expected to begin enrollment in the US in the second half of 2021
https://www.ariva.de/news/...nnounce-fda-clearance-of-ind-for-9384311
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Außerdem laufen die Vorbereitungen für den Beginn der bereits kommunizierten Phase-IIa-Studie in Kombination mit Docetaxel bei Patienten mit nicht-kleinzelligem Lungenkrebs. Weitere Informationen zu dieser Studie finden Sie unter ClinicalTrials.gov: NCT04880863.
"Wir sind sehr erfreut über das Engagement, das NeoTX für das Naptumomab-Programm aufbringt, und wir freuen uns darauf, über den Fortgang des Projekts zu berichten", sagte Helén Tuvesson, CEO von Active Biotech."
Übersetzt mit www.DeepL.com/Translator (kostenlose Version)
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https://www.ariva.de/news/...es-status-update-of-its-clinical-9642251
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"Active Biotech: Tasquinimod clinical development in multiple myeloma advances into combination therapy following completion of the initial phase of the ongoing trial in the US
Lund Sweden, October 3, 2021 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces that the ongoing trial of tasquinimod in multiple myeloma has reached an important milestone. Ten patients have been treated with increasing doses of tasquinimod, which was generally well tolerated. The optimal dose and schedule of tasquinimod, when used as a single agent in patients with multiple myeloma has been established at 1 mg per day after a one-week run in of 0.5 mg daily. This is similar to the treatment schedule used in previous studies of tasquinimod.
The trial will now advance to a previously planned combination part, in which treatment with tasquinimod will be tested in patients with multiple myeloma together with the orally administered antimyeloma agents ixazomib, lenalidomide, and dexamethasone (IRd). Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients. Key secondary endpoints will include antimyeloma activity using the response criteria of the International Myeloma Working Group...."
https://www.ariva.de/news/...quinimod-clinical-development-in-9796239
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http://www.nasdaqomxnordic.com/aktier/microsite?Instrument=SSE877
Kommt endlich Volumen rein :)
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October 20, 2021 07:00 (CEST)
https://www.activebiotech.com/en/media/pressreleases/?id=2316994
"Lund, October 20, 2021 - Active Biotech (NASDAQ STOCKHOLM: ACTI) and its partner NeoTX announce today that the first patient has been enrolled in the phase IIa clinical trial of naptumomab estafenatox (naptumomab), in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC).
The phase IIa, open label trial in US will assess naptumomab in combination with docetaxel in patients who had been previously treated with checkpoint inhibitors and have advanced or metastatic NSCLC. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria. The trial will also evaluate safety, duration of response, progression free survival, overall survival, pharmacokinetics, and pharmacodynamics. For more information about the trial, visit https://clinicaltrials.gov. NCT04880863.
“We are very pleased that NeoTX takes the next step in the development of Naptumomab in NSCLC, a disease with a high unmet medical need, and are excited to follow the progress of the trial.” says Helén Tuvesson, CEO, Active Biotech AB."
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https://www.realtid.se/telegram/...rterar-en-okad-rorelseforlust-i-q3
"Veröffentlicht am 2021-11-04
Das Forschungsunternehmen Active Biotech meldet für das dritte Quartal keine Einnahmen wie geplant. Betriebsverlust erhöht.
Das Betriebsergebnis betrug -11,3 MSEK (-8,3).
Das Ergebnis nach Steuern betrug -11,2 MSEK (-8,2), das Ergebnis je Aktie -0,05 MSEK (-0,05).
Der Cashflow aus betrieblicher Tätigkeit belief sich auf -31,0 MSEK (-27,9).
Die Zahlungsmittel und Zahlungsmitteläquivalente beliefen sich auf 68,4 (30,9) MSEK.
Die Vorstandsvorsitzende Helén Tuvesson ist von den Fortschritten bei den Projekten des Unternehmens begeistert.
"Seit wir unsere neue Ausrichtung für 2020 vorgestellt haben, bereiten wir uns auf den neuen Plan vor und leiten die entsprechenden Aktivitäten ein. Ich freue mich sehr, dass wir jetzt erste Ergebnisse sehen, und ich freue mich darauf, die Pläne entsprechend der neuen Ausrichtung zu vollenden. Wir haben die ersten ermutigenden Ergebnisse aus der laufenden Tasquinimod-Studie beim Multiplen Myelom und den Start einer neuen Kombinationsstudie mit Naptumomab und Docetaxel bei Lungenkrebs bekannt gegeben - zwei Krebsarten, bei denen der medizinische Bedarf trotz der Verfügbarkeit neuer Therapien immer noch hoch ist", schreibt Tuvesson in der Erklärung des CEO.
