Small Lymphocytic Lymphoma

Ongoing international oncology collaboration works to empower health care workers and save lives across diverse resource environments. Accra, GHANA, Oct. 29, 2024 /PRNewswire/ -- International oncology experts are gathering in Accra, Ghana for a series of meetings beginning today, to update cancer treatment recommendations in the NCCN Harmonized Guidelines™ for Sub-Saharan Africa. This is the latest event from a longstanding collaboration between the African Cancer Coalition (ACC), American Cancer Society (ACS), and National Comprehensive Cancer Network® (NCCN®), and the Clinton Health Access Initiative (CHAI) that collectively form the group Allied Against Cancer. Together, the organizations are focused on providing context-appropriate, evidence-based cancer care strategies that address the unique challenges faced across the region. Continue Reading NCCN Harmonized Guidelines for Sub-Saharan Africa available for free at NCCN.org/harmonized. The NCCN Harmonized Guidelines™ for Sub-Saharan Africa are free resources for optimizing and standardizing cancer care across the region. They are available at NCCN.org/harmonized or via the Virtual Library of NCCN Guidelines® App. "The Sub-Saharan Africa region is dealing with a rising rate of cancer incidences. Standardizing care based on the latest evidence-based expert consensus-driven recommendations helps ensure consistency in treatment and enables better planning for how to use available resources," said Dr. Henry Ddungu, Senior Consultant, Hematology/Oncology; African Cancer Coalition. "We can ensure people with cancer receive the most effective treatment by harnessing local expertise combined with global best practices." During the meeting, the updates to the NCCN Harmonized Guidelines™ for Sub-Saharan Africa will focus on caring for blood malignancies and children's cancers, including: Acute Lymphoblastic Leukemia Acute Myeloid Leukemia B-cell Lymphomas Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Chronic Myeloid Leukemia Hodgkin Lymphoma Multiple Myeloma Pediatric Acute Lymphoblastic Leukemia Pediatric Aggressive B-Cell Lymphomas Pediatric Central Nervous System Cancers Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma "Since the launch of Allied Against Cancer and publication of the first NCCN Harmonized Guidelines™ for Sub-Saharan Africa in 2017, we have grown to include guidelines covering more than 90% of adult cancer incidences, and most pediatric cancers," said Anu Agrawal, MD, Vice President, Global Cancer Support, American Cancer Society (ACS). "We are proud of the work we've accomplished collaboratively and excited to see continued progress in cancer care across the region." "As we strive for health equity across the globe, it is vital that health care providers are equipped with the best tools and resources to deliver optimal care for a variety of different settings," said Crystal S. Denlinger, MD, Chief Executive Officer, NCCN. "These guidelines are a critical step for helping cancer care professionals stay current on the latest advancements in treatment. They provide a roadmap for ideal options while also taking into account the challenges that exist when delivering care in resource limited settings." Dr. Denlinger was joined by NCCN's Chief Medical Officer, Wui-Jin Koh, MD, along with the following NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel leadership: Ranjana H. Advani, MD, Stanford Cancer Institute Jessica K. Altman, MD, Robert H. Lurie Comprehensive Cancer Center of Northwestern University Hiroto Inaba, MD, PhD, St. Jude Children's Research Hospital/The University of Tennessee Health Science Center The NCCN Harmonized Guidelines™ offer color-coded tiers of treatment recommendations based on resource availability. They cover more than 40 different cancer types, plus screening, supportive care, and specific population concerns. They have been utilized nearly 70,000 times since 2017 and have been endorsed by the Federal Ministries of Health and leading cancer centers in Ethiopia, Liberia, Malawi, Nigeria, Tanzania, Uganda, and Zambia. Learn more about Allied Against Cancer's collaborative work to improve cancer care in Sub-Saharan Africa at alliedagainstcancer.org. Visit NCCN.org/global for other free international cancer prevention and treatment resources. About the National Comprehensive Cancer Network The National Comprehensive Cancer