On January 20, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will participate in the B. Riley Securities 2022 Virtual Oncology Conference (Press release, Spectrum Pharmaceuticals, JAN 20, 2022, View Source [SID1234605642]). A fireside chat is scheduled for Thursday, January 27, 2022 at 9:30 a.m. ET / 6:30 a.m. PT.

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A live webcast of the fireside chat will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after the event.

On January 20, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its partner BioInvent International AB, for BI-1206, an investigational anti-FcyRllB antibody, for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma (NHL) (Press release, BioInvent, JAN 20, 2022, View Source;1206-granted-orphan-drug-designation-by-the-us-fda-for-the-treatment-of-patients-with-follicular-lymphoma-301464561.html [SID1234605641]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors.

Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "BioInvent continues to make progress with the development and regulatory framework for BI-1206. The CTA approval in China in December 2021 and the recent FDA Orphan Drug Designation demonstrate the strong potential of this first-in-class antibody. CASI has China commercial rights of BI-1026, and our team is preparing for China’s clinical study. CASI and BioInvent are seamless partners and have the common goal to benefit patients with innovative pharmaceutical technologies."

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.