On January 20, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in a fireside chat at B. Riley Securities’ 2022 Oncology Conference on Thursday, January 27, 2022 at 12:00 p.m. ET (Press release, Syndax, JAN 20, 2022, View Source [SID1234605640])

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A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On January 20, 2022 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported its lead candidate VT1021 will advance into a Phase 2-3 registrational study through the company’s collaboration with the Global Coalition for Adaptive Research (GCAR) (Press release, Vigeo Therapeutics, JAN 20, 2022, View Source [SID1234605637]). VT1021 will be part of GCAR’s GBM AGILE Phase 2-3 adaptive platform trial for patients with glioblastoma.

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VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 then blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis, inhibit angiogenesis, and reprogram macrophages from the M2 to M1 phenotype.

GBM AGILE is a patient-centered adaptive platform trial to support registration that tests multiple therapies for patients with newly diagnosed and recurrent glioblastoma (rGBM) – the deadliest form of brain cancer.

VT1021 was selected for inclusion in the global AGILE Phase 2-3 trial based on the unique and relevant mechanism of action and the existing strong preliminary clinical data from the completed open-label, multicenter Phase 1/2 study (NCT03364400), evaluating the safety and preliminary anti-tumor efficacy of single-agent VT1021 in subjects enrolled in both dose escalation and dose expansion cohorts.

In the rGBM expansion cohort, VT1021 demonstrated significant single agent activity. Among 22 evaluable GBM subjects, 3 had complete response (CR), 1 had partial response (PR), and 7 had stable disease (SD). The overall disease control rate (DCR) was 50%. In the responder group, the average time on study was over 300 days with 2 subjects on study for over 480 days at the conclusion of the study. These two subjects continued to receive VT1021 through an extension study and have both have gone over 525 days receiving VT1021.

"We are excited that GCAR selected VT1021 for its Phase 2-3 study for patients with glioblastoma," said Vigeo COO Dr. Jing Watnick. "In the expansion study, VT1021 demonstrated noteworthy single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47, and we believe it could be an important new treatment option for patients. We look forward to providing an update when the trial commences."

Vigeo also plans to initiate efficacy studies in additional solid tumor indications, including pancreatic cancer, with its lead candidate, VT1021 during the first half of 2022.

About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

On January 20, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will host a key opinion leader (KOL) webinar on hematological malignancies and prostate cancer on Tuesday, January 25, 2022 from 2:30 – 4:30 pm (ET) (Press release, Oncternal Therapeutics, JAN 20, 2022, View Source [SID1234605636]).

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The webinar will feature a presentation by KOL Michael Wang, M.D., from the MD Anderson Cancer Center, who will discuss the current landscape and unmet medical need in the treatment of Mantle Cell Lymphoma (MCL). Oncternal’s management will provide further details on the development of zilovertamab, the company’s investigational anti-ROR1 monoclonal antibody, including the planned registrational Phase 3 superiority study ZILO-301, which is expected to be initiated in the first half of 2022, following the company’s recently announced agreement with the U.S. Food and Drug Administration (FDA) regarding the study design and major details. Dr. Wang will serve as the U.S. Principal Investigator and Chairman of the Steering Committee for this study. Oncternal’s management will also discuss the progress in the development of ONCT-808, its lead candidate of its autologous CAR-T program targeting ROR1-expressing malignancies.

A second KOL, Evan Yu, M.D., from the Fred Hutchinson Cancer Research Center, will provide perspectives on current standards of care and highlight the potential of next generation treatments for patients with advanced prostate cancer. Oncternal’s management will present an overview of the preclinical data and development plans for ONCT-534, the lead candidate in its preclinical dual-action androgen receptor inhibitor (DAARI) program, a potential next-generation treatment option for patients with resistant prostate cancer.

A live question and answer session will follow the formal presentations. To register for the webinar, please click here.

Michael Wang, M.D. is Professor in the Department of Lymphoma and Myeloma at MD Anderson Cancer Center. Dr. Wang has published more than 250 peer-reviewed papers and has presented his work at meetings nationally and internationally. He is the current Director of Mantle Cell Lymphoma (MCL) Program of Excellence and Co-Director of Clinical Trials at MD Anderson. During the past 22 years, he has focused on preclinical and clinical research and established a MCL-SCID-hu mouse model, which is the first human primary MCL animal model for the study of the biology and treatment of MCL. Dr. Wang has pioneered the work to improve the treatment of patients with MCL, including the introduction of BTK inhibitors such as ibrutinib and acalabrutinib in the treatment algorithm, and has performed extensive work with CAR-T cells for the treatment of these patients. His work has been published in the most prestigious medical journals, such as the New England Journal of Medicine and the Lancet. He is currently the PI of the B-Cell Lymphoma Moon Shot Program at MD Anderson. Dr. Wang obtained his M.D. from Shandong Medical University and M.S. from Beijing University, Medical School. He completed his clinical training as a resident at Norwalk Hospital, Norwalk, Conn., and as a Fellow in Oncology and in Hematology.

