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USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 14, 2025 /PRNewswire/ -- USA News Group News Commentary – Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Fate Therapeutics, Inc. (NASDAQ: FATE), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), and Nektar Therapeutics (NASDAQ: NKTR). Global Market Insights estimates the global oncology market at US$345.1 billion in 2025 and forecasts it will climb to US$866.1 billion by 2034, growing at a robust 10.8% CAGR. The U.S. alone is expected to contribute $377.1 billion to that total. Vision Research Reports projects an even larger figure for the global cancer drug sector, predicting it will surpass US$900 billion in sales by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its development journey—pursuing a potential registration-enabling trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) for its flagship asset, pelareorep. In its latest Q2 2025 report, the company confirmed it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin as early as Q4 2025. For investors and potential partners, this represents a clear transition from promising clinical data to potential regulatory approval in one of medicine's most challenging cancer types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The strategic focus on mPDAC reflects both compelling clinical results and a significant market opportunity. Pelareorep is a systemically delivered oncolytic virus designed to convert immunologically "cold" tumors—those typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. In first-line pancreatic cancer studies, pelareorep-based regimens have demonstrated a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark for standard chemotherapy alone. Even more compelling, when pelareorep was combined with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—particularly significant given that checkpoint inhibitors are not currently approved for use in this indication. These results stem from pelareorep's dual mechanism: it both replicates within cancer cells and activates the body's immune response against tumors. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME—all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Translational data from the GOBLET and AWARE-1 studies demonstrate how pelareorep transforms the tumor microenvironment, increasing PD-L1 expression, heightening interferon signaling, and mobilizing tumor-infiltrating lymphocytes in the blood—changes that correlate with tumor size reduction. This mechanistic validation, combined with survival data from over 1,100 patients across multiple studies, has solidified the company's decision to prioritize this indication. Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. In line with their focus on capital efficiency, the company has terminated its At-the-Market and Equity Line of Credit facilities, citing sufficient resources to advance key milestones without near-term shareholder dilution. Regulatory advantages are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses streamline review processes and enhance the program's attractiveness to potential pharmaceutical partners. The context underscores the opportunity: pancreatic cancer remains one of the deadliest common cancers, with a five-year survival rate of less than 14%. Unlike other cancers where immunotherapies have transformed treatment, mPDAC has largely resisted immunotherapeutic approaches—making pelareorep's