Non-Randomized Phase 2 Trial of Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma

This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.

Start Date06 Dec 2021

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT03978689

/ Active, not recruitingPhase 1

A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC

This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Start Date30 Jul 2019

Sponsor / Collaborator

Cue Biopharma, Inc.

[+1]

100 Clinical Results associated with CUE-101

100 Translational Medicine associated with CUE-101

100 Patents (Medical) associated with CUE-101

Literatures (Medical) associated with CUE-101

15 Apr 2020·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

CUE-101, a Novel E7-pHLA-IL2-Fc Fusion Protein, Enhances Tumor Antigen-Specific T-Cell Activation for the Treatment of HPV16-Driven Malignancies

Q1 · MEDICINE

Article

Author: Seidel, Ronald ; Witt, Luke ; Quayle, Steven N. ; Girgis, Natasha ; Haydock, Mark ; Pienta, Kenneth J. ; Almo, Steven ; Cemerski, Saso ; Histed, Alex ; Spaulding, Emily ; Chaparro, Rodolfo ; Kemp, Melissa M. ; Zhao, Fan ; Merazga, Zohra ; Thapa, Dharma R. ; Beal, Dominic R. ; Hulot, Sandrine ; Simcox, Mary Ellen ; Suri, Anish ; Ruthardt, Paige ; Soriano, Jonathan ; Moreta, Miguel ; Ross, John F. ; Kiener, Peter A. ; Ryabin, Jessica ; Kraemer, Lauren D. ; Nelson, Alyssa

Abstract:

Purpose::

To assess the potential for CUE-101, a novel therapeutic fusion protein, to selectively activate and expand HPV16 E711-20-specific CD8+ T cells as an off-the shelf therapy for the treatment of HPV16-driven tumors, including head and neck squamous cell carcinoma (HNSCC), cervical, and anal cancers.

Experimental Design::

CUE-101 is an Fc fusion protein composed of a human leukocyte antigen (HLA) complex, an HPV16 E7 peptide epitope, reduced affinity human IL2 molecules, and an effector attenuated human IgG1 Fc domain. Human E7-specific T cells and human peripheral blood mononuclear cells (PBMC) were tested to demonstrate cellular activity and specificity of CUE-101, whereas in vivo activity of CUE-101 was assessed in HLA-A2 transgenic mice. Antitumor efficacy with a murine surrogate (mCUE-101) was tested in the TC-1 syngeneic tumor model.

Results::

CUE-101 demonstrates selective binding, activation, and expansion of HPV16 E711-20-specific CD8+ T cells from PBMCs relative to nontarget cells. Intravenous administration of CUE-101 induced selective expansion of HPV16 E711-20-specific CD8+ T cells in HLA-A2 (AAD) transgenic mice, and anticancer efficacy and immunologic memory was demonstrated in TC-1 tumor-bearing mice treated with mCUE-101. Combination therapy with anti-PD-1 checkpoint blockade further enhanced the observed efficacy.

Conclusions::

Consistent with its design, CUE-101 demonstrates selective expansion of an HPV16 E711-20-specific population of cytotoxic CD8+ T cells, a favorable safety profile, and in vitro and in vivo evidence supporting its potential for clinical efficacy in an ongoing phase I trial (NCT03978689).

News (Medical) associated with CUE-101

23 Jul 2025

·www.prnewswire.com

High‑Growth Oncology Market Projected For US$900bn in Revenue Despite Policy Headwinds

