MDNA.TO ( Mkap C$ 36M) (Cash C$20 M) Positive P2 Daten in Q1 könnten für Zulassung reichen (Seite 8)
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Medicenna Shows Promising Pre-Clinical Results in Solid Tumor Models with its IL-2 Superkine, MDNA109
TORONTO , Feb. 6, 2019 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA, OTCQB: MDNAF), a clinical stage immunotherapy company developing first-in-class Superkines and Empowered Cytokines, today announced that new pre-clinical data on its IL-2 Superkine program, MDNA109, will be presented today demonstrating lack of immunogenicity while achieving potent anti-tumor activity particularly when combined with anti-PD1 and anti-CTLA-4 checkpoint inhibitors.
The new results on MDNA109 and its long acting variants will be delivered in a podium presentation today titled, "Putting Pedal to the Metal: Combining IL-2 Superkine (MDNA109) with Checkpoint Inhibitors" by Moutih Rafei, PhD, Associate Professor, Department of Pharmacology and Physiology, Université de Montreal at the 5th Annual Immuno-Oncology 360o Meeting in New York, NY .
"We are continuing to make good progress in selecting a lead clinical candidate based on MDNA109, the only engineered IL-2 Superkine designed to specifically target CD122 (IL-2Rβ) without CD25 dependency", said Moutih Rafei PhD, Head of Discovery at Medicenna. "Our rationally engineered long acting MDNA109 candidates potently and selectively stimulate cancer killing effector T cells with exceptional synergy when combined with either anti PD-1 or anti-CTLA-4 checkpoint inhibitors. Competing IL-2 therapies in development with reduced CD25 binding require much higher doses for activating effector T cells to achieve a therapeutic effect. In contrast, MDNA109 in vitro activates effector T cells at about 10-fold lower doses due to a 1000-fold increase in affinity for the CD122 receptor."
The presentation will highlight the following:
MDNA109 is an engineered IL-2 superkine exhibiting 1000-fold enhanced affinity toward the CD122 receptor and best in class potency toward cancer killing effector T cells
When tested in vivo, MDNA109 was not immunogenic and led to potent delay in the growth of pre-established B16F10 tumors compared to IL-2.
Likewise, significant delay in the growth of pre-established MC38 and CT-26 colon cancer was observed in syngeneic mice receiving MDNA109, whereas its co-administration with anti-PD1 checkpoint inhibitor eliminated tumors in 90% of MC38 tumor-bearing mice.
Furthermore, MDNA109 in combination with anti-CTLA-4 antibody, complete responses were observed in a majority of mice in the CT26 model. When cured animals were re-challenged on the counter-lateral flank with CT26 tumor cells, tumor growth was blocked at the secondary site clearly suggesting the generation of potent memory responses.
Additional results on long-acting MDNA109 variants with impaired CD25 binding demonstrated abrogation of regulatory T cell activation at therapeutic doses in order to mitigate peripheral side effects, which are dependent on CD25 binding.
"Our IL-2, IL-4 and IL-13 Superkines and first in class Empowered Cytokines stimulate tumor-killing immune cells or block the immunosuppressive tumor micro-environment while synergizing with other cancer immunotherapy platforms for potent, targeted treatment", said Fahar Merchant , PhD, President and CEO of Medicenna. "We are excited with the results to date for MDNA109 and look forward to report further advances in the development of our first of many superkines."
About MDNA109
Developed by scientists at Stanford University, MDNA109 is an engineered version of IL-2 that binds up to 1,000 times more effectively to IL-2Rβ (CD122), thus greatly increasing its ability to activate and proliferate the immune cells needed to fight cancer. MDNA109 is an IL-2 Superkine that preferentially drives the expansion and responses of effector T cells and Natural Killer (NK) cells over Treg cells. It is the only IL-2 in development with a distinct mechanism by virtue of its high affinity towards CD122 allowing it to effectively combat NK cell anergy (exhaustion) which occurs frequently after cancer immunotherapy.
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immunotherapy company developing novel highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Cytokines™ (ECs). Our mission is to become the leader in the development and commercialization of ECs and Superkines for the treatment of a broad range of cancers and immune-mediated diseases. MDNA55 is Medicenna's lead EC currently enrolling in a multi-centre Phase 2 clinical trial for the treatment of recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer. MDNA55 has secured Orphan Drug Status from the United States Food and Drug Administration (FDA) and the European Medicines Agency as well as Fast Track Designation from the FDA for the treatment of rGBM. For more information, please visit www.medicenna.com.
