On November 7, 2022 A2 Biotherapeutics, Inc., "A2 Bio", is a biotechnology company focused on the development of first-in-class T cell therapeutics to tackle the fundamental challenge in solid tumor treatment—the ability of cancer medicines to selectively kill tumor cells while protecting normal cells (Press release, A2 Biotherapeutics, NOV 7, 2022, View Source [SID1234623294]).

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A2 Bio reported four poster presentations showcasing: (1) BASECAMP-1, a master pre-screening trial to identify patients whose tumors have permanently lost HLA-A*02 (NCT04981119); (2) use of the Tempus xT Next Generation Sequencing (NGS) diagnostic to identify such patients; (3) data for A2 Bio’s lead program, A2B530, targeting CEA Cell Adhesion Molecule 5 (CEA); and (4) data for A2 Bio’s second program, A2B694, targeting mesothelin (MSLN).

A2 Bio’s logic‑gated cell therapy utilizes dual receptors (an activator and blocker) and has demonstrated in vitro and in vivo the ability to kill tumor cells via the activator while protecting healthy cells via the blocker. Patients who may benefit from this therapy can be identified by using the Tempus diagnostic to pre-screen patients whose tumors have lost HLA-A*02. Once patients are identified, their T cells may be banked early in their disease course for potential utilization in a Phase 1 study in the event of relapse.

"The unmet medical need in lung, colorectal and particularly pancreatic cancer remains extremely high. BASECAMP-1 is a non-interventional pre-screening trial that identifies eligible patients and banks their T cells. If the patients have the misfortune to relapse or progress, A2 Bio will have their cells ready to be manufactured and dosed in our upcoming Phase 1 studies targeting CEA and MSLN," said William Go, MD, PhD, Chief Medical Officer of A2 Bio.

Diane Simeone, MD, Director of the Pancreatic Cancer Center, Perlmutter Professor of Surgery at NYU and Principal Investigator on the study, stated, "BASECAMP-1 is an exciting trial that identifies patients with limited treatment options for a new and unique logic-gated CAR-T immunotherapy approach. We are thrilled to enroll patients at BASECAMP-1 and get them prepped for potential inclusion in Phase 1 studies in 2023."

The four poster presentations will be given on November 10, 2022 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, MA.

Details of the posters being presented on November 10, 2022 from 9am-9pm EST at the Poster Hall:

Title: BASECAMP-1: Leveraging HLA loss of heterozygosity in solid tumors by NGS to identify patients with relapsed solid tumors for future CEA and MSLN logic-gated Tmod CAR T-cell therapy
Poster Number: 639
Presenter: Diane Simeone, MD, Director of the Pancreatic Cancer Center, Perlmutter Professor of Surgery at NYU and Chair of the Pancreatic Cancer Action Network’s (PanCAN) National Scientific and Medical Advisory Board

Title: An NGS assay to identify HLA loss of heterozygosity for future CEA and MSLN logic-gated CAR-T solid tumor protocols designed for reduced on-target, off-tumor toxicity
Poster Number: 77
Presenter: Scott Kopetz, MD, PhD – Deputy Chair and Professor, Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center

Title: A2B530, an autologous CEA-directed Tmod T-cell therapy with an inhibitory receptor gated by HLA-A*02 to target colorectal, pancreatic, and lung cancer
Poster Number: 229
Presenter: J. Randolph Hecht, MD, Carol and Saul Rosenzweig Chair for Cancer Therapies Development, the Director of the UCLA Gastrointestinal Oncology Program and Professor of Clinical Medicine in the David Geffen School of Medicine at UCLA

Title: A2B694, an autologous logic-gated cell therapy targeting mesothelin
Poster Number: 263
Presenter: Julian Molina, MD, PhD – Professor of Oncology and Consultant, Division of Medical Oncology at Mayo Clinic, Rochester

ePosters will be released for viewing on November 10 at 7:00 am ET and can be viewed from the A2 Bio website (View Source)

On November 7, 2022 Immunome, Inc. (Nasdaq: IMNM), a clinical-stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported that it is presenting a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting in Boston, Massachusetts highlighting the Company’s preclinical data of IMM20059, a novel anti-epsin 1(EPN1) antibody (Press release, Immunome, NOV 7, 2022, View Source [SID1234623293]).