immune-activating mechanism particularly promising for this underserved patient population. Back in July, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes for patients and biomarker validation. The expert panel reinforced the view that pelareorep's mechanism of activating innate and adaptive immune responses is both biologically sound and commercially relevant for first-line mPDAC treatment. With this latest milestone, Oncolytics is entering a phase where FDA feedback will shape both clinical plans and potential commercial partnerships. If the agency accepts the company's proposed trial framework centered on an overall survival endpoint, the resulting study could provide definitive proof of pelareorep's market potential in mPDAC. The company expects to provide an updated clinical timeline in Q3 2025, with trial start-up activities potentially beginning as early as Q4 2025. With compelling survival data, regulatory designations in place, and an experienced leadership team driving execution, Oncolytics is positioning pelareorep for a pivotal test in one of oncology's most challenging and underserved markets. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) reported strong Q2 2025 results with $60 million in total product revenue, driven primarily by its breakthrough melanoma therapy Amtagvi, which treated over 100 patients in the second quarter. "Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs." The company's tumor-infiltrating lymphocyte (TIL) therapy—which uses a patient's own immune cells to fight cancer—generated $54.1 million in revenue and represents the first FDA-approved T-cell therapy for solid tumors, offering new hope for advanced melanoma patients who have tried other treatments without success. With expanded clinical trials planned for lung cancer and endometrial cancer, plus international approvals expected in Canada and other markets, Iovance is positioned to bring its innovative cancer treatment to patients worldwide. Fate Therapeutics, Inc. (NASDAQ: FATE) recently announced promising clinical progress for its off-the-shelf CAR T-cell therapy FT819, which showed lasting responses in lupus patients and received FDA clearance to begin trials for a solid tumor program targeting MICA/B proteins. While primarily focused on autoimmune diseases, the company's next-generation FT836 CAR T-cell therapy represents a significant advancement in cancer treatment as it's designed to target solid tumors without requiring harsh conditioning chemotherapy, potentially making the treatment safer and more accessible. "Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA, President and CEO of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and Shield™ technology toward the clinic." The company's stem cell-based platform continues to advance multiple programs, including partnerships for HER2-positive solid tumors, positioning Fate as a leader in developing ready-made cancer cell therapies. Inovio Pharmaceuticals, Inc. (NASDAQ: INO) remains on track to submit its application for INO-3107 in the second half of 2025, targeting Recurrent Respiratory Papillomatosis (RRP), a rare cancer-related condition caused by HPV that affects the airways. The company's DNA medicine platform represents a novel approach to treating HPV-related diseases and cancers, with INO-3107 showing significant clinical benefit by reducing the need for repeated surgeries in RRP patients from an average of 4.1 procedures annually to just 0.9 