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[verwijderd] 7 april 2016 16:37

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Flosz bedankt voor het ophalen van dit draadje.

Pokerface 7 april 2016 19:44

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Ik verbaas me wel over het feit dat de resultaten pas in de tweede helft van 2017 verwacht worden. Waarom moet dat zo lang duren?

[verwijderd] 7 april 2016 23:50

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recruteren van patienten is erg lastig bij dit soort orphan diseases. als je al minimaal 20 wks resultaten wilt totaal, en je nog alles op moet starten, zit je zo een jaar verder (hier hebben ze het op redelijk safe gespeeld in mijn ogen)

aston.martin 8 april 2016 00:37

1

quote:
Pokerface schreef op 7 april 2016 19:44:
Ik verbaas me wel over het feit dat de resultaten pas in de tweede helft van 2017 verwacht worden. Waarom moet dat zo lang duren?

@pokerface
Ik heb zelf de markering in de tekst aangebracht waaruit moet blijken waarom de resultaten zolang op zich zullen laten wachten.
Het wordt blijkbaar een soort gecombineerde fase 1a/1b met gezonde vrijwilligers én met patiënten. Er staat namelijk duidelijk inclusief de mogelijke direct opvolgende studie in patiënten
Door het tweede deel van de studie zal men ook al wel iets over de mogelijke werking in patiënten willen te weten komen.

Het primaire doel van de Fase 1 studie is om de veiligheid en verdraagbaarheid na eenmalige
oplopende doseringen va nMOR106 te bestuderen. De studie is gerandomiseerd en geblindeerd
voor vrijwilligers en artsen, omvat een placebogroep en wordt gehouden in één centrum in België.
Het nieuwe antilichaam zal aan minimaal 56 gezonde vrijwilligers worden toegediend. Deze Fase
1 studie kan gemakkelijk worden aangepast, waardoor, afhankelijk van de uitkomst van de studie
in gezonde vrijwilligers, direct een meervoudige doseringsstudie in patiënten kan starten.
Het secundaire doel van de Fase 1 studie is het bepalen van het farmocokinetische profiel van
MOR106, en ook of er anti-medicijnantilichamen aanwezig zijn als maatstaf voor de mate waarin
het antilichaam een specifieke immuunrespons oproept na toediening van MOR106. De resultaten
van de hele studie, inclusief de mogelijke direct opvolgende studie in patiënten, worden verwacht
in de tweede helft van 2017.
“De alliantie met MorphoSys heeft een first-in-class kandidaat-antilichaam opgeleverd,” zegt Piet
Wigerinck, CSO van Galapagos. “MOR106 is het tiende Galapagos’ kandidaatmedicijn met een
nieuw werkingsmechanisme dat de klinische fase ingaat.”
“We zijn verheugd dat het eerste antilichaamprogramma binnen onze alliantie met Galapagos de
fase van klinische ontwikkeling heeft bereikt. MOR106 is ons vijfde eigen antilichaamprogramma
in klinische ontwikkeling en het eerste van ons nieuwe Ylanthia technologie platform. We zijn
enthousiast over de groeiende waarde en volwassenheid van onze ontwikkelingspijplijn. De start
van dit zeer innovatieve klinische ontwikkelingsprogramma geeft ook de kracht aan van onze
voortgaande samenwerking met Galapagos,” aldus Dr. Arndt Schottelius, Chief Development
Officer van MorphoSys AG

Pokerface 8 april 2016 13:34

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@Tradens: Thanks, maar dit onderzoek gaat om gezonde vrijwilligers en die zijn niet zo moeilijk te vinden lijkt me.

@aston.martin: Ook bedankt. Als ze inderdaad die vervolgstudieresultaten tegelijk met de resultaten in gezonde vrijwilligers willen presenteren, dan snap ik dat dat wel even gaat duren. Maar ik zou verwachten dat ze eerst de test met gezonde vrijwilligers doen en die resultaten publiceren en dat daarna pas met de volgende fase gestart wordt. Maar goed, ik ben een leek op dit gebied, dus ik wacht het verder af. Het wordt in ieder geval weer geen saai jaar.

NielsjeB 9 april 2016 12:32

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Thanks aston.martin. Hopelijk betekent dit dat als er ook patiënten betrokken gaan worden dat we in de ClinicalTrials-melding iets meer te weten komen over het ziektebeeld dat getarget gaat worden. Of zouden ze dat kunnen afschermen?

aston.martin 9 april 2016 15:01

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quote:
NielsjeB schreef op 9 april 2016 12:32:
Thanks aston.martin. Hopelijk betekent dit dat als er ook patiënten betrokken gaan worden dat we in de ClinicalTrials-melding iets meer te weten komen over het ziektebeeld dat getarget gaat worden. Of zouden ze dat kunnen afschermen?

