On November 21, 2024 Novocure (NASDAQ: NVCR) reported that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio for the treatment of adult patients with glioblastoma multiforme (GBM) (Press release, NovoCure, NOV 21, 2024, View Source [SID1234648567]).

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"At Novocure we recognize product innovation must deliver meaningful results for our patients"

Optune Gio is a wearable, portable device that produces alternating electric fields known as Tumor Treating Fields (TTFields), which are delivered through non-invasive, wearable arrays. TTFields exert physical forces on the electrically charged components of dividing cancer cells, which disrupt the rapid cell division exhibited by cancer cells.

The new HFE arrays utilize a flexible polymer material in place of the ceramic discs used in the current Optune Gio arrays, making them one-third lighter and 50% thinner.

"At Novocure we recognize product innovation must deliver meaningful results for our patients," said Mukund Paravasthu, Chief Operating Officer, Novocure. "The newly FDA approved HFE arrays are lighter, thinner and designed to be more comfortable, clear benefits for the patient. We look forward to introducing the new arrays in the U.S. and will continue our work to deliver product innovations that prioritize the needs of people using our treatments."

Novocure plans to convert Optune Gio users in the U.S. to the new HFE arrays through the first half of 2025 through a controlled transition plan.

Important Safety Information

What is Optune Gio approved to treat?

Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older.

Newly diagnosed GBM

If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if:

Your cancer is confirmed by your healthcare professional AND
You have had surgery to remove as much of the tumor as possible
Recurrent GBM

If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if:

You have tried surgery and radiation and they did not work or are no longer working AND
You have tried chemotherapy and your GBM has been confirmed by your healthcare professional
Who should not use Optune Gio?

Optune Gio is not for everyone. Talk to your doctor if you have:

An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly
A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction
Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.

What should I know before using Optune Gio?

Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure, the maker of Optune Gio.

Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor
Do not get the device or transducer arrays wet
If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment
What are the possible side effects of Optune Gio?

Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.

Please click here for the Optune Gio Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

On November 21, 2024 Bayer reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental new drug application (sNDA) for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Bayer, NOV 21, 2024, View Source [SID1234648566]).

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NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).2

"Bayer is dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease, and today’s acceptance of our sNDA application for NUBEQA plus ADT for the treatment of patients with mHSPC brings us closer to adding an additional treatment option for NUBEQA to benefit those living with mHSPC," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "If approved, this would expand the indication for NUBEQA in patients with mHSPC to include NUBEQA both with and without chemotherapy, providing physicians and their patients with an additional NUBEQA treatment option in this setting. We are working closely with the FDA to bring this additional NUBEQA treatment option to patients as soon as possible."

The sNDA application is based on positive results from the Phase III ARANOTE trial. Data from the trial were presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and published in The Journal of Clinical Oncology.

NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARANOTE Trial1

The ARANOTE trial (NCT04736199) was a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of NUBEQA plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 669 patients were randomized to receive 600mg of NUBEQA twice daily or matching placebo in addition to ADT.

The primary endpoint of this study was radiological progression-free survival (rPFS), measured as time from the date of randomization to the date of first documentation of radiological disease progression or death due to any cause, whichever occurs first. Secondary endpoints included overall survival (time from randomization to the date of death from any cause), time from randomization to the date of first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.

About NUBEQA (darolutamide)2

NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

In addition to the ARANOTE trial, NUBEQA is being evaluated in a robust clinical development program, which includes studies across various stages of prostate cancer, including in the ARASTEP Phase III trial evaluating NUBEQA plus ADT versus ADT alone in HSPC patients with high-risk biochemical recurrence (BCR) and no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline, as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.

INDICATIONS

NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.4,5

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed.6,7,8 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.

On November 21, 2024 NorthStar Medical Radioisotopes, LLC reported the signing of a strategic Master Supply Agreement with Cellectar Biosciences, Inc. (NASDAQ: CLRB) under which Cellectar will acquire and integrate NorthStar’s n.c.a. Ac-225 into Cellectar’s proprietary Phospholipid Ethers (PLE) delivery platform to expand the platform’s capability to produce a diverse range of radiotherapeutic molecules (Press release, NorthStar Medical Radiostopes, NOV 21, 2024, View Source [SID1234648565]).

