On January 10, 2024 WuXi Biologics ("WuXi Bio") (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), reported that its Research Service Unit (R in CRDMO) has signed a research service agreement with BioNTech SE (Nasdaq: BNTX, "BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases (Press release, WuXi Biologics, JAN 10, 2024, View Source [SID1234639191]).

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Under the terms of the agreement, WuXi Biologics leverages its proprietary antibody discovery technology platforms (R in CRDMO) to discover two undisclosed targets of preclinical investigational monoclonal antibodies for BioNTech to develop next-generation therapeutic product candidates. WuXi Biologics will receive a $20 million upfront payment for granting exclusive rights to these investigational monoclonal antibodies to BioNTech and is eligible to receive additional payments, including payments for research, development, regulatory, and commercial milestones, as well as tiered royalties.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "Our unique CRDMO model is proven again. We are very pleased to support BioNTech’s growing innovative pipeline with antibodies discovered through our leading integrated discovery platforms. This agreement demonstrates our continued recognition as an industry leader in discovery service solutions, and further validates our ability to provide integrated discovery technology platforms for global partners to develop new modalities. We are looking forward to working with BioNTech with the aim of bringing potential new therapeutics with improved outcomes to patients worldwide."

WuXi Biologics offers a full spectrum of both end-to-end and modular discovery services – from idea to preclinical candidate identification – using industry-leading technology platforms and comprehensive discovery capabilities. The company’s discovery technology platforms for the generation, characterization, engineering, optimization and selection of novel antibody and biologic therapeutics include: hybridoma technology; single B cell cloning technology; phage display and yeast display technology; immune and synthetic human scFv and VHH libraries; human IgG transgenic platforms through an OmniAb and Alloy partnership; WuXiBody and SDarBody bispecific/multispecific antibody platforms; and other antibody and biologics generation and optimization technologies. All technology platforms are supported by WuXi Biologics’ comprehensive research material generation and assay development capabilities.

On January 10, 2024 Ascentage Pharma (6855.HK), a commercial stage global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, reported that Dr. Dajun Yang, the company’s Chairman and CEO, gave a speech at the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Ascentage Pharma, JAN 10, 2024, View Source [SID1234639190]). In the presentation, Dr. Yang provided an update on Ascentage Pharma’s recent major milestones and the formidable competitiveness the company has built in the field of hematologic malignancies, all achieved under its patient-centric global innovation strategy.

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Approvals for multiple global registrational Phase III trials mark new milestones in global innovation
As an innovative drug company pursuing a patient-centric global innovation strategy, Ascentage Pharma has achieved major milestones with its global expansion in 2023, including approvals for multiple global registrational Phase III studies of olverembatinib (HQP1351) and lisaftoclax (APG-2575), two of the company’s key drug candidates.

In-house developed by Ascentage Pharma, the novel drug olverembatinib is the first and only China-approved third-generation BCR-ABL inhibitor that filled a major treatment gap for Chinese patients with drug-resistant CML. In July 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved a global registrational pivotal Phase III study of olverembatinib, Ascentage Pharma’s lead drug candidate, in combination with chemotherapy versus imatinib in combination with chemotherapy for the treatment of newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This approval marks a major milestone that could potentially pave the way for olverembatinib to become the first tyrosine kinase inhibitor (TKI) approved in China for the treatment of patients with Ph+ ALL in the first-line setting.

In August 2023, the US Food and Drug Administration (FDA) cleared a global registrational pivotal Phase III study of the Bcl-2 inhibitor lisaftoclax, another one of Ascentage Pharma’s key drug candidates, in previously treated patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This regulatory clearance marked a major step in the global clinical development of lisaftoclax as it can potentially accelerate the drug’s journey to market as the world’s second approved Bcl-2 inhibitor, further validating the company’s capabilities in innovation and global clinical development.

Two months after that, lisaftoclax achieved another breakthrough with a clinical trial approval by the China CDE for a global registrational pivotal Phase III study of lisaftoclax combined with the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib, versus immunochemotherapy for the first-line treatment of naïve patients with CLL/SLL.

