On November 13, 2021 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported new data from two clinical studies and one research study presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in Washington, D.C., and on a virtual platform (Press release, NextCure, NOV 13, 2021, View Source [SID1234595603]). The data come from clinical studies evaluating NC318, a Siglec-15 (S15) antibody, and NC410, a fusion protein of LAIR-2, in patients with advanced/metastatic solid tumors, as well as from a research study evaluating NC410’s impact on T cell activation and myeloid cell polarization conducted in collaboration with the National Cancer Institute at the National Institutes of Health.

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"We are pleased to share promising data from our NC318 and NC410 programs at this year’s SITC (Free SITC Whitepaper) annual meeting," said Han Myint, MD, NextCure’s chief medical officer. "Results from our ongoing Phase 1 and Phase 2 trials suggest that NC318 may have a clinical benefit in patients. Retrospective analysis of patient biopsies from the Phase 1 and Phase 2 trials showed better outcomes in S15+ patients compared to S15- patients receiving NC318. Selecting for patients with S15+ expression coupled with a higher and more frequent dosing regimen that increases overall drug exposure is anticipated to impact clinical outcomes. Additionally, data from our NC410 program show that NC410 is safe and well-tolerated in patients and demonstrates early indications of immune modulation. We look forward to continuing the advancement of both programs to improve the treatment landscape for cancer patients."

Details of the oral and poster presentations are below:

Clinical benefit through S15 targeting with NC318 antibody in subjects with S15 positive advanced solid tumors

Combined Phase 1 and Phase 2 data from the NC318 study show early evidence of possible clinical benefit in patients with lung cancer, squamous cell carcinoma of the head and neck and breast cancer and other advanced/metastatic solid tumors with dosing once every two weeks during dose escalation and with the 400mg dose selected for the Phase 2 studies. Highlights include:

Data are derived from patient cohorts in both Phase 1 (n=49) and Phase 2 (n=47) of these studies.
One NSCLC CR and one NSCLC PR patient from the Phase 1 study remain on therapy for 2.8 and 2.2 years, respectively.
NC318 appears to show evidence of disease control with better outcomes in S15+ patients compared to S15- patients.
The disease control rate across all tumors in both studies was 37% with a median progression-free survival (PFS) of 5.0 months.
Patients in the lung cohort from both studies showed 45% disease control rate with a median PFS of 5.2 months.
Data indicate that soluble S15 (sS15) level may serve as a biomarker for patient selection.
Pharmacokinetic and pharmacodynamic modeling predict that a dose of 800 mg once a week results in nearly 10 times greater drug exposure which may impact drug activity and clinical outcomes.
NC410, a fusion protein of LAIR-2 (Leukocyte Associated Immunoglobulin-like Receptor) fused to human IgG1 Fc domain appears safe and well-tolerated with evidence of immune modulation in subjects with advanced solid tumors

Interim data presented from the Phase 1 dose-escalation study show that NC410 appears to be safe and well-tolerated in patients with advanced tumors and show evidence of immune modulation. Highlights include:

The data come from the first five patient cohorts (n=19), who received doses of NC410 up to 60 mg once every two weeks.
There were no dose-limiting toxicities.
Data show a transient reduction in peripheral C1q, suggesting target binding of NC410.
LAIR-2 levels in peripheral blood increase in a dose-dependent fashion and may suggest mechanistic evidence of immune normalization.
Early evidence of extracellular matrix (ECM) remodeling and immune activation was shown by an increase in serum C4G, a Granzyme B-mediated collagen fragment, and a reduction in serum Pro-C3 and Pro-C6 fragments.
Time-dependent increase in CD4+ and CD8+ T cells without an increase in LAIR-1 expression provides further early evidence of immune activation.
Safety, tolerability, efficacy, and biomarker analyses are ongoing in higher dose cohort patients.
Blockade of the inhibitory collagen receptor LAIR-1, PD-L1, and TGF-β promotes anti-tumor activity through T cell activation and myeloid cell polarization

