Irofulven-2

Drug candidate LP-184 to be evaluated in combination with immune checkpoint inhibitors in biomarker-defined NSCLC patients with KEAP1 and/or STK11 mutations and low PD-L1 expression. The FDA has cleared the LP-184 investigational new drug (IND) application amendment for the treatment of a biomarker defined patient population of non-small cell lung cancer (NSCLC). The planned phase 1b/2 clinical trial plans to evaluate LP-184 in advanced NSCLC patients with KEAP1 and/or STK11 mutations and low expression of PD-L1 in combination with the immune checkpoint inhibitor therapies, nivolumab and ipilimumab. LP-184 is a synthetically lethal, novel small molecule advanced and developed with Lantern’s AI platform, RADR ® . The median overall survival for newly diagnosed, advanced NSCLC with KEAP1 and/or STK11 mutations treated with checkpoint inhibitors and chemotherapy is estimated to be 15 months and this population presents an annual market opportunity in excess of $2 billion USD. DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR®, today announced that the U.S. Food and Drug Administration (FDA) has cleared the amendment to its Investigational New Drug (IND) application to initiate a Phase 1b/2 clinical trial of LP-184 in a genomically defined patient population of non-small cell lung cancer (NSCLC) where there is a need to improve patient outcomes. “This study represents a potential therapeutic opportunity to improve outcomes for patients diagnosed with advanced non-small cell lung cancer with KEAP1, and STK11 alterations independent of KRAS status (...)" “This study represents a potential therapeutic opportunity to improve outcomes for patients diagnosed with advanced non-small cell lung cancer with KEAP1, and STK11 alterations independent of KRAS status. Historically, these co-alterations may lead to worse outcomes for patients, due to resistance to treatments such as single agent immunotherapy, chemotherapy, or chemoimmunotherapy. Research to date suggests that dual immunotherapy is the best approach for this disease type, but many patients still progress on treatment, highlighting an area of unmet need that we can potentially improve on by the addition of LP-184 to this combination,” said Misty Dawn Shields, M.D. Ph.D. — Division of Hematology/Oncology, Thoracic Oncology, Indiana University: Melvin & Bren Simon Comprehensive Cancer Center, and Lead Investigator for the planned Study. Strategic Trial Design to Address Critical Treatment Gap in Advanced NSCLC The biomarker focused Phase 1b/2 clinical trial is designed to target high-risk NSCLC subtypes by evaluating LP-184 in combination with the immune checkpoint inhibitors nivolumab and ipilimumab in patients with advanced NSCLC harboring KEAP1 and/or STK11 mutations and low PD-L1 expression—a population with limited response to existing first-line therapies. The study is designed to assess safety, preliminary efficacy, and biomarker correlations, potentially paving a path toward accelerated development in this genetically defined patient segment that is treatment resistant to many existing approved chemo and immunotherapies.1 Lantern Pharma expects to prepare an application for a Fast Track or Accelerated Approval Designation for this patient population based on data from the planned trial and ongoing analysis from existing models. This unique trial is aimed at addressing a critical unmet clinical need in lung cancer care: the median overall survival in newly diagnosed, advanced NSCLC patients with KEAP1 and/or STK11 mutations treated with chemo-immunotherapy averages 15 months, substantially lower than outcomes in mutation negative populations. For patients that fail earlier lines of therapies the overall survival tends to skew even lower at approximately 6.3 months.2 This represents a market opportunity exceeding $2 billion annually, given the prevalence and poor prognosis for patients with these mutations. Mechanistic Rationale for LP-184 in NSCLC LP-184 is a next-generation, synthetically lethal small