Olverembatinib approved for a new indication while having its global first-in-class potential further validated
Ever since launching olverembatinib, Ascentage Pharma has stepped up the commercialization of the drug and achieved a range of breakthroughs. In January 2023, as a frontrunner among National Major New Drug Development designated drugs in China, olverembatinib was included into the China 2022 National Reimbursement Drug List (NRDL), thus saw its accessibility and affordability drastically improved.

In November 2023, the NMPA approved a new indication of olverembatinib for the treatment of adult patients with chronic-phase chronic myeloid leukemia (CML-CP) resistant and/or intolerant of first-and second-generation TKIs, allowing a broader population of patients with CML to benefit from the drug.

At the recently concluded 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, eleven abstracts on olverembatinib were selected for presentations, including two Oral Presentations, making 2023 the sixth consecutive year in which data of olverembatinib were selected for Oral Presentations at the meeting. This is another indication of the strong global best-in-class potential of olverembatinib.

Data from the Chinese study of olverembatinib (HQP1351CC203), selected for an Oral Presentation at ASH (Free ASH Whitepaper) 2023, showed that in patients with CML-CP resistant and/or intolerant to prior treatment with TKIs, the olverembatinib arm achieved statistically significant improvement in event-free survival (EFS) compared to the control arm that was treated with the best available therapy (BAT), thus meeting the primary endpoint of the study with markedly improved prognosis for patients with CML in the olverembatinib arm, compared to those in the control arm.

Meanwhile, results from the US study of olverembatinib were equally encouraging. After releasing preliminary results of the US study in an Oral Report at the ASH (Free ASH Whitepaper) Annual Meeting in 2022, at ASH (Free ASH Whitepaper) 2023, Ascentage Pharma presented updated data from a larger patient sample that showed the favorable clinical benefit and tolerability of olverembatinib, as a monotherapy and in combinations, in heavily pretreated patients with CML and Ph+ ALL, particularly those who have failed prior treatment with the third-generation TKI ponatinib or the allosteric STAMP inhibitor asciminib. These results suggest that olverembatinib has global potential as an effective new therapy for patients with CML or Ph+ ALL.

The company is extensively exploring and validating olverembatinib’s therapeutic potential in indications other than CML, and the drug has shown particularly promising utility for the treatment of Ph+ ALL. Results from multiple studies evaluating olverembatinib in patients with Ph+ ALL were presented at ASH (Free ASH Whitepaper) 2023, including an Oral Presentation featuring a study that showed encouraging clinical benefit and favorable tolerability of olverembatinib, a potent third-generation TKI, combined with reduced-intensity chemotherapy in patients with Ph+ ALL, indicating the regimen has the potential of ushering in an era of chemotherapy-free treatment for Ph+ ALL.

While solidifying its presence and competitiveness in hematologic malignancies, Ascentage Pharma has also expeditiously advanced its clinical development of olverembatinib for the treatment of gastrointestinal stromal tumor (GIST). In 2023, the second year in which clinical results of olverembatinib in patients with GIST were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Ascentage Pharma released data that showed encouraging clinical benefit and favorable safety of olverembatinib in patients with TKI-resistant succinate dehydrogenase (SDH)-deficient GIST.

Bcl-2 inhibitor lisaftoclax showed promising clinical benefit for patients with CLL and strong therapeutic potential in AML and MM
Also during his speech, Dr. Yang reviewed the recent progress in the development of lisaftoclax, alluding to key data released at ASH (Free ASH Whitepaper) 2023.

As the first Bcl-2 inhibitor that has entered registrational pivotal trials in China and the second globally, lisaftoclax is a novel therapeutic with global best-in-class potential.

At ASH (Free ASH Whitepaper) 2023, Ascentage Pharma released results from three studies of lisaftoclax, including one study in patients with relapsed/refractory (R/R) CLL that showed an overall response rate (ORR) of 73.3%; a complete remission (CR)/CR with incomplete blood count recovery (CRi) rate of 24.4%; and a positive correlation between CR/CRi rate and dose levels, in patients who received lisaftoclax. In addition, the study observed a low incidence of tumor lysis syndrome (TLS) that is comparable to the results of earlier studies. While in long-term follow-up, the study observed a 30-month overall survival (OS) rate of 86.3% that indicated the drug’s high response rates, safety for long-term use, and potential in bringing durable survival benefit to patients with CLL.