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"We continue to be pleased with the robust capabilities of our Discovery Engine to identify novel anti-tumor targets, including those that are abnormally (ectopically) expressed on tumor cells which have the potential to fundamentally shift treatment paradigms," commented Purnanand Sarma, PhD, President and CEO of Immunome. "While further preclinical work will be required, we are quite encouraged by the results presented at SITC (Free SITC Whitepaper) today. Treatment with the IMM20059 + atezolizumab combination resulted in over a 50% reduction in tumor volume (p<0.05) compared to isotype-treated control, greater than either one separately. This leads us to believe that there is a potential combinatorial effect between the two pathways, and we look forward to exploring this phenomena further in additional pre-clinical studies."

Lack of response and immunoresistance to checkpoint inhibitors is a well-known challenge in cancer treatment. While the epsin-1 protein is known to be upregulated in a variety of tumor types, it can also be ectopically expressed on the tumor cell surface, as demonstrated in Immunome’s poster, offering a new approach to cancer therapy. Insights into the role of epsin-1 as a potential target for cancer is evolving, but research by others1 also suggests targeting EPN1 has the potential to inhibt tumor growth. The findings presented by Immunome at SITC (Free SITC Whitepaper) further suggest that combining an EPN1-targeting antibody, like IMM20059, with checkpoint inhibitor treatment could reactivate or increase immune response to the tumor.

Immunome Poster at SITC (Free SITC Whitepaper) Annual Meeting (November 8-12, 2022):

Title: IMM20059, a novel anti-EPN1 antibody, in combination with atezolizumab significantly enhances tumor regression in the B16.F10 syngeneic melanoma model compared to anti-PD-L1 monotherapy
Authors: Fang Shen, PhD, John P. Dowling, Pavel A. Nikitin, Cezary R. Swider, Chris Nicolescu, Halley Shukla, Jamie L. Bingaman-Steele, Nirja B. Patel, Eden L. Sikorski, Benjamin C. Harman, Jillian M. DiMuzio, Karen Lundgren, Yumi Ohtani, Michael J. Morin, Matthew K. Robinson
Link: View Source
Date/Time: Nov. 10, 2022/9:00am
Poster/Abstract Number: 823

The poster presentation, IMM20059, a novel anti-EPN1 antibody, in combination with atezolizumab significantly enhances tumor regression in the B16.F10 syngeneic melanoma model compared to anti-PD-L1 monotherapy, highlights novel discoveries related to combinatorial activity between existing immune checkpoint inhibitors and the novel tumor target epsin 1 (EPN1).

Immunome’s preclinical research of IMM20059 in this poster demonstrated that:

EPN1 is upregulated in multiple cancers and is ectopically expressed on tumor cell surfaces.
IMM20059 binds with high affinity to both purified EPN1 protein and to the surface of B16.F10 melanoma tumor cells.
In the combination treatment of IMM20059 and anti-PD-L1 atezolizumab, significant tumor regression was induced compared to IMM20059 or atezolizumab treatment alone, suggesting a combinatorial effect between the two anti-tumoral pathways.
Combination treatment enhanced the production of intratumoral chemokines, MIP-1a, MIP-1b, and RANTES.
About SITC (Free SITC Whitepaper)

Established in 1984, the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC (Free SITC Whitepaper) is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC (Free SITC Whitepaper) aims to one day make the word "cure" a reality for cancer patients everywhere. Learn more about SITC (Free SITC Whitepaper), our educational offerings and other resources at sitcancer.org and follow us on Twitter, LinkedIn, Facebook and YouTube.

On November 7, 2022 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported data updates from two phase 1/2a trials with AFM24, the company’s tetravalent, bispecific innate cell engager (ICE), in patients with solid tumors (Press release, Affimed, NOV 7, 2022, View Source [SID1234623292]). AFM24 binds both EGFR on tumor cells and CD16A on natural killer (NK) cells and macrophages, thereby facilitating the killing of EGFR-positive tumor cells. Abstracts for the upcoming data presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) were published today. The full updated clinical data sets will be presented in two poster presentations on November 10 and November 11, 2022 and will be made available through the following link on Affimed’s website: View Source

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"The new data presented at this conference demonstrate that AFM24 is capable to activate the innate but also the adaptive immune response in cancer patients while showing a very good safety profile. We are also very encouraged by the early efficacy data that we observe with the combination of AFM24 and atezolizumab," said Andreas Harstrick, M.D., Affimed’s Chief Medical Officer. "We look forward to the ongoing investigation of AFM24 in both trials as a new treatment option for a patient population that is in desperate need of effective therapies."

