On May 14, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported data presentations from the LOTIS-7 Phase 1b clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with glofitamab in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, MAY 14, 2025, View Source [SID1234653097]). Updated results will be shared at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress (EHA2025) taking place in Milan, Italy with an oral encore presentation at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. Updated LOTIS-5 safety run-in data evaluating the combination of ZYNLONTA plus rituximab (Lonca-R) will also be featured at EHA (Free EHA Whitepaper)2025.

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"We are excited to present the latest LOTIS-7 data from a larger subset of patients with longer follow-up at EHA (Free EHA Whitepaper) and ICML," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "The robust efficacy and manageable safety seen to date with the combination of ZYNLONTA and glofitamab, two potent anti-cancer agents with different mechanisms of action, reinforce the potential for this regimen to change the treatment paradigm for patients with aggressive lymphoma."

The LOTIS-7 abstract provides data as of the January 17, 2025, cutoff, in which 31 patients received ≥1 ZYNLONTA dose and were safety evaluable, with 22 patients efficacy evaluable. Four of these patients (2 each at 120µg/kg and 150 µg/kg) converted to complete response (CR) within 3 weeks after the data cutoff and are included as CRs. Updated data will be presented during EHA (Free EHA Whitepaper)2025.

Key highlights in the LOTIS-7 abstract are as follows:

In the efficacy evaluable population, overall response rate (ORR) was 95.5% (21/22), complete response (CR) rate was 90.9% (20/22), and median duration of response (DOR) was not reached.
Among 31 patients treated, the combination demonstrated a manageable safety profile.
Adverse events were consistent with known profiles of the individual agents, with neutropenia (32.3%) being the most common Grade ≥3 treatment-emergent adverse event (TEAEs). Grades 3/4 TEAEs of interest included generalized edema, pericardial effusion, photosensitivity reaction, rash, sepsis and pneumonia (each 3.2%). Grade 1/2 AE of CRS (29.0%/9.7%) and ICANS (0%/6.5%) were observed with no Grade ≥3 at the time of data cut off.
Details of the EHA (Free EHA Whitepaper)2025 poster presentations are as follows:
Title: Initial Results From LOTIS-7: A Phase 1b Study of Loncastuximab Tesirine Plus
Glofitamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Session: Poster Session 2
Session Date and Time: Saturday, June 14; 12:30-1:30 p.m. ET / 18:30 -19:30 CEST
Location: Poster Hall, Allianz MiCo, