On November 13, 2021 Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported financial results for the third quarter ended September 30, 2021 and highlighted recent corporate accomplishments (Press release, Compass Therapeutics, NOV 13, 2021, View Source [SID1234595476]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have made major progress on reaching our corporate goals, highlighted by achieving significant advancements for both of our clinical stage programs and raising capital to support our objectives," said Thomas J. Schuetz, MD, PhD, Co-founder and Chief Executive Officer. "We released promising interim Phase 2a data on our lead program, CTX-009, which support our conviction that CTX-009 is a promising novel bispecific antibody therapy with activity across a broad range of solid tumors. Additionally, CTX-471 continues to advance well in development, and has demonstrated encouraging activity as a monotherapy in the post anti-PD-1/PD-L1 patient population, an area of a particularly high unmet medical need."

"On the financing side, we completed a $125 million public offering and concurrently uplisted to Nasdaq," added Vered Bisker-Leib, PhD, MBA, President and Chief Operating Officer. "We expect this offering will extend our cash runway into the fourth quarter of 2024, which will support the advancement of our pipeline. These are significant achievements for Compass and position us well to grow and fund key milestones throughout the next several years."

Third Quarter Development Highlights:

CTX-009 (DLL4 and VEGF-A bispecific antibody):

A Phase 2a study was initiated in Q1 2021 testing CTX-009 in combination with paclitaxel in patients with Biliary Tract Cancers (cholangiocarcinoma). Enrollment in the first part of the study has been completed and the criteria to advance to the second part of the study have been met. Notably, five partial responses (PRs) have already been observed among the first 17 patients evaluated leading to a preliminary overall response rate (ORR) of 29%, and all patients evaluated have had stable disease or better with a decline in tumor burden observed in 16 of the 17 patients leading to a Clinical Benefit Rate (CBR) of 100%. The study is being conducted in South Korea by Handok Pharmaceuticals and the clinicaltrials.gov identifier for the study is NCT04492033. Compass plans to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) in the fourth quarter of 2021 and subject to the IND clearance with the FDA, to initiate a Phase 2 study in 2022 in the United States.
CTX-471 (monoclonal antibody agonist of CD137, a key co-stimulatory receptor on immune cells):

We initiated a Phase 1b dose expansion study for CTX-471 in 2019 and treated 36 patients with 13 different tumor types in the study as of October 21, 2021. Of the 25 evaluable patients in the dose expansion part of the study, two patients had a PR, one of which has been confirmed by RECIST 1.1 and the other PR has been seen at the first tumor evaluation at Week 9. 11 patients have reached stable disease, leading to a preliminary ORR of 8% and a CBR of 52%. The first PR observed in the study was in a patient with advanced small cell lung cancer who had a PR at Week 17 and this response was confirmed at Week 25. This patient has now been treated with CTX-471 for more than one year with a durable PR. In October 2021, a second PR was observed in a patient with metastatic melanoma who was previously treated with and progressed on nivolumab. We expect to complete the Phase 1b stage of this study during the first half of 2022.
CTX-8371 (bispecific antibody that simultaneously targets both PD-1 and PD-L1):

We initiated IND-enabling studies and the GMP manufacturing campaign for CTX-8371. Due in part to delays at our contract development manufacturing organization, we are currently targeting an IND submission in the second half of 2022.
Third Quarter Corporate Highlights:

In November 2021, Compass closed an underwritten public offering to sell 35,715,000 shares of common stock at a public offering price of $3.50 per share. The gross proceeds to Compass from the offering, before deducting the underwriting discounts and commission, were approximately $125 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 5,357,250 shares of common stock.
In connection with the public offering, Compass also uplisted its common stock to Nasdaq and its shares began trading on the Nasdaq Capital Market under the symbol "CMPX" on November 2, 2021.
Third Quarter 2021 Financial Results

Cash Position: As of September 30, 2021, cash and cash equivalents were $25.5 million as compared to $47.1 million as of December 31, 2020. The Company believes that our existing cash and cash equivalents, together with the proceeds of our November 2021 public offering, will allow us to fund our operating expenses and capital expenditures into the fourth quarter of 2024.
Research and development (R&D) Expenses: R&D expenses were $3.2 million for the third quarter of 2021, as compared to $3.7 million for the same period in 2020, a decrease of $0.5 million or 14%. The lower costs were principally driven by less depreciation expense of $0.3 million and program related expenses of $0.2 million.
General and Administrative (G&A) Expenses: G&A expenses were $2.7 million during the third quarter of 2021, as compared to $5.3 million for the same period in 2020, a decrease of $2.6 million or 49%. The lower costs were driven primarily by lower stock compensation expense of $1.4 million due to an accelerated vesting of shares and $0.5 million of professional fees related to the reverse merger in the third quarter of 2020. In addition, facilities expense decreased by $0.3 million.
Net Loss: Net loss for the third quarter was $6.0 million or $0.10 per diluted common share, compared to $9.2 million or $0.18 per diluted common share for the third quarter of 2020.

