Efficacy and Safety of Paclitaxel Oral Solution in Combination with Trastuzumab for Subcutaneous Injection and Pyrotinib as First-line Treatment for HER2-positive Recurrent/Metastatic Breast Cancer

Start Date31 Oct 2025

Sponsor / Collaborator

Beijing Institute for Cancer Research

[+2]

NCT07182721

/ RecruitingPhase 2IIT

A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment

This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.

Start Date30 Sep 2025

Sponsor / Collaborator

Fudan University

NCT06818773

/ Not yet recruitingPhase 4IIT

Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1/PD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer

To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.

Start Date01 Feb 2025

Sponsor / Collaborator

Shanghai Eastern Hepatobiliary Surgery Hospital

100 Clinical Results associated with Inetetamab

100 Translational Medicine associated with Inetetamab

100 Patents (Medical) associated with Inetetamab

Literatures (Medical) associated with Inetetamab

01 Oct 2025·CANCER LETTERS

Advancing neoadjuvant therapy with inetetamab for HER2-Positive breast cancer

Author: Zhou, Wenbin ; Ding, Qiang

HER2-positive breast cancer accounts for approximately 15 %-20 % of all breast cancer cases and is typically characterized by aggressive tumor biology, an elevated risk of recurrence, and poor long-term survival. Although HER2-targeted therapies such as trastuzumab and pertuzumab result in significantly improved clinical outcomes, the total pathological complete response (tpCR) rate remains suboptimal, particularly among hormone receptor (HR)-positive patients. Neoadjuvant therapy plays a critical role in facilitating tumor downstaging in locally advanced cases and provides a valuable opportunity to evaluate therapeutic efficacy and guide adjuvant treatment. Consequently, the development of novel anti-HER2 agents and combination strategies has become a major focus of ongoing researches. Inetetamab, a humanized monoclonal antibody targeting HER2 with an engineered Fc domain to enhance antibody-dependent cellular cytotoxicity, represents a promising candidate for improving treatment outcomes. In this issue of Cancer Letters, Zuo and colleagues present findings from a single-arm, multicenter phase II clinical trial investigating a neoadjuvant regimen combining inetetamab, pertuzumab, and nab-paclitaxel (TIP regimen) in patients with early-stage or locally advanced HER2-positive breast cancer. Through comprehensive evaluation of both efficacy and safety, the study demonstrates exceptional therapeutic potential of the TIP regimen, with a high tpCR rate observed in estrogen receptor (ER)-negative patients, indicating particular promise for this subgroup of HER2-positive breast cancer.

01 Sep 2025·DRUG RESISTANCE UPDATES

Spatial discovery of pyrotinib overcoming HER2-positive breast cancer resistance by breaking fibroblast-induced immune barriers

Article

Author: Xu, Yiying ; Cheng, Pu ; Zhang, Qiongying ; Li, Lili ; Ren, Guohong ; Hu, Hanwen ; Wang, Ouchen ; Yang, Chenghui ; Wang, Zhen ; Zhang, Anqi ; Lin, Zhongmin ; Ye, Zhiqiang

BACKGROUND:

The TCbHP regimen, consisting of combining docetaxel (T), carboplatin (Cb), trastuzumab (H), and pertuzumab (P), is the preferred neoadjuvant treatment for locally advanced human epidermal growth factor 2 (HER2)-positive breast cancer. However, about 40 % of patients develop resistance to this treatment. Adding TKIs like pyrotinib to anti-HER2 antibodies may enhance efficacy and reduce resistance, but the mechanisms are not fully understood.

METHODS:

Imaging mass cytometry (IMC) analyzed tissues from 26 patients treated with NeoPICD (docetaxel, carboplatin, pyrotinib, inetetamab) and 21 patients treated with TCbHP. Cellular changes and spatial relationships were assessed pre- and post-treatment. A co-culture system of tumor cells, fibroblasts, and PBMCs were used to examined cytotoxic T-cell function. A predictive model for treatment outcomes was constructed based on these results.

