On November 12, 2025 Leukogene Therapeutics Inc., a biopharmaceutical company developing next-generation therapies for hematologic and other immunologically "cold" malignancies, reported that it has received funding from the South Carolina Research Authority (SCRA) and its investment affiliate, SC Launch Inc.

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"We are honored to receive this strategic funding from SCRA and SC Launch Inc. It will allow us to advance our programs toward the clinic, strengthen our position as a leader in developing next-generation cancer therapeutics and continue building a world-class biotech company right here in South Carolina," said Dr. Sandeep Gupta, Chief Executive Officer of Leukogene. Nathan Dolloff, PhD, Founder and Chief Scientific Officer added, "This investment represents a strong validation of our vision and science and enables us to accelerate our mission of bringing transformative therapies to patients with hard-to-treat cancers."

"Leukogene Therapeutics exemplifies the kind of innovative, high-growth company that SCRA and SC Launch Inc. were designed to support," said Matt Bell, Executive Director of SC Launch. "Their groundbreaking immunotherapy platform and strong leadership team are well-positioned to make a lasting impact in oncology and the broader biotech sector. We are proud to partner with them as they advance toward clinical development."

(Press release, Leukogene Therapeutics, NOV 12, 2025, View Source [SID1234659861])

On November 12, 2025 Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the quarter ended September 30, 2025, and provided a business update.

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Q3 2025 and Recent Business Highlights

Dosed first patient in Phase 1/2 trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in August 2025
Presented positive preclinical data at BIO-Europe for ATR-01 program, targeting the treatment of ichthyosis vulgaris
Raised $2.8M in gross proceeds through our established equity line of credit with institutional investor Alumni Capital LP
"The third quarter of 2025 was an impactful period for Azitra as we continued to progress our live biotherapeutic programs, including dosing the first patient in our Phase 1/2 trial for ATR-04 targeting oncology patients with EGFRi-associated rash," said Francisco Salva, CEO of Azitra. "This candidate previously received Fast Track designation from the FDA as there is an incredible opportunity to help alleviate a major dermatologic toxicity associated with EGFR inhibitor treatments, which impacts approximately 150,000 people in the U.S. annually. The skin toxicity that can accompany EGFRi treatment often leads to interruption or discontinuation of the treatment, profoundly impacting patients as they seek live-saving care across a variety of cancers."

Mr. Salva added: "In addition, we were thrilled to present positive preclinical data for our ATR-01 program at BIO-Europe. ATR-01 is designed to treat ichthyosis vulgaris, an autosomal semidominant genetic disorder that impacts approximately 1.3 million people in the U.S., with no treatment options beyond symptom management. The disease is caused by missing or abnormal filaggrin levels. Our preclinical data showed production of active, functional filaggrin delivery through human stratum corneum and repair of damage in a skin model of disease."

Mr. Salva continued: "We continue to progress our lead program, ATR-12, targeting the rare, chronic and devastating Netherton syndrome. We are optimistic that this novel approach has potential to be life-changing for these patients, in an area of severe unmet need with no approved treatment options."

Mr. Salva concluded: "The second half of 2025 has already proven to be a positive period for Azitra, and we continue to look forward to showcasing the potential of our three development programs ATR-12, ATR-04, and ATR-01. All three programs were generated from our unique, proprietary platform to deliver engineered proteins using topical live biotherapeutic products."

Financial Results for the Quarter Ended September 30, 2025

Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2025, were $1.2 million compared to $1.0 million for the comparable period in 2024./PRNewswire/ —
General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2025, were $1.6 million compared to $1.9 million for the comparable period in 2024.
Net Loss was $2.8 million for the quarter ended September 30, 2025, compared to $1.0 million for the comparable period in 2024.
Cash and cash equivalents: As of September 30, 2025, Azitra had cash and cash equivalents of $1.4 million.

(Press release, Azitra, NOV 12, 2025, View Source [SID1234659807])

On November 12, 2025 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the third quarter ended September 30, 2025, and provided an update on its recent corporate progress.

