Aptose Tuspetinib Clinical Data Selected for Oral Presentation at the 2023 ASH Annual Meeting

On November 2, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, reported that clinical data for tuspetinib, a once daily oral therapy, has been selected for oral presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, CA (Press release, Aptose Biosciences, NOV 2, 2023, View Source [SID1234636730]).

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Lead investigator Naval Daver, MD, Professor, Director Leukemia Research Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, will present data from Aptose’s ongoing APTIVATE trial of tuspetinib in relapsed/refractory patients with acute myeloid leukemia.

The abstract accepted for presentation is listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website. Note that the actual presentation will include more recent updates and additional data not found in the abstract.

Oral Presentation Details

Title: Tuspetinib Myeloid Kinase Inhibitor Safety and Efficacy As Monotherapy and Combined with Venetoclax in Phase 1/2 Trial of Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
Publication Number: 162
Oral Presentation Session Date & Time: Saturday, December 9, 2023, 3:15 PM PT
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Novel Uses of Approved Therapeutic Agents
Location: San Diego Convention Center, Room 6A

Anaptys Announces Third Quarter 2023 Financial Results and Provides Business Update

On November 2, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the third quarter ended September 30, 2023 and provided a business update (Press release, AnaptysBio, NOV 2, 2023, View Source [SID1234636729]).

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"We’ve made strong progress this quarter executing against our multi-year plan to develop best-in-class immune cell modulators to drive differentiated clinical outcomes in heterogeneous, systemic autoimmune and inflammatory diseases," said Daniel Faga, president and chief executive officer of Anaptys. "Enrollment is ongoing in our global Phase 2b trials in atopic dermatitis for ANB032, our BTLA agonist, and rheumatoid arthritis for rosnilimab, our PD-1 agonist, while also initiating a global Phase 2 trial in ulcerative colitis for rosnilimab in Q4 2023."

Updates on Wholly Owned Immune Cell Modulator Pipeline

Rosnilimab (PD-1 agonist antibody)

Initiated in August a global Phase 2b trial in moderate-to-severe RA
420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
Top-line Week 12 data anticipated by mid 2025
Anticipate initiation in Q4 2023 of a global Phase 2 trial in moderate-to-severe UC
130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
Top-line Week 12 data anticipated by H1 2026
Hosted a virtual PD-1 Agonist (Rosnilimab) R&D Event in October 2023
Replay of the audio webcast is available here
Announcing two poster presentations at American College of Rheumatology (ACR) Convergence 2023 in San Diego, Nov. 10-15, 2023. Full preliminary program is available online on the ACR website –
Optimizing PD-1 Agonist Signaling with Membrane Proximal Binding of Rosnilimab, a Clinical Stage PD-1 Agonist IgG1 Antibody (abstract #0086)
Rosnilimab, a Novel PD-1 Agonist Monoclonal Antibody, Inhibits Peripheral T Cell Proliferation and Cytokine Secretion and Reduces Circulating PD-1 High Expressing T Cells: Results from a Phase 1 Healthy Volunteer Clinical Trial (abstract #0455)

ANB032 (BTLA agonist antibody)

Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (AD)
160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1
Top-line Week 14 data anticipated by year-end 2024
Presented poster on ANB032’s previously reported healthy volunteer Phase 1 data and a trial-in-progress poster presentation on ANB032’s Phase 2b study in moderate-to-severe AD at the 32 European Academy of Dermatology and Venerology (EADV) Congress in October 2023
Poster presentations are available here

ANB033 (anti-CD122 antagonist antibody)

Plan to submit an Investigational New Drug (IND) application in H1 2024

Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Announced positive top-line Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP)
53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131)
Demonstrated favorable safety and tolerability with no SAEs, low incidence and no increase of infections vs. placebo and no cases of DRESS or Guillain-Barre in imsidolimab-treated patients
Only one of 30 (3.3%) imsidolimab-treated patients had detectable ADA, which were non-neutralizing
Intend to out-license imsidolimab in 2024

Updates on GSK Immuno-Oncology Financial Collaboration

GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Anaptys has regained full global rights to GSK4074386, a Phase 2 ready LAG-3 antagonist antibody, from GSK

