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Business News
January 7, 2019 / 12:40 PM / Updated an hour ago
Lilly to buy Loxo Oncology in $8 billion cancer push
Tamara Mathias
3 Min Read
(Reuters) - Eli Lilly and Co (LLY.N) said on Monday it would buy Loxo Oncology Inc (LOXO.O) for about $8 billion in cash, making its biggest bet on a cancer therapy market expected to be worth several billions of dollars.
FILE PHOTO: The logo and ticker for Eli Lilly and Co. are displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 18, 2018. REUTERS/Brendan McDermid
The deal follows Bristol-Myers Squibb Co (BMY.N) agreement last week to buy Celgene Corp (CELG.O) for $74 billion, and gives Lilly access to Loxo’s portfolio of targeted medicines that treat cancers caused by rare gene mutations.
The portfolio is centered around the company’s first commercial medicine, Vitrakvi, which is sold in partnership with Bayer AG (BAYGn.DE).
Shares of Lilly were down 2.5 percent while those of Loxo were trading close the offer price of $235 per share, which was at a 68 percent premium to the stock’s Friday close.
“The acquisition of Loxo, along with last weeks acquisition of Celgene, may represent the cream of the crop in biotech being harvested by big pharma,” IFS Securities analyst David Bouchey said.
“The size of the deal may indicate Lily’s willingness to pay up to out-bid the competition.”
But BMO Capital Markets analyst Alex Arfaei said the $8 billion valuation seemed high as Loxo was not profitable yet and Wall Street expects revenue of $1 billion only by 2023.
The company bought Armo Biosciences Inc, a developer of drugs that help the body’s immune system to fight cancer, for $1.6 billion last year and indicated that it was on the lookout for similar acquisitions.
Indianapolis, Indiana-based Lilly’s oncology portfolio includes lung cancer drug Alimta, Erbitux, a treatment for certain types of colorectal cancers and gastric cancer medicine Cyramza. Alimta brought in $520.5 million in the latest reported quarter.
Loxo’s Vitrakvi, priced at $32,800 per month, could eventually generate over $750 million in sales along with another similar drug, LOXO-195, according to brokerage Piper Jaffray & Co.
Industrial orders fall in latest sign of German slowdown
Loxo is also developing a drug that targets a rare gene fusion mutation known as RET, seen in thyroid, lung and other cancers.
Lilly’s offer of $235 per share in cash represents a premium of about 68 percent to Loxo’s Friday close. Loxo’s shares jumped to $230 before the bell, while those of Lilly dropped 2.7 percent to $111.60.
Loxo’s shares have run up nearly 65 percent over the past 12 months, while Lilly’s stock has surged 34 percent in the same time.
The deal was announced just ahead of the start of the annual JPMorgan healthcare conference in San Francisco, scheduled to begin on Monday morning.
January 7, 2019 / 12:40 PM / Updated an hour ago
Lilly to buy Loxo Oncology in $8 billion cancer push
Tamara Mathias
3 Min Read
(Reuters) - Eli Lilly and Co (LLY.N) said on Monday it would buy Loxo Oncology Inc (LOXO.O) for about $8 billion in cash, making its biggest bet on a cancer therapy market expected to be worth several billions of dollars.
FILE PHOTO: The logo and ticker for Eli Lilly and Co. are displayed on a screen on the floor of the New York Stock Exchange (NYSE) in New York, U.S., May 18, 2018. REUTERS/Brendan McDermid
The deal follows Bristol-Myers Squibb Co (BMY.N) agreement last week to buy Celgene Corp (CELG.O) for $74 billion, and gives Lilly access to Loxo’s portfolio of targeted medicines that treat cancers caused by rare gene mutations.
The portfolio is centered around the company’s first commercial medicine, Vitrakvi, which is sold in partnership with Bayer AG (BAYGn.DE).