Network® (NCCN ®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information. Media Contact: Rachel Darwin 267-622-6624 [email protected] Photo - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Strengthens Lyell’s clinical pipeline with the addition of IMPT-314, a dual-targeting CD19/CD20 CAR T-cell product candidate Data from ImmPACT’s multi-center Phase 1-2 clinical trial of IMPT-314 in patients with large B-cell lymphoma treated in the 3rd line CAR-naïve setting to be presented at a major medical conference later this year; initiation of a pivotal trial for IMPT-314 expected in 2025 Lyell has prioritized its pipeline to focus on next-generation CAR T-cell therapies, including IMPT-314 and LYL119, and is discontinuing development of LYL797, LYL845 and earlier-stage TIL programs Cash runway following the close of the transaction is expected to fund operations into 2027, through important clinical milestones for each pipeline program Lyell will host an investor webcast at 4:30 PM ET today Oct. 24, 2024 -- Lyell Immunopharma, Inc. (Nasdaq: LYEL) announced today that it has entered into a definitive agreement to acquire ImmPACT Bio USA Inc. (“ImmPACT”), a privately-owned clinical-stage biotechnology company. ImmPACT’s lead program, IMPT-314, is a CD19/20-targeting chimeric antigen receptor (CAR) T-cell product candidate that Lyell will continue to develop for hematologic malignancies, including large B-cell lymphoma. IMPT-314 was designed to outperform the efficacy of approved CD19 CAR T-cell therapies via a dual-targeting CAR T-cell design and to improve CAR T-cell persistence by enriching for naïve and central memory T cells during manufacturing. The acquisition of ImmPACT is expected to significantly strengthen Lyell’s clinical-stage pipeline of next- generation CAR T-cell therapies and complement its suite of proprietary technologies designed to generate longer-lasting, functional T cells to achieve more durable outcomes for patients with solid tumors and hematologic malignancies. “Lyell’s vision is to bring meaningful and durable clinical benefit to patients suffering from cancer with our next-generation cell therapies,” stated Lynn Seely, M.D., Lyell’s President and Chief Executive Officer. “The emerging data from ImmPACT’s ongoing Phase 1-2 trial and the Phase 1 clinical data from a published UCLA-sponsored trial suggest the potential of IMPT-314 to have improved complete response rates and duration of response compared to the approved CD19 CAR T-cell therapies in CAR-naïve patients with aggressive B-cell lymphoma. Since licensing this product candidate from UCLA, the team at ImmPACT has made impressive progress in the multi-center IMPT-314 Phase 1-2 clinical program. We look forward to presenting initial data from this program at a major medical conference later this year and initiating a pivotal trial for IMPT-314 in 2025.” “I am incredibly proud of the ImmPACT team and all of their accomplishments in developing next-generation CAR T-cell therapies,” stated Sumant Ramachandra, M.D., Ph.D., Chief Executive Officer of ImmPACT. “This transaction validates our novel science and enhances the potential for this therapy to make a meaningful impact on patients' lives. I am confident that in Lyell, we have found a team that shares our passion for advancing novel science to benefit patients.” ImmPACT licensed its dual-targeting CD19/CD20 CAR T-cell product candidate from the University of California, Los Angeles (UCLA). Phase 1 data in 13 patients with relapsed/refractory (R/R) aggressive non-Hodgkin lymphoma treated in a UCLA-sponsored clinical trial were presented at the 2024 AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy. CAR T-cell naïve patients with R/R diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma after at least two lines of therapy or mantle cell lymphoma, follicular lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma after at least three lines of therapy were evaluated. Autologous T cells were obtained and enriched for CD14-/CD25-/CD62L+ naïve or memory T cells. Twelve out of 13 patients achieved a complete or partial response (92% objective response rate), with ten achieving a confirmed complete response (CR) (77% CR rate). The median progression-free survival was 50.1 months, and median overall survival was not reached with a median follow up of 32 months (range: 5.7 – not estimable). A favorable safety profile was