On November 12, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported its compelling preclinical evidence on its next-generation autotaxin inhibitor, IOA-289, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (#SITC) Annual Meeting on November 10–14, 2021 (Press release, iOnctura, NOV 12, 2021, View Source [SID1234640239]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Autotaxin is a secreted glycoprotein that hydrolyzes LPC to LPA. LPA has a direct effect on tumor cell growth and survival. It also modulates the tumor microenvironment at the level of immune and stromal cells, enabling tumors to evade host immunity and impairing the response to therapy. The expression of both autotaxin and LPA is elevated in most solid tumors, with corresponding increases measurable in patients’ plasma. iOnctura is developing IOA-289 as a novel therapy for oncology indications where the response to chemotherapy and / or immunotherapy is sub-optimal due to the presence of an immunosuppressive stromal microenvironment.

The data presented at SITC (Free SITC Whitepaper) showed that IOA-289 is able to dose-dependently reduce LPA levels, potently modulate fibrotic processes and restore T cell migration in preclinical models. Furthermore, the data also demonstrated IOA-289 exhibited monotherapy activity to inhibit primary tumor growth and metastasis in orthotopic, immunocompetent tumor models. Finally, autotaxin expression was found to be elevated in the plasma of pancreatic cancer patients and its presence was correlated with the tumor biomarker CA19-9, a blood marker used to follow progression in patients with pancreatic cancer.

iOnctura has recently completed recruitment into the healthy volunteer study of IOA-289, investigating the safety and pharmacokinetic profile of IOA-289 in humans. Detailed results will be presented at an upcoming medical oncology conference. iOnctura plans to advance IOA-289 into a Phase 1 clinical study in pancreatic cancer, AION-01, in the first half of 2022.

The poster presentation at SITC (Free SITC Whitepaper) entitled "A novel autotaxin inhibitor, IOA-289, modulates tumor, immune and stromal cell function and has monotherapy activity in fibrotic cancer models," is available at the SITC (Free SITC Whitepaper) platform and iOnctura’s website.

Contacts

iOnctura
Catherine Pickering
Chief Executive Officer
T : +41 79 952 72 52
E: [email protected]

Press Relations
Jeremy Nieckowski
LifeSci Advisors
T: +41 79 699 97 27
E: [email protected]
iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface. iOnctura’s best-in-class drug development programs combine immune-mediated and direct anti-tumor activity to deliver molecules with superior clinical efficacy and safety in oncology. Its lead program, IOA-244 is the only semi-allosteric PI3Kδ specific, orally dosed, small molecule inhibitor that is being developed in solid and hematologic malignancies to address tumor and stroma induced immune suppression. IOA-244 is currently in a Phase 1 study which will support transition to subsequent registration studies. iOnctura’s second program, IOA-289, is an oral small molecule that inhibits the cross-talk between the tumor and its stroma and is in a Phase 1 study. iOnctura is backed by blue chip investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. For more information, please visit www.ionctura.com

IOA-289, originally licensed from Cancer Research UK, is iOnctura’s second clinical compound, a next generation oral small molecule autotaxin inhibitor. iOnctura have completed recruitment in a single ascending dose study of IOA-289 in healthy volunteers and plans to advance IOA-289 into a phase 1 clinical study in pancreatic cancer, AION-01, in the first half of 2022. iOnctura has undertaken extensive validation of the autotaxin inhibition mechanism in multiple preclinical solid tumor models.

On November 12. 2021 Thyas reported that it has raised JPY 300 million in Series A3 financing with participation from Kyoto University Innovation Capital Co., Ltd., and D3 LLC (Press release, Thyas , NOV 12, 2021, View Source [SID1234629207]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The funds will be used for accelerating the research and development including preclinical studies of iPS cell-derived immune cell therapy and discovery research of new pipelines for the treatment of solid cancers and infectious diseases. In addition to R&D, Thyas further strives for business development and aims to deliver the early clinical applications to patients as soon as possible.