RESULTS:

In TCbHP-sensitive patients, IDO^hiHLA-DR^hi epithelial cells expressing PD-L1 were enriched and interacted with Ki67⁺ T cells and M1 macrophages. In TCbHP-resistant patients, fibroblasts formed a barrier that hindered immune cell access, critical for resistance. NeoPICD disrupted this barrier, enhancing immune cell infiltration and alleviating resistance. Machine learning based on spatial cell architecture can predict treatment outcomes.

CONCLUSION:

Spatial organization of cellular interactions in the tumor microenvironment (TME) provides insights into prognosis beyond pathological subtypes. The role of NeoPICD in disruption of fibroblast barriers and enhancement of immune cell function suggests therapeutic advantages in overcoming resistance to anti-HER2 therapies. This research offers new strategies for precision treatment of locally advanced HER2-positive breast cancer.

01 Sep 2025·CANCER LETTERS

Efficacy and safety of inetetamab plus pertuzumab and nab-paclitaxel as neoadjuvant therapy for HER2+ breast cancer: A single-arm multicenter phase II clinical trial

Article

Author: Wang, Zhi-Hong ; Jia, Xin-Jian ; Zuo, Wen-Jia ; Zhao, Wen-He ; Zhang, Ming-Liang ; Shao, Zhi-Ming ; Cao, Xu-Chen ; Ma, Lin-Xiao-Xi ; Yu, Hao ; Liu, Xiao-Yu ; Wang, Zhong-Hua ; Chen, Mao-Shan ; Zhang, Hao ; Wang, Jing ; Ma, Xiao-Peng ; Chen, Xiu-Chun ; Wang, Ya-Bing ; Wang, Hao ; Song, Dong ; Yang, Hong-Wei

The combination of inetetamab and vinorelbine has demonstrated survival benefits with an acceptable toxicity profile in HER2+ metastatic breast cancer (MBC) patients. This multicenter, single-arm, phase II trial further evaluates the efficacy of inetetamab combined with pertuzumab and nab-paclitaxel as neoadjuvant therapy. Treatment-naïve patients with HER2+ early-stage or locally advanced BC received four cycles of intravenous inetetamab (8 mg/kg loading dose, then 6 mg/kg for subsequent doses), intravenous pertuzumab (840 mg loading dose, then 420 mg for subsequent doses), and weekly nab-paclitaxel (125 mg/m²). The primary endpoint was the total pathological complete response (tpCR) rate, defined as ypT0/is and ypN0, assessed by independent central review. From March 2023 to February 2024, 62 patients were enrolled, with the majority (61/62) completing 4 cycles of neoadjuvant therapy. The tpCR rate was 56.5 % (95 % CI: 43.3 %-69.0 %). Further analysis showed that patients with estrogen receptor (ER) negative tumors derived greater benefit, with a tpCR rate of 90.9 %. The objective response rate was 90.3 % (95 % CI: 80.1 %-96.4 %). The most common grade 3 or higher adverse events were neutropenia (32.3 %), decreased white blood cell count (19.4 %), infectious pneumonia (3.2 %), anemia (3.2 %), and diarrhea (3.2 %). No death occurred during the neoadjuvant treatment. Neoadjuvant treatment with inetetamab, in combination with pertuzumab and nab-paclitaxel, demonstrates good efficacy and tolerability, especially in ER-negative patients.

193

News (Medical) associated with Inetetamab

08 Mar 2025

·www.prnewswire.com

Why the Global Cancer Market Could Surpass $900 Billion--And the Stocks Leading the Charge

