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.

On May 31, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported the acceptance of its Clinical Trial Application (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to allow expansion of its VERSATILE-002 study of PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) to the UK (Press release, PDS Biotechnology, MAY 31, 2022, View Source [SID1234615250]). The MHRA is among several regulatory agencies that PDS Biotech is seeking approval from to expand the trial into various site outside of the United States PDS Biotech anticipates that enrollment in the UK could begin during the third quarter of 2022.

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"The acceptance of this CTA marks another important regulatory milestone for PDS Biotech. Initiation of our global expansion is a key advancement to expedite enrollment into the VERSATILE-002 clinical study," stated Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "Additionally, this expansion allows PDS to expose global regulators to our novel molecularly targeted immunotherapies."

Chris Curtis, Chief Executive Officer of the UK-based charity group, The Swallows, stated "The reported preliminary safety data of PDS0101 in combination with pembrolizumab is highly encouraging, and we are pleased that European patients will be able to enroll in this promising clinical study of an HPV-targeted immunotherapy with standard of care, pembrolizumab."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On May 31, 2022 Fresenius Kabi reported the immediate availability in the U.S. of PEMEtrexed for Injection, USP, a new generic equivalent to Alimta (Press release, Fresenius Kabi Oncology, MAY 31, 2022, View Source [SID1234615286]). Fresenius Kabi produces its PEMEtrexed for Injection, USP in the United States, where the company offers the most comprehensive injectable oncology portfolio of any pharmaceutical manufacturer.

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Fresenius Kabi PEMEtrexed for Injection, USP is an affordable treatment option for adult patients with non-squamous non-small cell lung cancer and malignant pleural mesothelioma.

Available in four presentations for intravenous (IV) use, Fresenius Kabi now has the broadest portfolio of PEMEtrexed for Injection, USP products available from any manufacturer in the U.S., including two new strengths designed to help streamline pharmacy operations and reduce drug waste:

PEMEtrexed for Injection, USP 100 mg per single-dose vial
PEMEtrexed for Injection, USP 500 mg per single-dose vial
New strength: PEMEtrexed for Injection, USP 750 mg per single-dose vial
New strength: PEMEtrexed for Injection, USP 1 gram per single-dose vial
"We are pleased to introduce another generic chemotherapy medication to help make cancer treatments more accessible and affordable for patients," said John Ducker, president and CEO of Fresenius Kabi USA. "And we’re proudly producing our PEMEtrexed for Injection here in the U.S."

Fresenius Kabi offers more than 30 different oncology drugs in the U.S., and nearly 90 percent are formulated, filled and finished in the U.S. PEMEtrexed for Injection, USP is the newest example of the company’s commitment to investing "More in America." This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

PEMEtrexed for Injection, USP, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients. To determine eligibility, patients should speak to their physician. Enrollment is a simple online process. Details can be found on the KabiCare website at kabicare.us.

Important Safety Information

INDICATIONS AND USAGE

Pemetrexed for Injection is a folate analog metabolic inhibitor indicated:

in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.
initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
IMPORTANT SAFETY INFORMATION

Pemetrexed for Injection is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed.

Myelosuppression: Can cause severe bone marrow suppression resulting in cytopenia and an increased risk of infection. Do not administer pemetrexed for injection when the absolute neutrophil count is less than 1500 cells/mm3 and platelets are less than 100,000 cells/mm3. Initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed for injection.

Renal Failure: Can cause severe, and sometimes fatal, renal failure. Do not administer when creatinine clearance is less than 45 mL/min.

Bullous and Exfoliative Skin Toxicity: Permanently discontinue for severe and life-threatening bullous, blistering or exfoliating skin toxicity.

Interstitial Pneumonitis: Withhold for acute onset of new or progressive unexplained pulmonary symptoms. Permanently discontinue if pneumonitis is confirmed.

Radiation Recall: Can occur in patients who received radiation weeks to years previously; permanently discontinue for signs of radiation recall.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection, when administered as a single agent are fatigue, nausea, and anorexia.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation.

The most common adverse reactions (incidence ≥ 20%) of pemetrexed for injection when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Ibuprofen increased risk of pemetrexed for injection toxicity in patients with mild to moderate renal impairment. Modify the ibuprofen dosage as recommended for patients with a creatinine clearance between 45 mL/min and 79 mL/min.

On May 31, 2022 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported its unaudited financial results for the first quarter ended March 31, 2022 (Press release, Anpac Bio, MAY 31, 2022, View Source [SID1234615252]). The Company’s financial statements and related financial information for the quarter ended March 31, 2022 are unaudited and have not been reviewed by the Company’s independent registered accountant. These financial results could differ materially if they were reviewed by the Company’s independent registered accountant.