On November 12, 2021 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported the company will be presenting posters with new data from three of its pipeline programs on Saturday, Nov. 13, at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held virtually and in person in Washington, D.C. from Nov. 10-14 (Press release, Bolt Biotherapeutics, NOV 12, 2021, View Source [SID1234618693]). Each presentation highlights the progress made in preclinical studies to demonstrate the potential for each pipeline candidate as a novel approach for the treatment for cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are presenting new data for three of our pipeline programs that demonstrate the depth of our technology platform and the expertise of our team in modulating myeloid cell biology to develop promising therapeutic candidates," said David Dornan, Ph.D., Bolt Biotherapeutics’ Chief Scientific Officer. "Repolarizing tumor-associated macrophages, or TAMs, to become tumor destructive via the novel target Dectin-2 is groundbreaking work that may be synergistic with our entire Boltbody ISAC portfolio. Our work targeting CEA and PD-L1 reinforces our commitment to develop therapeutics that could have promising activity against solid tumors where limited treatment options are available."

Highlights of the three poster presentations follow, and copies of the posters are available on the Bolt Biotherapeutics website.
Poster #784: "BDC-2034: Discovery of a CEA-targeting Immune-Stimulating Antibody Conjugate (ISAC) for Solid Tumors"
Presenter: William G. Mallet, Ph.D.
Details: Saturday, Nov. 13, 2021, 7:00 a.m. – 8:30 p.m. EST, Poster Hall

Key findings from the study:
CEA is a well-validated tumor antigen for the development of targeted therapies addressing multiple types of solid tumors, such as colon cancer, where new treatment options are urgently needed. Given the abundance of innate immune cells in CEA-expressing cancers, innate immune stimulation presents a promising therapeutic strategy. Applying Boltbody platform technology, Bolt Biotherapeutics scientists have developed a novel CEA-targeted ISAC, BDC-2034, to exploit over-expression of CEA in cancers. BDC-2034 is designed to trigger the innate immune system, leading to adaptive anti-tumor immunity and tumor destruction.

BDC-2034 comprises a novel CEA-targeted, pro-phagocytic antibody conjugated to a proprietary TLR7/8 agonist payload. Both elements of this molecule are finetuned for selective immune activation in tumors.
New data reported at SITC (Free SITC Whitepaper) 2021 demonstrate both tumor cell clearance and innate immune activation in cellular and in vivo models of CEA-expressing cancers. Further, systemic administration in tumor-bearing animals results in tumor-selective immunity.
Based on these data, Bolt Biotherapeutics designated BDC-2034 as a clinical candidate and is currently conducting IND-enabling studies with the expectation to initiate BDC-2034 clinical development in 2022.
Poster #782: "PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models"
Presenter: Marcin Kowanetz, Ph.D.
Details: Saturday, Nov. 13, 2021, 7:00 a.m. – 8:30 p.m. EST, Poster Hall

Key findings from the study:
Bolt Biotherapeutics scientists are presenting for the first time preclinical data on a novel multifunctional PD-L1-targeted Boltbody ISAC that has demonstrated the potential to improve upon the efficacy of PD-L1/PD-1 inhibition, especially in tumor types that do not respond well to immune-checkpoint inhibition.

Bolt Biotherapeutics’ PD-L1 ISAC uniquely combines three mechanisms of action: the ADCP and myeloid cell activation of an ISAC, plus immune-checkpoint inhibition with the ability to act through PD-L1 expressed on both tumor and immune cells.
Data presented at SITC (Free SITC Whitepaper) 2021 demonstrate how PD-L1 ISAC induces robust, target-dependent activation of the immune system, including induction of immunological memory.
Treatment with PD-L1 ISACs led to an effective anti-tumor response that was substantially improved over PD-L1 antibody blockage in preclinical models.
Poster #862: "Dectin-2, a novel target for tumor macrophage reprogramming in cancer immunotherapy"
Presenter: Justin A. Kenkel, Ph.D.
Details: Saturday, Nov. 13, 2021, 7:00 a.m. – 8:30 p.m. EST, Poster Hall

Key findings from the study:
For the first time, Bolt Biotherapeutics is presenting data providing preclinical validation of Dectin-2, formerly referred to as TAM1, as a novel target for cancer immunotherapy. Expressed by tumor-associated macrophages (TAMs), Dectin-2 is a pattern recognition receptor that stimulates proinflammatory cytokine production and antigen presentation to drive innate and adaptive immune responses.

Findings reported at SITC (Free SITC Whitepaper) 2021 demonstrate that agonism of Dectin-2 on TAMs elicits secretion of pro-inflammatory cytokines and chemokines capable of invoking productive anti-tumor immunity.
In murine tumor models, Dectin-2 agonism mediates anti-tumor efficacy in a CD8 T cell-dependent manner and induces immunological memory against the tumor.
Bolt Biotherapeutics scientists have generated Dectin-2 agonist antibodies that show the potential to reprogram tumor-supportive macrophages into tumor-destructive macrophages.
About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy that combines the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, with the goal of durable responses for patients with cancer.