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NorthStar is a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer.

"Our PLE platform provides a unique ability to optimize delivery of any radioisotope and can be designed for the treatment of specific tumor types. Our leading alpha emitter program, CLR 121225, utilizes Ac-225 and has demonstrated promising preclinical results in pancreatic, triple negative breast and other solid tumors, justifying the progression to clinical development," said James Caruso, president and CEO of Cellectar. "We plan to advance CLR 121225 into human clinical trials in 2025 as part of a broader strategy to bring first-and best-in-class radiotherapeutics to market. This agreement with NorthStar provides a reliable source of Ac-225, which is a critical to our clinical development strategy."

"Cellectar’s novel TAT compounds, including CLR 121225 and others, have demonstrated their potential in devastating diseases like pancreatic cancer, that for too long have had no highly effective treatments," said Frank Scholz, president and CEO of NorthStar. "Recent years have seen an increased interest in alpha-emitting radiotherapies like Cellectar’s compound which is expected to enter a Phase 1 first-in-human study next year," he continued, "but developments have been hampered by the relative scarcity of Ac-225 supply. At NorthStar, our passion is to reduce technological and operational barriers to give companies like Cellectar a reliable source of environmentally preferred, high purity (n.c.a) Ac-225 that will help make these new therapies possible."

On November 21, 2024 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States and ranked among the nation’s top 5 cancer centers by U.S. News & World Report, reported that its doctors and scientists will take part in 100 oral and poster presentations, scientific symposia/workshops, education programs and other events at ASH (Free ASH Whitepaper) annual meeting from Dec. 7 to 10 in San Diego (Press release, City of Hope, NOV 21, 2024, View Source [SID1234648564]).

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City of Hope in ASH (Free ASH Whitepaper) Press Program

Two City of Hope researchers will present at ASH (Free ASH Whitepaper) press briefings, and one of its leaders is a senior author on an abstract that will be discussed in the press program as well.

Title: Increased Fiber Intake Results in Better Overall Survival and Lower GI-aGVHD in Allo-HCT Recipients and Pre-Clinical Gvhd Models
Oral Abstract Number: 259
Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST
Presenter: Jenny Paredes, Ph.D., City of Hope staff scientist, who will also receive an ASH (Free ASH Whitepaper) Outstanding Abstract Achievement Award for this research

Title: A High-Fiber Dietary Intervention (NUTRIVENTION) in Precursor Plasma Cell Disorders Improves Biomarkers of Disease and May Delay Progression to Myeloma
Oral Abstract Number: 671
Press Briefing Date/Time and Embargo Lift Time: Saturday, Dec. 7, 7:15 a.m. PST
City of Hope Senior Author: Marcel van den Brink, M.D., Ph.D., president, City of Hope Los Angeles/City of Hope National Medical Center and Deana and Steve Campbell Chief Physician Executive Distinguished Chair in Honor of Alexandra Levine, M.D.

Title: Epcoritamab Monotherapy in Patients (Pts) with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from CLL Expansion and Optimization Cohorts of Epcore CLL-1
Oral Abstract Number: 883
Press Briefing Date/Time and Embargo Lift Time: Sunday, Dec. 8, 8 a.m. PST
Presenter: Alexey Danilov, M.D., Ph.D., City of Hope Marianne and Gerhard Pinkus Professor in Early Clinical Therapeutics, and associate director, Toni Stephenson Lymphoma Center

City of Hope ASH (Free ASH Whitepaper) Oral Presentations

In addition, City of Hope doctors will present 22 oral abstracts with the following highlights:

Title: 980 Results From the First Phase 1 Clinical Study of DR-01, a Non-Fucosylated Anti-CD94 Targeting Antibody in Patients With Relapsed/Refractory Cytotoxic Lymphomas: Dose Escalation and Optimization
Session Date and Time: Monday, Dec. 9, 4:45 p.m. PST
Presenter: Jasmine Zain, M.D., City of Hope professor, Division of Lymphoma, and director, T Cell Lymphoma Program