Year-End Cash Guidance

Reiterating cash runway through year-end 2026 with updated expected year-end 2023 cash and investments of $400 to $410 million

Third Quarter Financial Results

Cash, cash equivalents and investments totaled $453.3 million as of September 30, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $130.9 million. The decrease relates to cash used for the $50 million stock repurchase program and operating activities.
Collaboration revenue was $3.3 million and $8.2 million for the three and nine months ended September 30, 2023, compared to $1.3 million and $3.5 million for the three and nine months ended September 30, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli.
Research and development expenses were $30.9 million and $98.8 million for the three and nine months ended September 30, 2023, compared to $22.1 million and $65.4 million for the three and nine months ended September 30, 2022. The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.2 million and $7.7 million for the three and nine months ended September 30, 2023 as compared to $1.5 million and $5.0 million in the same period in 2022.
General and administrative expenses were $10.2 million and $31.7 million for the three and nine months ended September 30, 2023, compared to $8.9 million and $27.2 million for the three and nine months ended September 30, 2022. The G&A non-cash, stock-based compensation expense was $5.6 million and $17.4 million for the three and nine months ended September 30, 2023 as compared to $4.7 million and $15.7 million in the same period in 2022.
Net loss was $37.3 million and $121.4 million for the three and nine months ended September 30, 2023, or a net loss per share of $1.41 and $4.49, compared to a net loss of $33.5 million and $102.3 million for the three and nine months ended September 30, 2022, or a net loss per share of $1.18 and $3.64.

Alnylam Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Period Activity

On November 2, 2023 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported its consolidated financial results for the third quarter ended September 30, 2023 and reviewed recent business highlights (Press release, Alnylam, NOV 2, 2023, View Source [SID1234636728]).

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"We continued to deliver strong commercial results in the third quarter, with the successful launch of AMVUTTRA contributing to 35% year-over-year growth in net product revenues," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "While we were disappointed by the recent Complete Response Letter for ONPATTRO for the treatment of the cardiomyopathy of ATTR amyloidosis, we remain confident in the HELIOS-B Phase 3 study of vutrisiran, which is on track to deliver topline results in early 2024. We’re also excited about advancements across our broad pipeline of RNAi therapeutics, including recent positive topline results from the KARDIA-1 Phase 2 study of zilebesiran, as well as upcoming Phase 1 results for ALN-TTRsc04 and ALN-KHK by year-end. With this continued execution we remain on track to meet our Alnylam P5x25 goals of becoming a top-tier biotech company delivering sustained innovation and exceptional financial results."

Third Quarter 2023 and Recent Significant Corporate Highlights

Commercial Performance

Total TTR: ONPATTRO (patisiran) & AMVUTTRA (vutrisiran)

Achieved global net product revenues for ONPATTRO and AMVUTTRA for the third quarter of $82 million and $149 million, respectively, representing 35% total TTR reported year-over-year growth compared to Q3 2022.
Attained over 3,790 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of September 30, 2023.
Total Ultra-Rare: GIVLAARI (givosiran) & OXLUMO (lumasiran)

Achieved global net product revenues for GIVLAARI and OXLUMO for the third quarter of $54 million and $29 million, respectively, representing 33% total Ultra-Rare reported year-over-year growth compared to Q3 2022.
Attained over 625 patients worldwide on commercial GIVLAARI treatment as of September 30, 2023.
Attained over 375 patients worldwide on commercial OXLUMO treatment as of September 30, 2023.
Leqvio (inclisiran)

Leqvio launch in the U.S. and other markets is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education. In the U.S., Leqvio is covered at or near label for 76% of patients. More than 55% of Leqvio source of business in the U.S. is now through "Buy and Bill" acquisition mode. FDA expanded the label to include primary hyperlipidemia (patients at increased risk of ASCVD) and the removal of four adverse reactions from the safety section as well as Limitations of Use. In Q3 2023, Leqvio was approved in China and in Japan and is now approved in 93 countries.
R&D Highlights

Reported positive topline results from the KARDIA-1 Phase 2 dose-ranging study of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high cardiovascular risk.

Published results from Phase 1 study of zilebesiran in the New England Journal of Medicine.