Active Biotech, SEKmQ3-2021Q3-2020VeränderungNettoumsatz00Betriebsergebnis-11,3-8,3Nettoergebnis-11,2-8,2Gewinn je Aktie, SEK-0,05-0,05Cashflow aus betrieblicher Tätigkeit-31,0-27,9Liquidität und Zahlungsmitteläquivalente68,430,9121,4%"
Übersetzt mit www.DeepL.com/Translator (kostenlose Version)
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Dem Kurs gefällts
http://www.nasdaqomxnordic.com/aktier/...iotech&ISIN=SE0001137985
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"New preclinical data on tasquinimod will be presented at the annual meeting of American Society of Hematology (ASH)
November 4, 2021 14:00 (CET)
Lund, November 4, 2021 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced that two abstracts with new preclinical data on tasquinimod, a small molecule immunomodulator, have been accepted for presentation at the 63rd ASH Annual Meeting & Exposition in Atlanta, Georgia, December 11-14, 2021.
The results that will be highlighted in the poster presentations are part of Active Biotech’s program to address the unmet medical needs to treat hematological malignances, with focus on multiple myeloma. Currently, a clinical phase Ib/IIa trial in patients with multiple myeloma is ongoing.
Information on the presentations:
P 1595. Tasquinimod Targets Immunosuppressive Myeloid Cells, Increases Osteogenesis and Has Direct Anti-Myeloma Effects by Inhibiting c-Myc Expression in Vitro and In Vivo. Poster session 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster I. Dec 11, 2021, 5.30-7.30 p.m. R. Fay et al., Vrije University, Brussels, Belgium.
P 2596. Targeting the Inflammatory Niche in MDS By Tasquinimod Restores Hematopoietic Support and Suppresses Immune-Checkpoint Expression in Vitro Poster session 636. Myelodysplastic Syndromes – Basic and Translational: Poster II., Dec 12, 2021, 6.00-8.00 p.m. M. Wobus et al., University Hospital Dresden, Germany.
Abstracts will be available at the ASH website from 9 am Eastern time (2 pm Central European Time) on November 4, 2021."
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November 30, 2021 15:00 (CET)
Lund, Sweden — November 30, 2021 – Active Biotech and its partner NeoTX announced that the preclinical data on naptumomab enhancing the potency of CAR-T cells was presented on Nov 12th at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting at the Walter E. Washington Convention Center, Washington D.C.
Clinical CAR-T therapy currently has limited efficacy against solid tumors due to low trafficking to the tumor, limited cell expansion in patients, tumor antigen heterogeneity, and an immunosuppressive microenvironment. The presented data shows that naptumomab generates more potent CAR-T cells and acts synergistically against tumor cell lines in vitro.
The ability of naptumomab to activate T cells outside of the immunosuppressive microenvironment, promote T cell infiltration into the tumor and induce long-term memory responses strongly suggests that the combination of CAR-T cells with naptumomab may overcome the limited effect of CAR-T therapy against solid tumors. To access the presented poster, please click here.
See also www.neotx.com for NeoTX’s communication related to this information.
https://www.activebiotech.com/en/...s-now-available-on-neotx-website/
https://neotx.com/wp-content/uploads/2021/11/...oster2021Final-FF.pdf
Conclusion;
Our studies show that NAP generates more potent CAR-T cells and acts
synergistically with CAR-T against tumor cell lines in vitro. The ability of
NAP administration to activate T cells outside of the immunosuppressive
microenvironment (in the lymphoid organs), promote T cell infiltration into
the tumor and induce long-term memory responses, strongly suggests that
combination of CAR-T cells with NAP may overcome the limited effect of
CAR-T therapy against solid tumors. NAP is currently being evaluated in
clinical studies in combination with durvalumab [NCT03983954] and
docetaxel [NCT04880863]
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December 10, 2021 08:30 (CET)
https://www.activebiotech.com/en/media/pressreleases/?id=2349825
Lund, December 10, 2021 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced that the first subject has been dosed in the phase I clinical study of the newly developed eye-drop formulation of the company’s candidate drug laquinimod.
Laquinimod is being developed as a new treatment for non-infectious non-anterior uveitis and has the potential to be used in the first line treatment as an add-on to steroids as well as in the second line treatment for patients that have failed steroid treatment.
