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.

On November 13, 2021 Seven and Eight Biopharmaceuticals Inc., a clinical stage biotechnology company developing proprietary novel immuno-oncology therapies to activate the immune system against cancer, reported the presentation of interim Phase 1 data for BDB001 in combination with atezolizumab in advanced solid tumors at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Seven and Eight Biopharmaceuticals, NOV 13, 2021, View Source [SID1234595520]).

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BDB001 is an immune modulator capable of activating dendritic cells to initiate both innate and adaptive immunity against cancer. BDB001 is a first-in-class TLR7/8 agonist delivered intravenously, allowing for broader treatment of solid tumors. Previously, Seven and Eight Biopharma reported that intravenous administration of BDB001 both as monotherapy and in combination with an anti-PD-1 mAb exhibit favorable tolerability and robust systemic immune activation leading to durable clinical responses in multiple advanced solid tumor types (SITC, 20201; ASCO (Free ASCO Whitepaper), 20212).

The presentation at SITC (Free SITC Whitepaper) 2021 provides interim safety and efficacy results for a Phase 1 dose escalation / expansion trial of BDB001 in combination with atezolizumab in advanced solid tumors (NCT04196530). The results show that BDB001 in combination with atezolizumab is well tolerated with evidence of robust immune activation leading to clinical responses in multiple tumor types.

"It is encouraging to see that BDB001 in combination with atezolizumab can be safely delivered intravenously and produces clinical responses in heavily pre-treated tumors" said lead author and study investigator Dr. Manish R. Patel, of Florida Cancer Specialists/Sarah Cannon Research Institute.

"These promising interim results show that BDB001 in combination with atezolizumab represents a novel and viable treatment for advanced solid tumors. It is especially encouraging to see responses in both PD-1 naïve and refractory tumors." said Dr. Robert H.I. Andtbacka, Chief Medical Officer, Seven and Eight Biopharma. "The Phase 1 trial helped establish the BDB001 phase 2 dose which is being evaluated in an ongoing Phase 2 trial (NCT03915678) of BDB001 in combination with atezolizumab and radiotherapy in selected tumor types."

"We are very excited about the clinical data for BDB001 in combination with atezolizumab, as we continue to advance our robust immuno-oncology pipeline in treatments beyond anti-PD-(L)1, including preclinical platform programs in TLR Ligand Antibody Conjugation" said Dr. Walter Lau, Chief Executive Officer, Seven and Eight Biopharma.

Presentation Details:

Abstract Title: BDB001, a Toll-Like Receptor 7 and 8 (TLR7/8) agonist, can be safely administered intravenously in combination with atezolizumab and shows clinical responses in advanced solid tumors.

Abstract Authors: Manish R. Patel, Drew W. Rasco, Melissa L Johnson, Anthony W. Tolcher, Angela Tatiana Alistar, David Sommerhalder, Omid Hamid, Lixin Li, Alexander H. Chung, Robert H.I. Andtbacka

Session: Poster Presentation

On-Demand Session Release Date and Time: November 13th, 2021 @ 7:00 AM

Abstract Number: 472

The poster presentation will be available at the SITC (Free SITC Whitepaper) 2021 Annual Meeting website.

Abstract Summary:

Seven and Eight Biopharma’s systemic delivery of the TLR 7 and 8 dual agonist BDB001 is first in class.
BDB001 was delivered safely intravenously in combination with atezolizumab.
BDB001 in combination with atezolizumab showed robust dose dependent immune activation without increased risk of cytokine release syndrome.
Overall, BDB001 was well tolerated and 31.7% of subjects did not have any treatment related adverse events. No DLTs occurred and there were no Grade 4 or 5 Adverse Events.
Clinical responses were seen in subjects with urothelial carcinoma and non-small cell lung cancer and showed evidence of robust anti-tumor immune activation.
Clinical responses were seen in tumors that had progressed on anti-PD-1 therapy and with low probability of responding to anti-PD-(L)1 therapy based on their PD-L1 negative, MSI-stable, and Tumor Mutational Burden-low status.
A Phase 2 trial has been initiated and is actively enrolling subjects to further investigate BDB001 in combination with atezolizumab and radiotherapy in patients with advanced solid tumors
BDB001 in combination with atezolizumab represents a novel and viable therapeutic option for patients with advanced solid tumors.

On November 13, 2021 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that do not require gene editing and co-opt the natural biology of T cells to treat patients with solid tumors, reported the presentation of preclinical data from its proof-of-concept study in gastric cancer (Press release, Triumvira Immunologics, NOV 13, 2021, View Source [SID1234595519]). These new data demonstrate that Triumvira’s novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) effectively eradicates CLDN18.2-expressing gastric tumor cells in vitro and in vivo. The results will be presented in a poster presentation today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place November 10-14, 2021, virtually and in-person at the Walter E. Washington Convention Center in Washington, D.C.

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CLDN18.2 is a promising, clinically validated target for cancer drug development as gastrointestinal malignancies, more prominently gastric tumor cells, have been found to selectively express CLDN18.2 on their surface, making it a preferred antigen for specific targeting of tumor cells using TAC-T cells. A key feature of TAC-T cells is the proprietary TAC receptor, a multi-domain chimeric molecule that works directly with the natural T cell receptor to help a T cell recognize and attack cancer cells. Unlike CAR-T cells, TAC-T cells do not exhibit tonic signaling, do not show premature exhaustion, show long term persistence, and demonstrate deep penetration into and activation in solid tumors in various preclinical models.

"We’re excited about the level of activity we are seeing with our Claudin 18.2-directed TAC-T cells in our preclinical models of gastric cancer," said Andreas Bader, Ph.D., Chief Scientific Officer of Triumvira. "These results confirm the versatility of our TAC platform for difficult-to-treat solid tumors and pave the way for initiating IND-enabling studies in an effort to bring CLDN18.2-TAC T cells to patients as quickly as possible in an area of significantly unmet medical need."

In addition to eradicating CLDN18.2-expressing gastric tumor cells in vitro and in vivo, the study demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. CLDN18.2-TAC T cells did not show signs of auto-activation or elevated exhaustion markers post-manufacturing, which is a key feature of the TAC technology designed to enhance the durability of TAC-T products.

Details of the poster presentation are as follows:

Poster Title: Development of Claudin 18.2 TAC T cells for the treatment of gastric cancer
Poster Number: 118
Category: Cellular Therapies
Date and Time: Saturday, November 13, 2021; 7:00 a.m. – 8:30 p.m. EST
Location: Walter E. Washington Convention Center, Hall E
Presenter: Christopher Helsen, Ph.D. – Executive Director, Research and Development, Triumvira

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]).

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"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.