On May 31, 2022, GlycoMimetics, Inc. (the "Company") reported that it received a notice from The Nasdaq Stock Market ("Nasdaq") that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days (Filing, 8-K, GlycoMimetics, MAY 31, 2022, View Source [SID1234615506]). The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Global Market.

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The Company has 180 calendar days, or until November 28, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the minimum bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the minimum bid price requirement by November 28, 2022, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period. The Company’s failure to regain compliance during this period could result in delisting.

The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the listing requirements. There can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rule 5450(a)(1) or will otherwise be in compliance with other Nasdaq listing criteria.

On May 31, 2022 Greenfire Bio, LLC reported that its subsidiary, Green3Bio, and its collaborators at MD Anderson Cancer Center will present an update on the ongoing first-in-human clinical trial of GRN-300 at the upcoming ASCO (Free ASCO Whitepaper) 2022 Annual Meeting (Press release, Greenfire, MAY 31, 2022, View Source [SID1234615421]). GRN-300 is a first-in-class, orally bioavailable novel small molecule inhibitor of the Salt Inducible Kinases 2 and 3 (SIK2/SIK3) that is highly expressed in ovarian cancer and has been identified to play a pivotal role in several other cancers. The transition of this emerging biologic pathway and a novel agent into the clinic marks a successful step in the progress of the GRN-300 program. The goal of the clinical study is to determine the recommended Phase 2 Dose (RP2D), safety/tolerability and the tumor response of GRN-300 as a monotherapy or in combination with paclitaxel in subjects with ovarian cancer.

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This study is registered at ClinicalTrials.gov Identifier: NCT04711161.

Format: Poster Presentation
Abstract number: TPS5616
Session: Poster Session/Gynecologic Cancer
Time: Saturday, June 4, 2022, 1:15 PM-4:15 PM CDT
Presenter: Siqing Fu, PhD, MD (Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center)

Title: GRN300–001: Phase 1/1b evaluation of the safety, pharmacokinetics and efficacy of GRN-300, a salt-inducible kinase inhibitor, alone and in combination with paclitaxel, in recurrent ovarian, primary peritoneal, and fallopian tube cancers.

About Ovarian Cancer

According to the American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women. They estimate that in 2022 there will be about 19,880 new cases of ovarian cancer diagnosed in the United States and that about 12,810 will die of the disease. According to the World Cancer Research Fund International, there were about 313,000 new cases of ovarian cancer diagnosed worldwide in 2020. Ovarian cancer is difficult to detect at an early, more treatable stage; therefore, the current lack of salvage treatment for women, who experience a recurrence, results in a 5-year survival rate of less than 30%.

About GRN-300

GRN-300 (previously ARN3261) is an orally bioavailable first-in-class novel, small molecule, dual inhibitor of the salt-inducible kinases 2 and 3 (SIK2, SIK3). This agent has the potential to overcome chemoresistance based on its mechanism of action (MOA) and synergistic effects with standard of care including chemotherapy, PARP inhibitors, and immune checkpoint inhibitors (ICIs). SIK2 is overexpressed in 30% of ovarian cancer specimens suggesting a multifunctional role of SIK2/3 in tumorigenesis. SIK2 and SIK3 are known to play an oncogenic role in other tumor types, including prostate cancer, breast cancer, diffuse large B-cell lymphoma, and melanoma. Higher levels of expression of SIK2 have been shown to be significantly correlated with poor progression-free survival in patients with high-grade serous ovarian cancers. GRN-300 attenuated tumor growth in several preclinical xenograft ovarian cancer models as a single agent and in combination with paclitaxel. The compound completed the first dose escalation groups without DLT, and preliminary PK analysis indicate dose proportionality.

On May 31, 2022 ConferMED, one of the nation’s leading eConsult companies, reported that it has been awarded a $2.3M grant from the Quest Diagnostics Foundation (Press release, Quest Diagnostics, MAY 31, 2022, View Source [SID1234615401]). The grant will enable ConferMED to enhance its eConsults platform and to provide specialty eConsults to medical providers at Federally Qualified Health Centers in five regions across the U.S.: Dade County, FL; Cook County, IL; Baltimore County, MD; Harris County, TX and Suffolk County, MA.

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ConferMED eConsults address the growing challenge of limited access to specialty care and high costs when patients are referred to providers outside primary care. Using the ConferMED eConsult platform, specialists are able to review cases accurately and quickly with front line providers and provide input and develop the optimal care plan for patients. This process improves chronic disease outcomes, reduces unnecessary emergency room visits and hospital admissions, and prevents long-term complications.

The Quest Diagnostics Foundation, as part of the Quest for Health Equity (Q4HE) initiative, is providing a grant to ConferMED to address a leading cause of health inequity: lack of access to specialty care. Q4HE is a multi-year initiative of Quest Diagnostics (NYSE: DGX) and the Quest Diagnostics Foundation focused on providing a combination of donated testing services, education programs, partnerships, and funding to support initiatives to close the gap in healthcare disparities in underserved communities.

