On March 15, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer,reported financial results for the fourth quarter and year ended December 31, 2017, as well as provided a business update (Press release, Adaptimmune, MAR 15, 2018, View Source;p=RssLanding&cat=news&id=2338214 [SID1234524788]).
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Clinical momentum
There have been three partial responses (two confirmed and one to be confirmed), and one stable disease in the first four patients dosed with NY‑ESO SPEAR T-cells in a second solid tumor: myxoid/ round cell liposarcoma (MRCLS). A summary of these data is planned at an upcoming congress.
In addition to the NY-ESO program which has been optioned by GSK, clinical momentum continues across the company’s wholly owned programs with:
Patients enrolling in the one billion target cell dose cohort of the MAGE-A10 triple tumor study
Dosing in the initial safety cohort (100 million cells) of the MAGE-A4 "basket" study
For Adaptimmune’s wholly owned therapies, the first patients were dosed with MAGE-A10, in non-small cell lung cancer (NSCLC), and in the triple tumor study, in 2017, and initial safety results were presented in January 2018. Initial efficacy data from the MAGE-A10 pilot studies are anticipated in the second half of 2018. Initial safety data from the MAGE-A4 "basket study" (required to support dose escalation to one billion cells) is anticipated in the first half of 2018. MAGE-A4 efficacy data and initial AFP safety data are anticipated throughout the second half of 2018.
Manufacturing progress
Adaptimmune continues to make progress towards its ambition of being a fully integrated cell therapy company. Since the announcement in January 2018 that the company’s Navy Yard facility in Philadelphia was up and running to produce SPEAR T-cells for its wholly owned programs, Adaptimmune has manufactured a number of batches for patients, which have all achieved cell volumes in the range of the therapeutic doses seen with NY-ESO in synovial sarcoma.
In addition, Adaptimmune announced in January of this year that it had executed an agreement with Cell and Gene Therapy (CGT) Catapult, providing its own dedicated manufacturing space to secure vector supply for the medium term.
Adaptimmune is also in a strong financial position with a cash runway to early 2020, based on management’s current estimates.
"Today’s news that NY-ESO has achieved partial responses in a second solid tumor is further validation of our SPEAR T-cell platform. We have previously reported good responses in another solid tumor, synovial sarcoma, as well as in multiple myeloma. These data combined are powerful confirmation of the broad applicability of our SPEAR TCR T-cell platform in solid tumors," commented James Noble, Adaptimmune’s Chief Executive Officer. "When one considers the NY-ESO data, the initial safety data with MAGE-A10, our anticipated readouts for the rest of the year, our manufacturing progress, and our strong financial position, we expect 2018 will be the year we demonstrate that we have the industry-leading clinical TCR pipeline for solid tumors."
Highlights:
NY-ESO Program (partnered with GSK):
Compelling clinical data supports the potential of Adaptimmune’s TCR T-cell therapies to treat solid tumors
Myxoid/round cell liposarcoma [MRCLS]: There have been three partial responses (two confirmed and one to be confirmed), and one stable disease in the first four patients dosed with NY-ESO SPEAR T-cells in MRCLS. A separate press release was issued today with additional detail (View Source).
Synovial sarcoma: Data presented at ASCO (Free ASCO Whitepaper) and CTOS (2017) indicate that NY-ESO SPEAR T-cells continue to be generally well-tolerated with confirmed responses in all cohorts with a median projected overall survival of 120 weeks (~28 months) in Cohort 1
Data update: The synovial sarcoma and MRCLS studies will be presented at an upcoming congress
Multiple myeloma:
– Data update presented at ASH (Free ASH Whitepaper) 2017 indicate that NY-ESO SPEAR T-cells in the setting of autologous stem cell transplant (ASCT) have promising efficacy and acceptable safety in multiple myeloma patients with durable responses and long-term survival demonstrated in this refractory population
– The study of NY-ESO SPEAR T-cells in combination with KEYTRUDA in multiple myeloma is ongoing and will transition to GSK
GSK option exercise and transition:
– GSK exercized its option to exclusively license the right to research, develop, and commercialize Adaptimmune’s NY-ESO SPEAR T-cell therapy program in September 2017, providing up to $61 million (£48 million) in milestones and option fees over the course of the transition period; GSK also nominated a second target, PRAME, in January 2017, which Adaptimmune will take through preclinical development.
