The company has received innovative licensing and access pathway designation from the UK MHRA for obe-cel, the company's CAR-T cell therapy being investigated in the ongoing trial in R/R aALL).
''The ILAP designation, alongside the recent PRIME designation from the EMA, is another step forward in accelerating the review process of this promising therapy,'' said Dr. Christian Itin. ''Obe-cel continues to show the potential to be differentiated on efficacy, durability and safety from other CAR-T cell products and could change standard of care by offering a potentially curative therapy for R/R aALL.''
J
As of the data cut-off date of May 17, twenty patients in Cohort A with R/R aALL had received obe-cel. The therapy was well tolerated, with no patients experiencing Grade 3 or higher CRS. Three patients (15%), all of whom had high leukaemia burden (over 50% blasts), experienced Grade 3 ICANS that resolved swiftly with steroids.
Of the twenty patients evaluable for efficacy, seventeen achieved minimum residual disease negative complete response at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival at twelve months and twenty-four months is 50.2% with the median not being reached.
J
As of the data cut-off date of May 17, thirteen patients in Cohort D with R/R IBCL had been enrolled in the trial and product was successfully manufactured for twelve patients, with one patient’s cells ongoing in manufacture. As of the data cut-off date, nine had received AUTO1 infusion. Three were pending infusion (including the patient above) and one patient died prior to lymphodepletion due to a Cov infection. Obe-cel was well tolerated and demonstrated a favourable safety profile, despite high disease burden. All treated patients achieved a complete metabolic response and had robust CAR-T engraftment, expansion, and persistence.
Grade 1 CRS was reported in four patients and Grade 2 CRS in one. No immune effector cell-associated neurotoxicity syndrome of any grade was observed. At a median follow-up of six months (range 4.0-8.1), eight of nine patients were disease free, with one relapse at month six, but was rescued with radiotherapy. One died of a Cov infection at month 5.6 whilst in complete metabolic response.
m
I started buying in @ $9 in January and have been buying more on dips. Average price of $6.75. Nice news today... curious how much it runs up... or if this has any staying power.
M
I made a video about Autolus Therapeutics (AUTL stock) Check it on YouTube: https://www.youtube.com/watch?v=yH-dpi-39mc Autolus Therapeutics plc, a clinical-stage biopharmaceutical company, develops T cell therapies for the treatment of cancer. The company is developing AUTO1 and AUTO3 for B cell malignancies; AUTO2 and AUTO8 for the treatment of multiple myeloma; AUTO1/22 for the treatment of dual-targeting CAR-T; AUTO3NG for the treatment of hematological cancer; AUTO4 and AUTO5 for T cell lymphoma; AUTO6NG for the treatment of programmed T cell therapies; AUTO6 for the treatment of neuroblastoma; and AUTO7 for the treatment of prostate cancer. Autolus Therapeutics plc was founded in 2014 and is headquartered in London, the United Kingdom.
Do not buy Autolus Therapeutics stock before seeing this video!📈 (AUTL Stock Analysis)
www.youtube.com
B
Too bad there's not options available for this corporation. It would be helpful now.
b
some movement:)) maybe good news coming..
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As of the data cut-off date of Feb 18, ten R/R IBCL patients had received AUTO1 and nine were evaluable. AUTO1 demonstrated a tolerable safety profile in adult patients with R/R low grade B-cell lymphoma despite high disease burden. Early data shows 100% CR rates and excellent engraftment and expansion. Gr1 CRS was reported in four patients and Gr2 CRS in one. No Immune effector cell-associated neurotoxicity syndrome was observed. At a median of 3.1 months (range 1-5.6), 8/9 patients are in ongoing remission. One patient died at month 5.6 due to COV-19.
K
AUTL is the real deal, I can think of another biotech with this strong of data, and cash position compared to MC. Undervalued UK company IMO
D
100% CR rate with stellar safety in 9 lymphoma patients. $AUTL is very mis-priced
b
I hope this is a steady rise above 10$ before we get the next results
I took some money off the table. Will try to get back in when it drops to near 6 tomorrow or I will have missed out on a further run up. Not sure which is right, but I have my money with no risk tonight.
B
Neither the analysts nor the public are recognizing the ramifications of recent releases. Highly underrated.
N
One of the top oncology companies in the world.
T
Great news, let's go
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The company has received the innovative licensing and access pathway designation* from the U.K. MHRA for AUTO4.
* ILAP was launched at the start of this year in order to accelerate the development and access to promising medicines and is geared toward those that are in the early stages of development. Other benefits include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorisation Application assessment, rolling review and a continuous benefit risk assessment.
b
Look at volume after 1 hour..finally some good news...
''The ILAP designation, alongside the recent PRIME designation from the EMA, is another step forward in accelerating the review process of this promising therapy,'' said Dr. Christian Itin. ''Obe-cel continues to show the potential to be differentiated on efficacy, durability and safety from other CAR-T cell products and could change standard of care by offering a potentially curative therapy for R/R aALL.''
Of the twenty patients evaluable for efficacy, seventeen achieved minimum residual disease negative complete response at one month. Most notably, the durability of remissions is highly encouraging. Across all treated patients, event free survival at twelve months and twenty-four months is 50.2% with the median not being reached.
Grade 1 CRS was reported in four patients and Grade 2 CRS in one. No immune effector cell-associated neurotoxicity syndrome of any grade was observed. At a median follow-up of six months (range 4.0-8.1), eight of nine patients were disease free, with one relapse at month six, but was rescued with radiotherapy. One died of a Cov infection at month 5.6 whilst in complete metabolic response.
Check it on YouTube: https://www.youtube.com/watch?v=yH-dpi-39mc
Autolus Therapeutics plc, a clinical-stage biopharmaceutical company, develops T cell therapies for the treatment of cancer. The company is developing AUTO1 and AUTO3 for B cell malignancies; AUTO2 and AUTO8 for the treatment of multiple myeloma; AUTO1/22 for the treatment of dual-targeting CAR-T; AUTO3NG for the treatment of hematological cancer; AUTO4 and AUTO5 for T cell lymphoma; AUTO6NG for the treatment of programmed T cell therapies; AUTO6 for the treatment of neuroblastoma; and AUTO7 for the treatment of prostate cancer. Autolus Therapeutics plc was founded in 2014 and is headquartered in London, the United Kingdom.
maybe good news coming..
Undervalued UK company IMO
* ILAP was launched at the start of this year in order to accelerate the development and access to promising medicines and is geared toward those that are in the early stages of development. Other benefits include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorisation Application assessment, rolling review and a continuous benefit risk assessment.