On October 20, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that a Phase II study of opamtistomig (LBL-024) in first-line gastric cancer has advanced to the expansion stage, after the safety lead-in produced positive preliminary efficacy signals. The study is evaluating opamtistomig, a PD-L1/4-1BB bispecific antibody, in combination with chemotherapy in locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The expansion makes gastric cancer the fifth gastrointestinal tumor type in the opamtistomig program, alongside biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). Four of the five studies have now progressed to the expansion stage.

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Gastric cancer remains a major clinical challenge, as early symptoms are often nonspecific and many patients are diagnosed at an advanced stage, when prognosis is poor. Although PD-1 inhibitors combined with chemotherapy have become a standard first-line treatment approach, median progression-free survival (PFS) remains approximately seven months, while median overall survival (OS) is generally 13–17 months. Patients with a PD-L1 combined positive score (CPS) below 5 may derive limited benefit from existing immunotherapy-based regimens, underscoring the need for more effective treatment strategies.

Opamtistomig conditionally activates 4-1BB while blocking PD-1/PD-L1, reactivating and substantially expanding T cells. Because that activation does not depend on high PD-L1 expression, the approach may reach patients that checkpoint monotherapy leaves behind. Across several clinical studies, opamtistomig has produced objective responses and OS benefit even in tumors with negative or low PD-L1 expression. That profile could move first-line treatment past the current ceiling for immunotherapy combinations and deliver more durable benefits for these patients.

The study is led by Professor Shen Lin of Peking University Cancer Hospital and is being conducted at multiple sites across China. Following a comprehensive assessment of the encouraging preliminary clinical data from the safety lead-in phase, the sponsor and investigators have decided to advance the study to the combination therapy expansion stage. This stage will use a randomized, controlled design to compare the efficacy and safety of opamtistomig plus chemotherapy directly with tislelizumab plus chemotherapy. The study will also explore associations between tumor tissue biomarkers and treatment outcomes to help identify patient populations most likely to benefit from opamtistomig-based combination therapy.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "Gastric cancer represents a significant unmet medical need, particularly for patients with low PD-L1 expression who may derive limited benefit from current first-line immunotherapy combinations. The encouraging preliminary signals observed in the safety lead-in support advancing opamtistomig into a randomized expansion stage, where its efficacy and safety will be evaluated against an established immunotherapy-based regimen. We look forward to generating more robust clinical evidence to determine whether opamtistomig can offer a differentiated first-line treatment option and improve outcomes for patients with advanced gastric cancer."

About Gastric Cancer
According to data from the International Agency for Research on Cancer of the World Health Organization in 2022, there were approximately 968,000 new cases of gastric cancer and approximately 660,000 deaths worldwide, making gastric cancer the fifth most commonly diagnosed cancer and the fourth leading cause of cancer death globally. In China, there were approximately 359,000 new cases, representing 37.1% of the global total, and approximately 260,000 deaths, representing 39.4% of the global total. Early-stage gastric cancer is often asymptomatic. In China, early gastric cancer accounts for only approximately 20% of diagnosed cases, and most patients are diagnosed with advanced disease. The overall prognosis for advanced gastric cancer remains poor, with a five-year survival rate of approximately 9%.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.

Recognizing its clinical potential in EP-NEC, opamtistomig received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) in October 2024, Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024, Fast Track Designation from the FDA and ODD from the European Commission in January 2026, and ODD from Japan’s Ministry of Health, Labour and Welfare (MHLW) in September 2026. In October 2026, the FDA granted a second Fast Track Designation, this one for first-line advanced or metastatic biliary tract cancer.

In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

(Press release, Nanjing Leads Biolabs, OCT 20, 2026, View Source [SID1234673631])

On October 20, 2026 CPTx, a company developing next-generation non-viral in vivo CAR T therapies, reported that it will present new findings from its preclinical studies at the 33rd Annual Congress of the European Society of Gene and Cell Therapy (ESGCT), taking place in Hamburg, Germany, from October 27-30, 2026.

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The presentations will feature new efficacy data from rodent studies and first safety data from non-human primate (NHP) studies evaluating CPTx’s fully non-viral in vivo CAR T platform. The platform combines proprietary immune-quiet hybrid DNA with targeted lipid nanoparticles (tLNPs) to program CAR T cells directly inside the patient.

Together, the new efficacy and safety data represent an important step in the platform’s preclinical development toward clinical translation.

"Building on the encouraging preclinical evidence generated to date, we are focused now on translating our DNA-based in vivo CAR T platform toward first-in-human studies." – Hendrik Dietz, PhD, Founder and CEO of CPTx.