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, March 8, 2025 /PRNewswire/ -- As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights. Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to the World Health Organization (WHO), breast cancer cases are projected to rise by nearly 40% by 2050. Despite the concerning trends in cancer incidence, 2025 has seen key advancements from biotech companies at the forefront of oncology research, with Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Exelixis, Inc. (NASDAQ: EXEL), Cardiff Oncology, Inc. (NASDAQ: CRDF), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and Verastem, Inc. (NASDAQ: VSTM) continuing to push the boundaries of cancer treatment. Continue Reading Pelareorep Facts (PRNewsfoto/USA News Group) The article continued: Within a new research report on the Global Oncology Market from Vision Research Reports, cancer therapies are projected to surpass US$903.81 billion by 2034, growing at a 10.9% CAGR along the way. The World Economic Forum is optimistic, recently touting 12 new breakthroughs in the fight against cancer. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, has just released its Q4 and full-year 2024 financial results, providing investors with a clearer picture of its progress as it moves toward potential future FDA approvals for its lead drug, pelareorep, a promising immunotherapy designed to help the immune system recognize and destroy cancer cells more effectively. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." The data mentioned by Pisano from BRACELET-1 showed that patients receiving pelareorep and paclitaxel lived longer and responded better to treatment compared to those receiving paclitaxel alone. Given the consistency of these results, Oncolytics believes that its upcoming registration-enabling trial could pave the way for an accelerated approval submission with the FDA. This is an important development, as HR+/HER2- breast cancer is one of the most commonly diagnosed and treated breast cancers worldwide, representing a massive market opportunity for the company. Beyond breast cancer, Oncolytics is making significant progress in two other hard-to-treat cancers: pancreatic cancer and anal carcinoma. "When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients," added Pisano. Oncolytics recently presented new data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, showcasing pelareorep's potential to improve patient outcomes in these aggressive diseases. In anal cancer, results from the ongoing GOBLET study showed that 33% of patients responded to treatment when pelareorep was combined with atezolizumab, a checkpoint inhibitor. Notably, one patient experienced a complete response, with their cancer disappearing and staying undetectable for over 15 months. This level of response in such a difficult-to-treat cancer is highly encouraging, leading Oncolytics to expand the trial to enroll additional patients. Meanwhile, in pancreatic cancer, the company successfully cleared a critical safety review for its combination study using pelareorep with modified FOLFIRINOX with and without atezolizumab, allowing the trial to progress to the next phase. Pancreatic cancer has one of the lowest survival rates of any major cancer, and with few effective treatments available, pelareorep's continued success in this area could position Oncolytics as a key player in gastrointestinal oncology. From a financial standpoint, Oncolytics reported a cash position of $15.9 million at the end of 2024, giving it enough runway to continue executing on its clinical development strategy through the third quarter of 2025. While the company operates at a loss—as is typical for clinical-stage biotechs—it has been strategically managing its spending to ensure that key trials remain funded. Research and development expenses remained stable compared to the previous year, reflecting a disciplined financial approach that prioritizes high-impact studies. With several potentially transformative catalysts on the horizon, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year, investors will be watching closely to see how Oncolytics navigates its next steps. The coming months will be crucial for Oncolytics as it pushes forward in its mission to bring pelareorep to market. With strong clinical results, growing regulatory support, and a well-managed cash position, the company is well-positioned to capitalize on its momentum. If its upcoming breast cancer study confirms the benefits seen in BRACELET-1, Oncolytics could find itself on a fast track to regulatory approval, potentially opening the door to a major commercial opportunity. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Exelixis, Inc. (NASDAQ: EXEL), reported promising results earlier this year from a subgroup analysis of its Phase 3 CABINET trial, which evaluated cabozantinib in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NETs). The data presented at ASCO GI 2025 showed that cabozantinib significantly improved progression-free survival (PFS) compared to placebo, with a median PFS of 8.5 months versus 5.6 months. The findings highlight cabozantinib's potential to become a new standard of care for GI NETs, an area with limited treatment options. The FDA is currently reviewing Exelixis' supplemental New Drug Application (sNDA), with a decision expected by April 3, 2025. "These new data add to the robust results from the CABINET trial that demonstrate the benefits of cabozantinib across a wide range of patients with neuroendocrine tumors and further underscore the potential of cabozantinib to become a much-needed new option for those with GI NET, which accounts for the majority of real-world patients with this tumor type," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "We look forward to continuing to work with the U.S. FDA as they review our regulatory application for cabozantinib for the treatment of patients with previously treated advanced neuroendocrine tumors." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently shared its Q4 2024 and FY 2024 results and business update as it continues to advance its lead program, onvansertib, a promising PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer (mCRC). "2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., CEO of Cardiff Oncology. In its latest Phase 2 trial (CRDF-004), patients receiving the 30mg dose of onvansertib showed a 64% objective response rate, nearly doubling the 33% response rate in the control group. Cardiff also secured a new U.S. patent covering the use of onvansertib in combination with bevacizumab (bev) for previously untreated KRAS-mutant mCRC patients, adding long-term value to its intellectual property. ALX Oncology Holdings Inc. (NASDAQ: ALXO) is pushing forward with key advancements in its clinical pipeline, including the continued development of evorpacept, a CD47-blocking immunotherapy designed to enhance the effects of existing cancer treatments. The company announced plans to expand clinical trials into breast and colorectal cancer, aiming to evaluate evorpacept in combination with trastuzumab for HER2-positive breast cancer and with cetuximab for colorectal cancer. "Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data," said Jason Lettmann, CEO at ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data." In addition to its immunotherapy efforts, ALX Oncology is preparing to advance ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), into the clinic, with an Investigational New Drug (IND) application planned for Q1 2025. Verastem, Inc. (NASDAQ: VSTM) is making strides in RAS/MAPK pathway-driven cancers, with new Phase 2 trial data on its lead combination therapy, avutometinib plus defactinib, set to be presented at the 2025 Society of Gynecologic Oncology (SGO) Annual Meeting. The investigational treatment has already earned Priority Review from the FDA, with a PDUFA decision expected by June 30, 2025, for patients with KRAS-mutant low-grade serous ovarian cancer (LGSOC). "The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, President, and CEO of Verastem Oncology. "We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers." As Verastem moves forward with its RAMP clinical trials, the company continues to expand its pipeline, including a Phase 3 confirmatory trial (RAMP 301) in LGSOC and a collaboration with Amgen to evaluate its therapy in combination with LUMAKRAS™ for KRAS G12C mutant lung cancer. 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. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo: SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultASCOImmunotherapyPhase 3

05 Mar 2025

·ir.alxoncology.com

ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event

" data-uw-rm-brl="PR" data-uw-original-href="https://ir.alxoncology.com/">Overview News Events & Presentations Stock Information Stock Quote & Chart Analyst Coverage Stock Quote & Chart Analyst Coverage Corporate Governance Governance Overview Leadership Board of Directors Committee Composition Governance Overview Leadership Board of Directors Committee Composition Financials & Filings SEC Filings Annual Reports & Proxy Quarterly Results SEC Filings Annual Reports & Proxy Quarterly Results IR Resources Investor FAQs Email Alerts Contact IR RSS Feeds Investor FAQs Email Alerts Contact IR RSS Feeds Print Page Email Alerts RSS Feeds Event to include updates on ongoing evorpacept clinical development program and introduction of clinical trials in breast and colorectal cancers Advancing novel EGFR-targeted antibody-drug conjugate (ADC) candidate, ALX2004, into clinical-stage development with IND submission planned for Q1 2025 Company implements strategic prioritization, resource optimizations and reductions to extend cash runway into Q4 2026 Webcast featuring company leadership and external key opinion leaders to take place today at 6:00 a.m. PT/9:00 a.m. ET SOUTH SAN FRANCISCO, Calif., March 05, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, will highlight progress across its clinical pipeline, including continued advancement of investigational CD47-blocker evorpacept and planned entry into the clinic of its novel EGFR-directed ADC clinical candidate ALX2004, and provide key business and financial updates in an R&D Day webcast event today. ALX Oncology leadership will be joined by external key opinion leaders in the oncology field, Paula R. Pohlmann, M.D., M.S., Ph.D., Chief, Clinical Research, Department of Breast Oncology, and Associate Professor, Department of Breast Medical Oncology and Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, and Eric Van Cutsem, M.D., Ph.D., Professor of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven in Leuven, Belgium. “Our conviction in evorpacept’s potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data. These results support our confidence moving into further clinical trials evaluating evorpacept in breast and colorectal cancers and pave additional regulatory paths forward,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data. To ensure that the company is strongly positioned to focus on our highest priority programs, we are streamlining our organization and prioritizing resources to execute on our current studies, progress our de-risked anti-cancer antibody combinations for evorpacept, as well as advance our novel ADC into the clinic. In order to achieve these additional value generating milestones for breast cancer, colorectal cancer and ALX2004 with our existing cash, we are optimizing resources and making the difficult decision to reduce our workforce, primarily in preclinical research. We look forward to sharing more information at today’s R&D Day event, which provides an opportunity for our leadership team and leading clinicians to detail our most recent data, scientific progress and corporate strategy.” Evorpacept Clinical Program Updates During the R&D Day event, ALX Oncology leadership will discuss the mechanistic rationale and clinical data that support further development of evorpacept with anti-cancer antibodies. In addition to updates on ongoing trials leveraging this combination approach, new plans will be introduced around the initiation of studies evaluating evorpacept in combination with trastuzumab in HER2-positive breast cancer and in combination with cetuximab in colorectal cancer (CRC). Both are anticipated to initiate in the first half of 2025. Drs. Pohlmann and Van Cutsem will also discuss current treatment paradigms and unmet needs within these cancers, and how evorpacept may provide a new treatment option for patients in the future. Introduction of New EGFR-Targeted ADC with IND Submission Planned for Q1 2025 During the R&D Day event, Jaume Pons, Ph.D., will introduce a new ALX Oncology ADC clinical candidate, ALX2004. This is a potential best- and first-in-class compound that is designed to optimize ADC-based mechanisms of anti-tumor activity and has demonstrated potent anti-tumor activity in multiple clinically relevant xenograft models. ALX Oncology intends to submit an Investigational New Drug (IND) application for ALX2004 to the U.S. Food & Drug Administration (FDA) in Q1 2025. Corporate and Financial Updates In order to support the newly planned clinical trial programs in breast cancer and CRC, ALX Oncology has conducted a strategic prioritization and resource optimization exercise resulting in substantial decreases in preclinical research investments, including an approximately 30% workforce reduction primarily in the preclinical research function. As a result, ALX Oncology now expects its cash runway to extend into Q4 of 2026. R&D Day Webcast Information The ALX Oncology virtual R&D Day will be webcast live and a replay will be available after the event by visiting the “Investors” section of ALX Oncology’s website and selecting “Events and Presentations.” Date & Time: Wednesday, March 5, 2025, 6:00 a.m. PT/9:00 a.m. ET Webcast Access: https://edge.media-server.com/mmc/p/yfucf8t5 About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary note regarding forward-looking statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown, Inc. audrafriis@sambrown.com (917) 519-9577 Print Page Email Alerts RSS Feeds

ADC

29 Jan 2025

·www.globenewswire.com

Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe

STAFFORD, Texas, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the expansion of the clinical trial into Europe. The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators have cleared the way to activate approximately 110-115 sites in Europe. Based on the interest of principal investigators at additional sites, the Company plans to submit applications to EMA regulators to add 5-10 additional sites in Ireland, Romania, and potentially other countries in Europe. CEO Snehal Patel commented, "In 2024, we activated sites in all 5 countries in Europe, which represent a large population similar to that of the US. We visited these sites to train the study team, doctors, pharmacists, and nurses and hope to complete the activation of the last sites in the coming quarters in 2025. The expansion of FLAMINGO-01 into Europe has been complimentary to the activated sites in the US, which also increased in 2024. In total we now have approximately 100 sites globally that are activated and screening patients. We believe that the interest level in Europe is very high as we have seen a large increase in patient screening in the second half of 2024." About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

ImmunotherapyPhase 3

100 Deals associated with Inetetamab

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10 top approved records.