procedures. "We believe that INO-3107 could become the preferred treatment option for Recurrent Respiratory Papillomatosis (RRP) patients and their physicians—a treatment option with the potential to change the trajectory of this disease," said Dr. Jacqueline Shea, President and CEO of INOVIO. "I look forward to building on the significant progress of this past quarter and providing updates as we work toward a potential approval date in mid-2026." Beyond RRP, Inovio's technology platform is designed to treat various HPV-related cancers and other tumors by teaching the body's immune system to recognize and fight cancer cells. With breakthrough therapy designation from the FDA and plans for a trial involving 100 patients, INO-3107 could become the first DNA-based therapy approved for treating this serious cancer-related condition. Nektar Therapeutics (NASDAQ: NKTR) reported impressive Phase 2b data for rezpegaldesleukin in treating moderate to severe atopic dermatitis, with the company positioning this immune system regulator as a first-in-class treatment for autoimmune diseases. While primarily focused on autoimmune conditions, Nektar's pipeline includes NKTR-255, a treatment designed to boost the immune system's ability to fight cancer, which is being tested in multiple ongoing clinical trials with various partners. "As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders," said Howard W. Robin, President and CEO of Nektar. "Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target." The company's technology platform creates novel treatments that could potentially address both autoimmune diseases and cancer by enhancing the immune system's cancer-fighting abilities. With additional data expected from hair loss trials in December 2025 and continued development of next-generation programs, Nektar is advancing a unique approach to immune system therapy that could benefit millions of patients with serious diseases. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. 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对于许多实体瘤患者而言，反复接受化疗和放疗的过程往往令人难以忍受。若能有一种可实现持久疗效的一次性治疗方法，将极大减轻患者的痛苦——如今，这一愿景已得到切实的临床数据支持！ 在2025年ASCO大会上，Iovance的研究人员公布了针对153例晚期黑色素瘤患者的五年分析数据。结果显示，该疗法作为一次性治疗展现出持久效果：客观缓解率达31.4%，中位缓解持续时间约为三年。这不仅为晚期黑色素瘤患者带来了长期生存的希望，更在实体瘤治疗领域点亮了新的曙光，相信随着研究的深入，更多患者将迎来告别反复治疗、重获生活质量与长生存的那一天！ ▲截图源自“STAT” Lifileucel五年随访交出亮眼答卷：中位缓解超3年，31.4%客观缓解率见证持久抗癌力 2025年ASCO大会公布的这项II期C-144-01临床研究（NCT02360579）的5年随访结果，评估了Lifileucel的长期疗效与安全性。 结果显示：截至数据截止日期， 客观缓解率（ORR）为31.4% ，其中 完全缓解率（CR）占5.9% （9/153）， 部分缓解率（PR）占25.5% （39/153）； 79.3% （111/140） 的患者肿瘤负荷减轻 。 在缓解者中， 31.3% （15/48） 完成了5年评估并持续保持缓解 ，经独立评审委员会（IRC）评估的 中位缓解持续时间长达36.5个月 （95%CI，8.3至未达到；详见下图）。 ▲图源“JCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 另有 4名患者在输注Lifileucel1年后达到完全缓解 （详见下图）， 最长缓解持续时间达58.7个月 。 ▲图源“JCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 此外，总体人群的 中位总生存期（OS）为13.9个月 （95%CI，10.6至17.8）， 5年总生存率为19.7% （详见下图）。 ▲图源“JCO”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 综上，这项5年分析证实，一次性Lifileucel治疗可带来长期获益，总生存期表现显著，且未出现新的长期安全性问题。 TIL细胞唤醒体内沉睡的抗癌力量：实体瘤治疗迎来破晓之光 01、 TIL细胞为何能对抗肿瘤？ 对于实体瘤癌症，当病情进展到转移性阶段时，人体自身的免疫细胞已无法战胜癌症——此时癌细胞已过于强大。但即便如此，若切除肿瘤，仍能在其中发现这些对抗癌细胞的免疫细胞。可见，身体一直在生成针对特定肿瘤的免疫细胞，只是它们已不堪重负。 20世纪80年代，美国国立卫生研究院（NIH）的研究人员发现了肿瘤浸润淋巴细胞（TIL）的潜力，并率先从小鼠模型中分离出这种细胞。TIL是天然存在于肿瘤组织中的“免疫战士”，在与癌细胞的长期博弈中积累了独特的抗癌“经验”，能精准识别肿瘤微环境。不过，多数TIL会在持续战斗中受损衰退，因此需要从肿瘤组织中提取存活细胞，筛选出高活性个体后，通过体外培养扩增数万倍，形成“免疫军团”再回输患者体内，从而实现对残留癌细胞的精准围剿。 不同于许多针对单一抗原或一组抗原的癌细胞疗法，自体TIL细胞疗法旨在部署数十亿个个性化、患者特异性的TIL细胞，以识别并靶向呈递多种新抗原的癌细胞。