Details of the presentation:
Oral Presentation OR082: Targeted immune-silent ssDNA-tLNP delivery enables in vivo CAR-T generation and eradication of disseminated tumors
Session: 12d – Non-viral vectors/Nanotechnology and RNA therapeutics II
Presenter: Matthias Bozza
Date and time: Friday, October 30th, 12:30 – 12:45 pm
Location: Hall 4, Level 0, Congress Center Hamburg

Poster P0370: Advanced characterization of ssDNA-loaded targeted lipid nanoparticles for in vivo CAR T cell therapy
Session: Poster Session II
Presenter: Nadja Berger
Date and time: Thursday, October 29th, 2:00 – 4:00 pm
Location: Poster Halls, Congress Center Hamburg

(Press release, CPTx Bio, OCT 20, 2026, View Source [SID1234673630])

On October 20, 2026 Freenome, Inc. (Nasdaq: FRNM), an early cancer detection company developing blood-based tests, reported the launch of SimpleScreen Lung and a first-of-its-kind offering that enables eligible patients to be screened for both lung and colorectal cancer (CRC) through a single blood draw, using two independently validated, indication-specific tests. Freenome’s Personalized Cancer Detection (PCD) approach combines risk-based screening with a portfolio of single-cancer and multi-cancer tests that are developed specifically for each population and to meet individual patient screening needs.

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SimpleScreen Lung is a laboratory-developed test intended for adults ages 50 to 80 with a ≥20 pack-year smoking history who are not currently participating in guideline-recommended screening. It can be ordered independently or alongside the FDA-approved SimpleScreen CRC test when average-risk patients are also eligible for blood-based CRC screening. Together, these tests offer patients and providers an opportunity to address one or both screening needs in a single encounter, with the potential to expand access and improve screening participation.

Lung cancer is the leading cause of cancer death in the United States, and less than 20% of people (more than 10 million individuals) eligible for lung cancer screening are up to date with low-dose computed tomography (LDCT), the standard-of-care screening method.1 Colorectal cancer is the second leading cause of cancer death,2,3 and nearly two in five eligible adults – up to 60 million people in the U.S. – are not up to date with CRC screening.4

"Lung cancer screening can save lives, but its potential depends on reaching people who are eligible," said Douglas Flora, M.D., the executive medical director of oncology services for St. Elizabeth Healthcare in Kentucky and president-elect of the Association of Cancer Care Centers. "When so many people are not up to date, we need to understand what is keeping them from participating and consider new approaches. A blood-based test adds a practical option to our patient conversations and helps us make progress toward our goal of connecting more eligible people with screening and getting them to take the next step."

SimpleScreen Lung was clinically validated in a case-control study of adults ages 50 to 80 with a ≥20 pack-year smoking history who meet American Cancer Society (ACS) lung cancer screening eligibility.5 In an independent cohort of 172 lung cancer cases and 436 controls, the test achieved 85% sensitivity at 50% specificity and a 99.8% negative predictive value (NPV). This NPV means that about two of every 1,000 people with a negative result would be expected to have lung cancer. Sensitivity was 82% for stage I, 75% for stage II, 91% for stage III, and 94% for stage IV.

Performance estimates were adjusted to reflect target distributions of age, sex, lung cancer stage and histologic subtype. The intended use population includes former smokers regardless of how long ago they quit, consistent with the 2023 ACS lung cancer screening guideline update.

A person who qualifies for lung cancer screening may also be eligible for CRC screening. During a patient visit, a provider can discuss both screening needs and, when appropriate, add SimpleScreen CRC to a SimpleScreen Lung order. The Freenome-developed SimpleScreen CRC is FDA-approved for adults 45 and older at average risk, is included in the ACS CRC screening guideline, and meets Medicare coverage criteria. Abbott has exclusive U.S. commercial rights to SimpleScreen CRC when it is ordered as a standalone test. In the PREEMPT CRC study, which enrolled more than 48,000 participants, the test demonstrated 81% sensitivity for CRC, 90% specificity for advanced colorectal neoplasia, and a 99.9% NPV in an analysis adjusted to the 2020 U.S. Census age and sex distribution.6

"SimpleScreen CRC proved what our discovery platform can achieve for colorectal cancer screening, and expanding into lung cancer screening is the next step in extending this science to broader patient populations," said Aaron Elliott, Ph.D., CEO of Freenome. "By coupling indication-specific screens together, we make it vastly easier for patients to say yes to screening. As our portfolio grows, Personalized Cancer Detection will offer clinicians more screening options and enable health systems to provide more comprehensive coverage without adding complexity to existing clinical workflows."

Freenome will be introducing the SimpleScreen portfolio and the PCD approach to attendees at booth 2705 at the American Academy of Family Physicians Family Medicine Experience (FMX) conference, Oct. 20 to 24 in Nashville.

