On November 13, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, reported its financial results for the third quarter of 2024 (Press release, Xenetic Biosciences, NOV 13, 2024, View Source [SID1234648294]).

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"Over the course of the past quarter, we have continued to make progress advancing our DNase platform. Our focus is to leverage institutional partnerships to drive our development strategy, such as our recently announced agreement with Tokyo Medical University and extension of our agreement with The Scripps Research Institute, efficiently utilizing our capital while minimizing our non-program cash spend. We are encouraged by the preclinical data generated to date and remain focused on building a growing body of data and further developing our pipeline to build value in the near and long term," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

Xenetic continues to advance its DNase-based oncology program towards Phase 1 clinical development for the treatment of pancreatic carcinoma and other locally advanced or metastatic solid tumors. Preliminary preclinical studies evaluating the combinations of DNase I with chemotherapy and DNase I with immuno-therapies in colorectal cancer models as well as CAR-T therapy have been completed. The Company and its partners plan to report further preclinical data at scientific conferences as it recently did at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference (SITC 2024).

Summary of Financial Results for Third Quarter 2024
Net loss for the quarter ended September 30, 2024 was approximately $0.4 million. Research & development expenses for the three months ended September 30, 2024 decreased by approximately $0.7 million, or 63.9% to approximately $0.4 million from approximately $1.0 million in the comparable quarter in 2023. The decrease was primarily due to decreased spending in connection with our process development efforts related to our DNase platform. General and administrative expenses for the three months ended September 30, 2024 was relatively flat with the three months ended September 30, 2023. Increases in legal fees during the three months ended September 30, 2024 compared to the same period in 2023 were offset by decreases in personnel costs during the third quarter due to the departure of our former Chief Executive Officer in the second quarter of 2024.

The Company ended the quarter with approximately $6.8 million of cash.

On November 13, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported financial results for the third quarter of 2024 and provided a business update (Press release, Viracta Therapeutics, NOV 13, 2024, View Source [SID1234648290]).

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"Last quarter, based on productive feedback from FDA, we announced a sharpened focus on the second-line EBV-positive PTCL subpopulation in the NAVAL-1 trial’s expansion phase, which is ongoing," said Mark Rothera, President and Chief Executive Officer of Viracta. "To optimally support both the NAVAL-1 trial as well as a randomized controlled trial that we are planning for the second half of next year and reduce cash burn, we recently announced a reprioritization of resources intended to right-size our organization and further reduce our operating expenses. With a clearly defined regulatory path forward for Nana-val, we believe this will allow us to be efficient while we work toward the possible submission of a New Drug Application in 2026 and seek to introduce the first EBV-targeted therapy for lymphoma patients, subject to obtaining requisite funding."

"We are pleased to have determined a recommended Phase 2 dose for Nana-val in patients with advanced EBV-positive solid tumors," said Darrel P. Cohen, M.D., Ph.D., Chief Medical Officer of Viracta.

"Although the EBV-positive solid tumor program has been paused, clinical development in this patient population is ready for Phase 2, with additional financing or with a partner, using nanatinostat and valganciclovir doses that were well tolerated with evidence of antitumor activity."

Clinical Trial Updates and Anticipated Milestones

Phase 1b/2 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with recurrent/metastatic (R/M) Epstein-Barr virus-positive (EBV+) nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors (Study 301)

Clinical Trial Update:

In October, determined the recommended Phase 2 dose in patients with advanced EBV+ solid tumors.
Phase 2 NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma

Clinical Trial Updates:

In August, announced positive combined Stage 1 and Stage 2 data (n=21) in the R/R EBV+ PTCL cohort of patients treated with nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study.
Combined data from Stages 1 and 2 demonstrated Nana-val’s substantial antitumor activity and generally well-tolerated safety profile with a median duration of response (DOR) that has not yet been reached.
In August, announced that a productive FDA meeting was held to align on a potential regulatory path forward for Nana-val in patients with R/R EBV+ PTCL.
Based on feedback from the FDA and the particularly robust response rates observed in the second-line treatment setting, and to target its resources, Viracta will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase.
The Company plans to begin a randomized controlled trial (RCT) of Nana-val in the second-line treatment of EBV+ PTCL patients in the second half of 2025, subject to obtaining financing.
Anticipated Milestones

