MDNA.TO ( Mkap C$ 36M) (Cash C$20 M) Positive P2 Daten in Q1 könnten für Zulassung reichen (Seite 8)

[Bullrich83]

Antwort auf Beitrag Nr.: 59.624.021 von Readyx am 14.01.19 10:00:16

Hier 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…

[Readyx]

Antwort auf Beitrag Nr.: 59.622.326 von Biohero am 13.01.19 22:26:42

Klar kann hier ein Totalverlust folgen, nur das nach den Phase 2 Daten.. Ist das so gemeint? Gruss

[Biohero]

Antwort auf Beitrag Nr.: 59.622.119 von Bullrich83 am 13.01.19 21:24:41

Naja 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."

[Bullrich83]

Antwort auf Beitrag Nr.: 59.587.337 von Biohero am 08.01.19 20:21:01

Sieht 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

[Biohero]

Antwort auf Beitrag Nr.: 59.560.169 von Biohero am 04.01.19 17:23:35

MDNA 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

[Biohero]

Antwort auf Beitrag Nr.: 56.964.653 von Biohero am 07.02.18 19:02:01

Kleines 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

[Biohero]

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/…

[Maggi110]

Medicenna Presents Clinical Data on Initial Experience from Ongoing Phase 2b Study of MDNA55


http://www.prnewswire.com/news-releases/medicenna-presents-c…

[techinvestor69]

Medicenna Updates On-Going Phase 2b Clinical Trial Protocol for Recurrent Glioblastoma

Canada NewsWire

TORONTO and HOUSTON, Sept. 28, 2017

Safety Review Committee Reports Encouraging Drug Distribution and Tolerability

TORONTO and HOUSTON, Sept. 28, 2017 /CNW/ - Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA), a clinical stage immuno-oncology company, announced today that based on encouraging drug distribution and safety data observed in the on-going Phase 2b clinical trial of MDNA55 for the treatment of patients with recurrent glioblastoma (rGBM), the Company has commenced implementation of an updated protocol following its submission to the U.S. Food and Drug Administration (FDA) and approval by the respective Institutional Review Boards (IRBs). The amended protocol incorporates an enhanced drug delivery procedure which will be used for the treatment of the remaining patients. The updated protocol includes higher doses and volumes of MDNA55 as well as an increase in the total expected study size – from 43 patients under the original protocol to 52 total planned patients now expected to enroll. Patient enrolment and treatment continues at multiple sites.

"Based on data that will be presented at the 2017 CNS conference in Boston (7-11 October 2017), we are pleased with the encouraging drug distribution, safety and tolerability of MDNA55 in our ongoing Phase 2b rGBM study," stated Dr. Fahar Merchant, Chairman, President and CEO of Medicenna. "These data indicate a wider therapeutic window than originally anticipated and we can leverage this new, preliminary safety understanding for the remainder of the study. The decision to amend the study protocol by increasing the dosage and volume of MDNA55 has the potential to address the needs of an expanded patient population, including patients with larger or multi-focal tumors."

This protocol amendment was based on a planned safety analysis following a unanimous recommendation from MDNA55's Safety Review Committee (SRC) after enrollment of the first six patients. Based on the exceptional safety profile, the concentration of MDNA55 will be doubled to 3.0 mg/mL and the volume administered will be maximized to a fixed volume of 60mL to ensure complete tumor coverage along with the surrounding margin of the tumor, irrespective of tumor size. The protocol amendment was discussed with all current investigators and input was received from thought leaders in the area of glioblastoma and Convection-Enhanced Delivery (CED) in order to optimize patient benefit following a single treatment with MDNA55. The maximum dose of 180mg is well within the established safety profile based on earlier studies.

"By increasing the infusion volume, we are seeking to ensure optimal coverage of the tumor and the surrounding penumbra. Early results from the interim safety analysis indicates that the current dose of MDNA55 has been well tolerated in the initial cohort of patients," said John H. Sampson, MD, PhD, MBA, MHSc, Chair of the Department of Neurosurgery, Duke University School of Medicine.

In the amendment of the protocol, the primary endpoint of the study remains the same: To determine the objective response rate (ORR) per a modified RANO (Response Assessment in Neuro-Oncology) criteria following a single intra- and peri-tumoral infusion of MDNA55 using CED.

A single-stage binomial design test for a null ORR of 6% versus an alternative ("pursue") ORR of 18%, at alpha = 0.1, 1-sided, will have 80% power with 36 evaluable subjects. The sample size of the study has been increased from 43 to 52 patients including 35 patients under the amended protocol. The Company expects enrollment to be completed by early 2018, with interim top-line results expected during the first half of 2018.

Details regarding the protocol amendment for MDNA55-05 will be available on ClinicalTrials.gov. 

About Medicenna Therapeutics Corp.

Medicenna is a clinical stage immuno-oncology company developing novel highly selective versions of IL-2, IL-4 and IL-13 Superkines™ and first in class Empowered Cytokines™ (ECs). Its wholly owned subsidiary, Houston-based Medicenna BioPharma, is specifically targeting the Interleukin-4 Receptor (IL4R), which is over-expressed by at least 20 different types of cancer affecting more than one million new cancer patients every year. Medicenna's lead IL4-EC, MDNA55 is enrolling patients in a Phase 2b clinical trial for rGB at leading brain cancer centres in the US. MDNA55 has completed 3 clinical trials in 72 patients, including 66 adults with rGB, demonstrated compelling efficacy and obtained Fast-Track and Orphan Drug status from USFDA. Unlike most other cancer therapies, Medicenna's IL4-ECs have the potential to purge both the tumor and the immunosuppressive tumor microenvironment, offering a unique treatment paradigm for a large majority of cancer patients.

For more information, please visit www.medicenna.com.

[Biohero]

Hier wird es schon am 10. Oktober ein Update über die laufende Phase 2b studie geben aber nur was Sicherheitsprofil und Tolerierbarkeit angeht könnte trotzdem den Kurs eventuell einen kleinen schub geben .


Medicenna Announces Late Breaking Oral Presentation at the 2017 Congress of Neurological Surgeons (CNS) Annual Meeting
https://finance.yahoo.com/news/medicenna-announces-breaking-…

Title:Real time, image guided high flow CED in recurrent glioblastoma (rGBM); initial experience from phase II study of a targeted immunotherapy, MDNA55 (cpIL-4PE)

Date:Tuesday, October 10, 2017

Time:7:48 AM

Session:Late Breaking Abstract Session

Session ID:250 (sub session 250-90)

Location:258B – Boston Convention and Exhibition Center