On July 9, 2026 Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, reported that the U.S. Food and Drug Administration (FDA) has approved ENNUMO (pegfilgrastim-pccg), a biosimilar to NEULASTA (pegfilgrastim). ENNUMO is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).1 ENNUMO is approved by the FDA for the same indications as its reference product, NEULASTA.

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With this approval, Accord BioPharma is now the only company in the U.S. offering two distinct pegfilgrastim biosimilars — ENNUMO and UDENYCA (pegfilgrastim-cbqv) — alongside FILKRI (filgrastim-laha), its short-acting granulocyte colony-stimulating factor (G-CSF) biosimilar approved in February 2026. Together, these three products form a G-CSF portfolio designed to meet the diverse clinical and operational needs of oncology practices, hospitals, and the patients they serve.

"Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies," said Chrys Kokino, President, Accord North America. "With ENNUMO, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company. We are on track to deliver 20 biosimilars by 2030. We recognize that both patients and oncology practices are counting on us for the long term as we expand our oncology product offerings. Most importantly we are proud that we have and will continue to increase patient access to these critically important medicines."

Expanding Access Through Portfolio Breadth
Febrile neutropenia is one of the most serious and frequently occurring complications of myelosuppressive chemotherapy, contributing to treatment delays, dose reductions, hospitalizations, and increased mortality risk in patients with cancer.2 Granulocyte colony-stimulating factors have become a cornerstone of oncology supportive care, and biosimilars are playing an increasingly critical role in expanding access to these therapies across a range of clinical settings.

"From speaking with our customers, we know the needs of oncology practices are not one-size-fits-all, and we’ve built our portfolio to address this reality," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. "With ENNUMO and UDENYCA, we have pegfilgrastim biosimilar options to offer—alongside FILKRI for short-acting G-CSF—so we can meet physicians and their patients where they are."

Part of a Broader Biosimilar Growth Story
The approval of ENNUMO marks the latest milestone in Accord BioPharma’s rapid portfolio expansion. The company has set a strategic goal to launch 20 biosimilar products in the U.S. by 2030, building on a growing commercial portfolio that now spans oncology and immunology, with an aim to further expand into central nervous system therapies. Backed by Intas Pharmaceuticals, Ltd., one of the world’s largest and most experienced biosimilar developers with nearly five decades of global pharmaceutical expertise, Accord BioPharma is uniquely positioned to deliver on this ambition.

"ENNUMO’s approval is another proof point that what we’re building at Accord BioPharma can genuinely change the treatment landscape for patients in the U.S.," said Binish Chudgar, Chairman and Managing Director, Intas Pharmaceuticals, Ltd. "Our goal of 20 biosimilars by 2030 is not just a number. It reflects the depth of our pipeline and our determination to deliver."

Contact: [email protected]

IMPORTANT SAFETY INFORMATION

Contraindications: ENNUMO is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis.

Splenic Rupture: Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Patients who report left upper abdominal or shoulder pain after receiving ENNUMO should be evaluated for an enlarged spleen or splenic rupture.

Acute Respiratory Distress Syndrome: Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients for ARDS who develop fever, lung infiltrates or respiratory distress after receiving ENNUMO. Discontinue ENNUMO in patients with ARDS.

Serious Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after the discontinuation of initial therapies to manage the reaction. Permanently discontinue ENNUMO in patients with serious hypersensitivity reactions.

Use in Patients with Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue ENNUMO if sickle cell crisis occurs.

Glomerulonephritis: Glomerulonephritis has occurred in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause and if likely, consider dose-reduction or interruption of ENNUMO.

Leukocytosis: White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of complete blood count (CBC) during ENNUMO therapy is recommended.

Thrombocytopenia: Pegfilgrastim products can cause thrombocytopenia. Monitor platelet counts during ENNUMO therapy.

Capillary Leak Syndrome: Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Closely monitor patients who develop symptoms of capillary leak syndrome and provide standard symptomatic treatment, which may include a need for intensive care.

Potential for Tumor Growth Stimulatory Effects on Malignant Cells: The G-CSF receptor through which pegfilgrastim products and filgrastim products act has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: MDS and AML have been associated with the use of pegfilgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.

Aortitis: Aortitis has been reported in patients receiving pegfilgrastim products and may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue ENNUMO if aortitis is suspected.