Shares of Lilly were down 2.5 percent while those of Loxo were trading close the offer price of $235 per share, which was at a 68 percent premium to the stock’s Friday close.
“The acquisition of Loxo, along with last weeks acquisition of Celgene, may represent the cream of the crop in biotech being harvested by big pharma,” IFS Securities analyst David Bouchey said.
“The size of the deal may indicate Lily’s willingness to pay up to out-bid the competition.”
But BMO Capital Markets analyst Alex Arfaei said the $8 billion valuation seemed high as Loxo was not profitable yet and Wall Street expects revenue of $1 billion only by 2023.
The company bought Armo Biosciences Inc, a developer of drugs that help the body’s immune system to fight cancer, for $1.6 billion last year and indicated that it was on the lookout for similar acquisitions.
Indianapolis, Indiana-based Lilly’s oncology portfolio includes lung cancer drug Alimta, Erbitux, a treatment for certain types of colorectal cancers and gastric cancer medicine Cyramza. Alimta brought in $520.5 million in the latest reported quarter.
Loxo’s Vitrakvi, priced at $32,800 per month, could eventually generate over $750 million in sales along with another similar drug, LOXO-195, according to brokerage Piper Jaffray & Co.
Industrial orders fall in latest sign of German slowdown
Loxo is also developing a drug that targets a rare gene fusion mutation known as RET, seen in thyroid, lung and other cancers.
Lilly’s offer of $235 per share in cash represents a premium of about 68 percent to Loxo’s Friday close. Loxo’s shares jumped to $230 before the bell, while those of Lilly dropped 2.7 percent to $111.60.
Loxo’s shares have run up nearly 65 percent over the past 12 months, while Lilly’s stock has surged 34 percent in the same time.
The deal was announced just ahead of the start of the annual JPMorgan healthcare conference in San Francisco, scheduled to begin on Monday morning.
Hallo Simon,
2018 war ein Boomjahr für Biotech IPOs in den USA - so viele IPOs wie noch nie.
Klar, so ein Boom zieht viele schwarze Schafe an und viele nutzen es wie du schon schriebst als Gelddruckmaschine. Von den letztjährigen IPOs bringen bestimmt 95% keinen Mehrwert für den Aktionär.
Das Risiko ist in den ersten Jahren enorm. Ich hab HBM Healthcare für solch kleine unbekannte Perlen. Ich würde da wenn eher auf IPOs mit Top-Leute setzten, die es dem Markt schon einmal bewiesen haben und mit an Bord sind (Familie Clozel, Mr. Lobacki als aktuelle Bsp.).
Wenn du 40 Biotechforscher kennst, kann so ein IPO für uns auch lukrativ werden
2018 war ein Boomjahr für Biotech IPOs in den USA - so viele IPOs wie noch nie.
Klar, so ein Boom zieht viele schwarze Schafe an und viele nutzen es wie du schon schriebst als Gelddruckmaschine. Von den letztjährigen IPOs bringen bestimmt 95% keinen Mehrwert für den Aktionär.
Das Risiko ist in den ersten Jahren enorm. Ich hab HBM Healthcare für solch kleine unbekannte Perlen. Ich würde da wenn eher auf IPOs mit Top-Leute setzten, die es dem Markt schon einmal bewiesen haben und mit an Bord sind (Familie Clozel, Mr. Lobacki als aktuelle Bsp.).
Wenn du 40 Biotechforscher kennst, kann so ein IPO für uns auch lukrativ werden
60 als Gruppe langfristig
Der Grossteil wird wertlos verfallen. Es wird aber auch ein paar 10Bagger geben.
Für Privatanleger, die Einzeltitel picken wollen, halt ich das Unterfangen für aussichtslos. Das mag allenfalls für Fonds funktionieren, die sich alle 60 Titel gleichzeitig kaufen und warten können.
Der Grossteil wird wertlos verfallen. Es wird aber auch ein paar 10Bagger geben.
