Small cell lung cancer recurrent

— Objective response rate (ORR) of 74% across all tested dose levels of ZL-1310 in patients with recurrent extensive-stage small cell lung cancer (SCLC) — Favorable pharmacokinetics (PK) and safety profile support continued evaluation of ZL-1310 as a single agent and in combination for the treatment of extensive-stage SCLC in recurrent and first-line therapy — Zai Lab to host conference call and webcast to discuss data on October 24, 2024, at 8:30 a.m. ET, following presentation of the data at ENA SHANGHAI, China & CAMBRIDGE, MA, USA I October 24, 2024 I Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today presented data from the ongoing global Phase 1a/1b study of ZL-1310, a potential best-in-class next-generation antibody-drug conjugate (ADC), at the EORTC-NCI-AACR (ENA) Symposium 2024 in Barcelona, Spain, as an oral presentation during the plenary session. ZL-1310 is being tested in patients with previously treated extensive-stage Small Cell Lung Cancer (ES-SCLC) after at least one prior platinum-based chemotherapy regimen. Data shared in the ENA presentation from the ongoing Part 1a monotherapy dose-escalation portion of the study included results from 25 patients across four dose cohorts (0.8 mg/kg, 1.6mg/kg, 2.0 mg/kg, and 2.4 mg/kg). Nineteen patients had evaluable tumor assessments. Key efficacy results include (n=19): Key safety findings include (n=25): All patients had progressed following standard platinum-based chemotherapy, and 92% of patients progressed after immune checkpoint inhibitors. Fifty-six percent had failed at least two prior lines of therapy. Twenty-eight percent of patients had brain metastases at baseline. At the time of the data cutoff, Oct. 10, 2024, 19 patients had at least one post-baseline tumor assessment per RECIST v1.1. DLL3 expression H-scores were assessed in 16 out of 19 patients. “The preliminary results from the ongoing Phase 1 trial of ZL-1310 suggest that this next-generation ADC therapy has the potential to deliver anti-tumor responses in the majority of patients with ES-SCLC, with good tolerability,” said Dr. Alex Spira, a medical oncologist at Virginia Cancer Specialists and NEXT Oncology. “This is particularly encouraging given the urgent need for improved treatment options for these patients. These promising data support continued evaluation of ZL-1310 as a monotherapy in the dose-expansion phase of the ongoing Phase 1 clinical trial and in combination.” “The ZL-1310 clinical program demonstrates Zai Lab’s commitment and ability to pursue novel modalities and validated cancer targets, and to advance innovative global oncology programs,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “Based on the encouraging preliminary findings from our Phase 1 trial, we look forward to continuing development of ZL-1310 and advancing this promising asset across lines of therapy as part of our global oncology pipeline.” About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global . About ZL-1310 ZL-1310 is a novel ADC in Zai Lab’s growing, global oncology pipeline that targets Delta-like ligand 3 (DLL3), an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN ® , which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity. The ongoing Phase 1a/1b clinical trial is evaluating ZL-1310 as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of extensive-stage SCLC. SOURCE: Zai Lab

