Immunogen: Mirvetuximab soravtansine ein zukünftiger Blockbuster (Seite 37)

[Ville7]

Es gibt einen neuen CEO, der mit viel Geld angelockt wurde - die Nachricht wird am Markt mit einem Abschlag von 7% begrüßt. Oder der Markt zittert schon vor den Q3 Zahlen am Freitag.

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ImmunoGen Appoints Mark J. Enyedy as President and Chief Executive Officer

- Proven leader with deep experience building oncology businesses -

WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN) a biotechnology company developing targeted cancer therapeutics using its proprietary antibody-drug conjugate (ADC) technology, today announced that Mark J. Enyedy has been appointed President and CEO and elected to the Board of Directors, effective May 16, 2016. Mr. Enyedy succeeds Daniel Junius, who as previously announced is retiring from these positions and will continue to serve on ImmunoGen's Board.

"Today, ImmunoGen has a rich pipeline of wholly-owned oncology product candidates, validated technology, and strong research," said Stephen McCluski, Chairman of the Board. "Mark's proven leadership skills, combined with his deep experience building science-based oncology businesses, make him ideally suited to take ImmunoGen to the next level."

Mr. Enyedy, 52, brings over 25 years of combined general management, business development and legal experience in the biotechnology industry. He joins ImmunoGen from Shire plc, where he served as Executive Vice President and Head of Corporate Development, leading the company's Strategy, M&A, and Corporate Planning functions and providing commercial oversight for the company's pre-Phase 3 portfolio. Previously, Mr. Enyedy served as CEO of Proteostasis Therapeutics, Inc., following 15 years at Genzyme Corporation in diverse roles, most recently as President of the Transplant, Oncology, and Multiple Sclerosis divisions. During his tenure at Genzyme, Mr. Enyedy developed and executed the company's strategy to enter the oncology market, overseeing the launch of two new products and managing a global business generating over $675 million in revenue with operations in more than 50 countries.

Before joining Genzyme, Mr. Enyedy was an associate with the Boston law firm Palmer & Dodge. He holds a J.D. from Harvard Law School and a B.S. from Northeastern University. Mr. Enyedy also serves on the Board of Directors of Fate Therapeutics.

"I am pleased to be joining ImmunoGen at such an important time in the Company's evolution and helping to build upon its leadership position in the exciting ADC field," said Mr. Enyedy. "With a lead product in later-stage testing for ovarian cancer, a strong portfolio of earlier-stage candidates, and a productive technology platform, ImmunoGen is well-positioned for sustainable innovation in oncology and value creation for shareholders. I look forward to working with the company's outstanding leadership team, dedicated employees, and global partners to develop and commercialize novel ADC therapies, which hold the potential to deliver better outcomes for cancer patients across an expanding range of indications."

"It has been a privilege to serve as the CEO of ImmunoGen over these past seven years, and I am delighted to have Mark as my successor," said Mr. Junius. "Mark's experience, vision, and leadership skills will enable ImmunoGen to realize its full potential in developing better therapies for cancer patients."

[Ville7]

Antwort auf Beitrag Nr.: 52.230.751 von Ville7 am 20.04.16 08:44:34

Für einen Vergleich sollte man wahrscheinlich die molekulare Masse des AKs kennen. Diese ist bestimmt nicht bekannt.

[Ville7]

ASCO-Abstract Titel:

Abstract 513
Efficacy results of a phase 1b study of ont-380, a CNS-penetrant TKI, in combination with T-DM1 in HER2+ metastatic breast cancer (MBC), including patients (pts) with brain metastases.

Abstract 500
Pathologic complete response (pCR) rates after neoadjuvant trastuzumab emtansine (T-DM1 [K]) + pertuzumab (P) vs docetaxel + carboplatin + trastuzumab + P (TCHP) treatment in patients with HER2-positive (HER2+) early breast cancer (EBC) (KRISTINE).

Abstract 8005
Updated data from a phase II dose finding trial of single agent isatuximab (SAR650984, anti-CD38 mAb) in relapsed/refractory multiple myeloma (RRMM).

Abstract 8009
A phase Ib dose escalation trial of isatuximab (SAR650984, anti-CD38 mAb) plus lenalidomide and dexamethasone (Len/Dex) in relapsed/refractory multiple myeloma (RRMM): Interim results from two new dose cohorts.

Abstract 2511
A phase I study of SAR566658, an anti CA6-antibody drug conjugate (ADC), in patients (Pts) with CA6-positive advanced solid tumors (STs)(NCT01156870).

Abstract TPS8576
A pivotal randomized phase II study of anetumab ravtansine or vinorelbine in patients with advanced or metastatic pleural mesothelioma after progression on platinum/pemetrexed-based chemotherapy (NCT02610140

Abstract 2509
Phase I study of anti-mesothelin antibody drug conjugate anetumab ravtansine (AR).