molecule that induces DNA double-strand breaks upon activation by prostaglandin-reductase 1 (PTGR1). This enzyme is notably overexpressed in KEAP1-mutant tumors. Preclinical studies demonstrate that LP-184's cancer-killing potency directly correlates with PTGR1 expression levels in NSCLC cell lines. The company's proprietary RADR® platform-driven in silico analyses and preclinical studies suggest that LP-184 is particularly effective in DNA damage repair (DDR)-deficient cancers, including NSCLC with KEAP1 and STK11 alterations3. An additional advantage of LP-184 is its selective toxicity mechanism: PTGR1 enzymatically converts LP-184 from a prodrug to its bioactive, cytotoxic form specifically within tumor cells where PTGR1 is elevated, while normal tissues with low PTGR1 expression remain largely unaffected. This selective toxicity has been observed pre-clinically and in Lantern’s AI modeling. This tumor-selective activation creates a significant therapeutic window that may enable robust anti-tumor activity while minimizing systemic toxicities. Another key competitive advantage of LP-184 is its mechanism, which in preclinical models has been demonstrated to remain effective regardless of TP53 status—a common co-mutation that contributes to resistance against current therapies2. Individual or co-occurring KEAP1, STK11, and TP53 mutations are found in approximately 20-30% of NSCLC patients and define molecular subsets unresponsive to standard immune checkpoint blockade4. Targeting The Right Patients - Combining Potential Clinical Benefit & Likelihood of Response to LP-184 in a Combination Regimen Clinical data analysis conducted by Lantern Pharma in 517 lung cancer patients from a major cancer database (TCGA) revealed a clear target population for LP-184. About 35% of these patients had high levels of PTGR1 - the enzyme that has been hypothesized to activate LP-184 inside the cancer cell. (Figure 1) Among these PTGR1-high lung cancer patients, 40% also had KEAP1 mutations, which are linked to poor responses to current immunotherapies and chemotherapies. KEAP1 mutations actually cause higher PTGR1 expression, essentially making these difficult-to-treat tumors more vulnerable to LP-184 based on preclinical observations. "This clinical trial and the FDA clearance represents a pivotal milestone in our mission to develop precise, data-driven cancer therapies for patients with limited treatment options," said Panna Sharma, President and CEO of Lantern Pharma. "The STK11 and KEAP1 mutant NSCLC population represents an important market opportunity and, a group of patients desperately awaiting better treatment options. By combining our AI-driven approach with a deep understanding of cancer biology, we've identified LP-184 as a potential breakthrough for these patients. The clearance of this trial advances our precision oncology strategy while demonstrating the power of our RADR® platform to accelerate development timelines and reduce costs, as part of our mission to create value for both patients and shareholders as we work to transform oncology drug development." About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages approximately 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of product candidates that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. On average, our newly developed programs have been advanced from initial AI insights to first-in-human clinical trials in 2–3 years and at approximately $1.0 – $2.5 million per program. Our lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. 1 Skoulidis F, et al. "STK11/LKB1 mutations and PD-1 inhibitor resistance in KRAS-mutant lung adenocarcinoma." Cancer Discov. 2018;8:822–35. 2 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238358 - “STK11 (LKB1) mutations in metastatic NSCLC: Prognostic value in the real world1” 4 Bange E, et al. KEAP1 and TP53 frame genomic, evolutionary, and immunologic subtypes of lung adenocarcinoma with different sensitivity to immunotherapy. Journal of Thorac Oncol. 2021;16:2065-2077.

