Immunogen: Mirvetuximab soravtansine ein zukünftiger Blockbuster (Seite 36)

[Joschka Schröder]

Im letzten CC-Transcript (Januar 2016) hatte ich nachfolgende Aussage von Charlie Morris mit dem Kommentar "schlechtes Vorzeichen?" versehen -> "Last quarter, we also completed enrollment in the Phase 1 cohort assessing mirvetuximab in the treatment of relapsed/refractory folate receptor alpha-positive endometrial cancer. The findings aren’t specifically mature for submission to ASCO by next Tuesday’s deadline, but should be ready for presentation at the later medical conference."
Positive Daten werden gewöhnlich schnellstmöglich publiziert, zumal zwischen Posteranmeldung und Veranstaltung ein knappes halbes Jahr liegt, in dem man zusätzliche Daten generieren kann.

Ein wesentliches Problem besteht darin, dass es außer mirvetuximab soravtansine derzeit keine weitere aussichtsreiche Eigenentwicklung gibt. Wie würde die Kanzlerin sagen? ... Wenn mirvetuximab soravtansine scheitert, dann scheitert Immunogen.

[Joschka Schröder]

IMGN wurde bereits vor 35 Jahren gegründet und hat bislang kein eigenes Präparat zur Zulassung gebracht. Unter den heute kommunizierten Bedingungen ist zu befürchten, dass es auch mit Mirvetuximab soravtansine nicht klappen wird.

[Joschka Schröder]

Antwort auf Beitrag Nr.: 52.309.333 von Ville7 am 29.04.16 14:34:23

Stimmt, das sieht nicht schön aus. Heftiges Kursmetzel, eben lag der Kurs bereits bei 6,77 USD. Irgendwie drängen sich zunehmend Zweifel an der ADC-Technologe auf. In der Theorie großartig ... in der Praxis immer wieder enttäuschend. Gestern im Übrigen bereits SGEN mit enttäuschenden Verkaufszahlen für Adcetris.

[Ville7]

Der Markt quittiert es mit einem neuen 52 Wochen-Tief.

[Ville7]

Antwort auf Beitrag Nr.: 52.308.829 von Ville7 am 29.04.16 13:38:20

Die Firma kann nur enttäuschen! Und das kann sie sehr gut!

Der Grund wieso sie den Trial ändern ist, dass der ORR mit den weiteren Patienten unter 30% runtergerutscht ist, d.h. die Ergebnisse werden in gewisser Weise enttäuschen. Deswegen u.a. auch Übergang auf PFS. Neue Studie startet erst gegen Ende des Jahres, mit FDA wird erst gegen Jahresmitte gesprochen und es wird ein halbes Jahr länger dauern als die ursprünglich geplante Studie.

Man begründet die gesunkene ORR mit vielen Patienten, die mehr als 3 prior therapies hatten, deswegen beschränken sie in der Studie dann auf bis zu 3 prior therapies. Sie rücken damit auf earlier line therapy auf was sie dem Markt als positiv verkaufen wollen. Angeblich würde die Studie nun ein Potential an 5000-7000 Patienten/Jahr in US adressieren von zuvor 2000-3000.

[Ville7]

Antwort auf Beitrag Nr.: 52.308.418 von Joschka Schröder am 29.04.16 12:57:34

Sehe ich aus so.

Änderung von Forward 1:
* 1-stage auf 2-stage (das macht den trial m.E. schneller)
* Enpunkt von ORR auf PFS (das verlangsamt den trial)
* von Phase 2 auf zulassungsrelevante Phase 3

Positiv auch, dass medium und high expression dabei sind. Das lässt schliessen, dass auch die Daten der weiteren 26 Patienten sehr gut sind.

Hoffentlich sind die Ergebnisse dann noch in 2017 zu erwarten (bisher 2018 geplant). Eine Kapitalerhöhung ist ja sowieso wahrscheinlich unausweichlich, das spielt der Markt natürlich. Ich hoffe dass sie bombastische Daten zu ASCO bringen und den Hype zur sanfteren "Verwässerung" nutzen.

Vermutung: die Entscheidung der trial Änderung erfolgte in Abstimmung mit der FDA. Begründung: sie hatten stets kommuniziert, dass sie nur nach Abstimmung mit der FDA in den zulassungsrelevanten stage two part der Studie gehen wollen, u.a. Entscheidung ob nur high expression oder high+medium und Entscheidung ob 3 or 4 wks dosing.

Ich bin gespannt, was wir heute um 14 Uhr im CC mitgeteilt wird....

