Astellas and Adaptimmune Enter into Agreement to Co-Develop and Co-Commercialize Stem-Cell Derived A (Seite 2) | Diskussion im Forum

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ADAP: Adaptimmune Therapeutics provides updates data from its Phase 1 trial for Liver Cancer at ILCA (4.94)

Co announced updated data from its Phase 1 ADP-A2AFP trial for patients with liver cancer at ILCA.
Topline results from the ADP-A2AFP Phase 1 trial as of the April 5, 2021 data cutoff
Thirteen patients with advanced hepatocellular carcinoma (HCC) received ADP-A2AFP in Cohort 3 and expansion
The best overall responses in Cohort 3 and expansion (per RECIST v1.1) included 1 complete response (reported in 2020), 6 stable disease and 4 progressive disease. 2 patients did not have scan results at the time of data cut-off
The disease control rate for patients with at least one scan was 7/11 (64%) and 2 patients had stable disease lasting beyond 16 weeks
Conclusions
Antitumor activity, with one complete response, sustained decreases in serum AFP, and best overall response of stable disease observed in 6 patients, indicate that ADP-A2AFP is an active product in HCC
ADP-A2AFP up to doses of 10 billion transduced cells has been associated with an acceptable safety profile


https://www.briefing.com/in-depth-analysis/Content/Article?A…

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Trading to resume for Adaptimmune Theraptcs plc ADS (ADAP). Halt Reason: NEWS DISSEMINATED. Resume Time: 09/07/2021 07:30:00

[Sven_Bonn]

Handel ausgesetzt !!!

[Sven_Bonn]

NEWS !!!

https://quantisnow.com/insight/1743539?s=s

- Adaptimmune will receive $150 million upfront, $150 million over the next five years in additional payments, and development, regulatory and commercial milestones payments potentially exceeding $3 billion in aggregate value, as well as royalties, across multiple programs -

- The Company will host a virtual update about its allogeneic platform on Thursday, September 9 at 08:00 a.m. EDT (01:00 p.m. BST) -

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (NASDAQ:ADAP), a leader in cell therapy to treat cancer, announced today that it has entered into a strategic collaboration and license agreement with Genentech, a member of the Roche Group ((SIX: RO, ROG, OTCQX:RHHBY) to develop and commercialize allogeneic cell therapies to treat multiple oncology indications.

"We are proud to partner with Genentech, given their commitment to patients and science in the cancer immunology field. This collaboration broadens Adaptimmune's leadership position in developing allogeneic cell therapies building on our in-depth knowledge gained from our autologous clinical programs," said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. "Through this collaboration, our platform will form the basis of a personalized allogeneic cell therapy vision, where any patient can receive a T-cell product for their cancer; a significant step towards our goal of making cell therapies both curative and mainstream."

"We believe allogeneic cell therapies could be a game-changing approach for developing personalized therapy platforms based on individual cancer patients' unique needs," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This partnership, which combines Adaptimmune's allogeneic platform with Genentech's expertise in developing personalized therapies, complements our other efforts to discover and develop personalized cell therapies. It holds the promise to change how we treat cancer and brings us another step closer to making personalized healthcare a reality."

The collaboration has two components:

Development of allogeneic T-cell therapies for up to five shared cancer targets
Development of personalized allogeneic T-cell therapies

For each component, Adaptimmune will be responsible for developing clinical candidates using its induced pluripotent stem cell (iPSC) derived allogeneic platform to produce T-cells (iT cells). Genentech will be responsible for the input TCRs and subsequent clinical development and commercialization.

Under the terms of the agreement, Adaptimmune will receive an upfront payment of $150 million and additional payments of $150 million over five years, unless the agreement is earlier terminated. In addition, Adaptimmune may be eligible to receive research, development, regulatory and commercial milestones payments potentially exceeding $3 billion in aggregate value.

Adaptimmune will also receive tiered royalties on net sales in the mid-single to low-double digits.

