On March 14, 2022 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in cell therapy to treat cancer, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a business update (Press release, Adaptimmune, MAR 14, 2022, View Source [SID1234610017]).
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"We are focused on four things in 2022: filing our first BLA, building our MAGE-A4 franchise, scaling up our manufacturing capabilities, and making progress with our allogeneic platform," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "Last year, we delivered major milestones of our ‘2-2-5-2’ strategic plan. SPEARHEAD-1 met its primary endpoint and we identified further indications for late-stage development with our next-gen SPEAR T-cells targeting MAGE-A4. Furthermore, not only did we enter a strategic collaboration with Genentech, but we also made tremendous progress with our wholly owned allogeneic therapy targeting MAGE-A4, which is on-track for an IND in 2023."
Progress with the Company’s "2-2-5-2" strategic plan to be delivered by 2025
"2" marketed SPEAR T-cell products targeting MAGE-A4
Roadmap to BLA submission for afami-cel1 in 2022 (first-generation product targeting MAGE-A4)
●Advanced/metastatic synovial sarcoma is a rare and clinically challenging disease, with no clear standard of care after progression following chemotherapy, with reported response rates with second line therapies of 18% or lower
●SPEARHEAD-1 has met its primary endpoint2
1 Afamitresgene autoleucel "afami-cel" (formerly ADP-A2M4)
2 The primary endpoint is evaluated using a one-sided exact-based Clopper-Pearson 97.5% confidence interval (CI). Because the lower bound of the CI exceeds the response rate reported with historical second line therapy(ies) (18%), the trial has met the pre-specified threshold for demonstrating efficacy.
●As of the data cut-off of September 1, 2021 (CTOS), the overall response rate (ORR) per Independent Review was 34% (36% in patients with synovial sarcoma and 25% for patients with myxoid/ round cell liposarcoma [MRCLS])
●Afami-cel continues to show a favorable benefit:risk profile with more than 100 patients treated to date across multiple trials
●Cohort 1 of the SPEARHEAD-1 trial has completed, and treatment in Cohort 2 initiated in 2021
●Pediatric plans agreed with regulatory agencies
●Adaptimmune is commencing preparation of the BLA and targeting a BLA submission to the US Food and Drug Administration (FDA) in Q4 2022
Further indications for late-stage clinical development for SPEAR T-cells targeting MAGE-A4
●Initiated recruitment in the Phase 2 SURPASS-2 trial for people with esophageal and esophagogastric junction (EGJ) cancers
●Initiating the Phase 2 SURPASS-3 trial for people with ovarian cancer in 2022
"2" additional BLAs for SPEAR T-cell products targeting MAGE-A4
Phase 1 SURPASS trial with next-generation ADP-A2M4CD8 SPEAR T-cells targeting MAGE-A4
●Overall response rate of 36% with a complete response in ovarian cancer, and partial responses in ovarian, head and neck, EGJ, bladder, and synovial sarcoma cancers (ESMO 2021)
●Most patients experienced antitumor activity with a disease control rate of 86% (ESMO 2021)
●The benefit:risk profile of ADP-A2M4CD8 cell therapy remains favorable
●The SURPASS trial continues to enroll, focusing on people with gastroesophageal, head and neck, lung, bladder, and ovarian cancers
●Combination with a checkpoint inhibitor to be started this year
●Data confirmed preclinical observations that the enhanced TCR interaction in ADP-A2M4CD8 results in a more potent product (SITC 2021)
Other clinical updates
●Closed enrollment in the SPEARHEAD-2 trial investigating afami-cel in combination with a checkpoint inhibitor for people with head and neck cancer in 2021
●Presented data from the radiation sub-study of the completed Phase 1 trial with afami-cel (SITC 2021), which closed to enrollment in 2021
●Reported clinical benefit to people with liver cancer from the Phase 1 ADP-A2AFP trial (ILCA 2021)
oThis trial closed to screening in 2021
oThe Company continues to focus development on new cell therapies to target liver cancer
"5" autologous products in the clinic
Preclinical pipeline update
●Filed a clinical trial application (CTA) for tumor-infiltrating lymphocytes (TILs) incorporating IL-7 (a potent stimulator of T-cell proliferation and survival) in collaboration with the Center for Cancer Immune Therapy (CCIT, a leading TIL center) in Denmark, with the intent to initiate a single-center clinical trial in 2022
●Planning to initiate a Phase 1 trial in multiple indications with a new next-generation SPEAR T-cell targeting MAGE-A4, being developed in collaboration with Noile-Immune Biotech Inc., that incorporates IL-7 and CCL19 (to increase migration of SPEAR T-cells into tumors)
●Adaptimmune continues to develop TCRs to additional HLAs and new targets, as well as further next-generation approaches
"2" allogeneic products in the clinic
Allogeneic pipeline update
●Wholly owned allogeneic platform on track for planned IND submission in 2023 for first product targeting MAGE-A4
●Announced a strategic collaboration with Genentech to research, develop, and commercialize allogeneic T-cell therapies
oCollaboration covers the research and development of "off-the-shelf" cell therapies for up to five shared cancer targets and the development of a novel allogeneic personalized cell therapy platform
oAdaptimmune received $150 million upfront payment under the terms of the agreement
●First preclinical data presented from the Company’s mesothelin HLA-independent TCR (HiT) program, which is being co-developed with Astellas, demonstrating antigen-specific tumor cell killing in vitro and complete tumor regression in an animal model (ASGCT 2021).