TORONTO , Feb. 6, 2019 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA, OTCQB: MDNAF), a clinical stage immunotherapy company developing first-in-class Superkines and Empowered Cytokines, today announced that new pre-clinical data on its IL-2 Superkine program, MDNA109, will be presented today demonstrating lack of immunogenicity while achieving potent anti-tumor activity particularly when combined with anti-PD1 and anti-CTLA-4 checkpoint inhibitors.
The new results on MDNA109 and its long acting variants will be delivered in a podium presentation today titled, "Putting Pedal to the Metal: Combining IL-2 Superkine (MDNA109) with Checkpoint Inhibitors" by Moutih Rafei, PhD, Associate Professor, Department of Pharmacology and Physiology, Université de Montreal at the 5th Annual Immuno-Oncology 360o Meeting in New York, NY .
"We are continuing to make good progress in selecting a lead clinical candidate based on MDNA109, the only engineered IL-2 Superkine designed to specifically target CD122 (IL-2Rβ) without CD25 dependency", said Moutih Rafei PhD, Head of Discovery at Medicenna. "Our rationally engineered long acting MDNA109 candidates potently and selectively stimulate cancer killing effector T cells with exceptional synergy when combined with either anti PD-1 or anti-CTLA-4 checkpoint inhibitors. Competing IL-2 therapies in development with reduced CD25 binding require much higher doses for activating effector T cells to achieve a therapeutic effect. In contrast, MDNA109 in vitro activates effector T cells at about 10-fold lower doses due to a 1000-fold increase in affinity for the CD122 receptor."
The presentation will highlight the following:
MDNA109 is an engineered IL-2 superkine exhibiting 1000-fold enhanced affinity toward the CD122 receptor and best in class potency toward cancer killing effector T cells
When tested in vivo, MDNA109 was not immunogenic and led to potent delay in the growth of pre-established B16F10 tumors compared to IL-2.
Likewise, significant delay in the growth of pre-established MC38 and CT-26 colon cancer was observed in syngeneic mice receiving MDNA109, whereas its co-administration with anti-PD1 checkpoint inhibitor eliminated tumors in 90% of MC38 tumor-bearing mice.
Furthermore, MDNA109 in combination with anti-CTLA-4 antibody, complete responses were observed in a majority of mice in the CT26 model. When cured animals were re-challenged on the counter-lateral flank with CT26 tumor cells, tumor growth was blocked at the secondary site clearly suggesting the generation of potent memory responses.
Additional results on long-acting MDNA109 variants with impaired CD25 binding demonstrated abrogation of regulatory T cell activation at therapeutic doses in order to mitigate peripheral side effects, which are dependent on CD25 binding.
"Our IL-2, IL-4 and IL-13 Superkines and first in class Empowered Cytokines stimulate tumor-killing immune cells or block the immunosuppressive tumor micro-environment while synergizing with other cancer immunotherapy platforms for potent, targeted treatment", said Fahar Merchant , PhD, President and CEO of Medicenna. "We are excited with the results to date for MDNA109 and look forward to report further advances in the development of our first of many superkines."
About MDNA109
Developed by scientists at Stanford University, MDNA109 is an engineered version of IL-2 that binds up to 1,000 times more effectively to IL-2Rβ (CD122), thus greatly increasing its ability to activate and proliferate the immune cells needed to fight cancer. MDNA109 is an IL-2 Superkine that preferentially drives the expansion and responses of effector T cells and Natural Killer (NK) cells over Treg cells. It is the only IL-2 in development with a distinct mechanism by virtue of its high affinity towards CD122 allowing it to effectively combat NK cell anergy (exhaustion) which occurs frequently after cancer immunotherapy.
About Medicenna Therapeutics Corp.
Medicenna is a clinical stage immunotherapy company developing novel highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Cytokines™ (ECs). Our mission is to become the leader in the development and commercialization of ECs and Superkines for the treatment of a broad range of cancers and immune-mediated diseases. MDNA55 is Medicenna's lead EC currently enrolling in a multi-centre Phase 2 clinical trial for the treatment of recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer. MDNA55 has secured Orphan Drug Status from the United States Food and Drug Administration (FDA) and the European Medicines Agency as well as Fast Track Designation from the FDA for the treatment of rGBM. For more information, please visit www.medicenna.com.