Viracta plans to deliver on the following milestones, subject to obtaining financing:

Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025.
Initiate the RCT in the second half of 2025.
Report preliminary data from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the first half of 2025.
Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.
Present interim analysis outcomes from the NAVAL-1 trial’s expansion phase in second-line EBV+ PTCL patients in 2026.
File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort.
Business Updates

Announced on November 6th a reprioritization of resources intended to enhance focus on the Company’s lead program, reduce cash burn, and drive shareholder value:
Included a reduction in force affecting approximately 42% of the Company’s employees.
Also reduced the size of its Board of Directors from 10 to 6 seats following voluntary resignations from 4 directors.
Third Quarter 2024 Financial Results

Cash position – Cash, cash equivalents, and short-term investments totaled approximately $21.1 million as of September 30, 2024, which Viracta expects will be sufficient to fund operations late into the first quarter of 2025.
Research and development expenses – Research and development expenses were approximately $7.2 million and $23.7 million for the three and nine months ended September 30, 2024, respectively, compared to approximately $8.2 million and $24.0 million for the same periods in 2023. The decrease in research and development expenses for the three months ended September 30, 2024 compared to the same period in 2023, was driven by decreases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our Phase 2 trial of Nana-val in patients with R/R EBV+ lymphomas and personnel-related costs. The decrease in research and development expenses for the nine months ended September 30, 2024 compared to the same period in 2023, was largely due to decreases in costs incurred related to our clinical development programs and personnel-related costs, partially offset by a non-cash adjustment for insurance costs related to the February 2021 reverse merger with Sunesis Pharmaceuticals of $1.8 million.
General and administrative expenses – General and administrative expenses were approximately $3.0 million and $10.0 million for the three and nine months ended September 30, 2024, respectively, compared to $4.3 million and $13.2 million for the same periods in 2023. The decrease in general and administrative expenses was largely due to decreases in personnel-related costs, corporate liability insurance premiums and consulting and legal costs.
Net loss – Net loss was approximately $10.6 million, or $0.27 per share (basic and diluted), for the quarter ended September 30, 2024, compared to a net loss of $12.6 million, or $0.33 per share (basic and diluted), for the same period in 2023. This change was primarily the result of decreases in research and development expenses and personnel-related costs. Net loss was approximately $29.5 million, or $0.75 per share, (basic and diluted) for the nine months ended September 30, 2024, compared to a net loss of $37.3 million, or $0.97 per share, (basic and diluted) for the same period in 2023. This change was primarily the result of $5.0 million of other income received related to the monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc. in March 2024, and decreases in costs related to our clinical development programs and personnel-related costs, partially offset by the non-cash adjustment for insurance costs related to the February 2021 merger of $1.8 million.
About the NAVAL-1 Trial
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors.

About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On November 13, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the third quarter of 2024 and its recent business highlights (Press release, Sutro Biopharma, NOV 13, 2024, View Source [SID1234648288]).

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With its lead program, luveltamab tazevibulin (luvelta), Sutro recently initiated a registrational trial for a rare form of pediatric leukemia, a clinical trial for non-small cell lung cancer (NSCLC), and presented expansion data in combination with bevacizumab. The randomized portion of Sutro’s registrational trial for patients with advanced ovarian cancer is underway. Sutro expects to provide an update following alignment with the U.S. Food & Drug Administration (FDA) on the selected dose for the pivotal portion of this trial around the end of the year.

Recognizing the potential patient benefit and commercial opportunity for luvelta, Sutro engaged Lazard to assist in its efforts to identify a partner for luvelta who can provide financial resources and expertise for the multi-indication development and commercialization of luvelta.

Additionally, Sutro showcased at a recent Research Forum a portfolio of emerging next-generation ADCs, made possible by our unique cell-free platform, which are expected to drive value creation beyond luvelta. During the event, Sutro announced three planned IND filings over the next three years for wholly owned programs, including STRO-004, a tissue-factor targeting ADC, featuring a DAR8 exatecan payload and site-specific linker design, which is expected to enter the clinic next year.