– VIRO-25 trial to assess efficacy & safety of olvimulogene nanivacirepvec (Olvi-Vec) & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in recurrent non-small cell lung cancer – – Trial represents second indication in the clinic for Olvi-Vec via systemic administration – – Interim readout expected mid-2025 – WESTLAKE VILLAGE, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late-stage clinical immuno-oncology company, today announced that the first patient has been dosed in the U.S.-based Phase 2 (VIRO-25) trial evaluating systemically delivered Olvi-Vec in patients with recurrent non-small cell lung cancer (NSCLC) who have failed frontline platinum and immune checkpoint inhibitor (ICI) therapies. "Today's milestone holds profound significance for patients with recurrent non-small cell lung cancer who face limited therapeutic options," said Thomas Zindrick, President, CEO and Chairman of Genelux. "This Phase 2 trial, in addition to our ongoing Phase 1b/2 trial evaluating intravenous delivered Olvi-Vec in patients with recurrent small cell lung cancer, co-sponsored with Newsoara Biopharma Co. Ltd., signifies the key advancement of Olvi-Vec to potentially be an important systemically administered oncolytic virus treatment option, setting the stage for the future of this promising field." The VIRO-25 clinical trial (NCT06463665), is an open-label, randomized study in NSCLC designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of ICI compared with docetaxel in patients with advanced or metastatic NSCLC who have shown first disease progression while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care. Olvi-Vec’s previous data suggests a manageable safety profile, and this trial looks to further confirm the hypothesis that Olvi-Vec may resensitize to platinum in multiple tumor types. Genelux expects interim data readout in mid-2025. About Olvi-VecOlvi-Vec is a proprietary, modified oncolytic vaccinia virus, a stable DNA virus with a large engineering capacity. Genelux is developing Olvi-Vec for the treatment of multiple cancers based on the results of preclinical studies that suggest Olvi-Vec has the potential to infect and directly kill a wide range of tumor cell types in vitro and in vivo and produce an anti-tumor immune response. To date, Olvi-Vec has been administered to more than 150 patients in seven clinical trials. In these studies, Olvi-Vec was observed to be generally well tolerated and the data provided evidence of clinical benefit. About Genelux CorporationGenelux is a late-stage clinical biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus. Olvi-Vec currently is being evaluated in OnPrime/GOG-3076, a multi-center, randomized, open-label Phase 3 registrational trial evaluating the efficacy and safety of Olvi-Vec in combination platinum-doublet + bevacizumab compared with physician's choice of chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. The core of Genelux's discovery and development efforts revolves around its’ proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec. For more information, please visit www.genelux.com and follow us on Twitter @Genelux_Corp and on LinkedIn. Forward-Looking StatementsThis 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, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “believes,” “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to Genelux’s future plans and prospects, the planned timing of Genelux’s data results in its ongoing clinical trials and continued development of Olvi-Vec, and the potential capabilities and advantages of Olvi-Vec. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. These and other risks are identified under the caption “Risk Factors” in Genelux’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Genelux does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. Investor and Media Contacts Ankit Bhargava, MDAllele Communications, LLCgenelux@allelecomms.com Source: Genelux Corporation

YL201/IMDELLTRA combination therapy could offer a novel, synergistic action against ES-SCLC. Credit: Sebastian Kaulitzki/ Shutterstock Amgen and MediLink Therapeutics have agreed to a research and supply collaboration to develop a combination therapy for extensive-stage small cell lung cancer (ES-SCLC). Suzhou, China-based biotech MediLink announced the agreement in a 7 October release. Amgen will orchestrate a global Phase I trial investigating a combined regimen of its DLL3-/CD3-targeting T cell engager Imdelltra (tarlatamab) with MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 in ES-SCLC. For the Phase I study, MediLink will supply YL201, an ADC that has already shown promise as a monotherapy for ES-SCLC. The drug targets the immune checkpoint protein B7-H3, overexpressed on malignant and cancer-initiated cells, to deliver MediLink’s tumour microenvironment activable LINker-payload (TMALIN)-based ADC. Given the broad presence of B7-H3 expression in cancers, YL201 could have a wide application. At the European Society of Medical Oncology meeting (ESMO) 2024 , MediLink announced data from a Phase I/II trial investigating the drug in advanced solid tumours including SCLC. It is currently being investigated in four Phase I and II studies (NCT06394414, NCT05434234, NCT06057922, NCT06241846), with a Phase III trial planned (NCT06612151) in relapsed SCLC. Amgen’s Imdelltra has also demonstrated potential in this indication. Following an accelerated approval for treating ES-SCLC in May 2024 , Imdelltra generated $12m, as per its Q2 earnings report. Annual revenue is expected to expand as the drug gains approval in other markets, and reach $1bn by 2030, as estimated by GlobalData. The drug acts by binding both DLL3, a protein highly expressed in SCLC cells, and CD3, expressed in T cells, to promote lysis of cancer cells by the immune system. See Also: Merck unveils €290m biosafety testing facility in Maryland, US Boehringer and Circle Pharma link to develop new cancer treatment GlobalData is the parent company of Pharmaceutical Technology . ES-SCLC is a particularly aggressive carcinoma with a notably poor prognosis. It accounts for roughly two-thirds of SCLC cases, comprising around 15% of the 2.4 million new lung cancer cases worldwide each year. Current therapeutic options for SCLC include Merck & Co’s Keytruda (pembrolizumab), Bristol Myers Squibb ’s Opdivo (nivolumab), AstraZeneca ’s Imfinzi (durvalumab), and Roche’s Tecentriq (atezolizumab). MediLink is developing ADCs across several other cancer indications as well. In October 2 023 , it sold the developmental and commercialisation rights outside of China for its HER3-targeting ADC to BioNTech for $70m upfront in a deal including $1bn in milestone payments. In January 2024 , the company partnered with Roche to develop YL211 in solid tumours, a deal worth a further $1bn. Earlier this year it presented positive safety data on YL202/BNT326 for NSCLC and breast cancer at the American Society of Clinical Oncology (ASCO) meeting 2024 .