Bin hier jetzt auch dabei mit einer kleinen Position. Hatte die Aktie schon länger beobachtet, seitdem Biohero sie freundlicherweise vorgestellt hatte. Ich glaube, jetzt wird es hier langsam interessant.
Antwort auf Beitrag Nr.: 59.624.021 von Readyx am 14.01.19 10:00:16Hier schein ein wenig Bewegung reinzukommen: die vorläufigen MDNA55 Ergebnisse werden nächste Woche Donnerstag im Rahmen einer Konferenz vorgestellt... . Ich denke, das ist ganz ermutigend. Im Falle negativer Daten würden sie sicherlich nur eine News kommunizieren und keinen Talk auf einer Fachkonferenz.
https://web.tmxmoney.com/article.php?newsid=6185174120624739…
https://web.tmxmoney.com/article.php?newsid=6185174120624739…
Antwort auf Beitrag Nr.: 59.622.326 von Biohero am 13.01.19 22:26:42Klar kann hier ein Totalverlust folgen, nur das nach den Phase 2 Daten.. Ist das so gemeint? Gruss
Antwort auf Beitrag Nr.: 59.622.119 von Bullrich83 am 13.01.19 21:24:41Naja das hängt von den Daten ab und natürlich von der FDA, nach den Daten falls positiv wird man das mit der FDA besprechen dann wird man erfahren ob Zulassungsantrag oder Phase 3 Studie . So sieht übrigens ein Zock aus wenn Produkt scheitert wird es die Firma sehr schwer haben vor allem weil der Cashbestand nur bis ca anfang Q3 reicht . Kann mir hier trotzdem noch einen schönen Runup vorstellen aber den möglichen Totalverlust sollte man im Hinterkopf haben .
"We have completed 75 per cent of the recruitment to date, expect to be fully enrolled by early 2019, report top-line data in mid-2019, followed by an end of phase 2 (EOP2) meeting with the USFDA."
"We have completed 75 per cent of the recruitment to date, expect to be fully enrolled by early 2019, report top-line data in mid-2019, followed by an end of phase 2 (EOP2) meeting with the USFDA."
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Antwort auf Beitrag Nr.: 59.587.337 von Biohero am 08.01.19 20:21:01Sieht interessant aus, weshalb ich mal eingestiegen bin. Ich habe nirgends gelesen, wann die Phase 2 Daten kommen sollen. Woher weißt Du, dass die Daten Ende Q2 kommen? Und wie sehen die Chancen aus, dass die Phase 2 Daten für einen Zulassungsantrag reichen?
Danke im voraus und lieben Gruß
Danke im voraus und lieben Gruß
Antwort auf Beitrag Nr.: 59.560.169 von Biohero am 04.01.19 17:23:35MDNA ist nach wie vor kaum bekannt und wird auch sonst bisher von sogut wie niemanden empfohlen das sind gute voraussetzungen für kommende Kurssteigerungen weil viele erst beginnen werden zu pushen wenn die Aktien schon zum teil stark gestiegen sind .MDNA ist riskant aber anhand der ersten Ergebnisse die vorliegen stehen die chancen nicht schlecht für die Phase 2b Daten nächsten Quartal . Bis dahin sollte die Aktie aufgrund der unterbewertung schon steigen wie gesagt management hat sich bei der kürzlich abgeschlossenen KE mit $400k zu je $1 beteiligt also das kann man auch positiv sehen .Trotzdem High Risk obwohl das ja meistens gerade die besten Aktien sind mit denen man gutes geld verdienen kann .
https://finance.yahoo.com/news/medicenna-announces-closing-p…
As part of the Offering, Dr. Fahar Merchant and Ms. Rosemina Merchant (collectively, the "Merchants"), each of whom is a director and officer of the Company, purchased an aggregate of 400,000 Units. Prior to the Offering, the Merchants, together with their respective associates and affiliates, owned or exercised direction or control over an aggregate of 15,600,000 Common Shares and 1,100,000 stock options of the Company (representing approximately 65.04% of the then issued and outstanding Common Shares on a partially-diluted basis). Following completion of the Offering, the Merchants, together with their respective associates and affiliates, own or exercise direction or control over an aggregate of 16,000,000 Common Shares, 200,000 Warrants and 1,100,000 stock options of the Company (representing approximately 57.90% of the currently issued and outstanding Common Shares on a partially-diluted basis).
