MAGEA4

Marker Therapeutics to receive non-dilutive funding from NIH Small Business Innovation Research Program based on preliminary clinical results and non-clinical data in lymphoma Aug. 12, 2024-- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced that the Company has been awarded a $2 million grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy. The SBIR grant has been awarded based in part on Marker’s preliminary clinical data in patients with lymphoma (Press Release, September 11, 2023) as well as non-clinical data demonstrating the anti-tumor activity of MT-601 on anti-CD19 CAR resistant lymphoma cells (Press Release, May 31, 2023). The proceeds of the grant will support the nationwide multi-center Phase 1 APOLLO study (ClinicalTrials.gov identifier: NCT05798897), evaluating the safety and efficacy of MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, in patients with relapsed NHL including those previously treated with anti-CD19 CAR-T cell therapy. Including this SBIR grant, the Company has been awarded over $19 million in non-dilutive funding proceeds. “We are pleased to receive the SBIR grant from the NIH to support our clinical Phase 1 study in CAR-relapsed patients with non-Hodgkin’s lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “Although anti-CD19 CAR-T cells are rapidly expanding as a treatment option in patients with hematological malignancies, approximately 40-60% of patients will relapse within the first year of therapy with currently no standard of care for patients post CD19-targeting CAR-T cells. The NIH award process is highly competitive, and we believe that the decision the NIH made suggests the potential scientific merit and the capacity of Marker’s APOLLO study to address an unmet medical need.” Dr. Vera continued: “While our results of the APOLLO study are preliminary, as we move through the dose escalation part of the study, we are encouraged by the objective responses observed in all three study participants treated at City of Hope (Press Release, April 8, 2024) and the lack of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS) observed. We will continue to closely monitor all patients for long-term treatment effects and durability of response, and with the non-dilutive funding support from NIH we look forward to treating additional participants in this Phase 1 study.” “This grant award is a testimony of our continued commitment to apply for non-dilutive funding and allows us to leverage our data to drive innovation and growth while maximizing shareholder value. Obtaining non-dilutive funding is an ongoing effort, and we are actively applying for additional opportunities as they become available,” concluded Dr. Vera. The NIH Small Business Innovation Research (SBIR) Program sets aside more than $1.2 billion from its Research & Development Funding to specifically support early-stage small businesses throughout the United States. Many companies leverage the NIH SBIR funding to attract the partners and investors needed to take an innovation to market. The Small Business program focuses on a variety of high-impact technologies including research tools, diagnostics, digital health, drugs, and medical devices, and can provide the seed funding needed to bring scientific innovations from bench to bedside. The Company’s lead product, MT-601, is a multi-tumor associated antigen (multiTAA)-specific T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGE-A4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of lymphoma patients who are relapsed after or where CD19 CAR-T cell therapy is not an option.About APOLLO The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with lymphoma who relapsed after anti-CD19 CAR-T cell therapy or where anti-CD19 CAR-T cell therapy is not an option. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the safety and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. Under the APOLLO trial, it is anticipated that nine clinical sites across the United States will cumulatively enroll up to approximately 30 participants during the dose escalation phase. The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits. Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic multiTAA-specific T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research. The content above comes from the network. if any infringement, please contact us to modify.