About the SimpleScreen Portfolio

SimpleScreen CRC is a cancer screening option for colorectal cancer. It uses a simple blood draw and detects signals associated with CRC from cell-free DNA (cfDNA) in the blood. The test is indicated for adults aged 45 years and older who are at average risk for CRC and referred by a healthcare provider for CRC screening. A positive result indicates a signal was detected that may suggest the presence of colorectal cancer or advanced precancerous lesions and should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

The SimpleScreen Lung laboratory-developed test has not been reviewed or cleared/approved by the U.S. Food and Drug Administration (FDA).

(Press release, Freenome, OCT 20, 2026, View Source [SID1234673629])

On October 20, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Lumara Bio, a dedicated oncology therapeutics division of ITM, reported that data supporting its targeted precision oncology portfolio were featured in three oral presentations and one e-poster at the European Association of Nuclear Medicine (EANM) 2026 Congress, held from October 17-21 in Vienna, Austria. The presentations further support ITM’s late- and early-stage radiopharmaceutical pipeline, highlighting novel therapeutic and diagnostic candidates across Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs), clear cell Renal Cell Carcinoma (ccRCC), and glioblastoma.

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"The data presented at EANM 2026 underscore the therapeutic potential of our deep targeted radiopharmaceutical pipeline, which leverages different targets, both established and novel radioisotopes, and addresses several difficult-to-treat oncology indications," said Dr. Celine Wilke, chief medical officer of ITM. "Whether derived from ITM’s Phase 3 COMPETE trial or through the valuable insights of independent, investigator-initiated research, this growing evidence base supports the continued development of these novel radiopharmaceuticals across cancers with significant unmet medical need."

Higher Cumulative Tumor Absorbed Dose of 177Lu-edotreotide is Associated with Improved Clinical Response in GEP-NETs
Dr. Anthime Flaus of the Hospices Civils de Lyon in Bron, France gave an oral presentation featuring a late-stage dose-response analysis from ITM’s Phase 3 COMPETE trial evaluating non-carrier-added (n.c.a.) 177Lu-edotreotide (ITM-11) in patients with Grade 1 or 2 GEP-NETs. The analysis assessed the relationship between tumor cumulative absorbed dose and treatment response in 106 evaluable patients who received 4 treatment cycles of ¹⁷⁷Lu-edotreotide therapy.

Higher cumulative tumor absorbed doses were associated with a better Best Overall Response (BOR). The Objective Response Rate (ORR) increased from 12% in the lowest dose quartile (Q1) to 64% in the highest dose quartile (Q4), with three complete responses occurring in patients with a cumulative dose above 86.1 Gy (Q3 and Q4). Cumulative tumor absorbed dose and tumor type were the main predictors of response in multivariate logistic regression models. Lesion-level analysis also identified a statistically significant association between absorbed dose and response.

"The dosimetry data from the COMPETE trial offer insights into how tumor absorbed dose correlates with objective response," said Dr. Anthime Flaus, study author and physician at the Hospices Civils de Lyon. "Understanding this dose-response relationship provides important evidence that could potentially support the development of more individualized radiopharmaceutical treatment approaches, with the goal of optimizing patient care and outcomes."

Early-Stage Pipeline Data Presented at EANM 2026
The conference also highlighted promising clinical and translational data supporting the further development of other ITM pipeline candidates. These data, derived from independent trials and research initiated by investigators, offer valuable clinical insights to support the further development of ITM candidates currently in Phase 1 trials, including: Ga-DPI-4452 (also known as [68Ga]Ga-DPI-4452, or CAIX peptide), an investigational diagnostic imaging agent for ccRCC; [161Tb]Tb-DOTA-LM3 (Tb-DOTA-LM3) as a potential therapeutic for somatostatin receptor (SSTR)-positive tumors; and n.c.a. 177Lu-TTM for intra-cavitary immunoradiotherapy in patients with glioblastoma.

Ga-DPI-4452 Demonstrates High Tumor Uptake and Superior Detection of ccRCC Compared to Conventional CT
Dr. Alina Küper of the Department of Nuclear Medicine at University Hospital Essen in Germany highlighted in an oral presentation the interim results from an independent bicenter retrospective registry evaluating Ga-DPI-4452 PET/CT for imaging 98 patients with suspected or proven ccRCC. In the analysis, Ga-DPI-4452 demonstrated abnormal findings in 91.8% of patients with subsequently confirmed ccRCC. Additionally, Ga-DPI-4452 exhibited high tumor uptake and superior detection efficacy across 153 predefined anatomical regions compared to conventional CT imaging, including in renal primary tumors/recurrence, regional lymph nodes, distant lymph nodes, bone metastases, and visceral metastases.