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Financial highlights for the First Quarter 2022

Total revenue was approximately RMB2.0 million (US$309,000) for the first quarter of 2022, a decrease of 9.9% from approximately RMB2.2 million for the same period of 2021.
Gross profit margin was 55.4% for the first quarter of 2022, representing a decrease of 3.0% from 58.4% for the same period of 2021.
The average selling price ("ASP") of CDA-based tests was RMB233 (US$36.8) for the first quarter of 2022, a decrease of RMB168.0, or 41.9% from RMB401.0 for the same period of 2021, primarily due to focusing on more conventional cancer detection tests at lower prices.
Net loss was approximately RMB14.9 million (US$2.4 million) for the first quarter of 2022, compared to a net loss of approximately RMB29.3 million for the same period of 2021, 49.1% decrease from the same period in 2021. The net loss for the first quarter of 2022 was mainly attributable to approximately RMB2.9 million (US$463,000) of selling and marketing expenses, approximately RMB2.4 million (US$380,000) of research and development expenses and approximately RMB10.3 million (US$1.6 million) of general and administrative expenses.
Non-GAAP net loss¹ was approximately RMB12.1 million (US$1.9 million) for the first quarter of 2022, reduced from a non-GAAP net loss of approximately RMB15.0 million for the same period of 2021. Non-GAAP net loss was reduced by 19.0% compared with the same period of 2021.
Short-term debt was approximately RMB11.5 million (US$1.8 million) as of March 31, 2021, a decrease of 66.1% from approximately RMB33.8 million at the end of last fiscal year (December 31, 2021). The decrease in short-term debt was mainly due to the company issued an aggregate of 4,842,198 shares for the Registered Convertible Debentures in principal balance of approximately RMB17,8 million (US$2,8 million) by March 16, 2022.
(1) Non-GAAP net loss is defined as net loss excluding change in fair value of convertible debts and stock-based compensation. For more information, refer to "Use of Non-GAAP Financial Measures" and "Reconciliations of Non-GAAP Results" at the end of this press release.

Business Highlights for the First Quarter of 2022

The Company continued to receive validation on the efficacy of CDA testing through clinical study follow-ups. As of March 31, 2022, AnPac Bio had contacted 27,254 individuals tested using CDA packages in China and received substantive feedback regarding health conditions and disease development from 16,052 individuals.
As of March 31, 2022, the Company filed 260 patent applications globally, among which 155 patents had been granted, including 22 patents granted in the United States, 68 in greater China (including eight in Taiwan), and 65 in other countries and regions.
The Company continued to build a cancer risk assessment database, which totaled approximately 258,238 samples as of March 31, 2022, including approximately 214,085 samples from commercial CDA-based tests and approximately 44,153 samples from research studies.
On March 29, 2022, the Company signed an investment agreement with Shanghai Stonedrop Investment Management Center (Limited Partnership) ("Stonedrop"), a previous investor of the Group. Stonedrop agreed to invest RMB2 million (approximately $314,000) to the Group in exchange for 872,829 shares. The Group received RMB 1 million (approximately $157,000) and issued 872,829 shares to Stonedrop as the date of this filing.
The Company delivered an aggregate of 4,842,197 shares reserved for convertible debentures in principal balance of approximately RMB17.9 million (US$2.8 million) by March 16, 2022 at conversion prices ranging from US$0.34 to US$1.0 per share. The Company also issued 6,000,000 shares as reserve for potential convertible loans conversion in the first quarter of 2022.
Dr. Chris Yu, Co-CEO and Co-Chairman of AnPac Bio commented: "We are pleased with our overall performance in the first quarter of 2022. Our financial performance was improved in a number of important areas. We have significantly reduced our net loss by 49.1% and our short debt was reduced by 66.1% in Q1 2022, compared with the same period last year. In product development and commercialization area, following successfully passing Class III medical device tests at our National Medical Product Administration (NMPA) designated testing laboratory in December 2021, we have begun developing plans for our Class III medical device clinical trials and selecting suited hospitals for the trials. While we are still experiencing negative effects of COVID-19, we intend to work very hard to make progress in a number of critical areas, including fund raising, cost cutting, product commercialization, including Class III medical device certification, and market penetration."

Key Items of Financial Results for the First Quarter of 2022

Revenues

Total revenues decreased by 9.9% to approximately RMB2.0 million (US$309,000) for the first quarter of 2022 from approximately RMB2.2 million for the first quarter of 2021, primarily due to a significant decrease in our revenue from cancer screening and detection tests.