In addition, Ascentage Pharma released the first dataset of lisaftoclax in patients with multiple myeloma (MM) and acute myeloid leukemia (AML) at ASH (Free ASH Whitepaper) 2023. These data revealed strong therapeutic potential and provide a solid foundation for the continued development of lisaftoclax in indications outside CLL. Dr. Yang also mentioned in his speech that a registrational Phase III study of lisaftoclax in AML has already been approved by the China CDE and is being initiated.

Accelerating global innovation to achieve enhanced global competitiveness
Under its overarching global innovation strategy, Ascentage Pharma has built a rich pipeline composed of highly promising drug candidates with first-in-class and/or best-in-class potentials, and is conducting more than 40 clinical studies in China, the US, Australia, Europe, and Canada. The company’s innovative and clinical development capabilities have received growing recognition from the global research community as the clinical data on a number of its drug candidates were frequently showcased at major international congresses.

In his talk, Dr. Yang outlined a series of potential catalysts for 2024, including the FDA clearance for the registrational Phase III study of olverembatinib, NDA submissions for lisaftoclax, rapid progress with multiple global registrational Phase III studies, and the NRDL inclusion of olverembatinib’s new indication.

"It is my great pleasure to attend the annual J.P. Morgan Healthcare Conference this year and have the opportunity to provide an update on the key progress we delivered in 2023," said Dr. Dajun Yang. "In the past year, we received clearance for multiple global registrational Phase III studies, taking major steps forward in our global expansion; we continuously expanded the target indications of our core drug candidates and further solidified our leadership position in the arena of hematologic malignancies. Moving forward, we will continue to execute our global innovation strategies, accelerate our global registrational Phase III studies, and make further strides fulfilling our mission of addressing unmet clinical needs in China and around the world for the benefit of more patients."

On January 10, 2024 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, reported that the European Commission (EC) granted conditional marketing authorization for KRAZATI (adagrasib) as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy (Press release, Mirati, JAN 10, 2024, View Source [SID1234639189]).

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KRAZATI has demonstrated a positive benefit-risk profile based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg administered orally twice daily in 116 patients with KRASG12C-mutated advanced NSCLC who previously received treatment with a platinum-based regimen and an immune checkpoint inhibitor. The primary efficacy endpoints were confirmed ORR and DOR as evaluated by blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST v1.1).

"KRAZATI offers an efficacious and tolerable therapeutic option for patients living with advanced KRASG12C -mutated NSCLC and this approval expands the potential treatment options available," Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Germany. "With it’s differentiated profile, KRAZATI offers an impactful treatment option for patients living with lung cancer. This approval will assist physicians in tailoring treatment approaches for patients."

Conditional marketing authorization for KRAZATI is valid in all 27 EU member states plus Iceland, Norway and Liechtenstein. This authorization follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in November 2023.

"This is a meaningful day for patients living with this difficult-to-treat cancer in the European Union as we can now offer a differentiated and potentially best-in-class therapeutic option to this underserved population," Charles Baum, M.D., PhD, founder, president and chief executive officer, Mirati Therapeutics, Inc., "Mirati is resolute in our commitment to improve upon treatment options for these patients and looks forward to continued partnership with EU members states to create broad access for all qualified patients."

Mirati thanks the patients, physicians, investigators and site coordinators who participated in the clinical trials that led to this important approval.

Important Safety Information

The Summary of Product Characteristics (SmPC) for KRAZATI (adagrasib) will be available from the European Medicines Agency at the Union Register of medicinal products.

About KRAZATI (adagrasib)

Mirati has risen to meet one of the most challenging mutations in cancer research by developing KRAZATI, a highly selective and potent oral small-molecule inhibitor of KRASG12C.

Intentionally designed to meet the challenge of KRASG12C, adagrasib is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours.1 Adagrasib has shown clinically to be a CNS penetrant, which may be important given that CNS metastases frequently occur in NSCLC and lead to poor prognosis.2-34

The FDA provided KRAZATI Accelerated Approval (Subpart H), allowing for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints.

Adagrasib continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer. For more information, visit Mirati.com/science.