Lower Peptide Mass of [161Tb]Tb-DOTA-LM3 Increases Tumor Absorbed Dose in Metastatic GEP-NETs
In an oral presentation, Dr. Julia G. Fricke and Prof. Damian Wild, Physician-Scientists and Researchers in Nuclear Medicine and Theranostics at the University Hospital Basel, Switzerland, shared safety, dosimetry, and preliminary efficacy data from the Phase 0b BETA PLUS study for the SSTR2 antagonist [161Tb]Tb-DOTA-LM3. In the study evaluating dosimetry in 6 patients with metastatic GEP-NETs, a peptide mass-dependent effect was observed, wherein a lower peptide mass (<100 µg vs. 300–400 μg) increased the tumor absorbed dose (23.3 vs. 12.5 Gy/GBq, p=<0.001). Improved tumor-to-kidney (8.24 vs. 7.23, p=0.14) and tumor-to-bone marrow (53.4 vs 45.9, p=0.074) absorbed dose ratios were also observed with a lower peptide mass. The radiopharmaceutical candidate showed preliminary evidence of antitumor activity with no dose-limiting toxicities, supporting further clinical evaluation.

Immunohistological Expression Patterns of Carbonic Anhydrase XII in Glioblastoma Support Continued Development of n.c.a. 177Lu-TTM
An e-poster by Julia Schuler of the Institute of Pathology at the Technical University of Munich in Germany highlighted translational research evaluating the presence of carbonic anhydrase XII (CAXII) in the infiltration zone of primary glioblastomas. Immunohistochemical analysis found high CAXII expression in the infiltration zone. These findings highlight CAXII as a promising target for intracavitary radioimmunotherapies and support the continued investigation of this targeted approach for the treatment of glioblastoma.

177Lu-edotreotide (ITM-11), Ga-DPI-4452, Tb-DOTA-LM3, and n.c.a. 177Lu-TTM are investigational products and are not approved by any regulatory authority for the safety and/or efficacy of any intended use.

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

About Ga-DPI-4452 (ITM-94)
Ga-DPI-4452 (also known as [68Ga]Ga-DPI-4452, CA-IX peptide, or ITM-94) is an investigational gallium-68-radiolabeled PET imaging agent targeting carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in tumor growth, invasion, and metastasis. ITM-94 is designed to non-invasively improve the characterization of indeterminate renal masses and enable more accurate diagnosis and disease staging of clear cell renal cell carcinoma (ccRCC). ITM-94 received Fast Track Designation from the FDA in October 2025. ITM-94 is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

About Tb-DOTA-LM3 (ITM-63)
Tb-DOTA-LM3 (also known as [161Tb]-DOTA-LM3 or ITM-63) is an investigational terbium-161-radiolabeled targeted therapeutic acting as a somatostatin receptor 2 (SSTR2) antagonist. It is designed to deliver highly localized therapeutic radiation directly to SSTR-positive tumors and is currently being evaluated for the treatment of metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-63 is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

About n.c.a. 177Lu-TTM (ITM-31)
N.c.a. 177Lu-TTM (also known as LuCaFab or ITM-31) is an investigational targeted radiotherapeutic consisting of a carbonic anhydrase XII (CAXII)-specific antibody Fab fragment coupled with ITM’s medical radioisotope, non-carrier-added (n.c.a.) lutetium-177. It targets CAXII, a cell surface protein commonly expressed in the infiltration zone of primary glioblastomas. ITM-31 is designed as an intracavitary radioimmunotherapy to directly target and eliminate remaining tumor cells following surgical resection and standard-of-care therapies in patients with glioblastoma. ITM-31 is an investigational product and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.

(Press release, ITM Isotopen Technologien Munchen, OCT 20, 2026, View Source [SID1234673628])

On October 20, 2026 AN2 Therapeutics, Inc. (NASDAQ: ANTX), a clinical stage biopharmaceutical company discovering and developing novel small molecule therapeutics derived from its boron chemistry platform, reported company management will participate in three upcoming investor conferences in November.

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Details of the events are as follows:

Guggenheim 3rd Annual Healthcare Innovation Conference, November 9-11, 2026

Eric Easom, Co-Founder, Chairman, President and CEO, will participate in a fireside chat on Monday, November 9, 2026 at 9:30am ET, and members of management will be available for 1X1 meetings.

Stifel 2026 Healthcare Conference, November 10-12, 2026

Eric Easom, Co-Founder, Chairman, President and CEO, will provide a corporate overview on Tuesday, November 10, 2026 at 8:40am ET, and members of management will be available for 1X1 meetings.

Jefferies London Conference, November 16-19, 2026

Members of management will be available for 1X1 meetings on Tuesday, November 17, 2026.
Webcasts of the presentation and fireside chat can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

(Press release, AN2 Therapeutics, OCT 20, 2026, View Source [SID1234673627])