observed. The ongoing Phase 1-2 clinical trial initiated by ImmPACT is a multi-center, open-label clinical trial designed to evaluate the tolerability and clinical benefit of IMPT-314 in patients with R/R aggressive B-cell lymphoma and determine a recommended Phase 2 dose. Initial Phase 1-2 clinical data evaluating IMPT-314 primarily in patients who have received at least two prior lines of therapy for large B-cell lymphoma will be presented at a major medical conference this year. IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of R/R aggressive B-cell lymphoma. Lyell expects to initiate a pivotal trial in 2025 for IMPT-314 in patients in the 3rd line setting who have not yet been exposed to CAR T-cell therapy. In connection with the acquisition, Lyell has prioritized its pipeline to focus resources on its most differentiated CAR T-cell clinical programs, including IMPT-314 following the close of the acquisition and LYL119. The enhanced anti-exhaustion technology incorporated into LYL119, including c-Jun overexpression, NR4A3 knockout, Epi-R and Stim R, has the potential to achieve improved efficacy at lower cell doses with an acceptable safety profile. In a validated in vivo preclinical model of non-small cell lung cancer, LYL119 achieved tumor control at a 10-fold lower cell dose than LYL797 with more gradual cell expansion to peak, and a substantial increase in the duration of cell killing demonstrated by a repetitive tumor cell killing assay in vitro. Lyell is discontinuing development of LYL797, its ROR1-targeted CAR T-cell product candidate to focus on the Phase 1 clinical trial of its next-generation ROR1-targeted CAR T-cell product candidate LYL119, which is expected to initiate enrollment of patients with platinum-resistant ovarian cancer or relapsed/refractory endometrial cancer this year or early next year. The LYL845 tumor-infiltrating lymphocyte (TIL) program is also being discontinued as the clinical data in patients with advanced melanoma did not meet our rigorous pre-determined criteria for continued development. Its next-generation TIL and rejuvenation programs that are in preclinical development will also be discontinued. Following the close of the transaction, Lyell expects its cash balance will fund operations into 2027, through important clinical milestones for each pipeline program, including initiation of a pivotal trial for IMPT-314, which is expected to start in 2025. Upon closing, Lyell will acquire worldwide rights to ImmPACT’s pipeline, including the next- generation bispecific CD19/CD20 autologous CAR T-cell therapy, currently in clinical development for B-cell lymphoma and autoimmune diseases, and an activating TGF-beta Claudin 18.2 CAR T-cell candidate, which is in preclinical development. Lyell will prioritize the development of IMPT-314 for patients with B-cell lymphoma. Deal terms include upfront consideration payable upon closing the potential transaction of $30 million in cash, subject to certain adjustments, and 37.5 million shares of Lyell common stock. ImmPACT shareholders will also be eligible to receive contingent consideration consisting of 12.5 million shares of Lyell common stock that may be earned upon the achievement of a value-enhancing clinical milestone and a low single-digit royalty on future net sales of the dual-targeting CD19/20 CAR T-cell product in the United States. The proposed transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the fourth quarter of 2024. The closing of the proposed transaction is subject to expiration of the Hart-Scott-Rodino antitrust waiting period and the satisfaction of other customary closing conditions. Goldman Sachs & Co LLC is acting as sole financial advisor to Lyell in this transaction and Skadden, Arps, Slate, Meagher & Flom LLP is acting as its legal advisor. Cooley LLP is acting as ImmPACT’s legal advisor. Lyell’s management will host an investor conference call and Webcast beginning at 4:30 pm ET today. The Webcast can be accessed here. A replay of the event and presentation materials will be archived on the Investor page of the Lyell Website following the end of the event. Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. Lyell is based in South San Francisco, California with facilities in Seattle and Bothell, Washington. To learn more, please visit www.lyell.com. The content above comes from the network. if any infringement, please contact us to modify.