Für Privatanleger, die Einzeltitel picken wollen, halt ich das Unterfangen für aussichtslos. Das mag allenfalls für Fonds funktionieren, die sich alle 60 Titel gleichzeitig kaufen und warten können.
***
Trump's ... not worried about a drop in Apple
Ist das jetzt der neue nationale Geldanlageberater?
Welche Aktien empfiehlt er ausserdem?
***
Biotech ... 60 IPOs in den USA 2018
Ja, das ist venture capital pur. Schreiben (fast) alle Verluste, haben (oft) noch nichtmal Umsätze...
Davon bleiben am Ende wenn's gut kommt 10% übrig...
Ich bin eher unsicher, ob diese 60 als Gruppe langfristig den einfachen S&P500 outperformen werden...
Aber auch sonst waren 2018 nur wenige (überhaupt beurteilbare und nicht rein hoffnungsgetriebene) gute IPOs dabei, finde ich.
Irgendwie hab ich den Eindruck, Biotech ist eine schnelle Gelddruckmaschine geworden... für frühe Investoren... einfach 10 Mio Eigenkapital zusammenbringen, dann noch 10Mio Fremdkapital dazu, damit ein kleines Forschungslabor ausrüsten, 40 Biotech-Forscher anstellen, und dann das Ganze für 100Mio an die Börse bringen...
Trump's ... not worried about a drop in Apple
Ist das jetzt der neue nationale Geldanlageberater?
Welche Aktien empfiehlt er ausserdem?
***
Biotech ... 60 IPOs in den USA 2018
Ja, das ist venture capital pur. Schreiben (fast) alle Verluste, haben (oft) noch nichtmal Umsätze...
Davon bleiben am Ende wenn's gut kommt 10% übrig...
Ich bin eher unsicher, ob diese 60 als Gruppe langfristig den einfachen S&P500 outperformen werden...
Aber auch sonst waren 2018 nur wenige (überhaupt beurteilbare und nicht rein hoffnungsgetriebene) gute IPOs dabei, finde ich.
Irgendwie hab ich den Eindruck, Biotech ist eine schnelle Gelddruckmaschine geworden... für frühe Investoren... einfach 10 Mio Eigenkapital zusammenbringen, dann noch 10Mio Fremdkapital dazu, damit ein kleines Forschungslabor ausrüsten, 40 Biotech-Forscher anstellen, und dann das Ganze für 100Mio an die Börse bringen...
***
wundere ich mich über die Aktienauswahl. Wie passt eine CSX hier rein?
Das ist fraglos kein Glamour-Titel, aber ich wollte eben den zumeist glamour- und growth-biasierten Contest-Depots etwas gegenüberstellen.
Darum hab ich in Erwartung eines Large-Jahres gezielt unter den 100 schwersten Aktien (=erste fünf Marketcap-Dezile) und dort wiederum im billigsten Drittel (sog "deep value") gesucht. Ich wollte aber trotzdem auch eine gewisse Branchendiversifikation haben, darum blieb mir manchmal gar nicht viel Wahl.
Ich arbeite zuletzt wieder vermehrt mit KGV-Historien. Im Industrie&Services -Bereich sieht derzeit Transport relativ zur eigenen Historie speziell billig aus (FDX bspw auch):
Ich habe derzeit circa für 400 Titel solche KGV-Historien und erweitere die "Bibliothek" noch.
CSX sieht nach KGV recht billig aus (allerdings nach KUV oder KFCFV eher nicht, stimmt)
***
Das Eisenbahnnetz ist kapitalintensiv,
Ja, aber der Transport materieller Güter wird auch in Jahrzehnten noch ein Kernbereich der Wirtschaftstätigkeit sein. Wer bin, in diesem Punkt Buffett zu widersprechen?
wundere ich mich über die Aktienauswahl. Wie passt eine CSX hier rein?
