On January 20, 2022 Scopus Biopharma reported that as previously updated, on November 21, 2021, Scopus BioPharma Inc. ("Scopus," the "Company", "we," "our," or "us") entered into certain securities purchase agreements (the "Original Purchase Agreements"), dated as of November 21, 2021, and certain registration rights agreements (the "Original Registration Rights Agreements"), dated as of November 21, 2021, with certain institutional investors named therein (the "Investors") (Filing, 8-K, Scopus BioPharma, JAN 20, 2022, View Source [SID1234605639]).

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On January 14, 2022, the Company entered into amendments (the "Amendments") to each of the Original Purchase Agreements and each of the Original Registration Rights Agreements with the Investors, pursuant to which the parties (i) agreed to remove the requirement that the Company hold a shareholder meeting to increase the amount of authorized Common Stock in the Company’s Certificate of Incorporation (the effectiveness of such increase, the "Authorized Share Increase Date") and (ii) agreed to have the Series B Additional Investment Options issued in connection with the Original Purchase Agreements be immediately exercisable upon effectiveness of that certain Registration Statement of Form S-3 (File No 333-261991) (such date, the "Effectiveness Date") rather than the Authorized Share Increase Date. In addition, as a result of the Amendments, those certain Placement Agent Additional Investment Options issued in connection with the Original Purchase Agreements also become immediately exercisable upon the Effectiveness Date and the restriction on the Company conducting subsequent equity sales for a period of 60 days contained in the Original Purchase Agreements shall run from the date of the Effectiveness Date rather than the date of the Authorized Share Increase Date.

The foregoing descriptions of the Amendments are not complete and are subject to, and qualified in their entirety by, the full text of such documents, forms of which are attached as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K and are incorporated herein by reference.

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On January 13, 2022, the Company received a deficiency notification letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(2) requiring listed securities to maintain a minimum Market Value of Listed Securities ("MVLS") of $50,000,000 (the "MVLS Requirement").

The Company has 180 calendars days, expiring July 12, 2022, to regain compliance with the MVLS Requirement. If the Company maintains a MVLS at or greater than $50,000,000 for a minimum of ten consecutive business days, it will regain compliance. If the Company does not regain compliance within 180 calendar days, it will receive a written notification from Nasdaq that its securities are subject to delisting, and may have the opportunity to transfer its listing to The Nasdaq Capital Market ("Capital Market") if it meets the Capital Market’s continued listing requirements and pays the applicable fee.

The Company intends to monitor its MVLS and may, if appropriate, consider implementing available options to regain compliance with the MVLS Requirement. There can be no assurance that the Company will be able to regain compliance with the MVLS Requirement or maintain compliance if the Company regains compliance.

This Current Report on Form 8-K is filed to satisfy the obligation under Nasdaq Listing Rule 5810(b) and Item 3.01(a) of Form 8-K that the Company publicly disclose the deficiency within four (4) business days after the date of the deficiency letter.

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.