Recent Business Highlights and Select Anticipated Milestones

Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise:

•
Sutro presented updated data from the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, demonstrating a 56% response rate at the recommended Phase 2 dose of luvelta (4.3 mg/kg) for this study. An expansion study of this combination is ongoing, with data expected in the first half of 2025.
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Part 2 (randomized portion) of the Phase 3 trial, REFRαME-O1, for treatment of platinum-resistant ovarian cancer (PROC), is ongoing.
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REFRαME-P1, a registration-enabling trial for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is underway.

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A Phase 2 trial for the treatment of NSCLC is underway, with initial data expected in 2025.
Additional Pipeline Development and Collaboration Updates:

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In October 2024, Sutro hosted a Research Forum highlighting next-generation ADC innovation and near-term pipeline milestones, including:
o
STRO-004, a tissue factor-targeting ADC, which features a drug-antibody-ratio (DAR) of eight exatecan payloads and site-specific linker design, demonstrated greater anti-tumor activity and lower toxicities than a tissue factor benchmark ADC in preclinical models. Sutro anticipates filing an IND for STRO-004 in the second half of 2025.
o
Dual-payload ADCs (ADC2) provide therapeutic benefits compared to standard ADCs, including potential to overcome tumor resistance mechanisms, and show increased anti-tumor activity and desirable properties in preclinical models.
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iADCs provide a novel mechanism of action, bridging innate and adaptive immunity to enable broad protection in a single molecule, and show increased and durable anti-tumor activity in a preclinical model compared to standalone ADCs or immune-stimulating antibody conjugates.
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Sutro’s proprietary and partnered preclinical ADC portfolio has potential across a broad range of tumor types and the Company plans to deliver three INDs over the next three years.
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Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $975 million in payments through September 30, 2024, including equity investments.
Upcoming Events: Sutro plans to participate in three upcoming investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the events.

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Jefferies London Healthcare Conference, November 19-21, 2024, in London
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The Citizens JMP Hematology and Oncology Summit, December 2, 2024, Virtual
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Piper Sandler 36th Annual Healthcare Conference, December 3-5, 2024, in New York
Third Quarter 2024 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2024, Sutro had $388.3 million in cash, cash equivalents and marketable securities.

Realized Gain on Sale of Vaxcyte Common Stock

Included in non-operating interest and other income (expense), net, on the Statement of Operations for the nine months ended September 30, 2024 was a realized gain of $32.1 million from the sale of approximately 0.7 million shares of Vaxcyte common stock, with net proceeds of approximately $74.0 million. As of September 30, 2024, Sutro does not hold any shares of Vaxcyte common stock.

Revenue

Revenue was $8.5 million for the quarter ended September 30, 2024, as compared to $16.9 million for the same period in 2023, with the 2024 amount related principally to the Astellas collaboration and the Vaxcyte agreement. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses

Total operating expenses for the quarter ended September 30, 2024 were $76.4 million, as compared to $60.9 million for the same period in 2023. The 2024 quarter includes non-cash expenses for stock-based compensation of $6.5 million and depreciation and amortization of $1.8 million, as compared to $6.0 million and $1.7 million, respectively, in the comparable 2023 period. Total operating expenses for the quarter ended September 30, 2024 were comprised of research and development expenses of $62.1 million and general and administrative expenses of $14.3 million.

On November 13, 2024 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the third quarter ended September 30, 2024, and provided a corporate update (Press release, Sellas Life Sciences, NOV 13, 2024, View Source [SID1234648287]).

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"We continue to make considerable progress across our pipeline, and we are particularly excited to announce the updated SLS009 Phase 2a data at ASH (Free ASH Whitepaper) in December and to provide topline data from cohorts four and five in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) this quarter," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are extremely grateful to the patients and their families, principal investigators and study teams, SELLAS employees, and all of those who have contributed to our Phase 3 REGAL study of galinpepimut-S (GPS). We are excited to be on the cusp of potentially adding a novel immunotherapy to physicians’ arsenals in their mission to prolong patients’ lives. We are looking forward to the significant milestones on the horizon, with interim analysis from our Phase 3 REGAL study of GPS in AML anticipated in the coming weeks."

Pipeline Highlights

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: In June, the IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projected that the interim analysis (60 events) will occur in the fourth quarter of 2024.
Granted FDA Rare Pediatric Disease Designation (RPDD): The FDA granted Rare Pediatric Disease Designation (RPDD) to GPS for the treatment of pediatric AML. GPS has already demonstrated promise in clinical settings for AML, which could extend to pediatric patients.