Non-clinical data from a research study conducted in collaboration with the National Cancer Institute at the National Institutes of Health show NC410’s impact on T cell activation, myeloid cell polarization and anti-tumor activity. Highlights include:

NC410 and bintrafusp alpha, a TGF-beta trap molecule, synergize for effective tumor control in a mouse model of colon cancer.
Tumor control is mediated by an increase in activated CD8+ T cells and a reduction in M2 tumor-associated macrophages in tumor infiltrates.
Collagen remodeling is demonstrated in tumors treated with NC410.
About NC318
NC318 is a first-in-class immunomedicine against Siglec-15 (S15), a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

About NC410
NC410 is a first-in-class immunomedicine designed to block immune suppression mediated by LAIR-1, an immunomodulatory receptor expressed on T cells and myeloid cells, including dendritic cells, a type of antigen presenting cell. In preclinical research, it has been shown that LAIR-1 inhibits T cell function and myeloid activity. In preclinical studies, NC410 blocks the negative effects of LAIR-1 and promotes T cell function and myeloid cell activity. NextCure believes NC410 has the potential to treat multiple cancer types.

On November 13, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported the Company made two presentations on novel lead asset, INT230-6, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC) (Free SITC Whitepaper) in Washington, D.C (Press release, Intensity Therapeutics, NOV 13, 2021, View Source [SID1234595530]).

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"Patients with metastatic and refractory cancers continue to have poor survival. Response rates remain low in most tumor types even with the use of immunotherapies such as checkpoint inhibitors," said Jacob S. Thomas, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine at the University of Southern California (USC) and oncologist at USC’s Norris Comprehensive Cancer Center, part of Keck Medicine of USC. "INT230-6 demonstrates direct tumor killing in injected lesions. In addition, analysis shows increases of immune cells in tumors and the shrinkage of uninjected tumors or abscopal results. These data suggest dosing INT230-6 may activate a T-cell mediated immune response. Results presented at SITC (Free SITC Whitepaper) indicate that use of intratumoral INT230-6 appears to be a viable approach in treating metastatic disease alone or in combination with immunotherapies."

"Sarcoma continues to be a very challenging cancer to treat and has proven resistant to checkpoint blockade. Novel immunotherapy-based approaches are still needed, and sarcoma is an attractive cancer for intratumoral injection of INT230-6, which is a direct tumor killing agent," said Matthew Ingham, M.D., Assistant Professor of Medicine in the Division of Hematology and Oncology, Columbia University Irving Medical Center. "Biopsies from tumors treated using INT230-6 showed substantial tumor necrosis, reduction of viable cancer, a decreased cancer proliferation as measured by Ki67, and increased tumor infiltrating lymphocytes such as CD4 and CD8 T-cells. An exploratory analysis suggests promising survival for subjects receiving INT230-6 compared to historical standards."

"Our Phase 1/2 data show INT230-6 alone or in combination with checkpoint inhibitors was well tolerated with no severe toxicities," remarked Dr. Ian Walters, Intensity’s Chief Medical Officer. "We now have promising early results from 115 patients with this drug, and the safety remains favorable even with injections into multiple deep tumors. The most common adverse event related to the drug is pain at the injection site. We have also demonstrated rapid tumor necrosis and promotion of systemic immune responses."

These presentations illustrate three different treatment regimens of INT230-6; as monotherapy, with pembrolizumab, or with ipilimumab. The results showcase the broad treatment potential of our locally-delivered anti-cancer product candidate in a variety of tumor types," stated Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Extended survival is the goal of any new cancer treatment, and these data show the potential for longer survival using INT230-6 when compared to historical results. Survival also appears to be improved with higher INT230-6 loading into tumors and treating more tumors over the course of therapy. Based on these encouraging early results, we are planning to initiate a randomized Phase 3 study with INT230-6 in patients with advanced soft tissue sarcomas next year."