Abstract 5567
IMGN853 (mirvetuximab soravtansine), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC): single agent activity in platinum-resistant epithelial ovarian cancer (EOC) patients (pts).

[Ville7]

IC50

Meine Schulzeit (Chemie) ist schon zu lange her..

@Joschka: kannst du mir helfen die Einheit ng/ml mit der Einheit pM zu vergleichen. Wie muss ich umrechnen?

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IC50 Vergleich präklinischer Veröffentlichungen bzgl. IC50 - je niedriger, desto besser:

SGEN-CD33A hat IC50 von 22ng/ml

(https://ash.confex.com/ash/2012/webprogram/Paper48592.html)

IMGN779 wird mit 70 pM (= 70 * 10(hoch −12) mol/dm3 entspricht 70* 10(hoch −9) mol/m3) angegeben

(http://www.immunogen.com/documents/Publications/IMGN779%20pr…)

[Joschka Schröder]

Antwort auf Beitrag Nr.: 52.215.649 von Ville7 am 18.04.16 17:43:29

Diese Frage habe ich mir auch schon länger gestellt ... und kann sie leider bis heute nicht beantworten. Immunogen erwartet für ihren IMGN779 unter Hinweis auf präklinische Daten ein besseres Nebenwirkungsprofil bzw. "therapeutisches Fenster" als für den Konkurrenz-ADC SGN-CD33A, eine detaillierte Begründung ist man aber schuldig geblieben.

[Ville7]

Hi Joschka,

was könnte an der IMGN technologie besser sein als an der von SGEN?

Auf den ersten Blick erscheint mir das was IMGN nun an Technologie in die Klinik gebracht hat etwas zu sein, was SGEN schon länger hat...

SGEN:
"pyrrolobenzodiazepine"

IMGN:
"indolino-benzodiazepines"

[Joschka Schröder]

ImmunoGen Announces Initiation of Clinical Testing of First-in-Class IMGN779 for Acute Myeloid Leukemia

Novel CD33-targeting product candidate is the first antibody-drug conjugate (ADC) to employ an IGN, a new type of cancer-killing agent.
Phase 1 study in acute myeloid leukemia (AML) is designed to efficiently inform the IMGN779 development pathway.

WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its extensive ADC technology portfolio, today announced the start of clinical testing of the Company's IMGN779 product candidate for the treatment of AML, a CD33-positive cancer.

IMGN779 contains a CD33-targeting antibody - enabling it to bind to AML cells - with a powerful cancer-killing agent attached to kill them. IMGN779 is the first ADC to utilize one of ImmunoGen's new family of indolino-benzodiazepine cancer-killing agents, which the Company calls IGNs. DNA-alkylating IGNs have been designed to be ultra-potent, yet provide the tolerability necessary for ongoing retreatment.

"There is substantial need for new therapies for AML and considerable appeal to an ADC approach," said Ravi Chari, Ph.D., VP of Chemistry and Biochemistry. "A key challenge has been achieving the potency needed for clinical benefit with the tolerability required for continued patient retreatment. We developed our DNA-alkylating IGNs to meet these dual needs and believe this innovative new class can further extend the types of cancers that can be effectively treated with ADC therapeutics."

The IMGN779 Phase 1 trial in CD33-positive AML will assess two alternative dosing schedules - weekly and biweekly administration - concurrently in its dose-finding stage. The selected dose and schedule will then be used in the two planned expansion cohorts: one assessing IMGN779 in patients with AML in first relapse and one assessing it in patients with relapsed/refractory AML.

"IMGN779 has the potential to make an important difference for patients with AML," said Anna Berkenblit, MD, VP and Chief Medical Officer. "This Phase 1 trial has been designed to efficiently inform the development pathway for IMGN779 by assessing alternative dosing schedules concurrently and then evaluating the selected schedule in specific under-served patient populations."

[Ville7]

http://www.oncologytube.com/v/1037772/mirvetuximab-soravtans…

[Joschka Schröder]

Antwort auf Beitrag Nr.: 52.134.729 von Ville7 am 07.04.16 07:18:42

Die haben, glaube ich, seit über einem halben Jahr mit Headhuntern nach einem Nachfolger gesucht. Bevorstehende schlechte Nachrichten als Ursache des Ausscheidens erscheinen vor diesem Hintergrund eher unwahrscheinlich.

[Ville7]

Daniel Junius, (der in seiner Schaffenszeit recht erfolglose CEO), tritt zurück. Mit der Altersangabe 63 in der Meldung werden Altersgründe suggeriert. Man könnte aber auch spekulieren, ob da etwas nachgeholfen wurde....und ob es nicht noch irgendwelche versteckten bad news gibt, die die eigentliche Ursache dieses Rücktritts sind.