Reported updated positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP in patients with early-onset Alzheimer’s disease at the 2023 Alzheimer’s Association International Conference and at the 16th Clinical Trials on Alzheimer’s Disease conference.

Based on the achievement of specified clinical proof-of-principle criteria for the Phase 1 ALN-APP program, Alnylam received a $100 million milestone payment from Regeneron.
Presented new 24-month results from an interim analysis of the open-label extension period of the APOLLO-B Phase 3 study of patisiran in patients with the cardiomyopathy of transthyretin-mediated amyloidosis at the Heart Failure Society of America Annual Scientific Meeting 2023.

Published results from Phase 3 APOLLO-B study of patisiran in the New England Journal of Medicine.

Sanofi reported positive data for fitusiran, in development for the treatment of hemophilia A or B, with or without inhibitors, from the Phase 3 open-label extension study (ATLAS-OLE).

Sanofi is currently in discussions with the FDA regarding filing in 2024.
Additional Business Updates

Entered into a global strategic collaboration with Roche for the co-development and co-commercialization of zilebesiran.
Recognized by Science magazine as a Top Employer for the fifth consecutive year.
Upcoming Events

Alnylam announces today that it will present a review of its RNAi platform and pipeline progress at a virtual R&D Day on December 13, 2023.

Alnylam announces today that results from the KARDIA-1 Phase 2 dose-ranging study of zilebesiran will be presented as a Late-Breaker at the American Heart Association Scientific Sessions 2023 on November 11, 2023, in Philadelphia, Pennsylvania.

In addition, in late 2023:

Alnylam intends to report topline results from the Phase 1 study of ALN-TTRsc04.
Alnylam intends to report topline results from the Phase 1 study of ALN-KHK.
Vir is conducting multiple trials evaluating the potential for ALN-HBV02 (VIR-2218) and VIR-3434 to achieve a functional cure for chronic hepatitis B. Phase 2 data readouts are on track for Q4 2023.
Vir also announced that initial Phase 2 data readouts for the SOLSTICE trial evaluating ALN-HBV02 (VIR-2218) and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis delta, the most aggressive form of viral hepatitis, are expected in Q4 2023.

Allogene Therapeutics Reports Third Quarter 2023 Financial Results and Business Update

On November 2, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported a corporate update and reported financial results for the quarter ended September 30, 2023 (Press release, Allogene, NOV 2, 2023, View Source [SID1234636727]).

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"Our experience continues to deepen as we successfully execute across our platform, creating a code for allogeneic cell therapy that can be applied not just in the industry’s first potentially pivotal trial of an allogeneic CAR T product candidate, but in other harder modes such as earlier line trials, solid tumors, and next-generation products and indications," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "We look forward to the months ahead and sharing these insights, potentially unlocking new opportunities and broadening patient access to CAR T therapy."

Pipeline Updates

Anti-CD19 AlloCAR T Program
ALPHA2 is the industry’s first potentially pivotal Phase 2 allogeneic CAR T clinical trial. This global trial for the ALLO-501A product candidate will enroll approximately 100 patients who have received at least two prior lines of therapy and have not received prior anti-CD19 therapy.

The single-arm ALPHA2 trial in relapsed/refractory (R/R) large B cell lymphoma (LBCL) utilizes a single dose of ALLO-501A (120 million CAR+ cells) following lymphodepletion with FCA90 (fludarabine, 30 mg/m2; cyclophosphamide 300 mg/m2; and investigational ALLO-647 30 mg, daily for 3 days). The primary endpoint is overall response rate (ORR), and the key secondary endpoint is duration of response (DoR). Patients may receive treatment as an outpatient at the investigator’s discretion. Enrollment is expected to be completed by the 1H 2024 with the first data readout by the end of 2024.

The Company announced it will have two poster presentations from the ALPHA/ALPHA2 trials focused on lymphodepletion in allogeneic cell therapy at the 65th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) December 2023.

The first poster is a comprehensive safety review of all 85 patients treated in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to characterize the overall safety profile when ALLO-647 is added to standard lymphodepletion.

The second poster showcases translational results from ALPHA2 generated through a collaboration with The University of Texas MD Anderson Cancer Center. This study compared expansion kinetics among 11 allogeneic CAR T recipients treated with the ALLO-501A product candidate in the ALPHA2 trial. The study revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. Results of this study could help define strategies to improve allogeneic CAR T expansion, persistence and efficacy.