Mark Masselli, chair of the ConferMED board and CEO/President of Community Health Center, Inc., commented, "We applaud the Quest Foundation and its Quest for Health Equity initiative for recognizing and generously supporting the need for specialty eConsults for patients living in medically underserved communities. The collaboration between Quest and ConferMED is groundbreaking and will significantly advance the cause of health equity in key locations across the U.S."

Through the grant, ConferMED also will help health centers and specialists with eConsult implementation and integration in addition to providing enhanced technology and interoperability to ensure ease of use for front line providers and staff. "Access to specialty eConsults is more important than ever as the COVID-19 pandemic has laid bare the health inequities for patients in the underserved communities primarily served by community health centers," says ConferMED President and Founder Daren Anderson, MD. "Fewer barriers to specialty care means better patient outcomes and ultimately a healthier community. We are thrilled to be deepening our relationship with Quest to support this work."

"We are proud of this important collaboration with ConferMED that will improve access to critical specialty care services in under-resourced communities," said Ruth Clements, President of the Quest Diagnostics Foundation. "We believe that these services will improve health outcomes and support wellness, which is more important than ever after many have deferred care due to the pandemic."

On May 31, 2022 Shanghai Hansoh Pharma reported that published positive results from a China Phase III trial of its third-gen EGFR-TKI inhibitor in the Journal of Clinical Oncology (Press release, Jiangsu Hansoh Pharmaceutical, MAY 31, 2022, View Source [SID1234615397]). Hansoh’s Amelie (aumolertinib mesylate tablets) was administered as a first-line therapy for NSCLC. It significantly out-performed AstraZeneca’s Iressa (gefitinib), especially among patients with brain metastases. Hansoh, which developed Amelie in-house, said it was the first publication of clinical data from a China-originated third-generation EGFR-TKI in the official ASCO (Free ASCO Whitepaper) journal. Hanson out-licensed ex-China rights for the drug to EQRx

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On May 31, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported upcoming abstract presentations at three key medical conferences taking place in June, which highlight TAVNEOS (avacopan), an orally administered selective complement 5a receptor (C5aR) inhibitor, and its role in ANCA-associated vasculitis and potential application in C3 glomerulopathy, as well as the immuno-oncology potential of CCX559, an orally administered small molecule PD-L1 inhibitor (Press release, ChemoCentryx, MAY 31, 2022, View Source [SID1234615357]).

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European Alliance of Associations for Rheumatology (EULAR), June 1-4, Copenhagen

Effect of Avacopan on Relapse Rates and Relapse-Free Time in Patients with ANCA-Associated Vasculitis: Results of the Phase 3 ADVOCATE Study

Oral Presentation: OP0180
Time: June 2, 2022, at 10:35 – 10:45 AM CEST
Session: Vessels glowing in the dark
Location: Congress Hall A2
Differences Between Avacopan & Prednisone Treatment of ANCA-Associated Vasculitis at Different Thresholds of Glucocorticoid Toxicity

Poster: POS0833
Available: June 1, 2022, 08:00 AM CEST
Poster View 5: June 1, 2022, 01:20 – 01:28 PM CEST
Relapse Rates in Newly Diagnosed and Established Patients with Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis

Poster: POS0835
Available: June 1, 2022, 08:00 AM CEST
Poster View 5: June 1, 2022, 01:36 – 01:44 PM CEST
American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 3-7, Chicago

Results From an Ongoing Phase 1 Dose-Escalation Study of CCX559, an Orally Administered Small Molecule PD-L1 Inhibitor, in Patients With Advanced Solid Tumors

Poster: 248 (Abstract: 2593)
Time: Sunday, June 5 at 8:00 – 11:00 AM CDT
Session: Developmental Therapeutics – Immunotherapy
European Society for Pediatric Nephrology (ESPN), June 22-25, Ljubljana, Slovenia

Safety and Efficacy of Avacopan (CCX168) in a Pediatric Patient with C3 Glomerulopathy

E-Poster Available: June 22, 2022
INDICATION

TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Serious hypersensitivity to avacopan or to any of the excipients

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.

ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased and paresthesia.

DRUG INTERACTIONS

Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

About TAVNEOS (avacopan)

TAVNEOS (avacopan), approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, TAVNEOS, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. TAVNEOS’s selective inhibition of only the C5aR is believed to leave the beneficial C5a pathway through the C5L2 receptor functioning normally.

ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), severe hidradenitis suppurativa (HS) and Lupus Nephritis (LN). The US Food and Drug Administration granted TAVNEOS orphan drug designation for ANCA-associated vasculitis and C3G. The European Commission has granted orphan medicinal product designation for TAVNEOS for the treatment of two forms of ANCA-associated vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener’s granulomatosis), as well as for C3G. TAVNEOS has not been approved for indications discussed as in development, and the safety and efficacy of those uses has not been established.

About ANCA-Associated Vasculitis

ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.