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, July 23, 2025 /PRNewswire/ -- USA News Group News Commentary – Cancer diagnoses are climbing fastest among younger women, sparking alarm that looming cuts to U.S. research budgets could stall progress in prevention and treatment. Adding to the strain, federal and state regulators are re‑examining mRNA vaccines, creating a cloud of uncertainty over future cancer‑funding priorities. Yet even amid this policy turbulence, a new wave of oncology innovators is lining up near‑term milestones that could reshape the landscape—led by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Cue Biopharma, Inc. (NASDAQ: CUE), Verastem, Inc. (NASDAQ: VSTM), Allogene Therapeutics, Inc. (NASDAQ: ALLO), and Perspective Therapeutics, Inc. (NYSE-American: CATX). While regulatory red tape tightens, surging diagnoses of colorectal and other GI cancers in young people demand quicker innovation in oncology. Forecasts suggest worldwide cancer‑drug revenues could blow past US$900 billion by 2034. Within that, next‑gen therapies built on precision techniques are slated to reach US$175.2 billion, advancing at a brisk 7.35% annual clip. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently held a well‑attended key opinion leader (KOL) webinar where pancreatic and gastrointestinal cancer specialists dissected pelareorep's clinical history, its biomarker data package, and where the oncolytic virus could slot into evolving chemotherapy and immunotherapy regimens. "I want to thank our esteemed panel of oncologists for their meaningful contributions to our KOL event," said Jared Kelly, CEO of Oncolytics. "Their insights underscore a critical and timely message: pelareorep is a compelling immunotherapy platform that is well situated for combination strategies and a highly differentiated asset for pharma partners looking to expand or establish leadership in GI oncology. We are committed to moving forward aggressively toward registrational development while engaging with partners who share our vision of transforming outcomes in these difficult-to-treat cancers." The panel revisited survival gains in metastatic pancreatic ductal adenocarcinoma (mPDAC), reviewed translational evidence of "cold‑to‑hot" tumor conversion, and outlined next steps for a registration-enabling study. Management said feedback from the discussion would inform both upcoming trial designs and partnering talks now underway. The event came on the heels of Oncolytics having rolled out an expanded translational‑data review that tightened the scientific case for pelareorep, an intravenously delivered oncolytic reovirus. Renewed analyses from the GOBLET gastrointestinal cancer study and the AWARE‑1 breast cancer study confirmed that the virus replicates inside tumors, switches on interferon signaling in the immune system, and draws tumor‑infiltrating lymphocytes into the tumor microenvironment. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." Investigators also recorded higher PD‑L1 expression and tracked newly expanded cytotoxic T‑cell clones in blood samples that matched those inside shrinking lesions—molecular fingerprints that point to stronger responses when pelareorep is combined with standard-of-care treatments and checkpoint inhibitors. "The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, CEO of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs." Clinical outcomes already hint at real‑world benefit. In more than 100 first‑line mPDAC patients, pelareorep‑based regimens achieved a 21.9% two‑year overall‑survival rate versus a 9.2% historical benchmark. A separate single‑arm study that paired pelareorep with chemotherapy and a checkpoint blocker produced a 62% objective‑response rate—especially notable given that no checkpoint therapy is approved in this cancer today. In hormone‑receptor‑positive, HER2‑negative metastatic breast cancer (HR+/HER2‑ mBC), two randomized trials added more than ten months of median overall survival, while BRACELET‑1 nearly doubled median progression‑free survival to 12.1 months compared with 6.4 months for control patients. To steer these data toward value‑creating deals and late‑stage trials, the company strengthened its leadership earlier this year by appointing industry veteran Jared Kelly as CEO and naming Andrew Aromando Chief Business Officer. The duo previously helped guide Ambrx Biopharma into a US$2 billion sale to Johnson & Johnson, experience the board believes will support capital‑efficient development and strategic partnering for pelareorep. "Pelareorep's clinical data across multiple tumors is striking and represents the potential for a true backbone immunotherapy to address many in-need indications," said Kelly. "With a renewed focus and sharpened clinical development plan, we believe we will move pelareorep forward effectively and efficiently to a place where potential partners will see the value of a de-risked immunotherapy." As CBO, Aromando is now leading global business development and helping