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"During the third quarter, our team aggressively advanced each of our previously outlined strategic priorities, which we believe will position MacroGenics for long-term success. Importantly, we secured $75 million in additional non-dilutive partnership payments, which we expect to receive during the fourth quarter. As part of these recent partnering activities, we extended our relationship with Gilead to include a preclinical program based on our novel T-cell engager platform," said Eric Risser, President and CEO of MacroGenics. "On the clinical front, following a portfolio review and evaluation of interim data from the LORIKEET study, we have decided not to pursue further development of lorigerlimab in prostate cancer. Despite this decision, we remain committed to exploring lorigerlimab’s potential in ovarian and other gynecologic cancers and continue to enroll patients in the Phase 2 LINNET study. We also continue to advance our three other ADC programs and recently initiated two Phase 1 expansion cohorts for the MGC026 program."

"Our team continues to be laser-focused on building shareholder value by advancing treatment options that have transformative potential for patients. We look forward to continuing to deliver on our strategic priorities to position the company for success in 2026 and beyond," Mr. Risser concluded.

Key Strategic Priorities for 2025 and 2026

Determine development path for lorigerlimab.
Advance portfolio of antibody-drug conjugates (ADCs), including MGC026, MGC028, and MGC030.
Initiate Investigational New Drug (IND)-enabling studies for two new product candidates.
Forge partnerships and collaborations to accelerate development of MacroGenics’ proprietary product candidates and platforms.
Strengthen MacroGenics’ financial position through a combination of enhanced operational efficiency, collaboration revenue, and monetization of assets.
Recent Highlights in Advancing MacroGenics’ Strategic Priorities

Determine Development Path for Lorigerlimab
As MacroGenics assesses how best to invest its resources across its product portfolio, the Company has decided to not pursue further development of lorigerlimab (a bispecific, tetravalent PD-1 × CTLA-4 DART molecule) in combination with docetaxel and prednisone for the treatment of second-line metastatic castration-resistant prostate cancer (mCRPC). MacroGenics will continue the ongoing LINNET Phase 2 monotherapy study of lorigerlimab in patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC).

LORIKEET Study. The Company determined not to pursue further development of lorigerlimab in second-line mCRPC based on interim data from the Phase 2 LORIKEET trial, a 150-patient randomized study evaluating lorigerlimab in combination with docetaxel and prednisone vs. docetaxel and prednisone in second-line, chemotherapy-naïve patients with mCRPC. Based on review of study data with an October 17, 2025 data cut-off, the Company determined that the experimental treatment arm will not reach the study’s primary goal of showing an improvement in rPFS vs. that of the control arm for the targeted patient population. The Company intends to present or publish the final LORIKEET data at a future date.

LINNET Study. MacroGenics continues the ongoing LINNET study, a Phase 2 monotherapy trial evaluating lorigerlimab in patients with either PROC or CCGC. The Company believes lorigerlimab can be a differentiated treatment option for patients with gynecologic cancers and could be complementary with some of the emerging therapies being developed for this patient population. The Company continues to enroll patients in the LINNET study and currently expects to provide a clinical update on the first part of the two-stage trial by mid-2026.
Advance Innovative ADC Pipeline
MacroGenics is developing three ADCs that each incorporate a novel, glycan-linked topoisomerase 1 inhibitor (TOP1i)-based payload developed by the Company’s collaboration partner, Synaffix (a Lonza company).

MGC026 targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. The Company recently completed Phase 1 dose escalation and initiated dose expansion in two solid tumor indications.

MGC028 targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers. MGC028 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors.