Das ist fraglos kein Glamour-Titel, aber ich wollte eben den zumeist glamour- und growth-biasierten Contest-Depots etwas gegenüberstellen.
Darum hab ich in Erwartung eines Large-Jahres gezielt unter den 100 schwersten Aktien (=erste fünf Marketcap-Dezile) und dort wiederum im billigsten Drittel (sog "deep value") gesucht. Ich wollte aber trotzdem auch eine gewisse Branchendiversifikation haben, darum blieb mir manchmal gar nicht viel Wahl.
Ich arbeite zuletzt wieder vermehrt mit KGV-Historien. Im Industrie&Services -Bereich sieht derzeit Transport relativ zur eigenen Historie speziell billig aus (FDX bspw auch):
Ich habe derzeit circa für 400 Titel solche KGV-Historien und erweitere die "Bibliothek" noch.
CSX sieht nach KGV recht billig aus (allerdings nach KUV oder KFCFV eher nicht, stimmt)
***
Das Eisenbahnnetz ist kapitalintensiv,
Ja, aber der Transport materieller Güter wird auch in Jahrzehnten noch ein Kernbereich der Wirtschaftstätigkeit sein. Wer bin, in diesem Punkt Buffett zu widersprechen?
Trading Spotlight
Antwort auf Beitrag Nr.: 59.564.705 von flying.kangaroo am 05.01.19 13:02:46Schönes Update von MRKS. Mal sehen ob sich Trump dazu eines Tages auch mit "They've gone up hundreds of percent since I'm president" schmückt
MRKR
ich bitte um thousands of percent.
zu VCEL Paul Wotton hat ziemlich viele verkauft ... eigentlich müssten die Zahlen aber sehr gut werden - vediamo.
MRKR
ich bitte um thousands of percent.
zu VCEL Paul Wotton hat ziemlich viele verkauft ... eigentlich müssten die Zahlen aber sehr gut werden - vediamo.
VCEL
Vericel veröffentlicht die Ergebnisdaten von 954 mit Epicel behandelten Verbrennungspatienten im Journal of Burn Care and Research - die Ergebnisse zeigten eine erhöhte Überlebensrate (Gesamtüberlebensrate bei >84% anstatt 50%)
"The overall mortality rate by burn size was lower for Epicel-treated patients than that reported in the National Burn Repository 2016 Report. The mean TBSA of burns in patients from the Epicel cohort was 67.5%, with an overall survival at discharge rate of 84.4% (804/953). According to the data set reported in the 2016 American Burn Association National Burn Repository, burns greater than 65 to 70% TBSA are associated with a 50% case mortality rate.
This new dataset demonstrating increased survival rates for patients treated with Epicel over a period of 25 years supports the strong clinical benefit achieved with Epicel in large full thickness burns,” said Jon Hopper, Vericel’s chief medical officer. “These data are important to patients and physicians since Epicel is the only FDA-approved permanent skin replacement for adult and pediatric patients with full-thickness burns."
https://globenewswire.com/news-release/2019/01/04/1680692/0/…
In 2 Monaten gibt es die Q4 Ergebnisse - MACI sollte auch weiter stark zulegen. Bei Schwäche stocke ich vorher auf!
@Clearasil
Schönes Update von MRKS. Mal sehen ob sich Trump dazu eines Tages auch mit "They've gone up hundreds of percent since I'm president" schmückt
+++
Biotech 2018 allgemein
Biotech IPO Market: Closing The Books On 2018’s Crazy Year
60 IPOs in den USA 2018 die am Jahresende so aussahen:
Veränderung absolut
https://lifescivc.com/2019/01/biotech-ipo-market-closing-the…
cheers
Vericel veröffentlicht die Ergebnisdaten von 954 mit Epicel behandelten Verbrennungspatienten im Journal of Burn Care and Research - die Ergebnisse zeigten eine erhöhte Überlebensrate (Gesamtüberlebensrate bei >84% anstatt 50%)
"The overall mortality rate by burn size was lower for Epicel-treated patients than that reported in the National Burn Repository 2016 Report. The mean TBSA of burns in patients from the Epicel cohort was 67.5%, with an overall survival at discharge rate of 84.4% (804/953). According to the data set reported in the 2016 American Burn Association National Burn Repository, burns greater than 65 to 70% TBSA are associated with a 50% case mortality rate.