Nuclear Imaging: Increased hematopoietic activity of the bone marrow in response to growth factor therapy, including pegfilgrastim products, has been associated with transient positive bone imaging changes and should be considered when interpreting bone imaging results.

Most Common Adverse Reactions:

Most common adverse reactions (≥ 5% higher difference in incidence compared to placebo) are bone pain and pain in extremity.

INDICATIONS

ENNUMO is a leukocyte growth factor indicated in adults and pediatric patients aged newborn and older to:

Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Limitations of Use:

ENNUMO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ENNUMO (pegfilgrastim-pccg) injection for manual use is supplied in a 6 mg/0.6 mL single-dose prefilled syringe.

Click here for full Prescribing Information.

NEULASTA (pegfilgrastim) is a registered trademark of Amgen Inc.

(Press release, Accord BioPharma, JUL 9, 2026, View Source [SID1234669127])

On July 9, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage biopharmaceutical company focused on developing transformative therapies targeting functional cures for immunological disorders, reported that it has entered into a securities purchase agreement with a group of accredited investors for the private placement of (i) 1,418,071 shares of common stock at a purchase price of $33.21 per share and (ii) to certain investors, in lieu of shares of common stock, pre-funded warrants to purchase up to 87,500 shares of common stock at a price per pre-funded warrant of $33.209, for gross proceeds of approximately $50.0 million.

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The private placement is expected to close on or about July 13, 2026, subject to the satisfaction of customary closing conditions. The pre-funded warrants will have an exercise price of $0.001 per share, be immediately exercisable, and remain exercisable until exercised in full.

The private placement was led by Cormorant Asset Management, with participation from additional new investment funds including Columbia Threadneedle Investments.

The Company intends to use the net proceeds from the private placement to further fund clinical development and for other general corporate purposes.

"We are pleased to have such a high-quality group of biotech investors committing to the long-term support of Cue as we build our company and advance our portfolio targeting functional cures across immunological disorders," said Shao-Lee Lin, M.D., Ph.D., chief executive officer, president and board director of Cue Biopharma. "We look forward to our upcoming clinical milestones, including data from Ascendant Health’s ongoing Phase 2 CSU study in China, which is expected by the end of the third quarter of 2026."

The securities being issued and sold in the private placement, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"). Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. Concurrently with the execution of the securities purchase agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock sold in the private placement and the shares of common stock underlying the pre-funded warrants sold in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

(Press release, Cue Biopharma, JUL 9, 2026, View Source [SID1234669125])

On July 9, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the first patient has been dosed at the European Institute of Oncology (IEO) in Milan, Italy in its global Phase 2 clinical trial evaluating HEPZATO in combination with standard of care (SOC) treatment for liver-dominant metastatic breast cancer (mBC).

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The Phase 2 trial (DELUMA; NCT06875128) will evaluate the safety and efficacy of HEPZATO in combination with standard of care (SOC) versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial, which is expected to be conducted at more than 20 sites across the United States and Europe. The trial’s primary endpoint is hepatic progression-free survival, with several secondary endpoints, including progression-free survival, overall response rate, disease control rate and overall survival.

Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third-line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. Delcath aims to provide a novel treatment option for these patients, who have limited therapeutic alternatives.

"Dosing the first patient in this Phase 2 trial at the IEO in Milan, Italy is an important milestone in our effort to expand the clinical investigation of HEPZATO into liver-dominant metastatic breast cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. "Building on encouraging efficacy signals in real-world evidence presented at ESMO (Free ESMO Whitepaper) Breast Cancer 2026 and our commercial success in metastatic uveal melanoma, we’re strengthening how we engage sites, educate physicians on liver-directed therapy, and identify appropriate patients. We are encouraged by the momentum we are seeing and look forward to advancing our evaluation of HEPZATO’s potential to address significant unmet needs in oncology beyond metastatic uveal melanoma."

(Press release, Delcath Systems, JUL 9, 2026, View Source [SID1234669124])

On July 9, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported financial results for the fiscal quarter ended May 31, 2026, and highlighted significant corporate updates including Nurix’s entry into a global license and collaboration agreement with Roche for Nurix’s potential best-in-class BTK degrader bexobrutideg (NX-5948), continued advancement of its registrational program in chronic lymphocytic leukemia (CLL), expansion into immunology and neurology, and progress across its broader pipeline.