这些存在于实体癌内的免疫细胞，在得到强化后能有效对抗癌细胞，如同坚韧的战士，即便肿瘤已进展扩散，也能坚守防御阵地。 临床医生从肿瘤中提取TIL，在体外对其进行增强并增殖至数十亿个，再将这些细胞重新注入同一患者体内，让它们随时准备投入“战斗”。这正是我们的目标：借助身体中那些每天都在抵抗感染、抵御疾病的物质，来对抗癌症。 ▼TIL细胞正在摧毁肿瘤组织 ▲图源“Science News”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 02、 TIL细胞疗法可用于治疗哪些癌种？ 2024年2月16日，Lifileucel（LN-144）获美国FDA批准上市，适用于既往接受过PD-1抗体治疗的不可切除或转移性黑色素瘤成人患者的治疗（若BRAFV600突变阳性，需先接受BRAF抑制剂±MEK抑制剂治疗）。除黑色素瘤外，TIL疗法正针对多种实体瘤展开广泛临床研究，包括但不限于： 1、胸部肿瘤：如 非小细胞肺癌、间变性甲状腺癌 等； 2、消化系统肿瘤：如 结肠癌、胆管癌 等； 3、妇科肿瘤：包括 卵巢癌、HPV相关癌症（如宫颈癌） 等； 4、其他实体瘤：如 乳腺癌、头颈部肿瘤、肉瘤 等。 跨越14个月的“抗癌火种”：从冷冻病灶到抗癌利刃，TIL疗法助晚期非小细胞肺癌脑膜转移患者，创下20个月持续缓解 非小细胞肺癌（NSCLC）软脑膜转移（LM）在晚期患者中发生率为3%-5%，近10年呈上升趋势，患者中位总生存期（mOS）仅4.2-8.1个月，未携带可靶向突变者生存时间更短。因此，迫切需要寻求新的治疗方法。 过继细胞疗法（ACT）中，肿瘤浸润淋巴细胞（TIL）疗法极具潜力，但因需从难治期患者体内获取肿瘤组织，既往不适用于无颅外实性病变的脑膜转移（LM）患者。我国浙江研究团队近期报道的突破性案例填补了这一空白：一名59岁男性复发性NSCLC伴脑膜转移（无颅外病变）患者，通过冷冻保存的病理完全缓解（pCR）病变中，制备自体TIL治疗，实现了LM完全缓解，为这类患者带来了新的希望与选择。 该患者（ChiCTR-101）是一位59岁男性，57岁时确诊右肺上叶鳞状非小细胞肺癌（NSCLC）（IVA期）（图1A-1D），2022年经化学免疫治疗、伽玛刀放射外科及手术切除后，肺部病灶达病理完全缓解（pCR），其原发灶被冷冻保存。然而好景不长，2023年4月，患者确诊软脑膜转移（LM），接受相关手术后参与临床试验，使用冷冻14个月的病理完全缓解（pCR）病变，制备TIL细胞。并于童年8月接受单次输注5×10⁹个自体TIL细胞，这些细胞的调节性T细胞EZH2活性受抑制，以CD4⁺T细胞为主，超80%为中枢或效应记忆细胞，促炎及抗肿瘤细胞因子表达水平高于外周T细胞。 ▼该患者两轮全身治疗后肺部病变缩小 ▲图源“TLCR”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 结果显示：TIL细胞输注后， 患者头痛缓解，脑脊液压力恢复正常，疗效持续至20个月后随访 ； 脑脊液肿瘤细胞于20天后转阴 （详见下图）。 ▲图源“TLCR”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 此外， 循环肿瘤细胞（CTC）逐渐下降，89天后未再检测到 （详见下图）。 ▲图源“TLCR”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 总之，上述研究表明，此类TIL抗肿瘤功效显著，提前储存治疗反应性肿瘤组织，或可为原本不适合TIL疗法的难治性非小细胞肺癌（NSCLC）软脑膜转移（LM）患者提供安全有效的ACT方案，也支持利用初次手术获取的自体肿瘤组织库制备TIL的合理性。 · 全球肿瘤医生网温馨提示 · TIL细胞并非想存就能存。理论上讲， TIL细胞建议尽早储存，因为TILs细胞数量，会随肿瘤进展而逐渐降低；且术后接受辅助性放化疗，不仅杀伤癌细胞，还会杀死体内的正常细胞及免疫细胞 。 故最好在 刚刚确诊癌症、且未接受其他治疗（如放化疗）前储存TIL细胞为宜 ，因为 此时TIL细胞的抗癌能力最强 。比如上述这例幸运的非小细胞肺癌患者，就是在2022年发病之初，在术后及时冻存了原发灶，后续在出现软脑膜转移后，利用之前冻存的肿瘤组织，成功制备了TIL细胞，为自己争取到了一线生机。 因此，建议癌症患者珍惜有且仅有一次的宝贵抗癌机会，肿瘤进展前，先存下“抗癌底气”！在术前争得主治医生同意后，将新鲜的肿瘤标本组织留存，并交由专业的机构进行TIL细胞的分离培养及冻存，以用作早期辅助治疗手段，或晚期末线补救措施，以预防肿瘤复发/转移、延长生存时间、提高生活质量。 不止缩小肿瘤，更能长期控癌！TIL疗法暴击转移性乳腺癌，半数患者肿瘤缩小，最长5年未复发 2022年，美国国家癌症研究所（NCI）发表了一项“应用自体肿瘤浸润淋巴细胞（TIL），治疗转移性乳腺癌”临床研究的振奋数据。 结果显示：在6例可评估疗效的患者中， 50%经TIL治疗后出现可测量的肿瘤缩小 ，其中2位患者分别在治疗6个月、10个月后， 肿瘤缩小率达52%和69% 。更令人振奋的是，这些患者在 治疗后3.5~5年内，均未出现癌症复发 。 值得一提的是，研究中一例典型病例的治疗效果尤为显著。影像学结果显示：2015年12月治疗前， 患者肝脏（下左）、胸壁（上左）均存在转移性病变 （详见下图a）；经免疫治疗后，2021年5月复查显示 肿瘤完全消退，且随访5年未出现新发癌症 （详见下图b）。 ▼该患者在TIL治疗前后的影像学对比 ▲图源“Nat Med”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 小编寄语 TIL疗法是一类具有“悠久历史”的细胞疗法，自1988年初次尝试用于临床以来，已历经30余载的发展，其在治疗黑色素瘤、肺癌、头颈部肿瘤、宫颈癌等多种实体瘤领域，具有独特的优势，为实体瘤患者带来了新的希望与选择！比如文中提到的TIL细胞疗法让黑色素瘤中位缓解超3年、乳腺癌最长5年未复发等，再次展现了TIL细胞在治疗实体瘤方面不容小觑的实力。 不过，国际干细胞小编温馨提示，癌症作为一种高度突变且极度复杂的疾病，很难仅靠一种治疗手段就能达到预期的治疗效果。目前仍以手术、放化疗等传统治疗手段为主。在此基础上，存在TIL细胞制备条件的患者，可在初次手术及放化疗前，及时冻存TIL细胞，用于后续治疗，以预防复发/转移，或在癌症晚期其他措施束手无策时，作为末线补救措施。如果您还想了解TIL细胞储存的更多讯息，可将治疗经历等，提交至 全球肿瘤医生网医学部 ，进行初步评估。 参考资料 [1]Medina T,et al.Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study[J]. Journal of Clinical Oncology, 2025: JCO-25-00765. http://ascopubs.org/doi/10.1200/JCO-25-00765 [2]Zheng A H,et al.Immunotherapy with lymphocytes derived from banked tumor tissue in two refractory NSCLC patients with leptomeningeal metastases: a report of two cases[J]. Translational Lung Cancer Research, 2025, 14(7). https://tlcr.amegroups.org/article/view/103461/html [3]Zacharakis N,et al.Immune recognition of somatic mutations leading to complete durable regression in metastatic breast cancer. Nat Med. 2018 Jun;24(6):724-730. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6348479/ 本文为全球肿瘤医生网原创，未经授权严禁转载