Größten Aktionäre
Aries Biologics, Inc. 5 500 000
Rosemina Merchant 5 250 000
Fahar Merchant, PhD 5 250 000
Albert George Beraldo, CPA 25 000
Elizabeth Williams, CPA 5 300
Chandrakant J. Panchal, PhD 1 500
https://finance.yahoo.com/news/medicenna-announces-closing-p…
As part of the Offering, Dr. Fahar Merchant and Ms. Rosemina Merchant (collectively, the "Merchants"), each of whom is a director and officer of the Company, purchased an aggregate of 400,000 Units. Prior to the Offering, the Merchants, together with their respective associates and affiliates, owned or exercised direction or control over an aggregate of 15,600,000 Common Shares and 1,100,000 stock options of the Company (representing approximately 65.04% of the then issued and outstanding Common Shares on a partially-diluted basis). Following completion of the Offering, the Merchants, together with their respective associates and affiliates, own or exercise direction or control over an aggregate of 16,000,000 Common Shares, 200,000 Warrants and 1,100,000 stock options of the Company (representing approximately 57.90% of the currently issued and outstanding Common Shares on a partially-diluted basis).
Größten Aktionäre
Aries Biologics, Inc. 5 500 000
Rosemina Merchant 5 250 000
Fahar Merchant, PhD 5 250 000
Albert George Beraldo, CPA 25 000
Elizabeth Williams, CPA 5 300
Chandrakant J. Panchal, PhD 1 500
Antwort auf Beitrag Nr.: 56.964.653 von Biohero am 07.02.18 19:02:01Kleines update :
Wie die meisten Aktien wurde auch MDNA nach unten geprügelt hinzu kam noch eine vor wenigen tagen abgeschlossene KE die die Aktie auf ein sehr attraktives niveau gebracht haben . Vor ca 2 monaten hat MDNA erste vorläufige Ergebnisse von der P2 Studie (rezidiviertes Glioblastom) veröffentlicht die äußerst vielversprechend sind Top line daten werden für ende 2Q 2019 erwartet .
Bei der letzten KE hat das Management die ohnehin schon über 15 Million von den aktuell 28.5 Million außenstehenden Aktien halten weitere 400k aktien zugekauft was mich dazu bewogen hat hier wieder mit einer kleinen spekulativen position einzusteigen . Kann mir gut vorstellen das die Aktie im vorfeld der P2 Daten bis $3 laufen könnte wenn nicht noch höher . MDNA ist hochriskant aber dementsprechend ist auch das Potential riesig vor allem weil die ersten Daten wirklich sehr gut sind und viele Investoren wesentlich mehr für ihre Aktien bezahlt haben .
Marktkap: 25 Mio C$
Cash: 4.8 Mio C$ (inkl KE) soll laut Management bis nach den P2 Daten reichen
Kurs: 0.87
Aktienanzahl:28.5 Mio
Aktuelle Präsentation
https://ir.medicenna.com/download/MEDICENNA+Corporate+Presen…
MEDICENNA PROVIDES POSITIVE INTERIM UPDATE FROM PHASE 2B TRIAL OF MDNA55 IN RECURRENT GLIOBLASTOMA
https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aMDNA-267…
Results from the low-dose cohorts showed promising median overall survival of 9.8 months following a single treatment, with an overall survival rate of 89 per cent at six months, 58 per cent at nine months and 47 per cent at 12 months. This materially exceeds survival rates reported for approved drugs for rGBM; survival rates for MDNA55 at six, nine or 12 months are 44 per cent to 81 per cent better than that of Avastin as well as 35 per cent to 57 per cent better than Lomustine.