MGC030 is a preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An IND application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026.
Forge Partnerships & Strengthen MacroGenics’ Financial Position

Gilead. In November 2025, Gilead licensed an additional MacroGenics preclinical program under a 2022 collaboration agreement, triggering a $25 million payment to MacroGenics. The licensed program leverages the Company’s novel, proprietary platform with the goal of improving upon the safety and efficacy of traditional T-cell engagers. Under this collaboration, MacroGenics and Gilead are now advancing three programs, including MGD024, a clinical-stage CD123 × CD3 bispecific DART molecule, a preclinical TRIDENT program and this latest preclinical DART program. The Company remains eligible to receive up to $1.6 billion in future milestones as well as royalties related to these three product candidates.

Sanofi. Sanofi continues to advance TZIELD (teplizumab-mzwv), an antibody targeting CD3 that the Company sold in 2018 to a partner that was subsequently acquired by Sanofi S.A. (Sanofi). In August and September 2025, TZIELD was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and by the National Medical Products Administration (NMPA) in China, respectively, triggering total milestone payments of $50 million, which are expected to be received during the fourth quarter. In October 2025, Sanofi announced that TZIELD had been accepted for expedited review in the U.S. for stage 3 type 1 diabetes through the FDA Commissioner’s National Priority Voucher pilot program. MacroGenics remains eligible to receive up to $330 million in additional milestones related to TZIELD.
Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of September 30, 2025, was $146.4 million, compared to $201.7 million as of December 31, 2024. The cash balance as of September 30, 2025, does not include the $50.0 million from Sanofi or the $25.0 million from Gilead, which are expected to be received by year-end 2025.
Revenue: Total revenue was $72.8 million for the quarter ended September 30, 2025, compared to $110.7 million for the quarter ended September 30, 2024. Total revenue included contract manufacturing revenue of $19.8 million for the quarter ended September 30, 2025, compared to $4.6 million for the quarter ended September 30, 2024, reflecting increased third-party production in 2025. Collaboration revenue was $53.0 million for the quarter ended September 30, 2025, compared to $101.4 million for the quarter ended September 30, 2024. The difference was due to $100.0 million recognized from milestones under the Incyte License Agreement in 2024 compared to $50.0 million recognized from milestones under the Provention (Sanofi) Asset Purchase Agreement in 2025.
R&D Expenses: Research and development expenses were $32.7 million for the quarter ended September 30, 2025, compared to $40.5 million for the quarter ended September 30, 2024. The decrease was primarily due to discontinued internal development of the vobra duo program, decreased IND-enabling costs for MGC028 and decreased costs related to margetuximab.
Cost of Manufacturing Services: Cost of manufacturing services was $11.6 million for the quarter ended September 30, 2025, compared to $1.7 million for the quarter ended September 30, 2024.
SG&A Expenses: Selling, general and administrative expenses were $9.9 million for the quarter ended September 30, 2025, compared to $14.1 million for the quarter ended September 30, 2024. The decrease was primarily due to lower stock-based compensation expense and cessation of MARGENZA (margetuximab-cmkb) commercialization activities.
Net Income: Net Income was $16.8 million for the quarter ended September 30, 2025, compared to net income of $56.3 million for the quarter ended September 30, 2024.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2025, were 63,258,532.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $146.4 million as of September 30, 2025, in addition to subsequent receipt of $75.0 million in partnering payments from Sanofi and Gilead, plus projected and anticipated future payments from partners and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway into late 2027.

(Press release, MacroGenics, NOV 12, 2025, View Source [SID1234659823])

On November 12, 2025 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the third quarter ended September 30, 2025, and provided a business update, including highlights of pipeline progress.

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"We continue to make great progress advancing the ENABLE Phase 1 trial of ELVN-001 in people living with CML. I’m pleased to report that during the quarter, we completed enrollment of the randomized Phase 1b portion of the ENABLE trial and achieved key readiness milestones across multiple geographies, positioning us to rapidly launch our Phase 3 trial globally next year," said Sam Kintz, Co-Founder and Chief Executive Officer of Enliven. "Since we announced our positive, updated ENABLE data in June, we have had oral presentations at multiple medical meetings, which is a testament to the strength of the data and the potential for ELVN-001 as a selective active-site inhibitor. Additionally, we are pleased that the CML community continues to validate our work and enthusiastically supports ELVN-001 as we move through clinical trials. We remain focused on clinical execution as we look to initiate our Phase 3 pivotal trial in 2026."