shape the company's corporate, clinical, and regulatory strategies. The leadership tandem is expected to prioritize partnering and expansion opportunities while preserving capital efficiency—a strategy well-suited for pelareorep's growing clinical profile. "I'm thrilled to join Oncolytics at such a pivotal moment in its evolution," said Aromando. "With promising data in difficult-to-treat cancers and a compelling body of clinical evidence in over 1,100 patients, I believe the Company is uniquely positioned to deliver meaningful value to patients and other stakeholders in the near term." Pelareorep currently holds FDA Fast Track designations in mPDAC (pancreatic cancer) and HR+/HER2‑ mBC (breast cancer), along with Orphan‑Drug status for pancreatic cancer in the United States and Europe. With mechanistic proof, survival data that outperform historical controls, and fresh validation from the recent KOL event, Oncolytics Biotech is aligning its clinical, regulatory, and business strategies to move pelareorep into registration‑enabling trials and position it as a backbone immunotherapy across solid tumors. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Cue Biopharma, Inc. (NASDAQ: CUE) recently reported that adding CUE‑101 to pembrolizumab produced a 50% overall response rate in patients with recurrent/metastatic HPV‑positive head and neck cancer who had a combined positive score (CPS) ≥ 1, including the same 50% response in those with low CPS 1–19. The regimen has now generated two complete responses, an 88% 12‑month overall survival rate, and a median overall survival of 32 months, handily outperforming historical pembrolizumab data. "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care," said Dan Passeri, CEO of Cue Biopharma. "With this maturing data, we are further emboldened in our conviction that our Immuno-STAT® platform represents transformative potential for selectively modulating the patient's immune system." Verastem, Inc. (NASDAQ: VSTM) recently published Phase 2 RAMP 201 results in the Journal of Clinical Oncology, showing avutometinib + defactinib delivered a 31% confirmed overall response rate in recurrent low‑grade serous ovarian cancer, rising to 44% in KRAS‑mutant tumors. "The publication of the primary analysis of the RAMP 201 study in recurrent low-grade serous ovarian cancer in the Journal of Clinical Oncology reflects the meaningful clinical advancement demonstrated by the combination of avutometinib plus defactinib for patients with recurrent low-grade serous ovarian cancer," said John Hayslip, M.D., Chief Medical Officer at Verastem Oncology. "The findings supported the recent FDA approval of the combination in KRAS-mutated recurrent low-grade serous ovarian cancer and our ongoing global Phase 3 RAMP 301 trial of the combination in recurrent low-grade serous ovarian cancer with and without a KRAS mutation." Median progression‑free survival reached 12.9 months overall and 31.0 months in the KRAS‑mutant subgroup, with 82% of patients experiencing some tumor shrinkage regardless of mutation status. Back in June, Allogene Therapeutics, Inc. (NASDAQ: ALLO) presented updated Phase 1 TRAVERSE data showing a single dose of ALLO‑316 achieved a 31% confirmed response rate in heavily pre‑treated renal cell carcinoma patients whose tumors expressed CD70 in ≥ 50 % of cells. "ALLO-316 is showing clear evidence of targeted antitumor activity in patients who had failed most or all approved therapies for advanced or metastatic renal cell carcinoma," said Zachary Roberts, M.D., Ph.D., EVP, Research and Development and Chief Medical Officer at Allogene. "Our proprietary Dagger technology allows the use of a standard cyclophosphamide and fludarabine-based lymphodepletion regimen with a single dose of ALLO-316. Strong CAR T-cell kinetics and extensive infiltration of tumor tissue by CAR T cells are combining to generate deep and durable remissions. These are results that were previously considered out of reach for patients with advanced solid tumors." Four of five responders remain in remission—including one lasting more than 12 months—while safety remained manageable with no graft‑versus‑host disease observed. Investigators say the results highlight allogeneic CAR T's potential in solid tumors and justify continued expansion of the study. Perspective Therapeutics, Inc. (NYSE-American: CATX) recently began recruiting the third dose‑escalation cohort of its Phase 1/2a trial testing [²¹²Pb]VMT‑α‑NET in unresectable or metastatic somatostatin receptor 2 (SSTR2)‑positive neuroendocrine tumors, raising the fixed dose by 20% to 6 mCi. Earlier cohorts showed anti‑tumor activity with mostly low‑grade adverse events, prompting FDA alignment to explore whether the higher dose can further enhance efficacy. "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile." The company plans additional safety and efficacy readouts, including dosimetry analyses, at scientific meetings in 2H 2025. 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