The posters are accessible on the "Publications, Papers and Posters" section of Intensity’s website at: View Source

Highlights from the presentations are as follows:

Abstract Number: 501 "Survival and Immune Response Data from Intratumoral INT230-6 Alone (IT-01) and with Pembrolizumab [KEYNOTE-A10] in Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors"

Authors: Jacob Thomas, MD; Anthony El-Khoueiry, MD; Anthony J. Olszanski, MD, RPh; Nilofer Azad, MD; Giles F. Whalen, MD; Diana Hanna, MD; Matthew Ingham, MD; Syed Mahmood, MD; Lewis H. Bender, MS, MA, MBA; Ian B. Walters, MD, MBA; Lilian L. Siu, MD

This presentation reports results from 78 subjects summarizing the preliminary efficacy and safety of either INT230-6 alone (n=60) or in combination with the anti-PD-1 therapy, pembrolizumab (n=18) from an ongoing open-label, multi-arm Phase 1/2 clinical trial. Patients had a variety of relapsed, refractory metastatic solid tumors and progressed following a median of four prior therapies. INT230-6 was administered at doses of 0.3 to 175mL (86 mg CIS, 17.2 mg VIN) in a single session, which are higher amounts than typical IV doses, with repeated intratumoral injections in multiple tumors.
The median overall survival (mOS) of 373 days for all monotherapy (n=53) patients compares favorably to results seen in studies with similar Phase 1 solid tumor populations. An exploratory analysis of dose relative to total tumor burden (TTB) showed that subjects receiving a dose of INT230-6 to <40% of their reported TTB had a mOS of 96 days, while in subjects receiving a dose of INT230-6 to ≥40% of TTB, had a mOS of 570 days (HR=0.104, 95% CI(0.038, 0.29)). Patients receiving the pembrolizumab combination had a mOS of 376 days (n=16). Comparison of the survival data of INT230-6 monotherapy to the pembrolizumab combo was not made due to different cancer types in the two cohort populations.
As of July 31, 2021, six patients in the monotherapy arm who received an INT230-6 dose of ≥40% of the TTB demonstrated abscopal effects (i.e., shrinkage of multiple non-injected tumors), further emphasizing the importance of dosing sufficient amounts to cause substantial tumor necrosis. Together with the immunohistochemistry biomarker findings, the results suggest a systemic immune system activation.
INT230-6, either as monotherapy or in combination with pembrolizumab, was well tolerated. The most common adverse events (AEs) were localized tumor-related pain, nausea, fatigue and vomiting. AEs were mainly mild to moderate with no Grade 4 or 5 AEs.
Abstract Number: 16284 "Intratumoral INT230-6 Shows a Favorable Safety Profile and Early Signs of Efficacy in Advanced Soft Tissue Sarcoma with Monotherapy and in Combination with Ipilimumab [Intensity IT-01; BMS#CA184-592]"

Authors: Matthew Ingham, MD; James Hu, MD; Giles F. Whalen, MD; Jacob Thomas, MD; Anthony El-Khoueiry, MD; Diana Hanna, MD; Anthony J. Olszanski, MD, RPh; Christian F. Meyer; Nilofer Azad, MD; Syed Mahmood, MD; Lewis H. Bender, MS, MA, MBA; Ian B. Walters, MD, MBA; Lilian L. Siu, MD; Albiruni R. Razak

The poster reports preliminary efficacy and safety results from 19 subjects treated with either INT230-6 alone (n=10) or in combination with checkpoint inhibitors primarily ipilimumab from an ongoing Phase 1/2 clinical trial. Patients had a variety of relapsed, refractory sarcoma types and progressed following a median of three prior therapies. Demographics were similar in subjects enrolled in monotherapy and checkpoint inhibitor combination arm. The cumulative dose of INT230-6 injections given every 2 weeks over 56 days ranged from 20 to 530mL with repeated intratumoral injections in multiple tumors. Pharmacokinetic (PK) profile analysis from 18 sarcoma subjects were analyzed for cisplatin, SHAO and vinblastine and showed that greater than 95% of the active drugs remains in the tumor.
Kaplan Meier estimates that approximately 60% of those of sarcoma subjects receiving INT230-6 monotherapy a dose volume greater than 40% of their total tumor burden will be alive at 1 year. These results compare favorable to results of survival data in studies of mixed refractory sarcoma patients with similar prognostic factors scores (ECOG, LDH, # of metastatic sites) where the median survival is estimated to be 3 to 8 months
Biopsies showed substantial tumor necrosis, reduction of viable cancer, a decreased cancer proliferation as measured by Ki67, and increased Tumor Infiltrating Lymphocytes (CD4 and CD8 T-cells). Monotherapy patients had abscopal effects (i.e., shrinkage of multiple non-injected tumors).
INT230-6 safety data showed that INT230-6 is well tolerated as monotherapy and preliminary data suggests that INT230-6 is well tolerated in combination with ipilimumab in sarcoma subjects. Most adverse events were low grade and transient. There were no grade 4 or 5 treatment emergent AEs and no events that were dose limiting.
About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In addition to local disease control, direct killing of the tumor by INT230-6 creates neoantigens leading to engagement of the immune system and systemic anti-tumor effects in the tumor. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