Pipeline Updates

ELVN-001 is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).

Completed enrollment of the randomized Phase 1b cohorts of the ongoing ENABLE trial of ELVN-001 in CML (NCT05304377).
Presented encore data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 at several medical meetings, including:
An oral and poster presentation at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting in Houston, Texas, on September 3, 2025.
An oral presentation at the European Society of Hematology International Chronic Myeloid Leukemia Foundation (ESH-iCMLf) 27th Annual John Goldman Conference on Chronic Myeloid Leukemia: Biology and Therapy in Estoril, Portugal, on October 10, 2025.
An oral presentation at the German, Austrian, and Swiss Societies for Hematology and Medical Oncology (DGHO) in Cologne, Germany, on October 25, 2025.
Featured in an oral presentation titled, ELVN-001 for the treatment of CML with and without T315I mutation: a Phase 1 trial in Japan, at the 87th Annual Meeting of the Japanese Society of Hematology (JSH) in Kobe, Japan, on October 10, 2025.
Remains on track to initiate a Phase 3 pivotal trial of ELVN-001 in 2026.
Upcoming Medical Meeting Presentations

The Company recently announced that data from the ENABLE Phase 1a/1b clinical trial of ELVN-001 in a subset of CML patients with atypical fusion transcripts will be presented at the 67th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) 2025 Annual Meeting and Exposition, taking place December 6-9, 2025, in Orlando, Florida. Andreas Hochhaus, M.D., will present the data in a poster presentation on December 7, 2025.

Upcoming Investor Conference Participation

Management will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025, at 2:00 p.m. GMT. The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at View Source The webcast will be archived for a period of 90 days following the conclusion of the live event.

Third Quarter 2025 Financial Results

Cash Position: As of September 30, 2025, the Company had cash, cash equivalents and marketable securities totaling $477.6 million, which is expected to provide cash runway into the first half of 2029.
Research and development (R&D) expenses: R&D expenses were $18.2 million for the third quarter of 2025, compared to $21.3 million for the third quarter of 2024.
General and administrative (G&A) expenses: G&A expenses were $6.9 million for the third quarter of 2025, compared to $5.8 million for the third quarter of 2024.
Net Loss: Enliven reported a net loss of $20.1 million for the third quarter of 2025, compared to a net loss of $23.2 million for the third quarter of 2024.
About ELVN-001

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active site inhibitor, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

About the ENABLE Trial

The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. The trial is currently in Phase 1a/1b development and is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response. Enliven is preparing for the potential start of a pivotal trial for ELVN-001 in 2026.

(Press release, Enliven Therapeutics, NOV 12, 2025, View Source [SID1234659846])

On November 12, 2025 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, reported it will present leading-edge findings at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition happening Dec. 6-9 in Orlando and online.

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Across 105 sessions, City of Hope experts will highlight advances in blood cancer research, cellular therapies and precision medicine.

The ASH (Free ASH Whitepaper) meeting is the world’s largest hematology gathering, attracting more than 30,000 hematology professionals globally.

"ASH is where the future of hematology takes shape," said Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive and president of City of Hope National Medical Center. "Our teams are proud to share discoveries that deepen scientific understanding and accelerate progress toward more effective, safer treatments for patients worldwide."

From innovative immunotherapies to strategies that improve transplant outcomes, City of Hope is leading progress in areas that matter most to patients.