Clinical ResultImmunotherapyFast TrackASCOPhase 1

14 Nov 2024

·www.globenewswire.com

Cue Biopharma Reports Third Quarter 2024 Financial Results and Recent Business Highlights

BOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and autoimmune disease, today provided a business and financial update for the third quarter of 2024. Recent Business Highlights Presented positive updated data from the Phase 1 trials of CUE-101 and CUE-102 at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) November 6-10 Updated data from Phase 1 trial of CUE-101 in combination with KEYTRUDA® (pembrolizumab) continued to demonstrate enhanced benefit versus historical studies with pembrolizumab alone. Key findings included an objective response rate (ORR) of 46%, 12-month overall survival (OS) of 91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M HNSCC patients, as well as an ORR of 50% in the subset of 1L patients with low PD-L1 expression (combined positive score (CPS) 1-19) Updated data from Phase 1 monotherapy trial of CUE-102 included evidence of selective expansion of WT1-specific T cells and anti-tumor activity, as well as a favorable tolerability profile with no dose limiting toxicities (DLTs) in patients with Wilms’ Tumor 1 (WT1)-expressing colorectal, gastric, ovarian and pancreatic cancers Demonstrated disease control rate (DCR) of 67% in late-stage pancreatic cancer patients treated with CUE-102 monotherapy, including an unconfirmed partial response (PR) with a 40% decrease in tumor burdenAnnounced pricing of $12.0 million public offeringAppointed industry veteran Lucinda Warren as Chief Business OfficerContinued advancement of preclinical programs, CUE-401 for induction and expansion of regulatory T cells, in collaboration with Ono Pharmaceutical, and CUE-501 for B cell depletion, positioning both programs towards drug candidate selection “We are very pleased with the validating updated clinical data from our Phase 1 trials for both CUE-101 and CUE-102,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Importantly, we believe the maturing data further supports and strengthens our competitive differentiation and positioning for selective modulation of disease-specific T cells. This data further bolsters our confidence that the CUE-100 series, exemplified by CUE-101 and CUE-102, represents the potential of establishing a new standard of care for cancer patients. We are also very pleased with the continued progress of our preclinical autoimmune programs, both of which have moved closer towards drug candidate selection.” Third Quarter 2024 Financial Results Collaboration revenue increased by $1.2 million to $3.3 million for the three months ended September 30, 2024, from $2.1 million for the three months ended September 30, 2023. The increase was due to revenue earned from the Ono Collaboration and Option Agreement, which was executed in February 2023. Research and development expenses decreased by $0.5 million to $9.4 million for the three months ended September 30, 2024, from $9.9 million for the three months ended September 30, 2023. The decrease was primarily due to lower clinical trial costs and employee compensation, which includes stock-based compensation, partially offset by an increase in drug substance manufacturing costs related to the continued advancement of CUE-401. General and administrative expenses decreased by $0.7 million to $2.9 million for the three months ended September 30, 2024, from $3.6 million for the three months ended September 30, 2023. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation. Collaboration revenue increased by $4.0 million to $7.7 million for the nine months ended September 30, 2024, from $3.7 million for the nine months ended September 30, 2023. The increase was due to revenue earned from the Ono Collaboration and Option Agreement, which was executed in February 2023. Research and development expenses decreased by $0.8 million to $29.1 million for the nine months ended September 30, 2024, from $29.9 million for the nine months ended September 30, 2023. The decrease was primarily due to lower clinical trial costs and employee compensation, which includes stock-based compensation, partially offset by an increase in professional outside services related to the continued advancement of CUE-401. General and administrative expenses decreased by $1.5 million to $10.6 million for the nine months ended September 30, 2024, from $12.1 million for the nine months ended September 30, 2023. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation. As of September 30, 2024, the Company had approximately $32.4 million in cash and cash equivalents compared with $48.5 million in cash and cash equivalents as of December 31, 2023. The Company expects its current cash and cash equivalents to fund operations into the fourth quarter of 2025. Cue Biopharma, Inc.Condensed Consolidated Statements of Operations and Other Comprehensive Loss(Unaudited)(In thousands, except share and per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Collaboration revenue$3,336 $2,100 $7,711 $3,669 Operating expenses: General and administrative 2,867 3,645 10,564 12,071 Research and development 9,381 9,874 29,111 29,915 Gain on fixed asset disposal (97) - (97) - Total operating expenses 12,151 13,519 39,578 41,986 Loss from operations (8,815) (11,419) (31,867) (38,317) Other income (expense): Interest income 343 700 1,332 1,756 Interest expense (188) (286) (643) (738) Total other income, net 155 414 689 1,018 Net loss$(8,660) $(11,005) $(31,178) $(37,299) Unrealized gain from available-for-sale securities - 5 - 96 Comprehensive loss$(8,660) $(11,000) $(31,178) $(37,203) Net loss per common share – basic and diluted$(0.17) $(0.24) $(0.62) $(0.82) Weighted average common shares outstanding – basic and diluted 51,229,701 46,358,555 50,292,983 45,274,124 Cue Biopharma, Inc.Condensed Consolidated Balance Sheets(Unaudited, In thousands) September 30, 2024 December 31, 2023 Assets Cash and cash equivalents$32,420 $48,514 Other assets 12,390 13,016 Total assets$44,810 $61,530 Liabilities and stockholders’ equity Liabilities$19,444 $24,445 Stockholders' equity 25,366 37,085 Total Liabilities and stockholders’ equity$44,810 $61,530 About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief that the CUE-100 series represents the potential of establishing a new standard of care for cancer patients; the company’s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cell and the applicability of the company’s platform across many cancers and autoimmune diseases; the company’s business strategies, plans and prospects, including the advancement of the company’s preclinical autoimmune programs toward drug candidate selection ; and the cash runway of the company and the sufficiency of the company’s cash and cash equivalents to fund its operations. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to shift its focus to its autoimmune assets and achieve the cost savings that it is projecting; the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Inc.mcampinell@cuebio.com Media ContactJonathan PappasLifeSci Communicationsjpappas@lifescicomms.com