Clinical data from May 2024 on ACTengine® IMA203 targeting PRAME in 30 heavily pre-treated metastatic melanoma patients at RP2D: 55% confirmed objective response rate, median duration of response of 13.5 months; IMA203 continues to maintain a favorable tolerability profileRegistration-enabling randomized Phase 2/3 trial for ACTengine® IMA203 in 2L+ melanoma planned to commence in 2024 Next data update on IMA203 and IMA203CD8 (GEN2) to be presented at medical conferences in 2H 2024First Phase 1 dose escalation clinical data from Immatics’ next-generation, half-life extended TCR Bispecific, TCER® IMA401 (MAGEA4/8), to be presented as an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024First next-generation, half-life extended TCER® IMA402 (PRAME) dose escalation data to be announced later in 2H 2024Appointment of Alise Reicin M.D. to Board of DirectorsCash and cash equivalents as well as other financial assets amount to $568.5 million1 (€531.1 million) as of June 30, 2024, funding company operations into 2027 Houston, Texas and Tuebingen, Germany, August 13, 2024 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today provided a business update and reported financial results for the quarter ended June 30, 2024. “It is an exciting time for Immatics as we prepare to reach several major clinical milestones in the second half of the year. Starting with the presentation of the first clinical data on our TCR Bispecific, TCER® IMA401, at ESMO, followed by further data updates from our cell therapy pipeline and the initiation of the IMA203 registration-enabling clinical trial, we look forward to the continued advancement of our product candidates in the coming months,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “Patients with advanced solid tumors are in need of transformative therapies that make a meaningful difference in their quality of life. With each clinical milestone we reach, we move one step closer to making an impact in the lives of these patients.” Second Quarter 2024 and Subsequent Company Progress ACTengine® Cell Therapy Program ACTengine® IMA203 and IMA203CD8 (GEN2) monotherapy On May 14, 2024, Immatics provided a data update on IMA203 monotherapy targeting PRAME from the ongoing Phase 1 trial at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR-T cells) in 30 heavily pretreated metastatic melanoma patients evaluable for efficacy. As of the data cut-off on April 25, 2024, treatment with IMA203 monotherapy in the efficacy population has demonstrated a confirmed objective response rate (cORR) of 55% (16/29), a disease control rate of 90% (27/30) and tumor shrinkage in 87% (26/30) of patients. Median duration of response (mDOR) was 13.5 months (min 1.2+, max 21.5+ months) including 11 of 16 confirmed objective responses ongoing at data cut-off and longest duration of response ongoing at >21 months after infusion. Confirmed response rates are similar across all melanoma subtypes (56% (9/16) in cutaneous melanoma and 54% (7/13) in other melanoma subtypes). IMA203 has exhibited a favorable tolerability profile (N=65 patients across all dose levels and all tumor types). The next data update, which will include translational and clinical data for IMA203, as well as further details on the clinical trial design for the planned IMA203 Phase 2/3 study, will be presented in 2H 2024 at a medical conference. Immatics is continuing dose escalation of IMA203CD8 (GEN2) with the goal of defining the optimal dose for further development. The next data update for IMA203CD8 (GEN2) is planned for 2H 2024 with a focus on continued dose escalation data in melanoma patients. In addition to treating melanoma patients, Immatics has also started to expand its clinical footprint outside of melanoma to address a broader patient population with a particular focus on ovarian and uterine cancers. TCR Bispecifics Programs Immatics’ T cell engaging receptor (TCER®) candidates are next-generation, half-life extended TCR Bispecific molecules. They are designed to maximize efficacy while minimizing toxicities and provide a patient-convenient dosing schedule through the proprietary format consisting of a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter binding to the T cell. Upcoming milestones for Immatics’ clinical TCER® pipeline Martin Wermke, M.D. will present the first clinical data from Immatics’ IMA401 (MAGEA4/8) at the ESMO Congress during an oral presentation titled, Initial safety, pharmacokinetics, and anti-tumor activity data of TCER IMA401, a MAGEA4/8-directed half-life extended TCR Bispecific, in Phase 1 dose escalation, on September 16, 2024, at 11:25 CEST. Data from approximately 30 patients from the dose escalation phase will be presented. Key objectives include: (1) Demonstrating tolerability of the novel, next-generation, half-life extended TCR Bispecifics format; (2) optimizing dosing schedule to a less frequent regimen during dose escalation, based on pharmacokinetics data; and (3) demonstrating initial clinical anti-tumor activity. IMA402 (PRAME) data are planned to be announced later in 