This new dataset demonstrating increased survival rates for patients treated with Epicel over a period of 25 years supports the strong clinical benefit achieved with Epicel in large full thickness burns,” said Jon Hopper, Vericel’s chief medical officer. “These data are important to patients and physicians since Epicel is the only FDA-approved permanent skin replacement for adult and pediatric patients with full-thickness burns."
https://globenewswire.com/news-release/2019/01/04/1680692/0/…
In 2 Monaten gibt es die Q4 Ergebnisse - MACI sollte auch weiter stark zulegen. Bei Schwäche stocke ich vorher auf!
@Clearasil
Schönes Update von MRKS. Mal sehen ob sich Trump dazu eines Tages auch mit "They've gone up hundreds of percent since I'm president" schmückt
+++
Biotech 2018 allgemein
Biotech IPO Market: Closing The Books On 2018’s Crazy Year
60 IPOs in den USA 2018 die am Jahresende so aussahen:
Veränderung absolut
https://lifescivc.com/2019/01/biotech-ipo-market-closing-the…
cheers
President Trump's latest interchange with reporters included new stock commentary, on news dominating the tech sector this week: He's not worried about a drop in Apple's (AAPL +3.7%) stock price.
"They've gone up hundreds of percent since I'm president," he says. "Apple was at a number that was incredible and they're gonna be fine; Apple is a great company." (Apple shares are up 26.7% since Trump's inauguration, adjusting for dividends and splits.)
He is calling for them to move manufacturing to the U.S., however.
"Don't forget this: Apple makes their product in China," he says. "I told [CEO] Tim Cook ... make your product in the United States. Build those big beautiful plants that go on for miles, it seems. "China is the biggest beneficiary of Apple, more than us ... I want Apple to make their iPhones and all of the great things that they make in the United States, and that'll take place."
"They've gone up hundreds of percent since I'm president," he says. "Apple was at a number that was incredible and they're gonna be fine; Apple is a great company." (Apple shares are up 26.7% since Trump's inauguration, adjusting for dividends and splits.)
He is calling for them to move manufacturing to the U.S., however.
"Don't forget this: Apple makes their product in China," he says. "I told [CEO] Tim Cook ... make your product in the United States. Build those big beautiful plants that go on for miles, it seems.
"China is the biggest beneficiary of Apple, more than us ... I want Apple to make their iPhones and all of the great things that they make in the United States, and that'll take place."
zu MRKR
weiterhin erstaunliche complete-response-daten quer durch alle Programme.
Kann das Zufall sein? Diese Krebspatienten sind alles schwere Fälle in sehr schwer zubehandelnden Indikationen mit oftmals mehrfach gescheiteren Therapien.
das netz schreibt, dass wall street den Titel nicht mag, da er über ein reverse merger der lange Zeit erfolglosen tapimmune>>>MRKR entstand und dabei anders als bei ALLO kein Geld verdient wurde.
+++
Marker Therapeutics up 12% premarket after pipeline update
Jan. 4, 2019 8:33 AM ET|About: Marker Therapeutics Inc (MRKR)|By: Douglas W. House, SA News Editor
Thinly traded micro cap Marker Therapeutics (NASDAQ:MRKR) is up 12% premarket on light volume following its update on its clinical programs for its MultiTAA T cell therapies. Highlights:
Lymphoma: 15 heavily pretreated patients have been treated in a Phase 1/2 study. The disease control rate (responders + stable cancer) is 67% (n=10/15) including six complete responders. No relapses and no cases of cytokine release syndrome have been observed.