Financial StatementPhase 1ImmunotherapyClinical Result

12 Nov 2024

·www.globenewswire.com

Cue Biopharma Presents Positive Updated Data from its Phase 1 Trials of CUE-101 and CUE-102 in Head and Neck Cancer and WT1 Positive Cancers at the SITC 39th Annual Meeting

Objective response rate (ORR) of 46%, 12-month overall survival (OS) of 91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M HNSCC patients treated with CUE-101 and KEYTRUDA® (pembrolizumab) ORR of 50% in 1L patients treated with CUE-101 and pembrolizumab with low PD-L1 expression (combined positive score (CPS) 1-19) 67% overall disease control rate (DCR) in late-stage pancreatic cancer patients treated with CUE-102 monotherapy, including an unconfirmed partial response (PR) with a 40% decrease in tumor burden CUE-101 data was presented in an oral session at SITC 2024 today Nov. 08, 2024 -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and autoimmune disease, today presented updated data from its Phase 1 dose escalation and expansion trial evaluating its lead oncology asset from the Immuno-STAT™ CUE-100 series, CUE-101, in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The data was presented in an oral session at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) being held in Houston, Texas and virtually November 6-10. In addition, on Saturday, November 9, 2024, the Company will present a poster with data from its Phase 1 trial evaluating monotherapy activity of its second clinical asset from the CUE-100 series, CUE-102, for the treatment of patients with late-stage Wilms Tumor 1 positive (WT1+) colorectal, gastric, ovarian and pancreatic cancers. Data showed substantial evidence of selective expansion of WT1-specific T cells, with anti-tumor activity and a favorable tolerability profile with no dose limiting toxicities (DLTs) observed. “The therapeutic responses observed with CUE-101 and pembrolizumab are very promising. The combination has been well-tolerated and demonstrates durable clinical benefit,” said Christine H. Chung, M.D., Department Chair, Head and Neck-Endocrine Oncology, Moffitt Cancer Center, and a principal investigator participating in the CUE-101 clinical trial. “The latest results highlight the potential of CUE-101 to improve response rates and quality of life for this patient population.” Key data highlights from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in 1L HPV+ R/M HNSCC patients (data cutoff of September 11, 2024) include: ORR of 46% and overall disease control rate (DCR) of 75% in patients with combined positive score (CPS) ≥1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response (CR) and 10 partial responses (PR), in addition to seven durable stable diseases (DSD) of >12 weeks. Survival metrics continue to mature: 12-month OS of 91.3% compared to 51% with pembrolizumab alone in the historical KEYNOTE-048 trial. mOS of 21.8 months compared to 12.3 months in the historical KEYNOTE-048 trial. ORR of 50% in patients with PD-L1 CPS 1-19. Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy with 20 second line and beyond (2L+) patients (majority third line and beyond (3L+) (data cutoff of September 11, 2024) include: mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in historical third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively. CUE-101 has been well tolerated as a monotherapy and in combination with pembrolizumab. No significant safety concerns have emerged in either the monotherapy or combination trials, and adverse events have been readily managed with appropriate medical care. Key data highlights from the completed CUE-102 dose escalation and ongoing dose expansion parts of the Phase 1 clinical trial (data cutoff of October 29, 2024) include: 67% overall DCR in late-stage pancreatic cancer patients treated with CUE-102 at 2 and 4mg/kg, including an unconfirmed PR with a 40% decrease in tumor burden. Evidence of selective stimulation and expansion of WT1-specific CD8 T cells, with no apparent increase in total numbers of non-specific CD8 T cells. No dose-limiting toxicities occurred in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102. Matteo Levisetti, M.D., chief medical officer of Cue Biopharma, added, "We are pleased with the positive results from both the CUE-101 and CUE-102 ongoing trials as the data continue to mature. The CUE-102 data further demonstrates the mechanism of action of Immuno-STAT biologics to activate and expand tumor-specific T cells, as well as its translation into evidence of clinical benefit. The versatility of the Immuno-STAT platform holds significant potential for treating a variety of cancers.” All posters will be available to conference attendees as e-posters on the virtual meeting platform November 7, 2024, at 9 a.m. CST through January 7, 2025. The CUE-101 oral presentation and CUE-102 poster will also be available on November 8, 2024, in the Investors & Media section of the Company’s website at www.cuebiopharma.com, under Scientific Publications and Presentations. The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting the HPV E7 protein to the HPV-specific T cell receptor. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA®). CUE-102 is Cue Biopharma’s second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1- specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 is being evaluated in a Phase 1 open label, two-part dose escalation and expansion study, for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1. Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical ResultASCO