2H 2024 and will include data from at least 15 patients in early stages of dose escalation across multiple solid cancers, but initially focused on melanoma. TCER® IMA401 (MAGEA4/8) The Phase 1 dose escalation basket trial to evaluate safety, tolerability and initial anti-tumor activity of TCER® IMA401 in patients with recurrent and/or refractory solid tumors is ongoing. IMA401 targets an HLA-A*02:01-presented peptide that occurs identically in two different proteins, MAGEA4 and MAGEA8. This target peptide has been selected based on natural expression in native solid tumors at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT® is >5x higher than for a MAGEA4 peptide target used in other clinical trials). MAGEA4 and MAGEA8 are expressed in multiple solid cancers including lung cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others. IMA401 is being developed in collaboration with Bristol Myers Squibb. TCER® IMA402 (PRAME) Immatics initiated the Phase 1/2 trial investigating the Company’s fully owned TCER® candidate IMA402 in patients with recurrent and/or refractory solid tumors in August 2023. Initial focus indications are ovarian cancer, lung cancer, uterine cancer and cutaneous and uveal melanoma, among others. IMA402 targets an HLA-A*02:01-presented peptide derived from the tumor antigen PRAME. This target peptide has been selected based on natural expression in native solid primary tumors and metastases at particularly high target density (peptide copy number per tumor cell identified by Immatics’ proprietary quantitative mass spectrometry engine XPRESIDENT®). Corporate Development In July 2024, Alise Reicin, M.D., was appointed to Immatics’ Board of Directors as the Company is advancing its pipeline of TCR-based cell therapy and bispecific product candidates into the next phase of development. Dr. Reicin brings extensive experience in early- and late-stage clinical development and has led the successful development of multiple important new therapies, including Keytruda®. Second Quarter 2024 Financial Results Cash Position: Cash and cash equivalents as well as other financial assets total €531.1 million ($568.5 million1) as of June 30, 2024, compared to €425.9 million ($455.9 million1) as of December 31, 2023. The increase is mainly due to the public offering in January 2024, partly offset by ongoing research and development activities. The Company projects a cash runway into 2027. Revenue: Total revenue, consisting of revenue from collaboration agreements, was €18.8 million ($20.1 million1) for the three months ended June 30, 2024, compared to €22.4 million ($24.0 million1) for the three months ended June 30, 2023. The decrease is mainly the result of a one-time revenue of €13.7 million associated with an opt-in payment by BMS during the three months ended June 30, 2023. Research and Development Expenses: R&D expenses were €35.2 million ($37.7 million1) for the three months ended June 30, 2024, compared to €27.3 million ($29.2 million1) for the three months ended June 30, 2023. The increase mainly resulted from costs associated with the advancement of the clinical pipeline candidates.General and Administrative Expenses: G&A expenses were €10.1 million ($10.8 million1) for the three months ended June 30, 2024, compared to €9.4 million ($10.1 million1) for the three months ended June 30, 2023. Net Profit and Loss: Net loss was €18.0 million ($19.3 million1) for the three months ended June 30, 2024, compared to a net loss of €24.6 million ($26.3 million1) for the three months ended June 30, 2023. The decrease in net loss despite decreased revenue and increased operating expenses is driven by an increased financial result. Full financial statements can be found in the 6-K filed with the Securities and Exchange Commission (SEC) on August 13, 2024, and published on the SEC website under www.sec.gov. Upcoming Investor Conferences Jefferies London Healthcare Conference, London, United Kingdom – November 19 – 21, 2024 To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations. - END - About ImmaticsImmatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on X, Instagram and LinkedIn. Forward-Looking StatementsCertain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND or CTA filing for pre-clinical stage product candidates, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: Media Trophic Communications Phone: +49 171 3512733 immatics@trophic.eu Immatics N.V. Jordan Silverstein Head of Strategy Phone: +1 346 319-3325 InvestorRelations@immatics.com Immatics N.V. and subsidiariesCondensed Consolidated Statement of Loss of Immatics N.V. Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 (Euros in thousands, exceptper share data) (Euros in thousands, exceptper share data) Revenue from collaboration agreements 18,755 22,354 49,024 32,150 Research and development expenses (35,216) (27,317) (67,324) (54,898) General and administrative expenses (10,128) (9,358) (21,770) (18,944) Other income 25 6 37 948 Operating result (26,564) (14,315) (40,033) (40,744) Change in fair value of liabilities for warrants (648) (13,105) 395 (5,708) Other financial income 9,665 3,954 20,580 6,748 Other financial expenses (305) (1,144) (515) (4,653) Financial result 8,712 (10,295) 20,460 (3,613) Loss before taxes (17,852) (24,610) (19,573) (44,357) Taxes on income (170) — (1,503) — Net loss (18,022) (24,610) (21,076) (44,357) Net loss per share: Basic (0.17) (0.32) (0.21) (0.58) Diluted (0.17) (0.32) (0.21) (0.58) Immatics N.V. and subsidiariesCondensed Consolidated Statement of Comprehensive Loss of Immatics N.V. Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 (Euros in thousands) (Euros in thousands) Net loss (18,022) (24,610) (21,076) (44,357) Other comprehensive income Items that may be reclassified subsequently to profit or loss Currency translation differences from foreign operations 462 (224) 798 340 Total comprehensive loss for the year (17,560) (24,834) (20,278) (44,017) Immatics N.V. and subsidiariesCondensed Consolidated Statement of Financial Position of Immatics N.V. As of June 30,2024 December 31,2023 (Euros in thousands) Assets Current assets Cash and cash equivalents 158,143 218,472 Other financial assets 372,964 207,423 Accounts receivables 2,811 4,093 Other current assets 25,200 19,382 Total current assets 559,118 449,370 Non-current assets Property, plant and equipment 50,289 43,747 Intangible assets 1,608 1,523 Right-of-use assets 14,616 13,308 Other non-current assets 1,336 2,017 Total non-current assets 67,849 60,595 Total assets 626,967 509,965 Liabilities and shareholders’ equity Current liabilities Provisions 3,437 — Accounts payables 18,791 25,206 Deferred revenue 95,521 100,401 Liabilities for warrants 18,598 18,993 Lease liabilities 3,178 2,604 Other current liabilities 10,021 9,348 Total current liabilities 149,546 156,552 Non-current liabilities Deferred revenue 75,298 115,527 Lease liabilities 14,235 12,798 Other non-current liabilities — 4 Total non-current liabilities 89,533 128,329 Shareholders’ equity Share capital 1,031 847 Share premium 1,006,064 823,166 Accumulated deficit (618,369) (597,293) Other reserves (838) (1,636) Total shareholders’ equity 387,888 225,084 Total liabilities and shareholders’ equity 626,967 509,965 Immatics N.V. and subsidiariesCondensed Consolidated Statement of Cash Flows of Immatics N.V. Six months ended June 30, 2024 2023 (Euros in thousands) Cash flows from operating activities Net loss (21,076) (44,357) Taxes on income 1,503 — Loss before tax (19,573) (44,357) Adjustments for: Interest income (12,660) (4,999) Depreciation and amortization 6,116 3,666 Interest expenses 420 401 Equity-settled share-based payment 8,605 11,615 Loss from disposal of fixed assets 1 Net foreign exchange differences and expected credit losses (7,723) 4,081 Change in fair value of liabilities for warrants (395) 5,708 Changes in: Decrease in accounts receivables 1,283 781 Decrease/(increase) in other assets (1,246) 765 (Decrease) in deferred revenue, accounts payables and other liabilities (48,493) (9,889) Interest received 8,260 2,051 Interest paid (420) (146) Income tax paid — — Net cash used in operating activities (65,825) (30,323) Cash flows from investing activities Payments for property, plant and equipment (11,797) (15,004) Payments for intangible assets (148) (154) Payments for investments classified in other financial assets (356,596) (170,326) Proceeds from maturity of investments classified in other financial assets 196,548 164,929 — — Net cash used in investing activities (171,993) (20,555) Cash flows from financing activities Proceeds from issuance of shares to equity holders 174,476 38,608 Transaction costs deducted from equity (1,157) Repayments related to lease liabilities (397) (1,866) Net cash provided by financing activities 174,079 35,585 Net decrease in cash and cash equivalents (63,739) (15,293) Cash and cash equivalents at beginning of the year 218,472 148,519 Effects of exchange rate changes and expected credit losses on cash and cash equivalents 3,410 (2,821) Cash and cash equivalents at end of the year 158,143 130,405 Immatics N.V. and subsidiariesCondensed Consolidated Statement of Changes in Shareholders’ Equity of Immatics N.V. (Euros in thousands) Sharecapital Sharepremium Accumulateddeficit Otherreserves Totalshare-holders’equity Balance as of January 1, 2023 767 714,177 (500,299) (1,481) 213,164 Other comprehensive income — — — 340 340 Net loss — — (44,357) — (44,357) Comprehensive loss for the year — — (44,357) 340 (44,017) Equity-settled share-based compensation — 11,615 — — 11,615 Share options exercised — 40 — — 40 Issue of share capital – net of transaction costs 37 37,374 — — 37,411 Balance as of June 30, 2023 804 763,206 (544,656) (1,141) 218,213 Balance as of January 1, 2024 847 823,166 (597,293) (1,636) 225,084 Other comprehensive income — — — 798 798 Net loss — — (21,076) — (21,076) Comprehensive loss for the year — — (21,076) 798 (20,278) Equity-settled share-based compensation — 8,605 — — 8,605 Share options exercised 1 1,036 — — 1,037 Issue of share capital – net of transaction costs 183 173,257 — — 173,440 Balance as of June 30, 2024 1,031 1,006,064 (618,369) (838) 387,888 1 All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2024 (1 EUR = 1.0705 USD). 