Evan Ya-Wen Yu, M.D., is a medical oncologist who treats prostate, bladder, and testicular cancer patients at Seattle Cancer Care Alliance (SCCA), Fred Hutch’s clinical care partner. In addition, Dr. Yu serves as the clinical research director of Genitourinary Medical Oncology at Seattle Cancer Care Alliance. Dr. Yu is also a professor of medical oncology at the University of Washington School of Medicine, a professor in clinical research at Fred Hutchinson Cancer Research Center, and medical director of clinical research support at Fred Hutchinson Cancer Research Consortium. As a physician-scientist, he provides a personalized-medicine approach to test novel therapies and discover unique cancer biomarkers. Dr. Yu also has a background in basic science; as a researcher, he studies the biological mechanisms of drug sensitivity and treatment resistance. In addition, his interests include cancer biomarkers, imaging (PET and MRI scans), and bone health. His overall goal is to discover novel biomarkers that can help guide treatment and aid in developing novel treatments for prostate cancer.

About Zilovertamab (formerly Cirmtuzumab)
Zilovertamab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Zilovertamab is currently being evaluated in a Phase 1b/2 clinical trial in combination with ibrutinib for the treatment of MCL or chronic lymphocytic leukemia (CLL), in a collaboration with the University of California San Diego (UC San Diego) School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, Oncternal is supporting two investigator-sponsored studies being conducted at the UC San Diego School of Medicine: (i) a Phase 1b clinical trial of zilovertamab in combination with paclitaxel for the treatment of women with HER2-negative metastatic or locally advanced, unresectable breast cancer, and (ii) a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically targeting ROR1 expressing tumors. This led to the development of zilovertamab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when zilovertamab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. The FDA has granted Orphan Drug Designations to zilovertamab for the treatment of patients with MCL and CLL/small lymphocytic lymphoma. Zilovertamab is in clinical development and has not been approved by the FDA for any indication.

On January 20, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer (mCRPC), and triple negative breast cancer (TNBC) (Press release, Nuvation Bio, JAN 20, 2022, View Source [SID1234605635]).

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"The clearance of our IND application for NUV-868 is an important milestone for Nuvation Bio as it marks the fourth IND in the last 14 months across our deep pipeline of innovative cancer therapeutics targeting multiple tumor types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We are encouraged by the selectivity and potentially improved tolerability demonstrated by NUV-868 in preclinical studies, and we look forward to advancing the program into Phase 1 development in mid-2022."

NUV-868 inhibits BRD4, which is a key member of the BET family that epigenetically regulates proteins that control tumor growth and differentiation. NUV-868 is designed to be more selective for BD2 than BD1 in an attempt to avoid the therapeutic limiting toxicities of other BRD4 inhibitors like gastrointestinal (GI) and bone marrow toxicities. Preclinical studies have demonstrated NUV-868 is almost 1,500 times more selective for BD2 than BD1. Non-selective BD1/2 inhibitors in development have been associated with tolerability issues, potentially due to too much BD1 inhibition.

With the clearance of this IND for NUV-868 in advanced solid tumors, Nuvation Bio will be initiating a Phase 1/2 study of NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in multiple tumor types. This protocol (NUV-868-01) will begin with a Phase 1 monotherapy dose escalation study in advanced solid tumor patients. A Phase 1b study will then be initiated exploring NUV-868 in combination with olaparib in previously treated ovarian cancer, pancreatic cancer, mCRPC, and TNBC patients and in combination with enzalutamide for mCRPC patients followed by a Phase 2b study to further explore safety and efficacy once the recommended Phase 2 combination dose is determined. A Phase 2 monotherapy study will also be initiated in mCRPC patients as well to further explore safety and efficacy.

On January 20, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported an enrollment update on the phase 1/2 GOBLET study in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) (Press release, Oncolytics Biotech, JAN 20, 2022, View Source [SID1234605634]).

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The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes three-patient safety run-ins for two of its four cohorts (first-line metastatic pancreatic and third-line metastatic colorectal cancer). Enrollment in these safety run-ins is complete. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

"There is a pressing unmet need for agents that can synergize with immune checkpoint inhibitors (ICI) in gastrointestinal (GI) cancers, as fewer than half of these patients respond to ICI monotherapy," said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "These low response rates are driven by immunosuppressive tumor microenvironments, which pelareorep has been shown to reverse in prior clinical studies in GI, breast, and hematological cancers. We thus believe pelareorep can increase the proportion of GI cancer patients responding to checkpoint inhibitors and are seeking to validate this hypothesis in the GOBLET study. We are very pleased with the trial’s progress to date and look forward to its continued advancement."

The GOBLET study builds on previously reported clinical proof-of-concept data for pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer (link to PR, link to poster). It is also supported by prior early clinical data showing that pelareorep-based combination treatments stimulated an adaptive immune response and led to a greater than 90% clinical benefit rate in KRAS-mutated colorectal cancer patients (link to PR, link to study) and a greater than 80% increase in progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, the study also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may allow selection of the most appropriate patients in future registration studies and increase their likelihood of success.

A copy of the ASCO (Free ASCO Whitepaper)-GI poster titled, "GOBLET: A phase 1 / 2 multiple-indication biomarker, safety, and efficacy study in advanced or metastatic gastrointestinal cancers exploring treatment combinations with pelareorep and atezolizumab," will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

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:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);
3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4.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 internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 20211. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer2 and 9,090 new cases of anal cancer3 in the U.S.