100 Deals associated with CUE-101

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Indication	Highest Phase	Country/Location	Organization	Date
HPV positive oropharyngeal squamous cell carcinoma	Phase 2	United States	Cue Biopharma, Inc.	06 Dec 2021
Squamous Cell Carcinoma of Head and Neck	Phase 1	United States	Cue Biopharma, Inc.	30 Jul 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03978689 (GlobeNewswire) Manual	Phase 1	Human Papillomavirus-Related Head and Neck Neoplasms HPV16+	-	CUE-101 + Pembrolizumab	zoobmevvom(cjfgihtcdu) = moezlxqjwv netsfcsuyn (xqqbjwfbge ) View more	Positive	16 Jul 2025
				Pembrolizumab (historical third-party KEYNOTE-048 trial)	zoobmevvom(cjfgihtcdu) = vvlaldhxjq netsfcsuyn (xqqbjwfbge ) View more
NCT04852328 (Phase 2 trial, ASCO2025)	Phase 2	HPV positive oropharyngeal squamous cell carcinoma Neoadjuvant	20	CUE-101 Schedule A	ungtvxyepw(czrhfohutp) = uythjntrtm jlqgijfucn (nutpmrqrep ) View more	Positive	30 May 2025
				CUE-101 Schedule B	sqdfhintej(rwthsexgnk) = dzlwvcssea wvtxeabsnt (kontczomby ) View more
NCT03978689 (CUE-101-01, SITC2024) Manual	Phase 1	Recurrent Squamous Cell Carcinoma of the Head and Neck	80	CUE-101 monotherapy	bohoftpvom(eapgqmvprq) = ugqrguqfur azxsowfaxo (vjbswxpkdx, 10.0 - NA)	Positive	05 Nov 2024
				CUE-101 + pembrolizumab	bohoftpvom(eapgqmvprq) = ulamcsuuul azxsowfaxo (vjbswxpkdx ) View more
NCT03978689 (CUE-101-01, ASCO2024) Manual	Phase 1	Recurrent Squamous Cell Carcinoma of the Head and Neck First line HLA-A*0201 Positive	80	CUE-101 monotherapy	nxaafaostt(zyazvmychq) = 6.3% ovgntbwudo (nhfxsdlnhi ) View more	Positive	24 May 2024
				CUE-101 plus pembrolizumab
NCT03978689 (CUE-101-01, Biospace) Manual	Phase 1	Head and Neck Neoplasms First line \| Second line HPV16+	76	CUE-101 (second line (2L) and beyond)	ktelyebyto(pdmsarxbbl) = mkgoupbdvf brngrgjqzk (djafwsiayg ) View more	Positive	29 Feb 2024
				CUE-101 + pembrolizumab (first line)	ktelyebyto(pdmsarxbbl) = cwsuieobdj brngrgjqzk (djafwsiayg ) View more
NCT03978689 (CUE-101â01, SITC2023)	Phase 1	Human Papillomavirus-Related Head and Neck Neoplasms Third line \| First line HPV16 cfDNA	71	CUE-101 monotherapy	vhazcbuily(cglzxzgtao) = 7.0% sbxlwcmzix (dpnwhxwppq ) View more	Positive	02 Nov 2023
				CUE-101 and pembrolizumab combination therapy
NCT03978689 (CUE-101-01, ASCO 12023 \| ASCO 22023) Manual	Phase 1	Human Papillomavirus-Related Head and Neck Neoplasms First line \| Second line HPV16 Positive	67	CUE-101	kzpbnawwjg(aljugodryi) = Frequent adverse events include fatigue (45%), anemia (34%), chills (27%), infusion related reactions (25%), constipation (22%), lymphopenia (22%) and nausea (22%). wdcpujkghb (yyjjqprgss ) View more	Positive	26 May 2023
				pembrolizumab+CUE-101
NCT03978689 (CUE-101-01, ASCO2022) Manual	Phase 1	Human Papillomavirus-Related Head and Neck Neoplasms	53	CUE-101	porzqeusej(ycmzkflxzh) = hsgqcaveak drzwzalwtb (maouppurpa ) View more	Positive	02 Jun 2022
				CUE 101+Pembrolizumab	porzqeusej(ycmzkflxzh) = jyxwvlbhpr drzwzalwtb (maouppurpa ) View more

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