SLS009: highly selective and specific CDK9 inhibitor
ASH Poster Presentation Upcoming December 8, 2024: Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment.

The study enrolled 30 patients across three dosing levels (DLs) of SLS009:45 mg IV QW, DL2: 60 mg IV QW, and DL3: 30 mg IV BIW. SLS009 was well-tolerated across the DLs tested with no dose-limiting toxicities (DLTs) observed. Among 29 evaluable pts, 16 (55%) had ≥50% reduction in bone marrow (BM) blasts compared to baseline (DL1: 60%; DL2: 33%; DL3: 80%). Nine (31%) patients achieved an overall response (i.e., CR+CRi+MLFS), including 5 (17%) who achieved CR/CRi. The response rates per dose level were 10% in DL1, 33% in DL2, and 50% in DL3. All 9 responders had AML- Myelodysplasia Related (AML-MR) (9/23 of AMLMR pts responded) and 8/15 pts (53%) with somatic MR mutations responded. Among those with ASXL1 mutations, 5/9 (56%) achieved an overall response. 2/9 (22%) with TP53 mutations achieved a response including one patient with concomitant TP53 and ASXL1 mutation who had an ongoing response at data cut-off. Fifteen patients were still alive at the time of the data cutoff and the median OS for the trial has not been reached.
Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Continue Enrollment: Development of SLS009 continued with the ongoing enrollment of two additional cohorts: AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia-related changes other than ASXL1 mutations. These cohorts are also open for enrollment of certain pediatric patients. Additional topline data updates are expected in the fourth quarter of 2024.

National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported in the fourth quarter of 2024.

Recently Granted Regulatory Designations for SLS009: The FDA granted Rare Pediatric Disease Designation (RPDD) to SLS009 for the treatment of pediatric ALL in June 2024 and the FDA granted RPDD to SLS009 for the treatment of pediatric AML in July 2024. Also, the EMA granted Orphan Drug Designation for SLS009 in AML and in PTCL in June 2024 and July 2024, respectively. The FDA previously granted SLS009 Orphan Drug Designations in AML and PTCL and Fast Track designations for r/r AML and r/r PTCL.

Financial Results for the Third Quarter 2024:

R&D Expenses: Research and development expenses for the quarter ended September 30, 2024, were $4.4 million, compared to $5.8 million for the same period in 2023. The decrease was primarily due to decreases in global clinical supply purchases, consultants, personnel-related expenses due to changes in headcount, and clinical trial expenses.
G&A Expenses: General and administrative expenses for the third quarter of 2024 were $3.0 million, compared to $3.5 million for the same period in 2023. The decrease was primarily attributed to personnel-related expenses due to changes in headcount and insurance premiums.

Net Loss: The net loss was $7.1 million for the third quarter of 2024, or a basic and diluted loss per share of $0.10, as compared to a net loss of $9.3 million for the third quarter of 2023, or a basic and diluted loss per share of $0.33. The net loss was $24.1 million for the nine months ended September 30, 2024, or a basic and diluted loss per share of $0.42, as compared to a net loss of $29.2 million for the same period in 2023, or a basic and diluted loss per share of $1.09.
Cash Position: As of September 30, 2024, cash and cash equivalents totaled approximately $21 million.

On November 13, 2024 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported new and updated data from its hematology pipeline will be shared across 23 abstracts at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting, taking place from December 7-10 in San Diego, CA (Press release, Regeneron, NOV 13, 2024, View Source [SID1234648286]). The latest research advances demonstrate the potential of Regeneron’s diverse pipeline, which aims to address unmet needs in ten types of blood cancers and disorders. These innovative and differentiated approaches include CD3 bispecific antibodies, costimulatory bispecific antibodies, and a pioneering combination of a monoclonal antibody and small interfering RNA (siRNA).

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"Our presentations at ASH (Free ASH Whitepaper) demonstrate the progress we are making toward transforming care for a range of blood cancers and disorders where advancements are desperately needed," said L. Andres Sirulnik, M.D., Ph.D., Senior Vice President and Hematology Clinical Development Unit Head at Regeneron. "These include new head-to-head data exploring a novel combination that aims to maximize disease control in paroxysmal nocturnal hemoglobinuria compared to a standard-of-care treatment, as well as initial results from our confirmatory odronextamab trial in first-line follicular lymphoma. Together, our presentations underscore our commitment to work towards translating scientific breakthroughs to differentiated medicines for hematology patients."