INT230-6 is currently being evaluated in several Phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant Phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

On November 13, 2021 CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, reported preliminary Phase 2 study (CORE1) results for CG0070 in combination with KEYTRUDA (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, NOV 13, 2021, View Source [SID1234595526]).

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The preliminary Phase 2 results showed that a combination of CG0070 and pembrolizumab was well tolerated with encouraging early efficacy data in 9 patients. The results (Abstract #955) were presented as a late-breaking oral presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting.

"We are excited to announce these preliminary results toward CG0070’s safety, tolerability and clinical efficacy in patients with bladder cancer unresponsive to BCG who have limited treatment options," said Arthur Kuan, Chief Executive Officer, CG Oncology. "We hope to see continued responses as the study progresses, as CG0070’s dual mechanism of action has shown to be highly effective in this difficult-to-treat patient population."

Summary of Preliminary Clinical Results

The analysis, based on a data cutoff on November 8, 2021, reported that 100% of patients evaluable for efficacy (n=9) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients that have reached additional timepoints, 100% (n=6) have also maintained a CR through 6 months and 100% (n=3) at the 9-month assessment.
Treatment related adverse events (AEs) were limited to transient grade 1-2 local genitourinary symptoms and immune-related adverse events including urinary frequency, bladder spasm, fatigue, chills, autoimmune thyroiditis, blood discharge, dysuria, and flu-like symptoms. No treatment-related grade 3 or higher AEs or severe adverse events (SAEs) have been observed.
"These preliminary results are exciting," said Dr. Roger Li, M.D., lead study investigator and Urologic Oncologist at Moffitt Cancer Center. "If similar trends hold moving forward, we may have a game changer to combat BCG-unresponsive bladder cancer for patients with significant unmet medical need."

About the CORE1 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus KEYTRUDA for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CG0700

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in NMIBC following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.

On November 13, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from three posters were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, highlighting the company’s immuno-oncology offerings for biopharmaceutical and academic researchers (Press release, Veracyte, NOV 13, 2021, View Source [SID1234595522]).

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The data demonstrate the ability of Brightplex to assess the spatial distribution of targeted immune cell subpopulations in tumors, which could potentially help clinical researchers design more effective immunotherapies in cancer treatment. Veracyte acquired the novel Brightplex technology – which combines information from multiplex immunohistochemistry (IHC) and advanced digital pathology analysis to provide a comprehensive picture of the tumor micro-environment – through its acquisition of HalioDx in August 2021.

The posters include new data regarding the use of Brightplex TCE (for T Cells Exhaustion) to stratify non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors in the "Biomarker analysis" part of the PIONeeR project1,2. This research program, promoted by the French government, is designed to better understand, predict and overcome anti-PD-1/PD-L1 resistance in advanced lung cancer patients and includes the analysis of hundreds of circulating and tumor biomarkers. The new findings on a preliminary PIONeeR patient data set suggest that one of those tests, the Brightplex TCE assay, can stratify NSCLC patients eligible for anti-PD-1/PD-L1 therapy into four Spatial Tumor-infiltrating lymphocyte (TILs) subtypes – Cold, Stroma-infiltrated, Parenchyma Hot and Hot – which may predict their outcomes. In the Hot subtype, for example, long-term progression-free survival (PFS) is observed for more than 40% of patients, regardless of PD-L1 status. In this Hot subtype, activated T-cell densities seem higher in tumors of patients with longer PFS, suggesting that immune-response evaluation with the Brightplex TCE assay could refine the stratification of patients, enriching responders to immune checkpoint inhibitor therapy.