Long-term follow up data was previously presented from the Phase 1 ALPHA/ALPHA2 trials in LBCL and has been extensively characterized in presentations earlier this year at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, European Hematology Association (EHA) (Free EHA Whitepaper) Congress, and International Conference on Malignant Lymphoma (ICML) in Lugano.

The Phase 1 trials enrolled heavily pre-treated patients with a median of three prior lines of therapy. Data from 33 CAR T-naïve LBCL patients receiving Alloy cell product, including 12 patients treated with the Phase 2 regimen, are the first to demonstrate the potential for an investigational allogeneic CAR T product to induce complete responses at rates and durability similar to approved autologous therapies. Treatment with the ALLO-501/501A product candidates was generally well tolerated with no incidence of Grade 3 or greater cytokine release syndrome, and no cases of immune effector cell-associated neurotoxicity syndrome or graft versus host disease. Cytopenia and infections were manageable and comparable to the experience with autologous CAR T cell therapies in patients with r/r LBCL.

The EXPAND trial, enrolling in the United States and Europe, is expected to support licensure of ALLO-647, the Company’s investigational anti-CD52 monoclonal antibody used in conjunction with standard low-dose FC (fludarabine, 30 mg/m2 and cyclophosphamide 300 mg/m2, daily for 3 days) lymphodepletion regimens. The trial will enroll approximately 70 patients with r/r LBCL who will be randomized to lymphodepletion with FCA90 (which includes 90 mg of ALLO-647) versus FC alone before receiving a single 120 million cell dose of ALLO-501A. The primary endpoint of the study is progression free survival (PFS).

Anti-CD70 AlloCAR T Program
The Phase 1 dose escalation TRAVERSE trial in patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies including an immune checkpoint inhibitor and a VEGF-targeting therapy is ongoing. Dose escalation in the TRAVERSE trial is expected to be completed by early 2024. The Company intends to target an academic forum in early 2024 to provide an update from this trial.

Next Generation Technologies and Targets

Cloak and Dagger Platform Technologies

The Company recently announced three poster presentations from its next generation AlloCAR T Platform at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The meeting will spotlight its novel, targeted Cloak and Dagger platform technologies designed to enhance engraftment, expansion and persistence of AlloCAR T cells.

These innovative approaches are intended to simplify lymphodepletion for allogeneic CAR T products and may provide a path to further expand the potential of off-the-shelf CAR T products beyond current targets and indications.

The Cloak platform technology is designed to prevent AlloCAR T cells from being recognized by host T cells without triggering substantial natural killer (NK) cell rejection while preserving CAR T cell function.

The Dagger platform technology, a feature of our ALLO-316 candidate, is designed to engineer AlloCAR T cells to selectively eliminate CD70 positive, alloreactive host immune cells, thereby mitigating potential premature rejection of AlloCAR T cells by the patient’s immune system. Translational results shared at AACR (Free AACR Whitepaper) suggest this unique immunomodulatory effect of ALLO-316 contributed to robust AlloCAR T cell expansion and persistence, and clinical remissions.

Based on preclinical results demonstrating the ability to combine anti-CD19 and other AlloCARs with the Dagger technology, the Company intends to explore this approach to potentially enhance the activity of next generation AlloCAR T products candidates, including those that target other hematological and solid tumors.

ALLO-182

SITC will also include a review of research which provided early validation of ALLO-182, an AlloCAR T candidate currently in the IND-enabling phase of development targeting Claudin18.2 for the treatment of patients with gastric and pancreatic cancers.

Corporate Updates
The Company has recently announced two new appointments to the leadership team. In August, the Company announced Earl Douglas as General Counsel, overseeing all aspects of the Company’s legal function. Following the close of the third quarter, the Company announced Geoffrey Parker as Executive Vice President, Chief Financial Officer, overseeing the Company’s financial operations and business development activities.