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Indication	Country/Location	Organization	Date
Breast Cancer	China	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	17 Jun 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	Phase 2	China	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	24 Mar 2023
Neoplasms	Phase 2	China	3SBio, Inc.	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2025	Not Applicable	HER2-positive	237	TKI plus anti-HER2 antibody	obmnqrqask(isngpijxvz) = wjgyvriocr jeskxyvdlv (eyangdfuie ) View more	Negative	17 Oct 2025
				TKI	obmnqrqask(isngpijxvz) = frejtgljop jeskxyvdlv (eyangdfuie ) View more
ESMO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2+	301	Inetetamab + Pyrotinib + Chemotherapy	uhudqyfbrc(twvuzwliyc) = axckgjrnke ducaykqtjw (efuoefsxiu, 9.8 - 14.2) View more	Positive	17 Oct 2025
				Inetetamab + Pyrotinib + Chemotherapy (1st line)	uhudqyfbrc(twvuzwliyc) = hoodlyjfix ducaykqtjw (efuoefsxiu )
NCT05749016 (Phase II clinical trial, ASCO2025)	Phase 2	Locally advanced breast cancer Neoadjuvant HER2-positive	44	Inetetamab	daptljfwix(aisrcgktlx) = kwgaeslyqe xpbjycjgyt (cdeuvipgwz )	Positive	30 May 2025
				Trastuzumab	daptljfwix(aisrcgktlx) = ywwzpamxjr xpbjycjgyt (cdeuvipgwz )
CTR20222482 (Pubmed) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	62	Inetetamab + Pertuzumab + Nab-paclitaxel	yveoiryuer(lkrlczkdcv) = xjlajudzmh xukgquhmqq (hsfuzbcuck, 43.3 - 69.0) View more	Positive	01 May 2025
SABCS2024 \| NEWS Manual	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	90	Inetetamab-containing regimens	jlcyajtwir(uyyldrwbhy) = zrimwfoaia ddgcifhyjk (eemrzgefns, 7.3 - 17) View more	Positive	26 Nov 2024
				Inetetamab-containing regimens (brain metastases)	jlcyajtwir(uyyldrwbhy) = vqqljronyv ddgcifhyjk (eemrzgefns, 4.7 - 19.3) View more
NCT05749016 (ESMO2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	39	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	aovadfpapm(pdxnbpcgid) = tplgvurzxa gjwmwxdmns (npqzlbmzoe ) View more	Positive	16 Sep 2024
				Neoadjuvant treatment with TCbIP	aovadfpapm(pdxnbpcgid) = ntgrbptpmk gjwmwxdmns (npqzlbmzoe )
NCT06305702 (ESMO2024)	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	500	Inetetamab	mmwuibgahq(hburezysac) = leukopenia was generally well-tolerated qjztsnzceo (wobnyqmbxb ) View more	Positive	16 Sep 2024
				Inetetamab + Tyrosine Kinase Inhibitors + Chemotherapy
NCT05749016 (Pubmed) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma Neoadjuvant HER2 Positive	-	Inetetamab + Pertuzumab + Taxanes + Carboplatin (TCbIP)	eirdrewmbj(pmjustpxmn) = odhmmtdcox qoiyzeyruj (eneprqmhfc ) View more	Positive	22 Jul 2024
				Trastuzumab + Pertuzumab + Taxanes + Carboplatin (TCbHP)	eirdrewmbj(pmjustpxmn) = apaqsqrcgv qoiyzeyruj (eneprqmhfc ) View more
NCT05749016 (ASCO2024) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma Neoadjuvant HER2 Positive	28	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	ryeczqpgnm(hpxjtcfxyk) = gpadzoxwsq kbakcfcdyo (zwfypqsexw ) View more	Positive	24 May 2024
				Trastuzumab + Pertuzumab + Paclitaxel + Carboplatin (TCbHP)	ryeczqpgnm(hpxjtcfxyk) = dmgxbhmlsg kbakcfcdyo (zwfypqsexw ) View more
NCT05823623 (Pubmed) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	30	Inetetamab + Pyrotinib + Oral Vinorelbine	notvqmfscg(xxgkirdhri) = cmwxbkwfcn dloodluepo (gteizhrmwx, 4.15 - 13.12) View more	Positive	01 Jan 2024

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