Adaptimmune has the right to opt in to a 50/50 U.S. profit/cost share on "off-the-shelf" products. If Adaptimmune elects to opt in, then Adaptimmune will be eligible to share 50 percent of profits and losses from U.S. sales on such products and is eligible to receive ex-U.S. regulatory and sales-based milestone payments, as well as royalties on ex-U.S. net sales.

The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Virtual update on Adaptimmune's allogeneic platform

Thursday, September 9, 2021 at 08:00 a.m. EDT

The Company will host a live virtual update to discuss its allogeneic platform and future development plans at 08:00 a.m. EDT (01:00 p.m. BST), on Thursday, September 9. You can join the event with this link: https://bit.ly/3jHI4KP. More details, as well as a replay of the event, can be found on the Investor Relations tab of the Company's website: https://bit.ly/2WRDa4C.

About Adaptimmune

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2021 and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

[Sven_Bonn]

Hallo zusammen,

sehr nette 2 Tage....
Sicher das Thema Buyout durch Pfizer einer der Gründe..
Nchdem Trillium übernommen wurde, rechtnet mal wohl mit Adaptimmune oder Homology mit dem nächsten BO...
Bin gespannt :-)

https://newsfilter.io/a/539ed9f8fca740c00c03c98d070bb1bc

LG
Sven

[Sven_Bonn]

noch ein entsprechender Artikel:

https://endpts.com/adaptimmune-gives-first-glimpse-at-pivota…

:-)

[Sven_Bonn]

Hallo zusammen,

nach langer Ruhezeit sollte man den Titel noch einmal nach oben holen.

Gestern sehr erfolgreiche Ergebnisse bekanntgegeeben :-)


https://www.fiercebiotech.com/biotech/asco-adaptimmune-s-cel…
https://www.conferencecalltranscripts.com/summary/?id=943280…

Sehr gute Ergebnisse. Nachbörslich in den USA 11 % im Plus..

Mal schauen, was heute passiert.

Lieben Gruß
Sven

[Sven_Bonn]

Adaptimmune Ther Ads (ADAP) reported a 4th Quarter December 2020 loss of $0.24 per share on revenue of $1.5 million. The consensus estimate was a loss of $0.23 per share on revenue of $1.2 million. Revenue grew 106.3% on a year-over-year basis.

https://www.earningswhispers.com/epsdetails/adap

[Sven_Bonn]

ACHTUNG HEUTE :-)

Adaptimmune to Report Fourth Quarter/ Full Year 2020 Financial Results and Business Updates on Thursday, February 25, 2021
Download as PDF
February 11, 2021 8:00am EST

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, will report financial results and provide business updates for the fourth quarter and year ended December 31, 2020, before the US markets open on Thursday, February 25, 2021. Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EST (1:00 p.m. GMT) that same day (details below).

The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at that same address.

To participate in the live conference call, please dial [phone] (U.S. or Canada) or [phone] (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (2099860).

About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company’s unique SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 5, 2020, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Adaptimmune Contacts:

Media Relations:

Sébastien Desprez — VP, Communications and Investor Relations
T: [phone]
M: [phone]
[e-mail]

Investor Relations:

Juli P. Miller, Ph.D. — Senior Director, Investor Relations
T: [phone]
M: [phone]
[e-mail]

https://www.adaptimmune.com/investors-and-media/news-events/…

[Sven_Bonn]

Investigators Aim Novel T-Cell Therapy at Solid Tumor Target

ADP-A2M4CD8, a novel T-cell therapy, is being investigated in a range of tumor types that express MAGEA4, an antigen expressed in solid tumors that investigators say represents a promising target for cellular immunotherapy.

The ongoing phase 1 SURPASS trial (NCT04044859), a first-in-human study, is open to patients with 8 cancer types, although investigators are focused on recruiting participants with gastroesophageal cancers, head and neck squamous cell carcinoma (HNSCC), and lung and bladder cancers.