At ASH (Free ASH Whitepaper), abstracts in blood disorders include an oral presentation from an exploratory cohort of a Phase 3 trial investigating a novel combination of pozelimab with cemdisiran compared to ravulizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were naïve to complement inhibition at baseline. Notably, the presentation will detail interim results from patients who were initially randomized to ravulizumab but crossed over to the combination in an open label extension portion of the trial.

Progress on the odronextamab development program will be featured in twelve abstracts. Among them are initial results in patients with previously untreated follicular lymphoma (FL) from Part 1 of the Phase 3 OLYMPIA-1 confirmatory trial, which consists of a non-randomized safety run-in (Part 1) followed by a randomized efficacy portion (Part 2) comparing odronextamab monotherapy to rituximab plus standard-of-care chemotherapies. Two oral presentations on the ELM-1 and pivotal ELM-2 trials will feature new analyses in settings with significant unmet needs: one in patients with diffuse large B-cell lymphoma (DLBCL) who progressed after CAR-T therapy and the other in relapsed/refractory (R/R) marginal zone lymphoma (MZL).

Other notable abstracts include the latest linvoseltamab efficacy and safety results from the pivotal LINKER-MM1 study in R/R multiple myeloma (MM), preclinical data evaluating a CD38xCD28 costimulatory bispecific antibody in combination with linvoseltamab, and preclinical data on TMPRSS6 inhibition in beta-thalassemia.

The full list of Regeneron presentations at ASH (Free ASH Whitepaper) includes:

Abstract Title Abstract Presenter Session Date/Time (PT)
Odronextamab
Efficacy and Safety of Odronextamab Monotherapy in Patients (Pts) with Diffuse Large B-Cell Lymphoma (DLBCL) Progressing after CAR T-Cell Therapy: Primary Analysis from the ELM-1 Study Abstract #866
Oral Presentation
Session

Matthew Matasar Monday, December 9, at 2:45-4:15 pm

Marriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17
Efficacy and Safety of Odronextamab in Relapsed/Refractory Marginal Zone Lymphoma (R/R MZL): Data from the R/R MZL Cohort in the ELM-2 Study Abstract #862
Oral Presentation
Session

Tae Min Kim Monday, December 9, at 2:45-4:15 pm

Marriott Marquis San Diego Marina, Marriott Grand Ballroom 11-13
Odronextamab Monotherapy in Previously Untreated Patients with High-Risk Follicular Lymphoma (FL): Results of the Safety Lead-in of the Phase 3 OLYMPIA-1 Study Abstract #4411
Poster Presentation
Session
Elizabeth Brem

Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Efficacy and Safety of Odronextamab in Rare Subtypes of Relapsed/Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (B-NHL): Data from a Dedicated Cohort of Other B-NHLs in the ELM-2 Study Abstract #4502
Poster Presentation
Session Emmanuel Bachy Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Treatment Duration and Risk of Fatal Infections in Patients with B-Cell Non-Hodgkin Lymphoma Achieving Complete Response with Odronextamab Abstract #3080
Poster Presentation Gottfried von Keudel

Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Dynamics of Complete Responses in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Treated with Odronextamab in the ELM-2 Study Abstract #4486
Poster Presentation
Session
Sabarish Ayyappan

Monday, December 9, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Long-Term Efficacy and Safety of Odronextamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Pooled Analysis from ELM-1 and ELM-2 Studies Abstract #3118
Poster Presentation
Session
John N. Allan Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Evaluation of CAR-HEMATOTOX Scoring as a Predictor of Infection Risk following Treatment with Odronextamab (a CD20×CD3 Bispecific Antibody) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Abstract #3076
Poster Presentation
Session
Mathew Matasar Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Evaluation of Baseline CAR-HEMATOTOX Scores to Predict Increased Severe Infection Risk in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Odronextamab Abstract #1650
Poster Presentation
Session
Matthew Matasar Saturday, December 7, at 5:30-7:30 pm