On November 12, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported the presentation of interim data further demonstrating the tolerability and antitumor activity potential of CUE-101 as a monotherapy as part of the Company’s ongoing clinical trial for the treatment of recurrent/metastatic HPV+ head and neck cancer in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021) (Press release, Cue Biopharma, NOV 12, 2021, View Source [SID1234608267]). Early data from the CUE-101 combination study with pembrolizumab will also be discussed, supporting the potential for mechanistic activity in frontline HPV+ HNSCC patients. SITC (Free SITC Whitepaper) 2021 will be held in Washington, D.C. and virtually November 10-14.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Additionally, the Company will present two posters highlighting the broad potential of the interleukin 2 (IL-2)-based CUE-100 series for treating multiple cancers. This includes representative preclinical data from CUE-102, Cue Biopharma’s next clinical candidate developed to selectively target Wilms’ Tumor 1 (WT1) cancers, and preclinical progress on the Company’s Neo-STAT and RDI-STAT (Re-Directed Immuno-STAT) platforms, which provide modularity, flexibility and scalability and address tumor heterogeneity and tumor resistance or escape mechanisms.

SITC 2021 Presentation Highlights:

Title: A phase 1 trial of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer
Poster #: 438
Presenter: Dr. Sara I. Pai, M.D., Ph.D., associate professor, Department of Surgery; Director, Translational Research in Head and Neck Cancer Massachusetts General Hospital, Harvard Medical School, Boston MA
Date: Saturday, November 13, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Data as of November 2, 2021, include:

A durable partial response (PR) with an ongoing duration of 30 weeks and five durable stable disease responses (SD), as determined by RECIST 1.1. criteria, out of the 13 evaluable patients dosed at the recommended Phase 2 dose of 4mg/kg as part of the monotherapy trial.
Pharmacodynamic (PD) signals of expansion of HPV16+ cytotoxic T cells were observed in the monotherapy trial, which confirm CUE-101 mechanism of action by activation of tumor-specific T cells.
Demonstrated favorable tolerability to date, with more than 190 cumulative doses administered. Reported mild adverse events resolved while patients continued therapy.
Early signs of clinical activity of CUE-101 in combination with pembrolizumab with 3 out of 3 patients from cohort 2 at 2mg/kg, demonstrating tumor reductions in target lesions on their first scan after having received two cycles of therapy. Cohort 3 is currently enrolling.
"I am encouraged by the preliminary anti-tumor activity of CUE-101 and the positive tolerability profile, which are necessary to improve the survival and quality of care for this relatively young patient population," said Sara Pai M.D., Ph.D., associate professor of surgery and director of Translational Research in Head and Neck Cancer at the Massachusetts General Hospital, and principal investigator of the CUE-101 Phase 1 clinical trial. "Until this trial we haven’t seen an ‘off-the-shelf‘ HPV-targeted biologic administered in an outpatient setting with such durable responses in the second- and third-line treatment for recurrent/metastatic HPV16+ head and neck cancer patients and it is a significant advancement, presenting a potential path forward for a new therapeutic standard."

Ken Pienta, acting chief medical officer of Cue Biopharma, added, "We are very pleased by the emerging clinical data and growing body of evidence demonstrating the clinical potential of CUE-101 as a monotherapy in a highly pretreated, refractory, metastatic HPV+ HNSCC setting. In addition, we are encouraged by the promising, albeit early, emerging data from our combination study with pembrolizumab demonstrating potential mechanistic activity with the prospects of expanding patient reach and enhancing therapeutic responses. It is also encouraging to observe histology data demonstrating enhanced penetration of cytotoxic CD8+ T cells or "killer" T cells within the tumor and anti-tumor activity in patients failing 2-3+ previous lines of treatment."