[Joschka Schröder]

Antwort auf Beitrag Nr.: 52.304.572 von Ville7 am 29.04.16 07:02:57

Ville, die Zahlen sind schon da ... Deine Prognose war richtig, die Guidance ist nach unten angepasst worden.

Positiv ist aber dieser Satz: "Based on the expanded findings, ImmunoGen is modifying its FORWARD I trial from a two-stage, Phase 2 trial with response rate as the primary endpoint to a single-stage, Phase 3 trial with progression-free survival as the primary endpoint. Patients with FRα-positive (medium or high) platinum-resistant ovarian cancer treated with up to three prior regimens will be eligible for enrollment."

Die Mirvetuximab soravtansine-Daten (-> ASCO 2016) müssen folglich sehr gut sein.

Nun bin ich gespannt, welchem Aspekt der Kapitalmarkt mehr Bedeutung beimessen wird. Aus meiner Sicht ist der Studiendaten-Gesichtspunkt viel wichtiger, es würde mich aber auch nicht überraschen, wenn der Kurs wegen der verfehlten Finanzguidance zunächst einmal deutlich nachgeben würde. "Nichts genaues weiß man nicht".

[Ville7]

ImmunoGen Reports Third Quarter Fiscal Year 2016 Financial Results and Provides Corporate Update

− Conference call at 8:00 am ET today will include update on mirvetuximab soravtansine, the first folate receptor α (FRα)-targeting antibody-drug conjugate (ADC), including the design of the FORWARD I trial −

WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company developing targeted cancer therapeutics using its proprietary ADC technology, today reported financial results for the three-month period ended March 31, 2016 - the third quarter of the Company's 2016 fiscal year. ImmunoGen also provided an update on the Company's lead program, mirvetuximab soravtansine, and other wholly owned clinical-stage product candidates.

"We are making important progress with our key product programs," commented Daniel Junius, President and CEO. "In early June, expanded Phase 1 findings with mirvetuximab soravtansine will be presented at ASCO. Based on these data, we are modifying the design of our FORWARD I trial to be a Phase 3 study intended to support full marketing approval. Patient enrollment is proceeding well in our Phase 1b/2 FORWARD II trial that is assessing this novel ADC in combination regimens, and patient dosing has begun in Phase 1 testing of IMGN779, the first ADC utilizing one of our new DNA-alkylating cancer-killing agents."

Mr. Junius continued, "Our partners are also making progress. Takeda has reported preclinical information on a GCC-targeting ADC it is developing utilizing our DNA-alkylating technology, and Novartis and Sanofi recently presented preclinical data on product candidates with our maytansinoid technology. Phase 1 clinical data with Bayer's anetumab ravtansine and Sanofi's SAR566658 are scheduled for poster discussion at ASCO, with data also being presented on Sanofi's isatuximab."

ImmunoGen Product Program Updates

Mirvetuximab soravtansine - First FRα-targeting ADC; potential new treatment for FRα-positive ovarian cancer.

Data will be presented at ASCO from a 46-patient Phase 1 expansion cohort assessing this ADC as monotherapy for FRα-positive platinum-resistant ovarian cancer (abstract #5567). This cohort was increased from 20 patients to provide additional experience in the patient population to better inform the design of ImmunoGen's FORWARD I trial. The data presented will be updated from the 20-patient data reported previously and from that available at the time of abstract submission.
Based on the expanded findings, ImmunoGen is modifying its FORWARD I trial from a two-stage, Phase 2 trial with response rate as the primary endpoint to a single-stage, Phase 3 trial with progression-free survival as the primary endpoint. Patients with FRα-positive (medium or high) platinum-resistant ovarian cancer treated with up to three prior regimens will be eligible for enrollment.
Patient enrollment is ongoing in the FORWARD II trial assessing mirvetuximab soravtansine in combination regimens. A cohort is being added to assess this novel ADC in combination with Merck's anti-PD1, pembrolizumab.

IMGN779 - First-in-class CD33-targeting ADC utilizing a DNA-alkylating cancer-killing agent from ImmunoGen's new family called IGNs.

Patient enrollment has started in the Phase 1 trial assessing this ADC for the treatment of acute myeloid leukemia.

IMGN529 and coltuximab ravtansine - CD37- and CD19-targeting, respectively, ADCs for diffuse large B-cell lymphoma (DLBCL).

Patient enrollment is expected to open shortly in a Phase 2 trial assessing IMGN529 in combination with rituximab and in 1H2017 for coltuximab ravtansine in a combination regimen.