Poster Number 729: Targeting Epidermal Growth Factor Receptor (EGFR)-Expressing Solid Tumors With AFM24, A Novel CD16A Bispecific Innate Cell Engager: Comprehensive Correlative Science Findings From A Phase 1 Study

The first poster presentation includes correlative science findings from the phase 1 part of the ongoing monotherapy phase 1/2a study (NCT04259450) evaluating the safety and efficacy of AFM24 in patients with metastatic, treatment-refractory EGFR-positive solid tumors. In total, 35 patients with a range of tumor types were treated to date including patients with colorectal cancer (19/35), non-small cell lung cancer (8/35) and other solid tumors (8/35) were treated.

NK cells in peripheral blood showed upregulation of activation markers which coincided with transient loss of NK cells from peripheral blood. This indicates migration of NK cells to the tumor. In addition, cytotoxic CD8-positive T-cell levels increased in the tumor, pointing to a crosstalk with the adaptive immune system.

In all patients, AFM24 monotherapy demonstrated a well-managed safety profile.

Poster Number 745: AFM24 and atezolizumab combination in patients with advanced epidermal growth factor receptor-expressing (EGFR-positive) solid tumors: Initial results from the Phase 1 dose-escalation study

The second poster to be presented at SITC (Free SITC Whitepaper) will include a data update from the phase 1/2a combination study (NCT05109442) evaluating AFM24 together with Roche’s PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced, treatment-refractory EGFR+ solid tumors. The aim of the two-part study is to establish the recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab as well as to assess initial data on the efficacy and safety of AFM24 in combination with atezolizumab.

So far, four patients with gastric (1/4) or pancreatic (3/4) adenocarcinomas have been enrolled in the first dose cohort, with three completing the safety lead-in phase and receiving 160 mg AFM24 and atezolizumab. The preliminary data indicate that the combination of AFM24 and atezolizumab is a promising approach, with no dose-limiting toxicities observed.

Among three patients evaluated in cohort 1, clinical activity was observed in two patients, while one patient awaited tumor assessment at cut-off date. One ongoing partial response was observed in a patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, and an ongoing stable disease at 4+ months with symptomatic improvement was observed in a patient with pancreatic adenocarcinoma. Dose escalation is proceeding with an AFM24 dose of 480 mg.

Combining AFM24 with atezolizumab may synergistically enhance the innate and adaptive immune responses, respectively, to target EGFR-positive tumors.

For more information as well as to access the full abstracts, please visit View Source

Both posters will be made available on Affimed’s website as of November 10, 2022, in line with SITC (Free SITC Whitepaper)’s embargo policy.

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

Affimed is evaluating AFM24 as monotherapy and in combination with other cancer treatments in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450.

AFM24 is also being evaluated in a phase 1/2a study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442).

Furthermore, Affimed and NKGen Biotech initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 (NCT05099549).

On November 7, 2022 Incyte (NASDAQ:INCY) and Mirati Therapeutics, Inc. (NASDAQ:MRTX), a clinical-stage targeted oncology company, reported a clinical trial collaboration and supply agreement to investigate the combination of INCB99280, Incyte’s small molecule PD-L1 inhibitor, and adagrasib, a KRASG12C selective inhibitor (Press release, Incyte, NOV 7, 2022, View Source [SID1234623291]).

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"While monoclonal antibodies targeting PD‑L1 or PD-1 have transformed the treatment landscape in oncology, they are limited by their route of administration and long-half life and receptor occupancy which can affect the management of immune-related adverse events," said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology, Incyte. "Incyte’s small molecule, oral PD-L1 program has shown promising safety and efficacy in early studies – INCB99280’s shorter half life may result in improved management of immune mediated adverse events and better clinical outcomes. We are pleased to collaborate with Mirati to conduct the first clinical trial of INCB99280 plus adagrasib, two orally-bioavailable molecules, in patients with KRASG12C-mutated solid tumors."

"We are pleased to enter into this agreement with Incyte, supplying adagrasib for evaluation in combination with INCB99280," said Charles Baum, M.D., Ph.D., President, Founder and Head of Research and Development, Mirati Therapeutics, Inc. "This agreement is part of our rational combination strategy for adagrasib and further demonstrates our focus to evaluate this asset in a broad range of combinations, including with novel approaches to checkpoint inhibition, to benefit people living with difficult-to-treat cancers."

Under the terms of the agreement, Incyte will initiate and sponsor the Phase 1/1b study of INCB99280 and adagrasib in patients with KRASG12C-mutated solid tumors. Mirati will supply Incyte with adagrasib for the study.

About INCB99280

INCB099280 is a potent and selective small molecule oral PD-L1 inhibitor which has demonstrated promising clinical activity and safety in patients with solid tumors. INCB099280 will be evaluated in Phase 2 studies as monotherapy and in combination with other antitumor agents.

About Adagrasib (MRTX849)

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life and extensive tissue distribution, and is well tolerated. In clinical trials, adagrasib also has shown, central nervous system penetrance and single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer and other solid tumors with KRASG12C mutations. Adagrasib is being evaluated in several clinical trials in combination with other anti-cancer therapies in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information visit Mirati.com/science.

On November 7, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) today reported interim results from the phase 1/2 GOBLET study’s first-line advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) cohort in an abstract published as part of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting (Press release, Oncolytics Biotech, NOV 7, 2022, View Source [SID1234623290]). The SITC (Free SITC Whitepaper) meeting is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 – 12, 2022.

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As of the abstract’s data cutoff date (July 28, 2022), seven of ten evaluable patients in GOBLET’s PDAC cohort, which evaluates pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel, achieved a partial response (3 confirmed, 4 unconfirmed as of the cutoff date). An additional two patients achieved stable disease for an ORR and clinical benefit rate of 70% and 90%, respectively. No safety signals were observed with the studied combination.

"The ORR reported in the SITC (Free SITC Whitepaper) abstract is remarkably nearly triple the average ORR seen in historical control trials of gemcitabine plus nab-paclitaxel, which is only about 25%," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "Further, PD-(L)1 inhibitors only benefit fewer than one percent of pancreatic cancer patients classified as MSI-high. GOBLET’s interim results, therefore, strongly suggest that pelareorep’s ability to reverse immunosuppressive tumor microenvironments produces synergies when combined with checkpoint inhibition and chemotherapy, leading to vastly improved responses. Given the urgent need for novel therapies in pancreatic cancer, I believe this exciting finding highlights an opportunity for pelareorep to transform the standard of care."

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, "GOBLET’s interim results represent a crucial clinical milestone, providing robust proof-of-concept in a difficult-to-treat indication. Our next step is to discuss these data with regulatory authorities and potential partners, with the goal of advancing our pancreatic cancer program into a pivotal study. By adding a second near-term registration opportunity alongside our breast cancer program, we have enhanced pelareorep’s value proposition and further de-risked our clinical pipeline. I look forward to discussing the strategic implications of our new data during our earnings call today and to hearing expert perspectives on GOBLET’s results at our key opinion leader webinar next week."

Updated results from GOBLET’s PDAC cohort, which is designed to enroll twelve evaluable patients, will be presented in a poster at the upcoming SITC (Free SITC Whitepaper) meeting. The trial’s metastatic colorectal and advanced anal cancer cohorts are proceeding as planned, with the cohort in third-line metastatic colorectal cancer now fully enrolled.

Alongside this potential PDAC opportunity, Oncolytics continues to advance pelareorep towards a registration study in metastatic breast cancer. The company’s randomized phase 2 trial in HR+/HER2- metastatic breast cancer, BRACELET-1, remains on track for a readout on overall response rate, progression-free survival, and evolving overall survival data in the first half of 2023.

Additional details related to the SITC (Free SITC Whitepaper) abstract and upcoming poster, entitled, Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study, are shown below.

Abstract Number: 650

Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET

Poster Session Location: Boston Convention and Exhibition Center, Hall C

A copy of the abstract is currently available for viewing in the Journal for ImmunoTherapy of Cancer (JITC) supplement. A copy of the poster will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the meeting.

Earnings Webcast and Conference Call

The Oncolytics management team will discuss the data published in the SITC (Free SITC Whitepaper) abstract and the Company’s clinical development strategy in pancreatic cancer during its third quarter earnings call taking place today, November 7, 2022 at 8:30 a.m. ET. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 4240-6541. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 406-541#.

Key Opinion Leader Webinar

Oncolytics will host a key opinion leader (KOL) webinar on November 14, 2022 at 10 a.m. ET. During the webinar, the KOLs and members of the Oncolytics management team will discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the updated interim GOBLET study results that will be presented at the SITC (Free SITC Whitepaper) meeting. A live question and answer session will follow the formal presentations.

To register for the webinar, please click here.

References

1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369

2. O’Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005

3. Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684

4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

About GOBLET

The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients (n=12);
Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).
Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO

AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.