– The transition of the NY-ESO program to GSK is well underway
Wholly Owned Programs:
2018 will be the year Adaptimmune has the opportunity to prove that the company has the industry leading clinical TCR pipeline to treat solid tumors
Continued momentum towards safety and efficacy readouts from SPEAR T-cells targeting MAGE-A10 and MAGE-A4 in multiple solid tumors throughout the second half of 2018, and initial safety data from AFP in hepatocellular carcinoma anticipated in late 2018
MAGE-A10:
– Safety: To date, no evidence of off-target toxicity in MAGE-A10 pilot studies in patients who received 100 million cells, and no reports of severe neurotoxic events similar to CAR‑T cell-related encephalopathy syndrome (CRES)1
– Triple tumor study: Announced in January of this year that the scientific review committee (SRC) recommended dose escalation to one billion transduced cells (target dose)
MAGE-A4:
– Basket study: Dosing in the pilot study of SPEAR T-cells targeting MAGE-A4 in bladder, melanoma, head & neck, ovarian, NSCLC, esophageal, and gastric cancers
AFP:
– Hepatocellular carcinoma: Study open and enrolling with initial safety data anticipated in late 2018
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1 Chimeric antigen receptor T-cell therapy – assessment and management of toxicities. Nat Rev Clin Oncol. 2017 Sep 19
Manufacturing:
Adaptimmune is building a fully integrated cell therapy company
Announced in January 2018 that the company’s Navy Yard facility in Philadelphia was up and running to produce SPEAR T-cells for its wholly owned programs
Adaptimmune has since manufactured a number of batches for patients, which have all achieved cell volumes in the range of the therapeutic doses seen with NY-ESO in synovial sarcoma
Executed an agreement with Cell and Gene Therapy (CGT) Catapult that will enable Adaptimmune to have its own dedicated vector manufacturing space in the UK
This agreement is intended to ensure vector supply for ongoing studies with all three wholly owned SPEAR T-cell therapies, MAGE-A4, MAGE-A10, and AFP
Other corporate news:
Adaptimmune is in a strong financial position to deliver success with SPEAR T-cell therapies
Funded through to early 2020 with cash and cash equivalents of $84.0 million and total liquidity2 of $208.3 million
Completed March 2017 public offering and April 2017 registered direct offering to Matrix Capital Management Company, LP, raising total net proceeds of $103.2 million
Financial Results for the three and twelve month period ended December 31, 2017
Cash / liquidity position: As of December 31, 2017, Adaptimmune had cash and cash equivalents of $84.0 million and Total Liquidity3 of $208.3 million.
Revenue: Revenue represents the upfront and milestone payments, which are recognized over the estimated period the Company delivers services to GSK. Revenue for the three and twelve months ended December 31, 2017 were $4.3 million and $37.8 million compared to $8.5 million and $14.2 million for the same periods of 2016. The increase in revenue year-on-year is primarily due to an increase in revenue amortization of $17.5 million in the third quarter resulting from a reduction in the period over which we recognize revenue as a result of GSK’s exercise of the NY‑ESO option and additional revenue amortization on milestones achieved in the year.
Research and development ("R&D") expenses: R&D expenses for the three and twelve months ended December 31, 2017 were $25.1 million and $87.4 million, compared to $16.8 million and $63.8 million for the same periods of 2016. The increase was primarily due to increased costs associated with clinical trials; costs of developing manufacturing capability in the Company’s U.S. facility and increased personnel expenses.
General and administrative ("G&A") expenses: G&A expenses for the three and twelve months ended December 31, 2017 were $8.8 million and $31.1 million, compared to $6.3 million and $23.2 million for the same periods of 2016. The increase was primarily due to increased personnel costs consistent with our planned growth an increase in costs associated with supporting and maintaining our IT infrastructure.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and twelve months ended December 31, 2017 was $27.3 million and $70.1 million ($(0.13) per ordinary share) compared to $15.4 million and $71.6 million ($(0.17) per ordinary share) in the same periods of 2016.
Financial Guidance
The Company believes that its existing cash and cash equivalents, short-term deposits and marketable securities will fund the Company’s current operating plan through to early 2020.
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2 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.
3 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.
Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EDT (12:00 p.m. GMT) today, March 15, 2018. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial 1-800-239-9838 (U.S.) or 44(0)330 336 9411 or 0800 279 7204 (United Kingdom). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (5199507).