Op ClinicalTrials is geen info te vinden over VX152 en VX440, de twee second generation correctors van Vertex. Toch weten we sinds deze week met zekerheid dat beide studies inderdaad opgestart en lopende zijn.
Misschien wordt om concurrentiële redenen over MOR106 voorlopig ook niets bekend gemaakt.

NielsjeB 14 april 2016 19:08

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First in Human Single Dose of MOR106
www.clinicaltrials.gov/ct2/show/NCT02...

Kan niets ontdekken dat richting de target disease wijst.

K. Wiebes 14 april 2016 19:32

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Fase 1: Gezonde deelnemers.

flosz 29 september 2016 11:25

3

www.morphosys.com/media-investors/med...
Mag hier niet ontbreken imho.

Bijlage:

[verwijderd] 30 september 2016 08:28

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Is Atopic dermatitis een specifieke mannelijke ziekte of is er een andere reden waarom de fase 1 (1e deel) alleen in mannen is uitgevoerd ?

Verder viel me op dat het eerste deel van de studie iets voor op schema is afgerond. 2H17 voor de eindresultaten lijkt dan ook (bewust?) ruim bemeten.

moi!! 30 september 2016 08:56

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quote:
winx08 schreef op 30 september 2016 08:28:
Is Atopic dermatitis een specifieke mannelijke ziekte of is er een andere reden waarom de fase 1 (1e deel) alleen in mannen is uitgevoerd ?

Verder viel me op dat het eerste deel van de studie iets voor op schema is afgerond. 2H17 voor de eindresultaten lijkt dan ook (bewust?) ruim bemeten.

Goede vraag!is mij bij andere onderzoeken ook opgevallen, dat er gekozen werd voor een groep mannen. Toen had dit te maken met dat mannen geen last van "maandelijkse vrouwen dingen" hebben. Dus stabieler zijn in de hormoonhuishouding. Met name in studies in kleine groepen wordt daarom gekozen voor mannen, je krijgt meer betrouwbare cijfers.

harvester 17 oktober 2016 22:25

2

MorphoSys Presents Updated Clinical Results for MOR202 - Multiple Myeloma -at Medical Conference

HOMEMEDIA AND INVESTORSMEDIA CENTER MORPHOSYS PRESENTS UPDATED CLINICAL RESULTS FOR...
October 17, 2016 / 7:30 am, CEST

In Ongoing Phase 1/2a Study, Anti-CD38 Antibody Continues to Show Encouraging Clinical Response Rates in Heavily Pre-Treated Patients
Multiple Myeloma
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) presented updated safety and efficacy data from an ongoing phase 1/2a clinical study evaluating MOR202, an investigational antibody targeting CD38, alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom), plus dexamethasone (Dex) in heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). Data were presented during a poster presentation at the 2016 annual meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology in Leipzig/Germany.

Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG, commented: "We are very pleased that these results are consistent with earlier data from the ongoing trial and show further improved responses with more patients being evaluable for efficacy and safety assessment. In addition to the very short infusion-time, we are particularly interested in the efficacy results in patients treated with MOR202 plus pomalidomide, who had a median of four prior therapies. The dose escalation study is ongoing as planned, currently focusing on the highest dose cohorts of 16 mg/kg MOR202 in combination with pomalidomide and lenalidomide."

78 % of evaluable patients (7 out of 9) treated with MOR202 in combination with Len/Dex showed an objective response (i.e. complete response (CR) or partial response (PR)). In the patient group treated with MOR202 plus Pom, 60 % (3 out of 5) showed an objective response, with two patients achieving a complete remission (CR). Considering only patients enrolled per protocol, the ORR (objective response rate) in this patient group rises to 75 % and the CR rate to 50 %. Of the patients treated with MOR202 alone, so far 29 % (5 out of 17) showed an objective response. Median time to response was six weeks with most responses deepening over time. 12 of the 15 responses are currently ongoing for up to 56 weeks.

When MOR202 was given as a 2-hour infusion up to the highest dose of 16 mg/kg, 92 % of patients treated showed no infusion-related reactions (IRRs). IRRs occurred in just 8 % of patients (3 % of grade 1, 5 % of grade 2) and were mainly limited to the first infusion. No unexpected safety signals were observed. The most frequent adverse events of grade 3 or higher were, as expected, hematological and included lymphopenia, neutropenia and leukopenia. No treatment-related deaths were reported.

Biomarker data on bone marrow plasma cells suggests that during MOR202 therapy, expression of CD38 as the target molecule for MOR202 seems to be preserved.

