Cetuximab

RT-NBTXR3 followed by anti-PD-1 demonstrated favorable safety profile, disease control and tumor response in patients both naïve and resistant to anti-PD-1, suggesting that NBTXR3 may prime the immune system before checkpoint therapySeveral clinical milestones expected over the next 12-18 months including updated data in pancreatic, and head and neck cancer, and initial data in esophageal and lung cancer€66.3 million in cash and cash equivalents as of June 30, 2024, with a cash runway extended into Q4 2025 PARIS and CAMBRIDGE, Mass., Sept. 18, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the “Company”), a late-clinical stage biotechnology company pioneering nanoparticle-based approaches to expand treatment possibilities for patients with cancer and other major diseases, provided an update on operational progress and announced its half year financial results for the six-month period ended June 30, 2024. “We continue to make strong progress advancing our nanoparticle-based therapeutic approach with lead candidate NBTXR3, which is part of our global licensing agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company. The agreement is designed to realize significant therapeutic and market opportunities in solid tumor cancers worldwide, starting with lung and head and neck. We also continue to establish additional expansion opportunities across multiple cancer settings as part of our ongoing collaboration with MD Anderson,” said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board. “The potential of NBTXR3 to prime immune activity before an anti-PD-1 inhibitor was further reinforced with new data from Study 1100 announced at the Annual Meeting of American Society for Clinical Oncology (ASCO) showing disease control and tumor response in patients with head and neck cancer that are naïve or resistant to prior anti-PD-1 therapy. We expect several clinical milestones over the next 12-18 months that, would further advance and broaden the potential patient population for NBTXR3 including updated data in pancreatic and head and neck cancer, and initial data in esophageal and lung cancer.” First Half 2024 Operational Highlights, Pipeline Status and Expected Milestones Strengthened Supervisory Board with the nominations of Dr. Margaret A. Liu and Ms. Anat Naschitz as board observers, two key additions intended to further equip the Company for sustainable long-term growth. Dr. Liu brings a wealth of experience in US and international academia, pharmaceuticals, biotechnology and public policy, and Ms. Naschitz brings world-class expertise in raising and deploying capital to support disruptive innovation for the benefit of patients, healthcare professionals and investors. Achieved a NANORAY-312 operational milestone as part of global exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV, a Johnson & Johnson company, for the investigational, potential first-in-class radioenhancer NBTXR3 and subsequently received the $20 million payment. Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): Local Control as Single Agent Activated by Radiotherapy (RT) NANORAY-312, a pivotal, global, randomized Phase 3 trial evaluating RT-activated NBTXR3 ± cetuximab vs RT ± cetuximab in elderly patients ineligible for cisplatin chemotherapy Interim analysis to be reported after both the requisite number of events has occurred and the last patient is recruited, expected by 1H2026Ongoing transfer of the sponsorship to Janssen to facilitate preparations for potentially positive trial results and subsequent steps Study 102, a successfully completed Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 in patients ineligible for cisplatin chemotherapy or intolerant to cetuximab. Final results showed topline safety and efficacy data supporting robust anti-tumor activity and a well-tolerated profile in elderly patients with a high burden of comorbidity (n=56) Non-Small Cell Lung Cancer (NSCLC) Janssen-led randomized Phase 2 study evaluating NBTXR3 + chemoradiation followed by anti-PD-L1 for patients with inoperable, stage 3 NSCLC Study may proceed letter received from the Food and Drug Administration (FDA)First patient randomized is the next expected milestone Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Priming Immune Response Followed by an Anti-PD-1 Treatment: Study 1100, a Phase 1 dose escalation and expansion trial evaluating RT-activated NBTXR3 followed by an anti-PD-1 as a second-or-later line treatment in patients with advanced cancers Completed dose escalation part – ongoing dose expansion part. New data in R/M HNSCC Naïve or Resistant to Anti-PD-1 presented at ASCO: Favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; “ITT”)48% overall response rate (ORR) in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.176% disease control rate (DCR) in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 monthsITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months Initial data from immunotherapy resistant patients with multiple primary tumors expected in 2025Data supports further evaluation in randomized clinical trials which may include a potential registrational pathway for NBTXR3 in combination with an immunotherapy. Pancreatic, Lung and Others: Expanding NBTXR3 Opportunity Through a Strategic Collaboration with The University of Texas MD Anderson Cancer Center to Validate Tumor-Agnostic, Combination-Agnostic Therapeutic Profiles Five ongoing clinical trials in advanced solid tumors: Advanced Solid Tumors with Lung or Liver Metastases: Phase 1/2 study (NCT05039632) of RT-activated NBTXR3 plus an anti-PD-1/L-1 immune checkpoint inhibitorRecurrent or Metastatic Head and Neck Cancer: Phase 2 study (NCT04862455) of RT-activated NBTXR3 in combination with anti-PD-1Inoperable Non-Small Cell Lung Cancer (NSCLC): Phase 1 study (NCT04505267) of single agent RT-activated NBTXR3 Dose escalation completed and dose expansion ongoing. Established RP2D after determination of injection feasibility and observation of a favorable safety profile. Esophageal Cancer: Phase 1 study (NCT04615013) of RT-activated NBTXR3 in combination with chemotherapy Pancreatic Cancer: Phase 1b study (NCT04484909) of RT-activated NBTXR3 after cytotoxic chemotherapy for patients with locally advanced pancreatic cancer (LAPC) Multiple expected clinical milestones: Updated Phase 1b dose escalation data in pancreatic cancer expected 2H2024Initial Phase 1 dose escalation data in inoperable, recurrent NSCLC amenable to re-irradiation expected 1H2025Completion of dose escalation in Phase 1b/2 trial in esophageal cancer expected in 2024, initiation of dose expansion part, and presentation of first data in 2025 Half Year 2024 Financial Results Revenue and Other Income: Revenue and other income has increased for the six months ended June 30, 2024, to €9.3 million, compared to €3.3 million for the six months ended June 30, 2023, primarily resulting from services and product supply revenue linked to the exclusive licensing, co-development, and commercialization agreement with Janssen Pharmaceutica NV executed on July 7, 2023. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to the development of NBTXR3. These expenses for the six months ended June 30, 2024, were €22.0 million, primarily driven by an increase of the clinical development activities in NANORAY-312, compared to €17.8 million for the six months ended June 30, 2023. Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. Total SG&A expenses for the six months ended June 30, 2024, were €10.8 million, compared to €10.9 million for the prior-year six-month period. Net loss: Net loss attributable to common shareholders for the six months ended June 30, 2024, was €21.9 million, or a €0.46 basic loss per share. This compares to a net loss attributable to common shareholders of €28.1 million, or €0.80 basic loss per share, for the same period in 2023. Cash and Cash Equivalents: Cash and cash equivalents as of June 30, 2024, were €66.3 million, compared to €75.3 million as of December 31, 2023. Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of €66.3 million as of June 30, 2024, will now fund our operations into Q4 2025, compared to Q3 2025 in prior guidance. Availability of the Half Year 2024 Financial Reports The 2024 half-year financial report has been filed with the French financial market authority (Autorité des marchés financiers). It is available to the public on the Company’s website, www.nanobiotix.com. About NBTXR3 NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study. Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV. About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations. Nanobiotix is the owner of more than 25 patent families associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter DisclaimerThis press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 24, 2024 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2023 universal registration document filed with the AMF on April 24, 2024, in Nanobiotix’ 2024 semi-annual report under the caption “Supplemental Risk Factor” filed with the SEC on Form 6-K and with AMF on September 18 2024, and subsequent filings Nanobiotix makes with the SEC from time to time which are available on the SEC’s website at www.sec.gov. The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly. Contacts NanobiotixCommunications DepartmentBrandon OwensVP, Communications+1 (617) 852-4835contact@nanobiotix.comInvestor Relations DepartmentCraig WestSVP, Investor Relations+1 (617) 583-0211investors@nanobiotix.comMedia RelationsFR – Ulysse CommunicationLaurent Wormser+ 33 (0)6 13 12 04 04lwormser@ulysse-communication.comGlobal – LifeSci AdvisorsKevin Gardner+1 (617) 283-2856kgardner@lifesciadvisors.com Attachment 2024-09-18 -- NBTX -- 1H24 Financial Results -- FINAL

近日，在2024年欧洲肿瘤内科学会（ESMO）上，康方生物（9926.HK）首次对外发布了公司独立自主研发的PD-1/VEGF双特异性抗体依沃西联合或不联合新一代CD47单抗莱法利联合FOLFOXIRI一线治疗微卫星稳定（MSS）或错配修复功能完整（pMMR）晚期转移性结直肠癌（mCRC）的疗效数据。 该研究的主要研究者、中山大学附属第六医院邓艳红教授在大会现场做Oral报告。 MSS/pMMR型mCRC肿瘤素有“免疫沙漠”之称，既往免疫疗法相关探索获益十分有限，MSS/pMMR型 mCRC患者的临床标准一线治疗仍是化疗联合贝伐珠单抗或西妥昔单抗方案，临床疗效非常有限。 初步临床研究结果显示，依沃西联合或不联合莱法利单抗联合FOLFOXIRI方案一线治疗MSS/pMMR型 mCRC，具有突破性临床价值，有望填补这类患者的免疫治疗空白。 截至2024年2月29日，依沃西联合莱法利联合FOLFOXIRI组的中位随访时间为9.6个月，依沃西联合FOLFOXIRI组的中位随访时间为9.0个月。 初步数据优异 研究显示，两组一线治疗MSS/pMMR型mCRC均具有高效的抗肿瘤活性，疾病控制高效，初步远期疗效令人满意，且依沃西联合莱法利单抗后的抗肿瘤疗效更佳。两组的初步研究数据均远高于现有标准治疗的数据。 依沃西联合莱法利联合FOLFOXIRI方案： 客观缓解率（ORR）达88.2%，疾病控制率（DCR）为100%。中位随访9.6个月时，中位无进展生存期（mPFS）尚未达到，9个月PFS率达86.2%。 依沃西联合FOLFOXIRI方案： ORR达81.8%，DCR为100%。中位随访9个月时，mPFS尚未达到，9个月PFS为81.4%。 两个试验组一线治疗mCRC安全性特征均良好，治疗相关不良事件（TRAE）易于管理。 研究结果支持进一步评估依沃西联合或不联合莱法利联合化疗用于MSS/pMMR 型mCRC的一线治疗。依沃西与莱法利单抗联合疗法针对MSS/pMMR型 mCRC一线治疗具有巨大的临床价值潜力，有望成为该类型患者疾病治疗全新、高效的免疫治疗方案。 关于莱法利 （AK117，CD47单抗） 莱法利单抗是康方生物自主研发的新一代人源化lgG4 单克隆抗体，可与肿瘤细胞上表达的CD47结合，阻断CD47与其受体SIRPα的相互作用，增强吞噬细胞对肿瘤细胞的吞噬活性，从而抑制肿瘤生长。莱法利联合阿扎胞苷治疗血液瘤，莱法利单药或联合依沃西和卡度尼利治疗多种实体瘤的II期临床研究正在高效开展，初步研究疗效数据优异，未观察到剂量限制性毒性事件，表现出优越的安全性。 目前，莱法利联合维奈克拉和阿扎胞苷一线治疗急性髓系白血病（AML）的II期临床研究，以及莱法利治疗骨髓增生异常综合征（MDS）的国际多中心II期临床研究均在入组中；莱法利联合AK129（PD-1/LAG-3） 治疗经典型霍奇金淋巴瘤（cHL）的Ⅰ期临床研究获得CDE批准开展正在启动中。与此同时，公司已启动莱法利一线治疗PD-L1阳性头颈鳞癌对比帕博利珠单抗的注册性III期临床，莱法利成为全球首个针对实体瘤开展注册性III期临床的CD47单抗。 关于康方生物 康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司打造了独有的端对端康方全方位新药研究开发平台（ACE Platform），建立了以Tetrabody双特异性抗体开发技术、抗体偶联（ADC）技术、mRNA技术及细胞治疗技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。 公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，22个候选药已进入临床（包括11个双抗/多抗/双抗ADC），4个新药已在商业化销售，5个新药7个适应症的上市申请处于审评审批阶段。 2021年8月，公司自主研发的差异化PD-1单抗安尼可®获批上市；2022年6月，公司全球首创的PD-1/CTLA-4双抗开坦尼®获批上市，成为全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。2024年上半年，开坦尼®联合方案一线治疗晚期胃癌和一线治疗晚期宫颈癌的新药上市许可申请（sNDA）均已获受理。2024年5月，公司另一全球首创双抗新药依达方®获得中国国家药品监督管理局批准上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，依达方®成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西对比帕博利珠单抗一线治疗PD-L1阳性NSCLC获显著阳性结果，同适应症的sNDA获CDE受理，并获优先审评。依沃西成为全球迄今唯一在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物，将有望成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。此前，2022年12月，公司对外许可了依达方®部分海外权益，并以50亿美金+销售提成的合作方案创下了彼时中国单药对外许可的最高交易金额纪录。 康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，成为全球领先的生物制药企业。 往期推荐 数据发布 全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表 临床 进展 康方生物卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组 临床 进展 康方AK117（CD47）联合方案治疗MDS国际多中心Ⅱ期临床首例患者入组 临床 进展 针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组 产品动态 依沃西1L治疗PD-L1阳性NSCLC的sNDA获NMPA受理，肺癌一线将迎“去化疗”新标准方案！ 数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准 临床 进展 史无前例！康方依沃西单药对比帕博利珠1L治疗PD-L1阳性NSCLC的III期临床获决定性胜出阳性结果 产品动态 依达方®首批发货成功！全国晚期肺癌患者迎来全球最新解决方案 产品动态 康方生物双抗卡度尼利一线治疗晚期宫颈癌全人群的sNDA获CDE受理 产品动态 康方生物卡度尼利联合方案一线治疗晚期胃癌的上市申请获NMPA受理 企业运营 康方生物上海全球研发中心启动建设 创新全球化战略再提速 产品动态 首个国产新药IL-12/IL-23单抗报产！康方生物依若奇单抗NDA获NMPA受理 临床 进展 国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 临床 进展 依沃西联合化疗对比替雷利珠联合化疗一线治疗sq-NSCLC III期临床试验完成首例给药 产品动态 康方生物伊努西（PCSK9单抗）两项适应症上市申请获NMPA受理 产品动态 高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议 产品动态 全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市