"We are delighted to highlight these new data on our Brightplex assays from the PIONeeR project, which help confirm its potential role in patient stratification for anti-PD-1/PD-L1 therapeutics," said Corinne Danan, Veracyte’s general manager, Biopharma. "Our Brightplex assays are a key technology for a growing number of biopharmaceutical researchers as we can develop multiplex, customized panels using more than 80 distinct, validated biomarkers to decipher the tumor micro-environment, to help meet our partners’ needs."

The following posters can be accessed here:

"Spatial distribution of infiltrating T lymphocytes with Immunoscore CR T Cells Exhaustion test helps stratification of NSCLC patients treated with PD1/L1 inhibitors in the PIONeeR project" (poster #460)
"Assessment of the spatial distribution of B cells subpopulations in the tumor microenvironment and tertiary lymphoid structures by Brightplex, a sequential chromogenic multiplex assay" (Poster #57)
Assessment of the spatial distribution of CD4+ T cells subpopulations in the tumor microenvironment by Brightplex, a sequential chromogenic multiplex assay" (Poster #41)

On November 13, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported clinical data for lifileucel in combination with pembrolizumab in patients with advanced cancers were presented in an oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Iovance Biotherapeutics, NOV 13, 2021, View Source [SID1234595521]). A slide presentation is also available on the Iovance website.

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Clinical data in the presentation show encouraging response rates after lifileucel plus pembrolizumab in patients with immune checkpoint inhibitor (ICI)-naïve cervical cancer, advanced melanoma, and head and neck squamous cell carcinoma (HNSCC). The clinical data also demonstrated that lifileucel can be safely combined with pembrolizumab and warrant continued investigation of tumor infiltrating lymphocyte (TIL) cell therapy combinations as early-line treatment in advanced solid tumor cancers.

David M. O’Malley, M.D., Professor, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center (OSUCCC – James) and investigator in the C-145-04 study, stated, "Immune checkpoint inhibitors are standard-of-care in the treatment of several types of advanced cancer, including cervical cancer, melanoma, and head and neck cancer. Unmet needs remain to help more patients respond and to enhance the depth and durability of responses. I was impressed by the increase in overall response rate for lifileucel in combination with pembrolizumab in cervical cancer patients, which was consistent with higher response rates in head and neck cancer and melanoma patients. Taken together the clinical data show great promise for TIL in combination with pembrolizumab across multiple solid tumors."

Early-line treatment with single-agent pembrolizumab achieves an overall response rate (ORR) of 33% in patients with advanced melanoma1 and 17% in patients with HNSCC.2 Cervical cancer patients previously treated with standard-of-care systemic therapy achieve an ORR of 11%-14% with pembrolizumab monotherapy.3 Novel early-line combination therapies are needed to improve the rate and depth of responses with manageable long-term safety. Clinical data in the SITC (Free SITC Whitepaper) oral presentation included cervical cancer patients who were ICI- and chemotherapy-naïve as well as patients with ICI-naïve advanced melanoma and HNSCC. Patients across all three cohorts had high tumor burden at baseline. The ORR in all cohorts was assessed by investigator using RECIST 1.1 as follows (September 22, 2021 data cutoff):