About the KRYSTAL-1 Study

KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion cohort trial evaluating adagrasib as monotherapy and in combination with other anti-cancer therapies in patients with advanced solid tumors harboring the KRASG12C mutation.

About KRASG12C in NSCLC

Lung cancer is one of the most common cancers worldwide, accounting for 2.21 million new cases and 1.8 million deaths worldwide in 2020.5 Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.6 KRASG12C is the most common KRAS mutation in NSCLC, present in approximately 14% of patients with lung adenocarcinoma, and is a biomarker mutation of poor prognosis.

On January 10, 2024 VerImmune, an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP) technology platform, reported a new research collaboration agreement with A*STAR’s Bioprocessing Technology Institute (BTI), a research institute in Singapore with integrated capabilities to assist industry in accelerating process innovation in biomanufacturing (Press release, VerImmune, JAN 10, 2024, View Source [SID1234639188]).

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The collaboration is centered around platform development and aims to develop a preclinical manufacturing platform, which will facilitate the generation of additional novel ViP-based product candidates for programs beyond VerImmune’s flagship Oncology program which is based on a First-in-Class immunotherapy approach known as Anti-tumor Immune Redirection (AIR).

Since its founding in 2020, VerImmune was originally solely based in the United States having offices and research laboratories at the JLABS@Washington DC incubator. In July 2023, VerImmune was awarded the Second Amgen X NSG Biolabs Golden Ticket Award which allowed the company to secure residency at NSG Biolabs to establish its presence within Asia-Pacific with Singapore as its new regional headquarters. The company intends to use these resources to build up a local platform development team.

"We believe that this collaboration focused on CMC has the potential to further advance and validate our ViP technology as a new modality bringing forth a new class of medicines." said Dr Joshua Wang, Founder and CEO of VerImmune Inc. "As the saying goes ‘the Process is the Product. However, globally, there is only a handful of research institutes that focus on early-stage CMC development. This is critical for any asset’s eventual success but unfortunately often not prioritized part of product development. As we build our presence in Singapore, we recognize the potential of having BTI as a strategic research partner due to their deep expertise in bioprocessing and analytical sciences for biotherapeutics."

On January 10, 2024 TG Therapeutics, Inc. (NASDAQ: TGTX) reported preliminary U.S. net product revenue for BRIUMVI for the fourth quarter and full year ended December 31, 2023 (unaudited), as well as financial guidance and development milestones for 2024, during a preannounced presentation at the 42nd Annual J.P Morgan Healthcare Conference (Press release, TG Therapeutics, JAN 10, 2024, View Source [SID1234639187]). An audio replay of the event, as well as the corresponding slide deck are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events.

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Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, "We are excited to share our preliminary fourth quarter and year end U.S. BRIUMVI net product revenue. As we head into 2024, we have our sights set on achieving revenue and expense targets and have built an ambitious plan to potentially expand the utility of BRIUMVI into new indications and for use as a subcutaneous injection. We are also excited to expand our R&D program with the recent licensing of azer-cel, an allogeneic CD19 CAR T therapy which we believe has the potential to become a meaningful therapy to treat various autoimmune disorders."

Preliminary Fourth Quarter and Full Year 2023 Updates (based on unaudited financial information)

BRIUMVI U.S. net product revenue expected to be approximately $40 million and $89 million for the fourth quarter and full year of 2023, respectively
Year-end 2023 cash position of approximately $215 million
Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results planned to occur February 2024.

2024 Target Guidance

BRIUMVI U.S. net product revenue targets of approximately $41-$46 million and $220-$260 million for the first quarter and full year 2024, respectively
Full year 2024 target operating expense of approximately $250 million
2024 Development Pipeline Anticipated Milestones

Commence clinical development of subcutaneous BRIUMVI
Commence a trial evaluating BRIUMVI in additional autoimmune diseases outside of Multiple Sclerosis (MS)
Commence a trial evaluating azer-cel in autoimmune disease
Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as relapsing forms of multiple sclerosis (RMS). BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated for the treatment of adults with RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:

Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

The full SmPC approved in the EU for BRIUMVI can be found here Briumvi | European Medicines Agency (europa.eu).

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.