Adaptimmune Therapeutics PLC 8-K, filed Nov 8, 2022
Adaptimmune Therapeutics PLC (ADAPY)
About this 8-K
Adaptimmune Therapeutics PLC filed this 8-K on November 8, 2022.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
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Item 7.01Regulation FD disclosure.
On November 8, 2022 Adaptimmune Therapeutics plc (“Adaptimmune”) issued a press release announcing updated clinical data from its MAGE-A4 franchise.
Adaptimmune will provide further details during a call to be held today, November 8, 2022, at 8:00 a.m. EST (1:00 p.m. GMT) during which management will be available for Q&A.
The press release is furnished as Exhibit 99.1 and is incorporated by reference herein.
The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
| Description of Exhibit |
99.1 | | |
104 | | Cover Page Interactive Date File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
| ADAPTIMMUNE THERAPEUTICS PLC | ||
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Date: November 8, 2022 | By: | /s/ Margaret Henry | |
| | Name: | Margaret Henry |
| | Title: | Corporate Secretary |
Exhibit 99.1
Adaptimmune Reports Increased Response Rate and Durability of Response in its Phase 1 SURPASS trial; ORR now 52% across Ovarian, Urothelial, and Head & Neck Cancers
- New responses in ovarian and urothelial cancers increase ORR to 52% from 44% in heavily pre-treated patients with late-stage ovarian, urothelial, and head & neck cancers after single dose of ADP-A2M4CD8 -
- Across the entire ongoing Phase 1 SURPASS trial, the ORR has increased to 37% from 33%, and the median duration of response has increased to ~20 weeks from ~12 weeks since last update -
- Increased ORR now 43% in ovarian cancer with one new response; Initiating Phase 2 trial (SURPASS-3) in ovarian cancer for ADP-A2M4CD8 in monotherapy and in combination with a checkpoint inhibitor -
- The Company recently received FDA RMAT Designation for ADP-A2M4CD8 for the treatment of patients with platinum resistant ovarian cancer -
- Increased ORR now 57% in urothelial cancer with one new complete response; new cohort in Phase 1 SURPASS trial planned to evaluate ADP-A2M4CD8 in combination with a checkpoint inhibitor in the second line setting in urothelial cancers –
- Adaptimmune also plans to add a further cohort to the Phase 1 SURPASS trial to evaluate ADP--A2M4CD8 in combination with first-line standard of care (pembrolizumab) in head & neck cancer -
PHILADELPHIA, PA. and OXFORD, UK, November 8, 2022 – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, today reports updated clinical data from its MAGE-A4 franchise. Clinical data continue to support the potential of Adaptimmune’s engineered T-cell therapies for people with cancer across multiple solid tumor indications. The company will provide further details on a call to be held today, November 8, 2022, at 8:00 a.m. EST (1:00 p.m. GMT) during which management will be available for Q&A.
“The data in the SURPASS trial continue to demonstrate the potential of our next-generation cell therapy targeting MAGE-A4 in a broad range of difficult-to-treat, late-stage solid tumors,” said Elliot Norry, Adaptimmune’s Chief Medical Officer. “We are initiating a Phase 2 trial, SURPASS-3, for people with ovarian cancer in collaboration with The GOG Foundation, Inc. I am pleased to announce that we recently received FDA RMAT Designation for ADP-A2M4CD8 for the treatment of patients with platinum resistant ovarian cancer. We also plan to gather data in urothelial and head & neck cancers with two additional cohorts that will focus on earlier lines of treatment. Finally, we will evaluate further development opportunities in the ongoing signal finding Phase 1 SURPASS trial in both monotherapy as well as in combination with the checkpoint inhibitor nivolumab.”
New positive data reported in the Phase 1 SURPASS trial
| ● | Since data were reported at ESMO in September, there have been additional clinical responses including a new complete response in urothelial cancer and one new response in ovarian cancer |
| ● | The objective response rate (ORR) has increased to 52% in heavily pre-treated patients with late -stage ovarian, urothelial, and head & neck cancers after a single dose of ADP-A2M4CD8 (ORR of 44% reported at ESMO) |
| ● | The overall ORR has increased to 37% (ORR of 33% reported at ESMO) |
| ● | Increased ORR in ovarian cancer to 43% (ORR of 36% reported at ESMO) |
| ● | Increased ORR in urothelial cancer to 57% (ORR of 43% reported at ESMO) |
| ● | There have been no new responses reported in head & neck cancer since the last update of 3 out of 4 patients responding as presented at ESMO |
| ● | Durability continues to increase in this ongoing trial and is now at a median of ~20 weeks; previously reported as ~12 weeks at ESMO |
Development plans for the SURPASS family of trials
| ● | The Phase 1 signal finding SURPASS trial is ongoing in both a monotherapy and a combination cohort evaluating ADP-A2M4CD8 with nivolumab (a checkpoint inhibitor) |
| ● | Adaptimmune is working with The GOG Foundation, Inc and has initiated a Phase 2 trial (SURPASS-3) evaluating ADP-A2M4CD8 in both monotherapy and in combination with nivolumab in platinum-resistant ovarian cancer |
| ● | The Company recently received FDA RMAT Designation for ADP-A2M4CD8 for the treatment of patients with platinum resistant ovarian cancer |
| ● | The Company plans to pursue two new cohorts in the SURPASS Phase 1 trial with ADP--A2M4CD8 |
| o | In combination with a checkpoint inhibitor in a second-line setting for advanced urothelial cancer |
| o | In combination with a checkpoint inhibitor in the first-line setting for advanced head & neck cancer |
Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, November 8, 2022. A live webcast of the conference call and replay can be accessed at https://www.gowebcasting.com/12251. Call in information is as follows: (800)- 319-4610 (US or Canada) or +1 (416)- 915-3239 (International and additional options available HERE).
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 Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2021, our Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not
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undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Adaptimmune Contact
Investor Relations
Juli P. Miller, Ph.D. — VP, Corporate Affairs and Investor Relations
T: +1 215 825 9310
M: +1 215 460 8920
Juli.Miller@adaptimmune.com
Media Relations
Dana Lynch, Senior Director of Corporate Communications
M: +1 267 990 1217
Dana.Lynch@adaptimmune.com
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