"The data presented today are very encouraging, particularly in patients with rGBM, who face a grim diagnosis," commented Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna Therapeutics. "While these are interim data, the ability to demonstrate a substantial survival benefit in this advanced and difficult-to-treat patient population is extremely rare. If the final data are consistent with these results, MDNA55 could offer new hope to GBM patients and their families. We have completed 75 per cent of the recruitment to date, expect to be fully enrolled by early 2019, report top-line data in mid-2019, followed by an end of phase 2 (EOP2) meeting with the USFDA. Medicenna is also exploring MDNA55 for use in newly diagnosed GBM, as these patients typically present with much stronger immune systems and may stand to derive an even greater benefit."
https://www.canadianinsider.com/company?menu_tickersearch=md…
Dec 22/18 Dec 21/18 Merchant, Rosemina Direct Ownership Common Shares 15 - Acquisition under a prospectus 200,000 $1.00
Dec 22/18 Dec 21/18 Merchant, Fahar Direct Ownership Common Shares 15 - Acquisition under a prospectus 200,000 $1.00
Wie die meisten Aktien wurde auch MDNA nach unten geprügelt hinzu kam noch eine vor wenigen tagen abgeschlossene KE die die Aktie auf ein sehr attraktives niveau gebracht haben . Vor ca 2 monaten hat MDNA erste vorläufige Ergebnisse von der P2 Studie (rezidiviertes Glioblastom) veröffentlicht die äußerst vielversprechend sind Top line daten werden für ende 2Q 2019 erwartet .
Bei der letzten KE hat das Management die ohnehin schon über 15 Million von den aktuell 28.5 Million außenstehenden Aktien halten weitere 400k aktien zugekauft was mich dazu bewogen hat hier wieder mit einer kleinen spekulativen position einzusteigen . Kann mir gut vorstellen das die Aktie im vorfeld der P2 Daten bis $3 laufen könnte wenn nicht noch höher . MDNA ist hochriskant aber dementsprechend ist auch das Potential riesig vor allem weil die ersten Daten wirklich sehr gut sind und viele Investoren wesentlich mehr für ihre Aktien bezahlt haben .
Marktkap: 25 Mio C$
Cash: 4.8 Mio C$ (inkl KE) soll laut Management bis nach den P2 Daten reichen
Kurs: 0.87
Aktienanzahl:28.5 Mio
Aktuelle Präsentation
https://ir.medicenna.com/download/MEDICENNA+Corporate+Presen…
MEDICENNA PROVIDES POSITIVE INTERIM UPDATE FROM PHASE 2B TRIAL OF MDNA55 IN RECURRENT GLIOBLASTOMA
https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aMDNA-267…
Results from the low-dose cohorts showed promising median overall survival of 9.8 months following a single treatment, with an overall survival rate of 89 per cent at six months, 58 per cent at nine months and 47 per cent at 12 months. This materially exceeds survival rates reported for approved drugs for rGBM; survival rates for MDNA55 at six, nine or 12 months are 44 per cent to 81 per cent better than that of Avastin as well as 35 per cent to 57 per cent better than Lomustine.
"The data presented today are very encouraging, particularly in patients with rGBM, who face a grim diagnosis," commented Dr. Fahar Merchant, PhD, president and chief executive officer of Medicenna Therapeutics. "While these are interim data, the ability to demonstrate a substantial survival benefit in this advanced and difficult-to-treat patient population is extremely rare. If the final data are consistent with these results, MDNA55 could offer new hope to GBM patients and their families. We have completed 75 per cent of the recruitment to date, expect to be fully enrolled by early 2019, report top-line data in mid-2019, followed by an end of phase 2 (EOP2) meeting with the USFDA. Medicenna is also exploring MDNA55 for use in newly diagnosed GBM, as these patients typically present with much stronger immune systems and may stand to derive an even greater benefit."
https://www.canadianinsider.com/company?menu_tickersearch=md…
Dec 22/18 Dec 21/18 Merchant, Rosemina Direct Ownership Common Shares 15 - Acquisition under a prospectus 200,000 $1.00
Dec 22/18 Dec 21/18 Merchant, Fahar Direct Ownership Common Shares 15 - Acquisition under a prospectus 200,000 $1.00
Die Aktie kam infolge der korrektur an den Märkten von $3 auf aktuell unter $2 und bietet für risikofreudige Anleger eine gute Einstiegschance .
Neue Präsentation
http://s21.q4cdn.com/710416940/files/doc_presentations/2018/…
Neue Präsentation
http://s21.q4cdn.com/710416940/files/doc_presentations/2018/…
Medicenna Presents Clinical Data on Initial Experience from Ongoing Phase 2b Study of MDNA55
http://www.prnewswire.com/news-releases/medicenna-presents-c…
http://www.prnewswire.com/news-releases/medicenna-presents-c…
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