Based on early positive data, investigators are planning a phase 2 trial in patients with gastroesophageal cancers.1

ADP-A2M4CD8 is an autologous therapy directed toward the HLA complex/MAGEA4 antigen. The therapy is manufactured from the patient’s peripheral blood cells, which are harvested through leukapheresis and transduced with a lentiviral vector containing a MAGEA4 T-cell receptor (TCR) and expanded. Specific peptide-enhanced affinity receptor (SPEAR) technology is used to selectively engineer TCRs modified to enhance binding to cancer cells.1,2

“The SPEAR T-cells are an interesting technology,” David S. Hong, MD, the lead investigator in the SURPASS trial, said in an interview with OncologyLive®. “The SPEAR T-cells are CD4 and CD8α cells that have been reengineered to express a TCR that can bind to these HLA-restricted receptor and antigen complexes on cancer cells.”

MAGEA4, a cancer testis antigen, is broadly expressed in many solid tumor types.

In a study of 585 samples in 21 tumor types, investigators found that MAGEA4 was expressed in 36.6% of samples (range, 30.7%-37.%). The antigen was identified in 9 tumor types, including 54.9% of esophageal cancers, 37.5% of HNSCCs, and 35.0% of gastric cancers.3

Investigators are seeking a solid tumor target for T-cell therapies, said Hong, who is deputy chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center in Houston.

So far, chimeric antigen receptor (CAR) T-cell therapies that bind to CD19 have succeeded in hematologic malignancies, with 4 FDA-approved products. “Thus far, we haven’t seen strong responses in treating solid tumors with available cellular therapies, in large part because antigens expressed are not restricted to the tumors,” Hong said in a news release.4

ADP-A2M4CD8 represents another step in the development of the MAGEA4targeting T-cell therapy. A previous version, called ADP-A2M4, showed activity in synovial sarcoma, Hong said, but investigators sought to improve its efficacy by adding SPEAR T cells that coexpress the CD8α receptor. “There was still a way to go with other tumor types, such as esophageal and head and neck and other cancers. Adding the CD8α coreceptors to the existing construct allows for greater cytotoxicity and enhances engagement across the wider immune system,” he said.
THE SURPASS TRIAL

In the SURPASS trial, investigators are seeking to recruit 30 patients. Although the focus is on gastroesophageal cancers, HNSCC, and lung and bladder cancers, enrollment also is open for patients with ovarian, melanoma, myxoid/round cell liposarcoma (MRCLS), or synovial sarcoma. Enrollment had been paused for several months because of the coronavirus disease 2019 (COVID-19) pandemic, but is now ongoing, Hong said.

“This is an in-patient trial, and the hospitals not only at MD Anderson but everywhere were worried they were going to get overwhelmed with COVID patients in the ICUs,” Hong said.

To be eligible for the trial, patients must have MAGEA4 expression of at least 2+in 30% or more of tumor cells on immunohistochemistry staining and test positive for at least 1 HLA-A*02 inclusion allele. Participants also must have received or refused standard antitumor regimens with no more than 3 lines of prior systemic therapy in the metastatic or unresectable locally advanced setting.1

The study uses a modified 3+3 design, with up to 2 dose cohorts plus an expansion cohort (FIGURE).1 After enrollment, patients undergo leukapheresis, and their white blood cells are sent to Adaptimmune Therapeutics, the developer of ADP-A2M4CD8, for engineering with SPEAR T cells. Four to 7 days before infusion, patients undergo lymphodepletion comprised of f ludarabine at 30 mg/m2 daily for 4 days and cyclophosphamide at 600 mg/m2 daily for 3 days.