Four of the six complete responders have remained in remission for 3 - 42 months post-infusion. The average duration of remission is over 26 months.
Multiple myeloma: Interim data from a Phase 1/2 trial showed an initial 100% (n=10/10) disease control rate, including one complete responder and two partial responders, but three patients progressed after 3 - 7 months. Four patients continue to have stable cancer.
Acute lymphoblastic leukemia: Preliminary Phase 1 data showed a complete response rate of 88% (n=7/8) over 1 - 22 months.
Ovarian cancer: Enrollment completed in a Phase 2 trial evaluating TPIV200 as maintenance therapy in patients in their first remission after surgery and platinum-based chemo. Interim data should be available by year-end.
Triple-negative breast cancer: Initial data from a dose-finding study of TPIV200 as maintenance therapy following first-line treatment showed a 96% (n=26/27) immune response rate.
+++
zu ALLO:
https://finance.yahoo.com/quote/ALLO?p=ALLO&.tsrc=fin-srch" target="_blank" rel="nofollow ugc noopener">
https://finance.yahoo.com/quote/ALLO?p=ALLO&.tsrc=fin-srch
MK mittlerweile 3.15 mrd. bislang deutlich weniger Patienten wie MRKR in den Testreihen - wall street loves this company.
Allogene Therapeutics Presents Data from Preclinical Study of ALLO-715 (anti-BCMA) Demonstrating Allogeneic CAR T Potential in Multiple Myeloma at the 2018 ASH Annual Meeting
GlobeNewswire•December 3, 2018
Preclinical Data Supports Advancement of ALLO-715 into Phase 1 in Multiple Myeloma
ALLO-715 Investigational New Drug Application and Initiation of a Phase 1 Trial Planned for 2019
SOUTH SAN FRANCISCO, Calif., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced results of a preclinical study of ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA) in development by Allogene. The findings demonstrate the potential of ALLO-715 as a novel AlloCAR T therapy for multiple myeloma and other BCMA-positive malignancies. The data were presented today by Cesar Sommer, Ph.D., Principal Scientist at Allogene, in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.
“Based on these promising preclinical data, we plan to submit an Investigational New Drug (IND) application for ALLO-715 and initiate a Phase 1 clinical trial in 2019 in relapsed or refractory multiple myeloma,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “AlloCAR T therapies have the potential to expand patient access to cell therapies for patients who may benefit due to the off-the-shelf and on-demand characteristics of AlloCAR T.”
The preclinical study evaluated the specificity of ALLO-715 to human BCMA and its anti-tumor efficacy in vitro and in animal models. ALLO-715 displayed potent cytotoxic activity against multiple myeloma cell lines. In animal models, ALLO-715 was highly efficacious at a single dose, demonstrating potent anti-tumor activity.
ALLO-715 utilizes the TALEN® gene-editing technology pioneered and owned by Cellectis. It was progressed under a joint research collaboration with the company and is directed at a target that was licensed exclusively from Cellectis. Allogene holds the global development and commercial rights for this investigational candidate.
ALLO in einem deutlich früheren Stadium - sehr viele Vorschusslorbeeren.
weiterhin erstaunliche complete-response-daten quer durch alle Programme.
Kann das Zufall sein? Diese Krebspatienten sind alles schwere Fälle in sehr schwer zubehandelnden Indikationen mit oftmals mehrfach gescheiteren Therapien.
das netz schreibt, dass wall street den Titel nicht mag, da er über ein reverse merger der lange Zeit erfolglosen tapimmune>>>MRKR entstand und dabei anders als bei ALLO kein Geld verdient wurde.