Title: 468 Randomized Phase 2 Trial of the Anti-PD-L1 Monoclonal Antibody Durvalumab Plus Lenalidomide Versus Single-Agent Durvalumab in Patients With Refractory/Advanced Cutaneous T Cell Lymphoma
Session Date and Time: Sunday, Dec. 8, 10:45 a.m. PST
Presenter: Christiane Querfeld, M.D., Ph.D., City of Hope professor, Division of Dermatology, and director, Cutaneous Lymphoma Program

Title: 211 Updated Results and Longer Follow-Up From the AUGMENT-101 Phase 2 Study of Revumenib in All Patients With Relapsed or Refractory (R/R) KMT2Ar Acute Leukemia
Session Date and Time: Saturday, Dec. 7, 2 p.m. PST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Title: 524 Real-World Outcomes of CD19CAR T Cell Therapy in Adult Patients With Relapsed Refractory Transformed Indolent Lymphoma
Session Date and Time: Sunday, Dec. 8, 9:45 a.m.
Presenter: Swetha Kambhampati Thiruvengadam, M.D., City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Title: 210 Disrupting Mitochondrial Dynamics and Metabolism in Leukemic Stem Cells through Mitochondrial PCNA Inhibition: The Role of AOH1996
Session Date and Time: Saturday, Dec. 7, 3:15 p.m. PST
Presenter: Hyunjun Kang, Ph.D., City of Hope staff scientist, Department of Hematologic Malignancies Translational Science

Title: 1043 Final Analysis of Phase 2a Study of Adding Itacitinib to Tacrolimus/Sirolimus Gvhd Prophylaxis After Fludarabine/Melphalan-Based Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, Myelodysplastic Syndrome (MDS), or Myelofibrosis (MF)
Session Date and Time: Monday, Dec. 9, 5:30 p.m. PST
Presenter: Haris Ali, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and section leader, Myeloproliferative Neoplasms Program

Title: 966 CD19-CAR T Cells As Definitive Consolidation for Older Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study
Session Date and Time: Monday, Dec. 9, 5:45 p.m. PST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Title: 685 The Composite Health Risk Assessment Model (CHARM) Predicts Risks of Toxicities, Functional and Cognitive Decline Among Survivors of Allogeneic Hematopoietic Cell Transplantation (allo-HCT): A Prospective BMT-CTN Study 1704
Session Date and Time: Sunday, Dec. 8, 4:30 p.m. PST
Senior Author: Andrew Artz, M.D., M.S., City of Hope professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and director, Aging and Blood Cancers Program

City of Hope doctors will also lead in the following ASH (Free ASH Whitepaper) events:

The 13th Annual BMT & Cell Therapy Winter Workshop, co-chaired by Dr. Van den Brink, will be held on Friday, Dec. 6, 2024, prior to the ASH (Free ASH Whitepaper) conference. The workshop focuses on innovative research pertinent to hematopoietic stem cell transplantation and cell therapy.
Dr. Van den Brink will also speak at a scientific symposium titled "Placing the Brakes on Accelerated Aging" about targeting rejuvenation therapies to decelerate aging on Monday, Dec. 9, 2024.
Jianjun Chen, Ph.D., Simms/Mann Family Foundation Chair in Systems Biology, will speak at a scientific workshop titled "Therapy Resistance Mechanisms in Blood Malignancies Program" about RNA modification and therapy resistance in acute leukemia on Friday, Dec. 6, 2024.

On November 21, 2024 AbCellera (Nasdaq: ABCL) reported that executives from the Company will present at the following investor conferences (Press release, AbCellera, NOV 21, 2024, View Source [SID1234648563]):

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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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Piper Sandler 36th Annual Healthcare Conference in New York, NY on Tuesday, December 3, 2024, at 11:30 a.m. Pacific Time (2:30 p.m. Eastern Time)
43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Wednesday, January 15, 2025, at 4:30 p.m. Pacific Time (7:30 p.m. Eastern Time)

Live audio webcasts of the presentation may be accessed through the link that will be posted on AbCellera’s Investor Relations website. Replays of the webcast will be available through the same links following the presentations.