Update on Partner Programs

Phase 1 findings with Sanofi's SAR566658 and Bayer's anetumab ravtansine ADCs with ImmunoGen technology have been accepted for poster discussion at ASCO, with data also being presented on Sanofi's isatuximab (SAR650984).
ImmunoGen, Novartis, and Sanofi had multiple ADC-related presentations at the American Association of Cancer Research (AACR) annual meeting earlier this month. Those by ImmunoGen scientists featured new, novel technologies while those by Novartis and Sanofi related to cadherin6- and LAMP1-targeting ADCs, respectively, utilizing ImmunoGen maytansinoid ADC technology.
Takeda reported data at a scientific conference on a GCC-targeting ADC the company is developing utilizing one of ImmunoGen's new IGN agents.

Financial Results

For the Company's quarter ended March 31, 2016 (3QFY2016), ImmunoGen reported a net loss of $31.9 million, or $0.37 per basic and diluted share, compared to a net loss of $21.6 million, or $0.25 per basic and diluted share, for the same quarter last year (3QFY2015).

Revenues for 3QFY2016 were $19.7 million, compared to $11.4 million for 3QFY2015. The current period includes a $10 million milestone earned from Bayer with the advancement of anetumab ravtansine into a Phase 2 clinical trial designed to support product registration. License and milestone fees for the prior year period include a $5 million milestone earned from Novartis with its initiation of LOP628 Phase 1 clinical testing. Revenues in 3QFY2016 include $7.4 million of non-cash royalty revenues, compared with $5.1 million in cash royalty revenues for the prior year period. Revenues for 3QFY2016 also include $1.2 million of clinical materials revenue and $1.1 million of research and development support fees, compared with $0.7 million and $0.5 million, respectively, in the prior year period.

Operating expenses in 3QFY2016 were $47.3 million, compared to $32.7 million in 3QFY2015. Operating expenses in 3QFY2016 include research and development expenses of $36.1 million, compared to $25.7 million in 3QFY2015. This change is primarily due to increased third-party costs related to the advancement of our wholly owned product candidates, increased clinical trial costs, primarily related to our expansion of the mirvetuximab soravtansine development program, and increased personnel expenses, principally due to recent hiring. Operating expenses include general and administrative expenses of $11.2 million in 3QFY2016, compared to $7 million in 3QFY2015. This increase is primarily due to a non-cash stock compensation charge resulting from the CEO transition, as well as increased personnel expenses and professional services.

ImmunoGen had approximately $182.9 million in cash and cash equivalents as of March 31, 2016, compared with $278.1 million as of June 30, 2015, and had no debt outstanding in either period. Cash used in operations was $91.6 million in the first nine months of FY2016, compared with $26.8 million in the same period in FY2015. The prior year period benefited from $25 million in upfront payments received including $20 million in connection with the execution of the right-to-test agreement with Takeda in March 2015, as well as lower operating expenses. Capital expenditures were $8.6 million and $4.5 million for the first nine months of FY2016 and FY2015, respectively.

Financial Guidance for Fiscal Year 2016

ImmunoGen has updated its guidance for its fiscal year ending June 30, 2016. Expected revenues are now projected to be between $60 million and $70 million, compared with previous guidance of between $70 million and $80 million. The change is primarily due to changes in the expected timing of partner events and is mainly non-cash. Operating expenses are now projected to be between $180 million and $185 million, compared with previous guidance of between $175 million and $180 million. The change is primarily related to greater clinical trial costs and non-cash stock compensation charges. The Company's guidance for its net loss is now expected to be between $135 million and $140 million, compared to its previous estimate of $120 million and $125 million with most of this change being non-cash related.

ImmunoGen now projects cash and cash equivalents at June 30, 2016 to be between $155 million and $160 million, compared to previous guidance of $165 million to $170 million. This change reflects the cash impact of less partner upfront and milestone payments. The Company's guidance for cash used in operations is now projected to be between $110 million and $115 million, which had previously been $100 million and $105 million. The Company's guidance for capital expenditures remains unchanged, which is between $13 million and $15 million.

Conference Call Information

ImmunoGen is holding a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 913-312-0936; the conference ID is 7099318. The call also may be accessed through the Investors section of the Company's website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 13, 2016.

[Ville7]

Heute um 14Uhr kommen die Q3 Zahlen. Wahrscheinlich mal wieder unterirdisch ....

[Ville7]

Neuer Phase 2 Trial zu anetumab ravtansine:

https://clinicaltrials.gov/ct2/show/NCT02751918?term=bay94-9…