●The animal model also demonstrated that Adaptimmune’s HiT T-cells targeting mesothelin outperformed a comparator TRuC construct (ASGCT 2021)
●Second target nominated for allogeneic product development in collaboration with Astellas
Patient supply
●To date, Adaptimmune has successfully manufactured hundreds of autologous batches in-house at its Navy Yard facility (Philadelphia, PA) across multiple products and tumor types
●Work underway at Navy Yard to scale up GMP manufacturing to meet commercial and clinical trial patient supply demands
●Started construction of a new cell manufacturing facility dedicated to allogeneic therapies in the UK, planned to be opened later this year
●Continued improvement of manufacturing processes including addition of an AKT inhibitor (AKTi). Data demonstrate that addition of AKTi during the ex vivo T-cell expansion phase of manufacturing provides further proliferative potential and enhanced memory phenotype of next-gen SPEAR T-cells (SITC 2021)
Corporate
●The Company appointed Cintia Piccina as its Chief Commercial Officer
Financial Results for the fourth quarter and year ended December 31, 2021
●Cash / liquidity position: As of December 31, 2021, Adaptimmune had cash and cash equivalents of $149.9 million and Total Liquidity3 of $369.6 million, compared to $56.9 million and $368.2 million, respectively, as of December 31, 2020.
●Revenue: Revenue for the fourth quarter and year ended December 31, 2021 was $1.4 million and $6.1 million, respectively, compared to $1.5 million and $4.0 million for the same periods in 2020. Revenue for the year ended December 31, 2021 has increased primarily due to an increase in development activities under our collaboration arrangements.
●Research and development (R&D) expenses: R&D expenses for the fourth quarter and year ended December 31, 2021 were $29.5 million and $111.1 million, respectively, compared to $25.8 million and $91.6 million for the same periods in 2020. R&D expenses increased due to an increase in the number of employees engaged in research and development, increases in subcontracted expenditures, and an increase in share-based compensation costs. These increases were partially offset by an increase in reimbursements receivable for research and development tax and expenditure credits.
●General and administrative (G&A) expenses: G&A expenses for the fourth quarter and year ended December 31, 2021 were $14.8 million and $57.3 million, respectively, compared to $13.2 million and $45.8 million for the same periods in 2020 due to increases in employee-related costs, share-based compensation expense, and professional fees.
●Net loss: Net loss attributable to holders of the Company’s ordinary shares for the fourth quarter and year ended December 31, 2021 was $38.8 million and $158.1 million respectively ($(0.04) and $(0.17) per ordinary share), compared to $36.6 million and $130.1 million ($(0.04) and $(0.15) per ordinary share) for the same periods in 2020.
Financial Guidance
The Company believes that its existing cash, cash equivalents and marketable securities, together with the upfront and additional payments under the Strategic Collaboration and License Agreement with Genentech, will fund the Company’s current operations into early 2024, as further detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission prior to this earnings release.
Conference Call Information
The Company will host a live teleconference and webcast to provide additional details at 8:30 a.m. EDT (12:30 p.m. GMT) today, March 14, 2022. 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 (833) 652-5917 (US or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (1343635).