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Patients with a certain type of synovial sarcoma have a new treatment option for the first time in more than a decade as the FDA has approved Adaptimmune's Tecelra, which is the first engineered T-cell therapy for a solid tumor. Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma.Tecelra’s approval comes with several firsts. It’s the first engineered cell therapy for a solid tumor, the first TCR-T therapy to enter the market, and the first new treatment in the indication in more than a decade.It also is the initial approval for the 16-year-old company, which has attracted and lost partnerships with several pharma giants—including GSK, Astellas and most recently Roche—who were drawn to the potential of Adaptimmune’s unique engineered T-cell receptor (TCR) platform. It enables the engineering of T-cells to target and destroy many types of solid tumor cancers.As the first engineered T-cell therapy for solid tumors, Tecelra marks a significant milestone, not only for the company but also for the advancement of cell therapy.“It’s the first product where we use a lentiviral vector to insert our engineered T-cell receptor into the cell,” John Lunger, Adaptimmune’s chief patient supply officer, explained in an interview. Iovance’s Amtagvi (lifileucel), which was approved by the FDA in February for melanoma, was the first T-cell treatment for solid tumors. The difference with Tecelra is that it is engineered.Amtagvi uses immune cells, called tumor-infiltrating lymphocytes (TILs), which are collected from a patient’s tumor, as opposed to CAR-T cell therapies, which are collected from a patient’s circulating blood.“Ninety percent of cancer is solid tumors,” Lunger said. “The idea of a company like ourselves, going after solid tumors using cells, we’re finally getting to that place where we’re demonstrating this can actually work.”The list price for the one-time therapy is $727,000. The addressable patient population in the US is roughly 400 per year, Lunger said.  Tecelra’s endorsement covers adults with advanced MAGE-A4+ synovial sarcoma of certain human leukocyte antigen (HLA) types who have received prior chemotherapy. Patients undergo companion diagnostic screening for their genetic HLA types and MAGE-4A expression.Sarcomas are rare solid tumor cancers that develop in the bones and soft tissues including fat, muscle, nerves and blood vessels, which often strike young adults. Of the roughly 13,400 new soft tissue sarcomas diagnosed annually in the US, 5 to 10% are of the synovial type. The five-year survival rate is 20%, with most patients going through multiple lines of therapy, Adaptimmune said.The approval is based on results of the SPEARHEAD-1 study of 44 patients, in which afami-cel provided a 43% overall response rate, with 4.5% seeing the disappearance of their cancer. For those who respond to Tecelra, the median treatment-free interval seen in the trial was 17 months.“We’ve also seen for those responders about a 70% chance that they’re still alive after two years and that data is still developing,” Lunger said.There were no treatment deaths in the study, though Tecelra can cause serious side effects including cytokine release syndrome and neurotoxicity.“From the patient experience, when you compare what we have with a one-time therapy to the usual standard of care—which is chemotherapy, radiation and surgery—it’s extraordinary,” Lunger said.As part of the accelerated approval, a confirmatory trial will be required.  Adaptimmune, which is based in Oxford, England, plans to have six to 10 designated treatment centers in operation by the end of this year, growing to 30 across the US by the end of 2025.Adaptimmune went public in 2015 but found itself in dire straits in April when Genentech—in cost-cutting mode—exited a $3 billion partnership in which it was developing two allogenic T-cell therapies directed at up to five targets.But seven weeks later, Galapagos stepped up, signing a $665 million deal for the rights to uza-cel, a MAGE-4A TCR T-cell therapy which Adaptimmune has in phase 2 for ovarian cancer. The Belgian biotech wants to take uza-cel into head and neck cancer and potentially other solid tumors.The Galapagos deal, which includes $100 million up front, will help fund Adaptimmune’s launch of Tecelra.Adaptimmune manufactures drug product for Tecelra in Philadelphia and farms viral vector production out to Miltenyi Biotec’s subsidiary Lentigen, which is based in Maryland. Adaptimmune handles all the manufacturing itself for uza-cel, performing viral vector production at one of its two sites in the UK.“This approval represents a much-needed new option for people diagnosed with this sarcoma and an important milestone for the use of cell therapies in solid tumor cancers,,” Sandra D’Angelo, a sarcoma medical oncologist at Sloan Kettering Cancer Center, and the principal investigator of the SPEARHEAD trial, said.