NX-5948 demonstrated robust clinical activity with objective responses observed in 7 of 9 (77.8%) evaluable Waldenstrom’s patients in the ongoing Phase 1a/1b clinical trial Responses are durable and deepen over time with two patients on treatment for greater than one year Data were presented at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) Oct. 19, 2024 -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of clinical data from its ongoing Phase 1a/1b clinical trial of NX-5948, an orally bioavailable, brain penetrant degrader of Burton’s tyrosine kinase (BTK), in patients with relapsed/refractory Waldenstrom’s macroglobulinemia (WM) at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM-12) which is being held in Prague, Czech Republic October 17–19, 2024. “We are encouraged by the emerging positive data from NX-5948 in patients with Waldenstrom’s macroglobulinemia, which add to the previously disclosed robust clinical activity observed in patients with chronic lymphocytic leukemia,” said Paula G. O’Connor, M.D., chief medical officer of Nurix. “These data support our decision to advance NX-5948 into the ongoing Phase 1b expansion cohort in patients who have previously received at least one prior line of therapy including a BTK inhibitor and patients presenting with Bing-Neel syndrome, a rare form of WM with central nervous system involvement where NX-5948’s ability to penetrate the brain may offer a distinct advantage.” The data presented at IWWM-12 included previously reported safety findings for all patients in the Phase 1a dose escalation study treated with NX-5948 at doses ranging from 50 mg to 600 mg once daily by oral administration regardless of diagnosis (n=79) based on an April 17, 2024 data cut. NX-5948 demonstrated a tolerable safety profile, and the safety profile for patients with WM was consistent with the safety profile for the overall population (WM patient safety data not shown separately). New data from an October 10, 2024 data cut include the baseline characteristics of the first 13 patients with WM enrolled across both the Phase 1a and Phase 1b portions of the trial, clinical response assessments in 9 response-evaluable patients, and duration on study for all 13 patients. Among the 13 WM patients, the median age was 74 years and the median number of prior lines of therapy was 3. All 13 patients previously had been treated with both BTK inhibitors (BTKi) and chemotherapy/chemo-immunotherapy. Three patients (23.1%) had received prior treatment with the non-covalent BTKi pirtobrutinib, and one patient (7.7%) had received prior treatment with a BCL2 inhibitor. Baseline mutation status in MYD88 and CXCR4 was captured from patient records, and eight patients (61.5%) had mutations in MYD88, and two patients (15.4%) had mutations in CXCR4. Among the nine patients who were evaluable for response, seven patients (77.8%) had an objective response and two patients experienced stable disease (22.2%). All seven responses were observed at the first assessment at 8 weeks, and five remain on treatment with two patients on treatment for longer than one year. Responses were observed in patients regardless of their baseline mutations in MYD88 and CXCR4. Two illustrative cases studies of patients treated with NX-5948 were presented. The first case study is a patient with baseline MYD88 and CXCR4 mutations and four prior lines of therapy, including autologous bone marrow transplantation and ibrutinib, who demonstrated a rapid response observed at the first assessment and remained on study at the time of the October 10, 2024 data cut with greater than one year of treatment (currently in cycle 16; 28 days per cycle). NX-5948 treatment resulted in deepening of response over time as measured by reduction in serum IgM levels, a key biomarker of clinical response in WM patients. The second case study is a patient with baseline MYD88 mutation and three prior lines of treatment, having most recently progressed while on zanubrutinib. This patient also experienced a rapid response at the first assessment with decreasing IgM through treatment which was ongoing in cycle 15 at the time of the October 10, 2024 data cut. The IWWM-1 presentation is available in the Scientific Resources section of Nurix website in the Posters and Presentations section. NX-5948 is an investigational, orally bioavailable, brain penetrant, small molecule degrader of BTK. NX-5948 is currently being evaluated in a Phase 1 clinical trial in patients with relapsed or refractory B cell malignancies. Nurix has previously reported that NX-5948 is highly potent against a range of tumor cell lines that are resistant to current BTK inhibitor therapies, an important consideration in heavily pretreated CLL/SLL patient populations. Additional information on the ongoing clinical trial can be accessed at clinicaltrials.gov (NCT05131022). WM is a rare, slow growing type of non-Hodgkin’s lymphoma that is characterized by the replacement of normal bone marrow cells by malignant lymphocytic cells that produce monoclonal IgM. This replacement leads to anemia, bleeding, and impaired immune function, while the elevated IgM levels may cause neurologic symptoms. In the United States the annual incidence rate is approximately 3 per million or between 1,000 to 1,500 newly diagnosed patients per year. Recommended first-line treatments including chemoimmunotherapy and BTK inhibitor therapy. There are no therapies approved to treat patients after BTKi. Additional therapeutic options are needed. Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative small molecules and antibody therapies based on the modulation of cellular protein levels as a novel treatment approach for cancer, inflammatory conditions, and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California. For additional information visit http://www.nurixtx.com. The content above comes from the network. if any infringement, please contact us to modify.