本期看点1. 在一项早期临床试验中，tuspabetinib（TUS）联用标准剂量的venetoclax和azacitidine的三联疗法使多名急性髓系白血病（AML）患者的肿瘤细胞完全消失。2. 放射增敏剂JNJ-1900用于局部晚期或临界可切除胰腺癌患者的1期临床试验结果亮眼，患者的中位总生存期（OS）优于历史对照组，并有两名患者成功实现R0根治性手术切除。3. 大环MEK抑制剂PAS-004的药效学（PD）数据积极，对评估MEK抑制剂活性的金标准PD生物标志物的抑制率高达91%。药明康德内容团队整理Tuspetinib：公布1/2期联合治疗试验的新数据Aptose Biosciences公司公布了其针对新确诊的AML患者开展的1/2期TUSCANY试验的新数据。这些患者分别接受了40毫克或80毫克剂量的tuspabetinib联用标准剂量的venetoclax和azacitidine（TUS+VEN+AZA三联疗法）。该三联疗法正在被开作发为一种安全且不依赖于特定突变的一线治疗方案，用于治疗那些无法接受诱导化疗的新诊断AML患者，这些患者具有多样的突变。在两种剂量下，均有多名携带不同突变（包括TP53突变/复杂核型、FLT3野生型）的患者达到了完全缓解（CR）或伴有血液学不完全恢复的完全缓解（CRi），40毫克剂量组中达到CR/CRi的3名患者的最小残留病（MRD）状态均为阴性。安全性方面，该三联疗法的安全性良好，在两个剂量水平下均未观察到剂量限制性毒性。JNJ-1900（NBTXR3）：公布1期临床试验数据Nanobiotix公司公布了其潜在“first-in-class”的新型放射增敏剂JNJ-1900（NBTXR3）用于局部晚期或临界可切除胰腺癌患者的1期临床试验数据。NBTXR3由功能化二氧化铪（HfO2）纳米颗粒组成，经由一次性瘤内注射给药并通过放射疗法激活。它的物理作用机制为：通过放疗激活，诱导被注射肿瘤内大量的肿瘤细胞死亡，随后触发适应性免疫反应和长期的抗癌记忆。得益于该物理作用机制，Nanobiotix公司认为NBTXR3可扩展到任何可以通过放疗治疗的实体肿瘤和任何联合治疗方案中，特别是与免疫检查点抑制剂联合。2023年，Nanobiotix宣布与强生旗下杨森公司（现名为强生创新制药）达成全球共同开发和商业化NBTXR3的许可协议。此次公布的研究结果显示，22名接受JNJ-1900治疗的患者的中位OS达到23个月（从诊断日期开始计算），优于历史对照组（19.2个月）；中位局部无进展生存期（PFS）为13.3个月（从放疗结束时开始计算）；两名患者成功实现R0根治性手术切除。探索性生物标志物分析显示，循环肿瘤突变负荷（cTMB）升高与更长的局部PFS和OS相关；CA19-9肿瘤标志物在59%的患者中恢复正常，同样与更长的OS相关。这些结果支持在随机对照试验中进一步评估JNJ-1900。PAS-004：公布1期临床试验数据Pasithea Therapeutics公司公布了其大环MEK抑制剂PAS-004治疗MAPK通路驱动的晚期实体肿瘤患者的1期临床研究的PD数据。与目前FDA批准的MEK抑制剂不同，PAS-004是大环化合物，环化可增强药物与靶受体的结合，被认为有望改善药代动力学和安全性。ERK磷酸化（pERK）的抑制被广泛认为是评估MEK抑制剂活性的金标准PD生物标志物。为了评估PAS-004的靶点作用，研究人员在基线和第22天稳态时检测了患者外周血单核细胞（PBMCs）中的pERK水平。结果显示，PAS-004对pERK的抑制率高达91%，证实其具有强大的靶点作用。该结果得到了初步临床观察的支持，表现为多名患者实现了疾病稳定（SD）和肿瘤缩小。其中，一名IV期携带KRAS G12R突变的胰腺癌患者已获得超过5个月的SD，肿瘤体积缩小了9.8%。REC-4881：公布1b/2期临床试验数据Recursion公司公布了其正在进行的1b/2期TUPELO试验中REC-4881的初步安全性和疗效结果。REC-4881是一种正在被开发用于治疗家族性腺瘤性息肉病（FAP）的选择性变构MEK1/2抑制剂。FAP是一种由APC基因突变引起的罕见遗传性疾病，患者若不治疗，几乎100%会发展为结直肠癌。目前，该病尚无获得美国FDA批准的治疗方法。REC-4881已获得FDA和欧洲药品管理局授予的孤儿药资格及FDA的快速通道资格。截至2025年3月17日的数据，在接受4 mg每日一次治疗的6例可评估患者中，第13周时息肉负荷的中位降幅为43%，其中83%的患者（5人）的降幅范围为31%至82%，1例患者的息肉负荷较基线大幅增加。50%的患者实现了Spigelman分期（衡量上消化道疾病严重程度的指标）改善≥1分。REC-4881的早期安全性特征与以往的MEK1/2抑制剂相似。在1b期和2期研究里的19名患者中，大多数治疗相关不良事件为1/2级，16%的患者发生了3级不良事件，目前未报告任何4级及以上的治疗相关不良事件。JANX007：启动1b期扩展研究Janux Therapeutics公司宣布在未接受过紫杉烷类药物的转移性去势抵抗性前列腺癌（mCRPC）患者中启动1b期扩展研究，该研究的启动得到了此前公布的1a期剂量递增研究数据的支持。JANX007是一款靶向前列腺特异性膜抗原（PSMA）的肿瘤激活T细胞接合器，分别靶向PSMA和T细胞表面表达的CD3受体。它的设计让JANX007在肿瘤微环境中经过蛋白酶切割而被激活，从而在降低了其潜在毒性的同时，最大化抗肿瘤免疫反应。截至2025年4月21日的数据，16名mCRPC患者的中位影像学PFS为7.5个月，6个月时的影像学无进展生存率为65%；接受6 mg和9 mg治疗剂量的9名患者的中位影像学PFS为7.9个月，6个月时的影像学无进展生存率为78%。安全性数据与2024年12月披露的数据保持一致。SPY001：公布1期临床试验的新数据Spyre Therapeutics公司公布了其抗体疗法SPY001的1期临床试验的新数据。SPY001是一种高效、具有选择性的抗α4β7单克隆抗体，采用工程化改造延长半衰期，正在被开发用于治疗炎症性肠病（IBD）。长达8个月的随访结果显示，SPY001具有良好的耐受性，药代动力学（PK）数据显示，其半衰期长达约80天，是现有标准治疗之一的vedolizumab的三倍以上。PD数据显示，在预期的2期谷浓度，单次给药SPY001仍能维持对靶点的持续作用，导致α4β7受体快速、持续饱和。该数据进一步支持SPY001在更高暴露量下可能实现更优的诱导治疗反应，以及具有每季度或每半年给药一次的潜力。参考资料：[1] Perfuse Therapeutics Announces Positive Results from the Completed Phase 1/2a Clinical Trial of PER-001 Intravitreal Implant in Patients with Glaucoma. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/perfuse-therapeutics-announces-positive-results-from-the-completed-phase-12a-clinical-trial-of-per-001-intravitreal-implant-in-patients-with-glaucoma-302446082.html[2] IDEAYA Biosciences Announces US FDA IND-Clearance for IDE849, a Potential First-in-Class DLL3 TOP1 ADC, for a Phase 1 Study in Solid Tumors. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/ideaya-biosciences-announces-us-fda-ind-clearance-for-ide849-a-potential-first-in-class-dll3-top1-adc-for-a-phase-1-study-in-solid-tumors-302446498.html[3] Cohen, R.B., Jimeno, A., Hreno, J. et al. Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors. Invest New Drugs (2025). https://doi.org/10.1007/s10637-025-01538-3[4] Opus Genetics Announces Presentation of OPGX-LCA5 Gene Therapy Data at ARVO; 12 Month Phase 1/2 Results Support Potential to Restore to Meaningful Vision. Retrieved May 9, 2025, from https://ir.opusgtx.com/press-releases/detail/484/opus-genetics-announces-presentation-of-opgx-lca5-gene-therapy-data-at-arvo-12-month-phase-12-results-support-potential-to-restore-to-meaningful-vision[5] Janux Therapeutics Initiates Phase 1b Expansion Studies with JANX007 in Patients with Prostate Cancer and Provides Program Updates. Retrieved May 9, 2025, from https://investors.januxrx.com/investor-media/news/news-details/2025/Janux-Therapeutics-Initiates-Phase-1b-Expansion-Studies-with-JANX007-in-Patients-with-Prostate-Cancer-and-Provides-Program-Updates/default.aspx[6] Lantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC). Retrieved May 9, 2025, from https://ir.lanternpharma.com/news-events/press-releases/detail/177/lantern-advances-drug-candidate-lp-184-with-ind-clearance[7] Spyre Therapeutics Announces Poster Presentations at Digestive Disease Week (DDW) 2025 Including Up to Eight months of Follow-up from an Ongoing Phase 1 Trial of SPY001. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/spyre-therapeutics-announces-poster-presentations-at-digestive-disease-week-ddw-2025-including-up-to-eight-months-of-follow-up-from-an-ongoing-phase-1-trial-of-spy001-302445258.html[8] Aptose Provides Clinical Update for the Tuspetinib-based Triple Drug Frontline Therapy in Newly Diagnosed AML Patients from the Phase 1/2 TUSCANY Trial. Retrieved May 9, 2025, from https://www.aptose.com/news-media/press-releases/detail/317/aptose-provides-clinical-update-for-the-tuspetinib-based[9] Regeneration Biomedical to Present Updated Phase 1 Trial Data on Autologous Stem Cell Therapy Injected Directly into the Brain for Alzheimer’s Disease in Podium Presentation at the ISCT 2025 Scientific Annual Meeting. Retrieved May 9, 2025, from https://www.globenewswire.com/news-release/2025/5/5/3073944/0/en/Regeneration-Biomedical-to-Present-Updated-Phase-1-Trial-Data-on-Autologous-Stem-Cell-Therapy-Injected-Directly-into-the-Brain-for-Alzheimer-s-Disease-in-Podium-Presentation-at-the.html[10] Nanobiotix Announces Full Results From Completed Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Pancreatic