After receiving the ADP-A2M4CD8 therapy, patients remain in the hospital for a minimum of 3 days and are discharged at the investigator’s discretion. Investigators will monitor patients until disease progression, withdrawal from the interventional phase of study, or death to assess for efficacy and safety. In the first year after infusion, investigations monitor and assess patients at months 3, 6, and 12. From years 2 to 5, investigators monitor patients every 6 months. After year 5, investigators assess patients annually for up to 15 years.

This is a complex trial to administer, Hong said. “We have to determine the timing for the leukapheresis and the timing for the dose-escalation trial, as well as the timing for the lymphodepletion. We have to determine insurance clearance, etc,” he said.

The trial is being conducted in 17 sites in the United States, Canada, and Spain.
ADP-A2M4CD8 T-Cell Therapy in Solid Tumors

FIGURE. ADP-A2M4CD8 T-Cell Therapy in Solid Tumors
INITIAL FINDINGS FROM SURPASS

Hong and colleagues presented data during the Society for Immunotherapy of Cancer’s annual meeting in November 2020 demonstrating early efficacy signals and a manageable safety profile for ADP-A2M4CD8. Among 6 patients with heavily pretreated advanced cancers, 3 were treated with target doses of 1 billion SPEAR T cells and 3 received target doses of 5 billion SPEAR T cells.1

Initial responses appear promising and have the potential to offer long-term benef it for patients in this space, Hong said. Notably, 5 out of 6 patients experienced initial tumor shrinkage following T-cell infusion. There were 2 confirmed partial responses (PRs)—in 1 patient with esophagogastric junction cancer ADP-A2M4CD8 is an autologous T-cell therapy directed at the HLA complex/ MAGEA4 antigen. (EJC) and 1 with HNSCC. The other 4 patients had stable disease; these included 1 each with MRCLS, esophageal, ovarian cancer, and EJC.1

In terms of safety, 3 patients experienced adverse effects (AEs) of grade 3 or more, including lymphopenia, neutropenia, and anemia. For any-grade AEs, 4 patients experienced cytokine release syndrome (CRS) and 3 had fatigue.1

“What’s interesting is that we don’t see the level and the percentage of cytokine release syndrome that you would see with CAR T therapy,” Hong said. “The most common adverse effects have been associated with the lymphodepletion, such as neutropenia or lymphopenia. The vast majority of these patients had mild symptoms of CRS. Some had mild fever. Some had some mild fatigue.”

Preclinical data presented at the 2019 American Association for Cancer Research annual meeting found that ADP-A2M4CD8 increased T-cell activation and improved engagement with the immune system in dendritic cells and T-cells cocultured with MAGEA4–positive cancer cell lines There was no additional off-target reactivity in vitro. This was a proof-of-concept study that focused on CD4+ T-cell function using in vitro assays.4

Adaptimmune plans to launch SURPASS-2, a phase 2 trial of ADP-A2M4CD8 in gastroesophageal cancers, during the first half of 2021. The company expects to file a biologics license application for ADP-A2M4CD8 in gastroesophageal cancers in 2024.5

Meanwhile, investigators continue to evaluate ADP-A2M4 in the phase 2 SPEARHEAD 1 trial (NCT04044768) in patients with advanced synovial sarcoma or MRCLS. The registrational study is projected to complete enrollment in the first quarter of 2021.

Additionally, ADP-A2M4 is being studied in combination with pembrolizumab (Keytruda) in a pilot phase 2 trial, SPEARHEAD 2 trial (NCT04408898), in patients with recurrent or metastatic head and neck cancer.

Updated findings from a phase 1 trial of ADP-A2M4 in patients with synovial sarcoma who are MAGEA4 positive found that 7 of 16 patients (44%) had confirmed PRs per RECIST criteria, with disease control in 15 patients (94%). There was a median duration of response of 28 weeks (range, 12-72+), with 2 PRs that were ongoing beyond 72 weeks; and 11 of the 16 patients were alive at the time of data cutoff on September 1, 2020.6

https://www.onclive.com/view/investigators-aim-novel-t-cell-…