+++
Marker Therapeutics up 12% premarket after pipeline update
Jan. 4, 2019 8:33 AM ET|About: Marker Therapeutics Inc (MRKR)|By: Douglas W. House, SA News Editor
Thinly traded micro cap Marker Therapeutics (NASDAQ:MRKR) is up 12% premarket on light volume following its update on its clinical programs for its MultiTAA T cell therapies. Highlights:
Lymphoma: 15 heavily pretreated patients have been treated in a Phase 1/2 study. The disease control rate (responders + stable cancer) is 67% (n=10/15) including six complete responders. No relapses and no cases of cytokine release syndrome have been observed.
Four of the six complete responders have remained in remission for 3 - 42 months post-infusion. The average duration of remission is over 26 months.
Multiple myeloma: Interim data from a Phase 1/2 trial showed an initial 100% (n=10/10) disease control rate, including one complete responder and two partial responders, but three patients progressed after 3 - 7 months. Four patients continue to have stable cancer.
Acute lymphoblastic leukemia: Preliminary Phase 1 data showed a complete response rate of 88% (n=7/8) over 1 - 22 months.
Ovarian cancer: Enrollment completed in a Phase 2 trial evaluating TPIV200 as maintenance therapy in patients in their first remission after surgery and platinum-based chemo. Interim data should be available by year-end.
Triple-negative breast cancer: Initial data from a dose-finding study of TPIV200 as maintenance therapy following first-line treatment showed a 96% (n=26/27) immune response rate.
+++
zu ALLO:
https://finance.yahoo.com/quote/ALLO?p=ALLO&.tsrc=fin-srch" target="_blank" rel="nofollow ugc noopener">
https://finance.yahoo.com/quote/ALLO?p=ALLO&.tsrc=fin-srch
MK mittlerweile 3.15 mrd. bislang deutlich weniger Patienten wie MRKR in den Testreihen - wall street loves this company.
Allogene Therapeutics Presents Data from Preclinical Study of ALLO-715 (anti-BCMA) Demonstrating Allogeneic CAR T Potential in Multiple Myeloma at the 2018 ASH Annual Meeting
GlobeNewswire•December 3, 2018
Preclinical Data Supports Advancement of ALLO-715 into Phase 1 in Multiple Myeloma
ALLO-715 Investigational New Drug Application and Initiation of a Phase 1 Trial Planned for 2019
SOUTH SAN FRANCISCO, Calif., Dec. 03, 2018 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced results of a preclinical study of ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA) in development by Allogene. The findings demonstrate the potential of ALLO-715 as a novel AlloCAR T therapy for multiple myeloma and other BCMA-positive malignancies. The data were presented today by Cesar Sommer, Ph.D., Principal Scientist at Allogene, in an oral session at the 60th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego.
“Based on these promising preclinical data, we plan to submit an Investigational New Drug (IND) application for ALLO-715 and initiate a Phase 1 clinical trial in 2019 in relapsed or refractory multiple myeloma,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “AlloCAR T therapies have the potential to expand patient access to cell therapies for patients who may benefit due to the off-the-shelf and on-demand characteristics of AlloCAR T.”
The preclinical study evaluated the specificity of ALLO-715 to human BCMA and its anti-tumor efficacy in vitro and in animal models. ALLO-715 displayed potent cytotoxic activity against multiple myeloma cell lines. In animal models, ALLO-715 was highly efficacious at a single dose, demonstrating potent anti-tumor activity.
ALLO-715 utilizes the TALEN® gene-editing technology pioneered and owned by Cellectis. It was progressed under a joint research collaboration with the company and is directed at a target that was licensed exclusively from Cellectis. Allogene holds the global development and commercial rights for this investigational candidate.
ALLO in einem deutlich früheren Stadium - sehr viele Vorschusslorbeeren.
Antwort auf Beitrag Nr.: 59.550.613 von clearasil am 03.01.19 14:28:26wie alt ist alt, 55? und bei 18 Jährigen, Arthrose heilen? Habe neulich einem 45 jährigen Mitradler Hoffnung gemacht, der könnte profitieren, aber nur weil er sowieso fit ist?!
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