Title: CUE-102 selectively activates and expands WT1-specific T cells for the treatment of patients with WT1+ malignancies
Poster #: 720
Presenter: Dr. Christie Zhang, Ph.D., senior scientist, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.–8:30 p.m. EST

Multiple in vitro assessments demonstrated that CUE-102 selectively activated and expanded WT1-specific CD8+ T cells from peripheral blood mononuclear cells (PBMC) of healthy donors.
These CUE-102-expanded CD8+ T cells exhibited polyfunctional and cytotoxic responses upon challenge with WT1-presenting target cells.
Data showed that the attenuation of the interleukin 2 (IL-2) domains of CUE-102 led to a reduction of indiscriminate IL-2 activity, similar to results obtained with CUE-101.
In vivo studies in human leukocyte antigen (HLA)-A2 transgenic mice confirmed that CUE-102 elicited and expanded WT1-specific CD8+ T cells from naïve mice without significantly altering the frequencies of other immune lineages.
The WT1-specific CD8+ T cells expanded in vivo exhibited polyfunctionality and selectively killed WT1-presenting target cells in vivo.
Title: Targeting engineered interleukin-2 (IL-2) to antigen specific T cells via novel biologic platforms
Poster #: 793
Presenter: Raymond J. Moniz, associate director, discovery and translational immunology, Cue Biopharma
Date: Friday, November 12, 2021, Poster Hall (Hall E) 7 a.m.– 8:30 p.m. EST

Data demonstrated that the Company’s Neo-STAT (NST) biologics can be engineered with a diversity of T cell epitopes by efficient conjugation into an empty HLA-binding pocket, and that these molecules activated and expanded antigen specific T cells in vitro.
Data additionally demonstrated that the Company’s RDI-STAT biologics, were able to expand anti-viral T cell repertoires and drive anti-viral T cell redirected killing of tumor-associated antigen (TAA)-expressing cells.
In contrast to pan anti-CD3 bispecific molecules, RDI-STATs demonstrated significantly lower induction of pro-inflammatory cytokines, thus avoiding systemic activation of all T cells and offering a superior safety profile.
Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma, said, "The demonstration of CUE-102 to activate and expand WT1-specific cytotoxic CD8+ T cells in vivo further supports the modularity of our platform and enhances the potential of our CUE-100 series to address a diversity of cancers, supporting the advancement of CUE-102 into the clinic. An Investigational New Drug filing for CUE-102 is scheduled for the first quarter of 2022. In addition, the data presented on our Neo-STAT and RDI-STAT platforms continue to demonstrate the versatility and modularity of our biologics to potentially address multiple cancers with flexibility and scalability. We are highly encouraged as we continue to explore the breadth of opportunities with our Immuno-STAT, Neo-STAT and RDI-STAT biologics platforms, to develop novel therapies that address diverse patient populations, tumor heterogeneity and tumor escape mechanisms."

For more information on all three posters please visit: View Source

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. 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 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.

About the CUE-101 Clinical Trial
The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed human papilloma virus positive recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HPV+ HNSCC) and HLA-A*02:01 serotype. Patients receive CUE-101 as a monotherapy ranging from 0.06 mg/kg to 8 mg/kg. The maximum tolerated dose (MTD) has not been identified and a Phase 2 4 mg/kg dose has been selected. The company has expanded the study to evaluate CUE-101 in combination with 200 mg of KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC. Enrollment continues in both monotherapy and combination cohorts.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain.

About the Neo-STAT and RDI-STAT (Re-Directed Immuno-STAT) Platforms
Immuno-STAT biologics are rationally engineered Fc fusion proteins comprised of bivalent tumor-peptide-human leukocyte antigen (pHLA) complexes and four affinity-attenuated interleukin 2 (IL-2) molecules to preferentially engage and activate tumor-specific T cells directly in the patient. Building on the CUE-100 series framework, our Neo-STAT (NST) platform contains HLA molecules manufactured with an "empty" peptide-binding pocket, into which diverse tumor-peptides can be chemically conjugated, hence addressing tumor heterogeneity in a cost- and time-efficient manner. Our RDI-STAT (Re-Directed Immuno-STAT) platform further expands on the Immuno-STAT biologics by redirecting the pre-existing protective viral-specific T cell repertoire to target tumor cells via scFv moieties. RDI-STATs are designed to circumvent potential tumor escape mechanisms linked to HLA loss or defects in antigen-presenting pathways.

About SITC (Free SITC Whitepaper)
The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy.

SITC is a 501(c)(3) not-for-profit medical professional society of influential research scientists, physician scientists, clinicians, patients, patient advocates, government representatives and industry leaders dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Through educational programs that foster scientific exchange and collaboration, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere.

Currently, SITC (Free SITC Whitepaper) has more than 4,650 members who represent over 35 medical specialties in 63 countries around the world.

Through emphasis on high-caliber scientific meetings; dedication to education and outreach activities; focus on initiatives of major importance in the field; and commitment to collaborations with like-minded domestic and international organizations, government and regulatory agencies, associations and patient advocacy groups, SITC (Free SITC Whitepaper) brings together all aspects of the cancer immunology and immunotherapy community.