Cancer. Retrieved May 9, 2025, from https://ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-full-results-completed-phase-1-study[11] Preliminary Phase 1b/2 Data for REC-4881 in Familial Adenomatous Polyposis (FAP) Demonstrates Reduced Polyp Burden. Retrieved May 9, 2025, from https://ir.recursion.com/news-releases/news-release-details/preliminary-phase-1b2-data-rec-4881-familial-adenomatous[12] TransCode Therapeutics Reports Further Progress on Phase 1a Clinical Trial with No Dose Limiting Toxicities Reported in Patients with Metastatic Cancer. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/transcode-therapeutics-reports-further-progress-on-phase-1a-clinical-trial-with-no-dose-limiting-toxicities-reported-in-patients-with-metastatic-cancer-302443677.html[13] Design Therapeutics Announces Favorable Phase 1 Data for DT-168 Supporting Advancement into Phase 2 Biomarker Trial for Patients with Fuchs Endothelial Corneal Dystrophy. Retrieved May 9, 2025, from https://investors.designtx.com/news-releases/news-release-details/design-therapeutics-announces-favorable-phase-1-data-dt-168[14] Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004. Retrieved May 9, 2025, from https://www.globenewswire.com/news-release/2025/05/06/3074902/0/en/Pasithea-Therapeutics-Reports-Positive-Pharmacodynamic-Results-Demonstrating-Robust-Target-Engagement-from-its-Ongoing-Phase-1-Clinical-Trial-of-PAS-004.html[15] Aspen Neuroscience Announces 6-Month ASPIRO Phase 1/2a Clinical Trial Results of Personalized Cell Therapy for Parkinson's Disease. Retrieved May 9, 2025, from https://www.prnewswire.com/news-releases/aspen-neuroscience-announces-6-month-aspiro-phase-12a-clinical-trial-results-of-personalized-cell-therapy-for-parkinsons-disease-302448009.html[16] Arbutus Presents Clinical Trial Data from its Two HBV Assets, Imdusiran and AB-101, at the European Association for the Study of the Liver (EASL) Congress 2025. Retrieved May 9, 2025, from https://investor.arbutusbio.com/news-releases/news-release-details/arbutus-presents-clinical-trial-data-its-two-hbv-assets[17] CRISPR Therapeutics Provides First Quarter 2025 Financial Results and Announces Positive Top-Line Data from Phase 1 Clinical Trial of CTX310™ Targeting ANGPTL3. Retrieved May 7, 2025 from https://ir.crisprtx.com/news-releases/news-release-details/crispr-therapeutics-provides-first-quarter-2025-financial[18] Marengo Doses First Patient in STARt-002 Clinical Trial Evaluating First-in-Class Dual T Cell Agonist, Invikafusp Alfa in Combination with TROP2-directed ADC Trodelvy® in Metastatic Breast Cancer. Retrieved May 7, 2025 from https://www.prnewswire.com/news-releases/marengo-doses-first-patient-in-start-002-clinical-trial-evaluating-first-in-class-dual-t-cell-agonist-invikafusp-alfa-in-combination-with-trop2-directed-adc-trodelvy-in-metastatic-breast-cancer-302449274.html[19] Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial. 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