ORAL ABSTRACT SESSIONS

Leukemia

Plenary 6: Results from paradigm – a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia
Time: Sunday, Dec. 7, 3:45 p.m. EST
Senior Author: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

443: CD19-CAR T cell therapy as a definitive consolidation in older adults with b-ALL in CR1 is safe and induces durable MRD-remission
Time: Sunday, Dec. 7, 10:30 a.m. EST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Lymphoma

151: 3-year follow-up of the S1826 study confirms improved progression-free survival with nivolumab-AVD compared to brentuximab vedotin-AVD in advanced stage classic Hodgkin lymphoma
Time: Saturday, Dec. 6, noon EST
Presenter: Alex Herrera, M.D., City of Hope professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

268: BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease
Time: Saturday, Dec. 6, 2:45 p.m. EST
Presenter: Elizabeth Budde, M.D., Ph.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

883: Interim analysis of the phase II study of glofitamab, lenalidomide and venetoclax (GLOVe) in untreated patients w/ high-risk mantle cell lymphoma. Response and safety outcomes after the completion of stage 1 of 2 enrollment.
Time: Monday, Dec. 8 at 2:45 p.m. EST
Presenter: Tycel Phillips, M.D., associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

1013: CAR T cell therapy outcomes in adolescent and young adult patients with non-Hodgkin lymphoma
Time: Monday, Dec. 8, 5:30 p.m. EST
Presenter: Lindsey Murphy, M.D., M.S., City of Hope assistant professor, Department of Pediatrics

Myeloma

405: Safety and efficacy of out-of-specification ciltacabtagene autoleucel (cilta-cel) in relapsed/refractory multiple myeloma (RRMM)
Time: Saturday, Dec. 6, 4:30 p.m. EST
Presenter: Azra Borogovac, M.D., M.S., City of Hope assistant professor, Department of Hematology & Hematopoietic Cell Transplantation

Transplantation

376: Total marrow and lymphoid irradiation (TMLI) with fludarabine-melphalan (FM) conditioning for matched donor hematopoietic cell transplant (HCT) in older patients with relapsed/refractory (R/R) disease
Time: Saturday, Dec. 6, 4:45 p.m. EST
Presenter: Monzr M. Al Malki, M.D., City of Hope professor, Department of Hematology & Hematopoietic Cell Transplantation

276: First-in-human trial of allogeneic CD6-CAR tregs in patients with chronic graft-versus-host disease after allogeneic hematopoietic cell transplantation
Time: Saturday, Dec. 6, 3:15 p.m. EST
Presenter: Amandeep Salhotra, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

160: A TLR4-HSP70 efferocytic program in thymic macrophages sustains thymic homeostasis and T cell output
Time: Saturday, Dec. 6, 12:45 p.m. EST
Presenter: Andri Lemarquis, M.D., Ph.D., City of Hope staff scientist

CITY OF HOPE-LED EDUCATIONAL SESSIONS

14th Annual BMT & Cell Therapy Winter Workshop, co-chaired by Dr. Marcel van den Brink
Time: Friday, Dec. 5, 1:30 – 8 p.m. EST
Register for virtual attendance here.

Satellite Symposia fss25-93: Moving Forward in B-ALL: Insights on Modern and Emerging Standards With Off-the-Shelf Bispecific Antibodies
Time: Friday, Dec. 5, 7 a.m. EST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Scientific Workshop on State of the Art (ws25-58): Integrating Functional and Genomic Precision Medicine for Hematologic Malignancies
Time: Friday, Dec. 5, 3 p.m. EST
Chair: Pamela Becker, M.D., Ph.D., professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Scientific Workshop: Microbiome and Diet and Cancer Immunotherapy
Time: Friday, Dec. 5, 3:06 p.m. EST
Presenter: Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive

How I Treat: How I Incorporate Novel Therapies into Hodgkin Lymphoma Treatment: Frontline vs. Relapse
Time: Sunday, Dec. 7 at 8 a.m. EST
Presenter: Alex Herrera, M.D., City of Hope professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Educational Spotlight: Measures to Minimize Infection Risk in Immunocompromised Patients after Cellular Therapies — How, for Whom, for How Long?
Time: Monday, Dec. 8, 4:30 p.m. EST
Presenter: Randy Taplitz, M.D., City of Hope professor, Department of Medicine

(Press release, City of Hope, NOV 12, 2025, View Source [SID1234659862])