Cost of Revenues

Cost of revenues decreased by 3.3% to approximately RMB878,000 (US$139,000) for the first quarter of 2022 from approximately RMB908,000 for the first quarter of 2021, primarily due to the decrease of approximately RMB 300,000 cost of revenue from cancer screening and detection tests, which was in line with the decrease in our revenue from sales of cancer screening and detection tests. Offset by the increased cost of revenues from technology services and retail products was approximately RMB270,000, no such cost incurred for the same period of 2021.

Gross Profit and Gross Margin

Gross margin was 55.4% for the first quarter of 2022, representing a slight decrease from 58.4% for the first quarter of 2021, primarily due to lower selling prices we charged for CDA-based tests.

Selling and Marketing Expenses

Selling and marketing expenses decreased by 24.1% to approximately RMB2.9 million (US$463,000) for the first quarter of 2022 from approximately RMB3.9 million for the same period of 2021, primarily due to less marketing activity.

Research and Development Expenses

Research and development expenses decreased by 28.3% to approximately RMB2.4 million (US$380,000) for the first quarter of 2022 from approximately RMB3.4 million for the first quarter of 2021, primarily due to less research and development activities for the first quarter of 2022 compared to the same period of 2021.

General and Administrative Expenses

General and administrative expenses decreased by 46.5% to approximately RMB10.3 million (US$1.6 million) for the first quarter of 2022 from approximately RMB19.2 million for the same period of 2021, primarily due to the decreased share-based compensation.

Change in fair value of convertible debt

The Company recognized the convertible debt at fair value. For the first quarter of 2022 and 2021, the Company recognized an aggregated unrealized loss of approximately RMB85,000 (US$13,000) and approximately RMB3.2 million, respectively, due to changes in fair value of convertible debt.

Net Loss

Net loss decreased to approximately RMB14.9 million (US$2.4 million) for the first quarter of 2022, compared to approximately RMB29.2 million for the first quarter of 2021. Basic and diluted loss per share was RMB0.85 (US$0.13) for the first quarter of 2022, compared to that of RMB2.43 for the first quarter of 2021.

The Company adopted ASU 2016-02, Leases (Topic 842) on January 1, 2022. The guidance requires the lessee to record operating leases on the balance sheet with a right-of-use asset and corresponding liability for future payment obligations. The Company recognized right of use assets and lease liabilities of approximately $1.30 million and $1.32 million as of March 31, 2022.

Balance Sheet

As of March 31, 2022, the Company had cash and cash equivalents of approximately RMB462,000 (US$73,000), compared to approximately RMB9.3 million as of December 31, 2021.

On May 31, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-101 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) (Press release, TScan Therapeutics, MAY 31, 2022, View Source [SID1234615269]). The target of TSC-101 is the minor histocompatibility antigen HA-2, which is a lineage-specific antigen expressed on blood cells. TScan believes that TSC-101 is the first clinical program to target the HA-2 antigen. As previously announced, TScan’s IND for TSC-100, which targets the minor histocompatibility antigen HA-1, was cleared by the FDA in January 2022. TSC-100 and TSC-101 are designed to address different subsets of patients undergoing allogeneic HCT.

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Study start-up activities are now ongoing for all three arms of TScan’s umbrella Phase 1 clinical trial, which includes active treatment arms for TSC-100, TSC-101, as well as a control arm using current standard-of-care for HCT patients. TScan expects to enroll the first patient in the middle of the year.

"This marks TScan’s second IND clearance in our leukemia program. Our TCRs against both HA-1 and HA-2 antigens are aimed at reducing the risk of relapse following HCT, thereby enabling increased use of more tolerable conditioning regimens to allow more leukemia patients to be cured by transplantation," said David Southwell, President and Chief Executive Officer. "With the FDA clearance of TSC-101, we will now proceed with all components of our planned multi-arm Phase 1 clinical trial, with preliminary data from all three arms of the trial expected by the end of 2022."

"We look forward to fully opening the Phase 1 umbrella trial for our leukemia program," said Gavin MacBeath, Chief Scientific Officer. "The trial will include patients positive for either the HA-1 or HA-2 antigens, with remaining patients receiving standard-of-care in the control arm. Importantly, the INDs for TSC-100 and TSC-101 were based on our proprietary T-Integrate cell engineering platform, which includes our advanced non-viral vector and our in-house GMP manufacturing capabilities. We will use this same platform to develop enhanced TCR-T cell therapies for our solid tumor program, with IND filings beginning later this year."

Primary endpoints in TScan’s HCT trial include safety and dose-finding, and secondary and exploratory endpoints include relapse rate versus standard-of-care as well as quantitative biological readouts including minimal residual disease and kinetics of donor chimerism.