The poster presented at the DGHO Annual Meeting can be downloaded from the Company's website.

harvester 2 november 2016 21:36

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MorphoSys and LEO Pharma Enter into Strategic Alliance to Develop Therapeutic Antibodies in Dermatology

You are here
HOMEMEDIA AND INVESTORSMEDIA CENTERMORPHOSYS AND LEO PHARMA ENTER INTO STRATEGIC...
November 02, 2016 / 7:30 am, CET

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and LEO Pharma today announced that they have entered into a strategic alliance for the discovery and development of therapeutic antibodies for the treatment of skin diseases. The objective of the alliance is to identify novel, antibody-based therapeutics for unmet medical needs that will be valuable additions to both companies' pipelines.

Collaborating on multiple targets selected by LEO Pharma, the two companies will work together to identify, validate and develop novel therapeutic antibodies. MorphoSys will apply its proprietary Ylanthia technology to generate fully human antibody candidates against the selected targets and will conduct all development activities up to the start of clinical testing. LEO Pharma will be responsible for clinical development and commercialization of resulting drugs in all indications outside of cancer. In skin cancer indications, MorphoSys will have options to co-develop and, in Europe, co-promote the respective antibody drugs. In addition, MorphoSys will have certain options to develop and commercialize programs arising from the collaboration in other cancer indications.

MorphoSys will receive R&D funding as well as success-based development, regulatory and commercial milestone payments, plus royalties on net sales of drugs commercialized by LEO Pharma. Assuming all development, regulatory and sales objectives are reached, milestone payments would sum up to EUR 111.5 million per antibody program.

"We are excited to join forces with LEO Pharma in a strategic alliance to develop novel, antibody-based drugs," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "Combining our antibody expertise with LEO Pharma's deep understanding of dermatology creates an ideal route to products in an area of severe unmet medical need. This alliance is another important step in the execution of our strategy of leveraging our capabilities to build a pipeline of innovative therapeutic antibodies."

"We see exciting potential to develop new treatments for people with skin diseases through our strategic alliance with MorphoSys," said Gitte Aabo, CEO & President of LEO Pharma. "By joining forces to discover and develop new therapeutic antibodies, we aim to address a high unmet medical need among people with skin diseases. This partnership demonstrates our commitment to expanding our treatment offering and strengthening our position in biologics within dermatology."

harvester 2 november 2016 21:40

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Nu zowel relatie LEO Pharma met Morphosys als met Galapagos

oude bericht (zit achter omzetstijging en resultaatsverbetering Fidelta dit jaar):
Regulated information 25 April 2014
Fidelta announces integrated drug discovery collaboration with LEO Pharma
Zagreb, Croatia, 25th April 2014 – Fidelta, a Galapagos company, announced today that it has signed an integrated drug discovery collaboration agreement with LEO Pharma. Under the terms of the agreement, Fidelta will apply its extensive drug discovery expertise to an undisclosed target within LEO Pharma’s dermatology drug discovery portfolio.
Phil Dudfield, Managing Director, Fidelta commented, “We are delighted about the contract with LEO Pharma, one of the leading research-based pharmaceutical companies and a new client for Fidelta. It is testament to the strength and depth of Fidelta’s drug discovery capabilities and expertise in chemistry and pharmacology. Fidelta continues to build its client base and execute further on its planned growth path.”
Thorsten Thormann, Senior Vice President, New Product Discovery at LEO Pharma: “LEO Pharma wishes to provide more new treatment solutions to people with skin diseases even faster. In order to achieve this, we wish to collaborate with partners that give us access to new expertise, knowledge and technology within our field. The collaboration with Fidelta is a step that contributes to strengthen our R&D strategy”.

------------------------------------------

quote:
harvester schreef op 2 november 2016 21:36:
MorphoSys and LEO Pharma Enter into Strategic Alliance to Develop Therapeutic Antibodies in Dermatology

You are here
HOMEMEDIA AND INVESTORSMEDIA CENTERMORPHOSYS AND LEO PHARMA ENTER INTO STRATEGIC...
November 02, 2016 / 7:30 am, CET

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and LEO Pharma today announced that they have entered into a strategic alliance for the discovery and development of therapeutic antibodies for the treatment of skin diseases. The objective of the alliance is to identify novel, antibody-based therapeutics for unmet medical needs that will be valuable additions to both companies' pipelines.

Collaborating on multiple targets selected by LEO Pharma, the two companies will work together to identify, validate and develop novel therapeutic antibodies. MorphoSys will apply its proprietary Ylanthia technology to generate fully human antibody candidates against the selected targets and will conduct all development activities up to the start of clinical testing. LEO Pharma will be responsible for clinical development and commercialization of resulting drugs in all indications outside of cancer. In skin cancer indications, MorphoSys will have options to co-develop and, in Europe, co-promote the respective antibody drugs. In addition, MorphoSys will have certain options to develop and commercialize programs arising from the collaboration in other cancer indications.