San Diego Convention Center, Halls G-H
Dynamics of Complete Responses in Patients with Relapsed or Refractory Follicular Lymphoma Treated with Odronextamab in the ELM-2 Study Abstract #1628
Poster Presentation
Session
Stefano Luminari Saturday, December 7, at 5:30-7:30 pm

San Diego Convention Center, Halls G-H
Trial in Progress: Odronextamab for the Treatment of Patients with Relapsed/Refractory Mantle Cell Lymphoma following Prior BTK Inhibitor Therapy – A Cohort of the ELM-2 Study Abstract Publication Only Srikanth Ambati N/A
Matching-Adjusted Indirect Comparisons (MAICs) of Odronextamab Versus Mosunetuzumab and Epcoritamab for the Treatment of Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) after Two or More Lines of Systemic Therapy Abstract Publication Only

Deepa Jagadeesh N/A
Linvoseltamab
Linvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma: Longer Follow-Up and Selected High-Risk Subgroup Analyses of the LINKER-MM1 Study Abstract #3369
Poster Presentation Mansi R. Shah Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Soluble BCMA Dynamics in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Linvoseltamab in LINKER-MM1 Abstract #3310
Poster Presentation Anasuya Hazra Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Characterization of Linvoseltamab’s BCMA Binding Epitope and Efficacy Against BCMA Mutations in Relapsed/Refractory Multiple Myeloma Abstract #3265
Poster Presentation Ken Lee & Yi Zhou Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
A CD38xCD28 Costimulatory Bispecific Antibody Demonstrates Potent Preclinical Combinatorial Activity with a BCMAxCD3 T Cell-Engager Abstract #3283
Poster Presentation Kara Olson & David J. DiLillo Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
Reducing Time Toxicity for Anti-B-Cell Maturation Antigen (BCMA) Bispecific Treatment: Evidence from Pivotal Single-Arm Trial Data on Teclistamab, Elranatamab, and Linvoseltamab for Triple-Class Exposed (TCE) Relapsed/Refractory Multiple Myeloma (RRMM)
Abstract #2271
Poster Presentation Session
Sikander Ailawadh Saturday, December 7, at 5:30-7:30 pm

San Diego Convention, Halls G-H
Exposure-Response Analyses of Various Efficacy and Safety Endpoints in Support of Registrational Dose Selection of Linvoseltamab in Patients with Relapsed/Refractory Multiple Myeloma Abstract Publication Only Oleg Milberg N/A
Comparative Effectiveness of Linvoseltamab Versus Current Real-World Standard-of-Care Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma Treated at IMWG Sites Abstract Publication Only

Shaji Kumar N/A
Comparative Effectiveness of Linvoseltamab Versus Current Real-World (RW) Standard-of-Care (SOC) Therapies in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma (RRMM): Key Subgroups Analysis Abstract Publication Only

Shaji Kumar N/A
Additional Presentations
Efficacy and Safety of Pozelimab Plus Cemdisiran vs Ravulizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria who are Naïve to Complement Inhibition* Abstract #306
Oral Presentation Session Christopher Patriquin Saturday, December 7, at 4 – 5:30 pm

San Diego Convention Center, Room 11
TMPRSS6 Inhibition Rapidly Reverses Liver Iron Overload and Prevents an Increase of Splenic Pro-Inflammatory Macrophages in a Mouse Model of Beta-Thalassemia Abstract #2473
Poster Presentation Session

Heinrich E. Lob Sunday, December 8, at 6:00-8:00 pm

San Diego Convention Center, Halls G-H
The Reality of Beta Thalassemia and Iron Chelation Therapy – A Qualitative Study Unveiling the Patient Burden Abstract Publication Only

Chris Hartford
*Agreement with Alnylam Pharmaceuticals, Inc.

Linvoseltamab as well as the combination of pozelimab and cemdisiran are investigational, and the potential uses of odronextamab in R/R MZL and rare subtypes of R/R aggressive B-cell non-Hodgkin lymphoma are also investigational and have not been approved by any regulatory authority. Odronextamab is approved in the European Union as Ordspono to treat R/R FL or DLBCL after two or more lines of systemic therapy, but the safety and efficacy of odronextamab have not been fully evaluated by any other regulatory authority.

About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.

Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.

Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.

About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron’s Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985.They were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo, Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb), Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz (pozelimab-bbfg).