Preclinical data suggest that laquinimod may influence inflammatory eye diseases when given both as a tablet and directly onto the eye. Active Biotech has developed an eye-drop formulation of laquinimod with the aim to use it for the treatment of inflammatory eye diseases, initially in patients with non-infectious non-anterior uveitis. These are patients who lack sufficiently effective and safe treatments and in addition, there is currently no eye-drop treatment available.
A preclinical program shows that the laquinimod eye-drop is safe and well tolerated, and the safety of this new formulation will now be tested in a phase I clinical study in healthy subjects. The primary endpoint of the study is to determine the safety and tolerability of laquinimod eye-drops after single and repeat doses. Secondary endpoints include eye toxicity and pharmacokinetics.
I am happy to report that we have initiated the clinical development of the new formulation of laquinimod and I look forward to review the results from this initial safety study. Laquinimod has the potential to be used in the treatment of serious eye diseases, which is underscored by preclinical data. In the next step we will continue the clinical investigation of laquinimod in patients with uveitis, with the goal to provide a new treatment to this sight-threatening eye disease” said Helén Tuvesson, CEO of Active Biotech."
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February 7, 2022 08:30 (CET) REGULATORY
https://www.activebiotech.com/en/...-tasquinimod-in-multiple-myeloma/
Lund Sweden, February 7, 2022 – Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced that the first patient has been dosed in the combination part of the phase Ib/IIa clinical study of tasquinimod in relapsed or refractory multiple myeloma. In this part of the study treatment with tasquinimod will be tested together with the orally administered antimyeloma agents ixazomib, lenalidomide, and dexamethasone (IRd).
Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients. Key secondary endpoints will include antimyeloma activity using the response criteria of the International Myeloma Working Group.
As previously communicated, the optimal dose and schedule of tasquinimod, when used as a single agent in patients with multiple myeloma, was established at 1 mg per day after a one-week run in of 0.5 mg daily. Tasquinimod was generally well tolerated and the established treatment schedule and safety profile of tasquiniomod in myeloma patients resembled that previously demonstrated in solid tumors.
The study is conducted in an academic partnership with the Abramson Cancer Center of the University of Pennsylvania, with Dr. Dan Vogl as principal investigator. Detailed information about the study is available on clinicaltrials.gov (NCT04405167).
“We are pleased to have enrolled the first patient to the combination part of the study where tasquinimod will be combined with a standard anti-myeloma treatment regimen. Our preclinical laboratory models suggest that this combination strategy may be a particularly effective way to utilize tasquinimod in myeloma therapy,” said Dr. Dan Vogl, Principal Investigator.
“The use of tasquinimod in combination with treatments used for earlier stage patients, is aligned with our current understanding of the mode of action of tasquinimod being able to block tumor sustaining signals from the bone marrow microenvironment. We are enthusiastic to follow the progress of the study ” said Helén Tuvesson, CEO, Active Biotech AB.
For further information, please contact:
Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.com
Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com
This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 08.30 am CET on February 7, 2022."
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February 9, 2022 22:30 (CET) REGULATORY
https://www.activebiotech.com/en/...e-biotech-bokslutsrapport-2021-2/
FOURTH QUARTER IN BRIEF
In 2021, we made substantial progress in our projects to address unmet medical need in hematological cancers and inflammatory eye disorders. The fourth quarter in particular proved to be a busy period, with continued strong development with all the prioritized projects in our portfolio.
Tasquinimod
Clinical development in multiple myeloma advanced into combination therapy following completion of the initial phase of the ongoing trial in the US (Oct 3)
Preclinical tasquinimod data presented at ASH 2021 (Dec 11-12)
Naptumomab
Active Biotech and NeoTX announced that the first patient had been enrolled in the phase IIa clinical trial of naptumomab estafenatox in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) (Oct 20)
Data on naptumomab estafenatox enhancing CAR-T cells potency presented by Active Biotech’s partner NeoTX at SITC 2021 (Nov 12)
Laquinimod
First subject dosed in phase I clinical study with eye drop formulation of laquinimod (Dec 10)
EVENTS AFTER THE END OF THE PERIOD
Dr. Erik Vahtola appointed Chief Medical Officer (Jan 01)
First patient dosed in the combination part of the Phase Ib/IIa study of tasquinimod in multiple myeloma (Feb 07)
Active Biotech entered into global patent license agreement with Oncode Institute for tasquinimod in myelofibrosis (Feb 9)"
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May 18, 2022 15:00 (CEST)
https://www.activebiotech.com/en/media/pressreleases/?id=2446074
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