MorphoSys will receive R&D funding as well as success-based development, regulatory and commercial milestone payments, plus royalties on net sales of drugs commercialized by LEO Pharma. Assuming all development, regulatory and sales objectives are reached, milestone payments would sum up to EUR 111.5 million per antibody program.

"We are excited to join forces with LEO Pharma in a strategic alliance to develop novel, antibody-based drugs," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "Combining our antibody expertise with LEO Pharma's deep understanding of dermatology creates an ideal route to products in an area of severe unmet medical need. This alliance is another important step in the execution of our strategy of leveraging our capabilities to build a pipeline of innovative therapeutic antibodies."

"We see exciting potential to develop new treatments for people with skin diseases through our strategic alliance with MorphoSys," said Gitte Aabo, CEO & President of LEO Pharma. "By joining forces to discover and develop new therapeutic antibodies, we aim to address a high unmet medical need among people with skin diseases. This partnership demonstrates our commitment to expanding our treatment offering and strengthening our position in biologics within dermatology."

harvester 28 november 2016 22:38

1

28/11/2016
MorphoSys Announces That Its Licensee Janssen Has Submitted a Marketing Authorisation Application For Guselkumab in Europe

Het ziet er naar uit dat Morphosys ook steeds meer cashflow gaat genereren, net als Galapagos. Goed voor Mor 106 joint development funding.

harvester 7 december 2016 12:25

1

December 06, 2016 / 7:30 am, CET - MOR202 Multiple Myeloma

Updated Results Include Clinical Response Rates from Ongoing Phase 1/2a Study with MOR202 in Patients with Relapsed / Refractory Multiple Myeloma

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) presented updated safety and efficacy data from an ongoing phase 1/2a clinical study evaluating MOR202 alone and in combination with immunomodulatory drugs (IMiDs) lenalidomide (Len) and pomalidomide (Pom), plus dexamethasone (Dex), in heavily pre-treated patients with relapsed/refractory multiple myeloma (MM). MOR202 is an investigational human antibody targeting CD38. Data were presented during an oral presentation at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, California/USA.

"The results presented include updated data from higher dosing cohorts of MOR202 in combination with IMiDs, in patients being evaluable for efficacy and safety assessment. In addition to the infusion time of 2 hours and the occurrence of infusion-related reactions in only 7% of the patients, we are particularly pleased with the responses seen in patients treated with MOR202 plus Len/Dex and Pom/Dex", Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG, commented. "We look forward to enrolling more patients in the highest dosing cohorts of 16 mg/kg MOR202 in these combinations."

harvester 7 december 2016 12:27

1

December 06, 2016 / 7:30 am, CET MOR208 relapsed/refractory NHL

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today the presentation of updated safety and efficacy data from two ongoing phase 2 clinical studies evaluating MOR208, an Fc-modified investigational antibody targeting CD19, in patients with advanced B-cell malignancies, at the 58th American Society of Hematology (ASH) Annual Meeting in San Diego, California/USA.

Continued long-lasting responses of more than 26 months reported in patients with relapsed/refractory NHL in a phase 2a trial with MOR208 monotherapy

harvester 7 december 2016 16:19

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Aandeel MorphoSys CHX:MOR, DE0006632003 koers weer stijgende vandaag 7 dec.
(na de berichten van gisteren)

Realtime (EUR) Verschil Volume Bied Laat Vandaag 52W
43,720 +0,970 (+2,27%)
16:14:14
30.799
Gem. 35,2K -12% 43,705
100
43,770
3
42,675
44,000

Dus vandaag weer op de emissieprijs van 15 Nov. 2016 waarop EUR 115 miljoen was opgehaald via versnelde bookbuilding.

harvester 4 januari 2017 17:20

0

Morphosys koers inmiddels opgelopen naar EUR 49.80.

In onderstaand artikel wordt gesuggereerd dat Gilead op overname pad zou kunnen gaan nu Alessandro Riva van Novartis naar Gilead komt.
Gezien haar specialisme (hematologie + kanker) zou ook Morphosys wel eens op het vizier kunnen zijn gekomen.

Gilead Sciences: With New Hire, M&A Might Be on the Way
•

Investors have been waiting for Gilead Sciences (GILD) to do something--anything--to reverse the stock's slide. Yesterday, however, news broke that Gilead had hired Alessandro Riva to head up its hematology and oncology division, a move that could ultimately lead to M&A, says Jefferies analyst Brian Abrahams and team. Shares of Gilead Sciences have gained 2.2% to $75.78 at 9:56 a.m. today, while Incyte has advanced 0.6% to $102.97.

Vertraagd	24 apr 2024 17:35
Koers	27,120
Verschil	-0,440 (-1,60%)
Hoog	27,760
Laag	27,100
Volume	86.317
Volume gemiddeld	80.194
Volume gisteren	52.063

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