Third Quarter Financial Results

The Company had $497.7 million in cash, cash equivalents, and investments as of September 30, 2023.
Research and development expenses were $46.0 million for the third quarter of 2023, which includes $6.7 million of non-cash stock-based compensation expense.
General and administrative expenses were $17.0 million for the third quarter of 2023, which includes $8.6 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2023 was $61.3 million, or $0.37 per share, including non-cash stock-based compensation expense of $15.4 million.
2023 Financial Guidance

As previously provided, the Company expects a decrease in cash, cash equivalents, and investments of approximately $230 million in 2023. Based on current assumptions, the Company continues to expect its cash runway to fund operations into 2H 2025. GAAP Operating Expenses are expected to be approximately $340 million, including estimated non-cash stock-based compensation expense of approximately $80 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details

Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Allogene Therapeutics Announces Poster Presentations at the 65th Annual Meeting of the American Society of Hematology

On November 2, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will have two poster presentations focused on the importance of lymphodepletion in allogeneic cell therapy at the 65th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) taking place December 9-12, 2023 in San Diego, CA (Press release, Allogene, NOV 2, 2023, View Source [SID1234636726]).

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"All CAR T cells require lymphodepletion to support the expansion and persistence needed to eradicate malignant cells. Because of the risk of allorejection by the patient’s immune system, creating the necessary window of persistence for an off-the-shelf, allogeneic CAR T product may require an enhanced approach to lymphodepletion. These results reinforce our belief that Allogene’s strategy of adding ALLO-647, an anti-CD52 monoclonal antibody candidate, to the standard fludarabine/cyclophosphamide (flu/cy) lymphodepletion regimen in our ALPHA/ALPHA2 studies can safely achieve this," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. "Our unique and proprietary lymphodepletion regimen that includes ALLO-647 has been shown to potentially induce deep and durable remissions in relapsed and treatment-refractory cancers."

The first poster is a comprehensive safety review of all 85 patients treated in the Phase 1 ALPHA/ALPHA2 studies in relapsed/refractory (r/r) Large B Cell Lymphoma (LBCL) and follicular lymphoma (FL) to characterize the overall safety profile when ALLO-647 is added to standard lymphodepletion.

In June 2023 at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, the Company presented updated data from the Phase 1 ALPHA/ALPHA2 trials of investigational ALLO-501/501A in 33 CAR T naïve patients with r/r LBCL treated with the Alloy manufacturing process material across different CAR T dosing and lymphodepletion regimens. Data from the 12 patients, a subset of these 33 CAR T naïve patients, who received the regimen being utilized in ongoing Phase 2 trials was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These data demonstrated that administration of the anti-CD19 allogeneic CAR T product candidate following a 3-day lymphodepletion regimen that includes fludarabine 30 mg/m2 and cyclophosphamide 300-500 mg/m2 (FC) and 39, 60, or 90 mg of ALLO-647 in divided doses can potentially yield durable responses and an acceptable safety profile in line with approved autologous CAR T therapies.

Title: ALLO-647 for Lymphodepletion in the Allogeneic CAR T Setting: Safety Experience with ALLO-501/501A in Patients (Pts) with Relapsed/Refractory (r/r) Large B-Cell and Follicular Lymphomas
Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Abstract: 2095
Presenter: Dr. Frederick Locke, M.D., Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy; program co-leader, Immuno-Oncology, Moffitt Cancer Center
Tampa, Florida
Session Date & Time: Saturday, December 9, 2023, 5:30 PM – 7:30 PM PT
Location: San Diego Convention Center, Halls G-H

The second poster showcases translational results from ALPHA2 generated through a collaboration with researchers from The University of Texas MD Anderson Cancer Center. This study compared expansion kinetics among 11 allogeneic CAR T recipients treated with investigational ALLO-501A in the ALPHA2 trial. The study revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. Results of this study could help define strategies to improve allogeneic CAR T expansion, persistence, and efficacy.

Title: Cellular Mechanisms Affecting Allogeneic CAR T Cell Expansion and Rejection in Large B-cell Lymphoma
Session: 703. Cellular Immunotherapies: Basic and Translational: Poster III
Abstract: #4832
Presenter: Andrew P. Jallouk, M.D., Ph.D,Vanderbilt / MD Anderson
Session Date & Time: Monday, December 11, 2023 6:00pm – 8:00pm PT
Location: San Diego Convention Center, Halls G-H

About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing potentially pivotal Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.