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"The second quarter of 2026 was a defining period for Nurix and the targeted protein degradation field," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Our global collaboration with Roche, an industry leader, validates both the differentiated clinical profile of bexobrutideg in malignant hematology and its broader potential in immunology and inflammation. The co-development, co-commercialization structure of the agreement allows Nurix to pursue multiple opportunities in significant markets in both oncology and autoimmune disease with financial strength and global reach."

Program Highlights*
Bexobrutideg Global Partnership with Roche
•Nurix announced a global collaboration agreement with Roche to co-develop and co-commercialize bexobrutideg across malignant hematology, immunology and neurology. Within 30 days following the effectiveness of the agreement, Nurix expects to receive a $700 million upfront payment and will be eligible to receive development, regulatory and commercial milestone payments for potential total payments of up to $2.3 billion, inclusive of the upfront payment. Development costs will be shared 40% by Nurix and 60% by Roche. Profits and losses in the United States will be shared equally and Nurix is eligible to receive tiered royalties on ex-U.S. sales.
•The collaboration includes a comprehensive development strategy spanning multiple hematologic malignancies and expansion into immune-mediated diseases, including planned Phase 2 studies in multiple sclerosis (MS) and chronic spontaneous urticaria (CSU).
•The collaboration agreement is subject to customary closing conditions, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other required antitrust clearances.
Bexobrutideg Clinical Data Presented at EHA (Free EHA Whitepaper) 2026
•Nurix reported new and updated clinical data from the ongoing NX-5948-301 Phase 1a/1b study demonstrating durable responses and a favorable tolerability profile in patients with relapsed/refractory CLL/SLL.
•Updated Phase 1a results demonstrated
◦Median progression-free survival of 22.1 months
◦Objective response rate (ORR) of 83%
◦Responses observed across difficult-to-treat patient populations, including patients with BTK resistance mutations, high-risk molecular features and central nervous system involvement
•New Phase 1b results demonstrated:
◦ORR of 92.9% among evaluable patients with 18 of 19 patients remaining on treatment at data cutoff in Cohort 5, evaluating patients previously treated with a BTK inhibitor but naïve to BCL2 inhibitor therapy

◦ORR of 84.2% among evaluable patients with 19 of 20 patients remaining on treatment at data cutoff in Cohort 15, evaluating BTKi-naïve patients including treatment-naïve patients
Bexobrutideg Clinical Development Program
•Enrollment continues in DAYBreak CLL-201, the pivotal Phase 2 trial designed to support a potential Accelerated Approval submission in patients with relapsed/refractory CLL whose disease has progressed following treatment with a covalent BTK inhibitor, a BCL2 inhibitor and a non-covalent BTK inhibitor.
•Preparations continue for DAYBreak CLL-306, the global randomized Phase 3 confirmatory trial evaluating bexobrutideg versus pirtobrutinib in patients with relapsed/refractory CLL following prior BTK inhibitor therapy with the dosing of the first patient anticipated in mid-2026.
•Preparations continue for the Phase 1b/2 Study Basket Combination Study to define optimal treatment regimens to support the initiation of combination pivotal trials in CLL and potentially mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM).
•Nurix continues to enroll select cohorts in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B cell malignancies. The Phase 1b study includes cohorts testing the safety and efficacy of the 600 mg dose of bexobrutideg in earlier lines of therapy in CLL patients and in NHL patients. Updated data from this study are anticipated to be presented at upcoming medical meetings throughout 2026. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at www.clinicaltrials.gov.
Expansion of Bexobrutideg Development into Immunology and Neurology
•Presented new preclinical and Phase 1 translational data from healthy volunteers at the 2026 Society for Investigative Dermatology Annual Meeting supporting the potential of bexobrutideg in chronic spontaneous urticaria. Data demonstrated potent and selective BTK degradation across key immune cell populations, robust degradation in blood and skin following oral administration of the new tablet formulation, and enhanced suppression of FcεRI-driven biology compared with BTK inhibition.
•Continued advancement of a healthy volunteer SAD/MAD study evaluating the new tablet formulation of bexobrutideg to support potential future development in immunology and neurology indications with planning underway for the initiation of Phase 2 trials in CSU and MS.
Broader Pipeline Highlights
Preclinical Oncology Pipeline
•Presented new data at the 2026 AACR (Free AACR Whitepaper) Annual Meeting highlighting progress across multiple targeted protein degradation programs, including pan-mutant BRAF degrader NRX-0305, CBL-B program NX-1607 and AURKA degrader NRX-4972.
•Data reinforced the potential for targeted protein degradation to overcome key limitations of conventional therapeutic approaches, including treatment resistance and incomplete pathway suppression.
NX-1607
•Nurix has completed enrollment of current Phase 1a dose escalation cohorts of NX-1607, an investigational oral CBL-B inhibitor, across multiple solid tumor oncology indications and is reviewing the data to determine next steps.
Zelebrudomide
•Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix has completed enrollment in the current dose escalation cohorts of the Phase 1 trial (NCT04830137) and is reviewing the data to determine next steps.
Strategic Collaborations
•In addition to the Roche collaboration, Sanofi continues to advance the STAT6 degrader, NX-3911, in IND-enabling studies. Nurix retains the right to opt-in after clinical proof of concept to a 50/50 U.S. profit share and co-development agreement. Gilead continues to advance the IRAK-4 degrader, GS-6791, in an ongoing first-in-human Phase 1 study in healthy volunteers. Nurix retains the right to opt-in after Phase 1 to a 50/50 U.S. profit share and co-development, `subject to certain restrictions. Nurix and Pfizer continue to progress multiple preclinical degrader antibody conjugate (DAC) programs. In the second fiscal quarter of 2026, Nurix earned a $2 million milestone payment from Sanofi.
*Expected timing of events throughout this press release is based on calendar year quarters.