57.1% ORR in cervical cancer (Cohort 3 in C-145-04 cervical cancer study, n=14): Eight out of 14 patients had an objective response, including one complete response (CR), six partial responses (PR), one unconfirmed PR (uPR), and five best responses of stable disease (SD). 71.4% (5/7 patients) have ongoing confirmed responses at a median study follow up of 7.6 months.
60.0% ORR in melanoma (Cohort 1A in IOV-COM-202 study, n=10): Six out of 10 patients had a confirmed objective response, including three CRs (30% CR rate) and three PRs. Three patients achieved best response of SD. One prior unconfirmed CR (uCR) and two complete metabolic responses previously reported at ASCO (Free ASCO Whitepaper) 2021 converted to confirmed CRs per RECIST 1.1 as presented at SITC (Free SITC Whitepaper) 2021. 66.7% (4/6 patients) have ongoing confirmed responses at a median study follow up of 11.5 months. These results compare to a 33% ORR (6% CR rate) for pembrolizumab monotherapy in metastatic melanoma.1 Iovance plans to expand enrollment in this cohort.
38.9% ORR in HNSCC (Cohort 2A in IOV-COM-202 study, n=18): Seven out of 18 patients had an objective response, including one CR, one uCR, four PRs, one uPR, and seven best responses of SD. 50.0% (3/6 patients) have ongoing confirmed responses at a median study follow up of 7.8 months.
Safety: The treatment-emergent adverse event (TEAE) profile across all three cohorts was consistent with the underlying disease and known adverse event (AE) profiles of pembrolizumab, nonmyeloablative lymphodepletion (NMA-LD), and IL-2.
Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "The encouraging results for Iovance TIL plus pembrolizumab across several tumor types validate the combination of checkpoint inhibition and TIL cell therapy as a potential platform approach in solid tumors. We observed response rates that are approximately double compared to what was seen with single-agent pembrolizumab in early-line melanoma and head and neck cancers as well as second-line cervical cancer. We are eager to continue our investigation of TIL combinations in melanoma, head and neck, cervical and non-small cell lung cancer patients in need of treatment options that provide higher response rates, and deeper responses with more complete responses."

Iovance Posters and Presentations at SITC (Free SITC Whitepaper) Annual Meeting (November 12-14, 2021)

Title: Phase 2 efficacy and safety of autologous tumor-infiltrating lymphocyte (TIL) cell therapy in combination with pembrolizumab in immune checkpoint inhibitor-naïve patients with advanced cancers
Authors: D O’Malley, et al.
Presentation Type: Oral Presentation
Date and Time: Saturday, November 13, 2021 at 4:30 p.m. ET
Abstract ID: 492

Title: First phase 2 results of autologous tumor-infiltrating lymphocyte (TIL; LN-145) monotherapy in patients with advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer (NSCLC)
Authors: A Schoenfeld, et al.
Presentation Type: Poster
Abstract ID: 458

Title: Successful generation of tumor-infiltrating lymphocyte (TIL) product from renal cell carcinoma (RCC) tumors for adoptive cell therapy
Authors: B Halbert, et al.
Presentation Type: Poster
Abstract ID: 176

Title: Expansion of tumor-infiltrating lymphocytes (TIL) using static bag for the clinical manufacturing rapid expansion protocol (REP) process
Authors: K Onimus, et al.
Presentation Type: Poster
Abstract ID: 101

Conference Call and Webcast on Saturday, November 13, 2021 at 5:30 p.m. ET
Iovance will host a webcast and conference call on Saturday, November 13, at 5:30 p.m. ET to discuss SITC (Free SITC Whitepaper) clinical data updates for Iovance TIL in advanced, immune checkpoint inhibitor-treated, non-small cell lung cancer as well as Iovance TIL in combination with pembrolizumab in patients with advanced cancers.

Iovance senior leadership will be joined by the following key opinion leaders and principal investigators in Iovance clinical studies:

Omid Hamid, M.D., Chief of Research/ImmunoOncology, The Angeles Clinic and Research Institute; Co-Director, Cutaneous Malignancy Program, Cedars Sinai CANCER
David M. O’Malley, M.D., Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine; Director of the Division of Gynecologic Oncology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James)
Adam J. Schoenfeld, M.D., Medical Oncologist, Memorial Sloan Kettering Cancer Center
The conference call dial-in numbers are 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and the access code is 3263399. The live webcast can be accessed in the Investors section of the company’s website at www.iovance.com. The archived webcast will be available for one year following the event.