Fiscal Second Quarter 2026 Financial Results
Revenue for the three months ended May 31, 2026, was $9.0 million compared with $44.1 million for the three months ended May 31, 2025. The decrease was primarily due to $30 million of license revenue from two Sanofi license extensions in the prior year. During the three months ended May 31, 2026, Nurix achieved a research milestone under its collaboration with Sanofi of $2 million.
Research and development expenses for the three months ended May 31, 2026, were $87.7 million compared with $78.1 million for the three months ended May 31, 2025. The increase was primarily related to clinical costs and contract manufacturing costs as Nurix continued to accelerate the enrollment of patients in the ongoing Phase 2 trial of bexobrutideg and to enable the initiation of Phase 3 trials.
General and administrative expenses for the three months ended May 31, 2026, were $15.6 million compared with $14.3 million for the three months ended May 31, 2025. The increase was primarily due to an increase in legal costs for collaboration and business development activities.
Net loss for the three months ended May 31, 2026, was $89.5 million or ($0.81) per share compared with $43.5 million or ($0.52) per share for the three months ended May 31, 2025.
Cash, cash equivalents and marketable securities were $443.5 million as of May 31, 2026, compared to $592.9 million as of November 30, 2025. In addition, we expect to receive the $700 million upfront payment from Roche in the third fiscal quarter of 2026.

About Bexobrutideg
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.
Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B-cell malignancies. A new tablet formulation of bexobrutideg is also being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about ongoing clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUL 9, 2026, View Source [SID1234669123])

On July 9, 2026 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, reported the following update on the use of commercially manufactured GP2 in FLAMINGO-01 in Europe.

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All European and US Sites to Treat Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first commercial lot filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US in early 2026. All approximately 40-50 US sites have been supplied with commercially manufactured GP2 vials and have begun treating patients with these vials. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

The European Medicines Agency (EMA) has completed their review and will also allow use of the same commercially manufactured GP2 lot in FLAMINGO-01 in Europe. Thus, all clinical sites in the US and Europe, which have increased from 160 sites to approximately 170-180 sites, are expected to be using the same lot with shipments to European pharmacies already under way. We are now seeking approval to use this lot in the UK and Canada in separate and independent regulatory processes.

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO (Free ASCO Whitepaper) Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company’s website here.
As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time.
As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated 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 and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally.

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: [email protected]

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.

(Press release, Greenwich LifeSciences, JUL 9, 2026, View Source [SID1234669122])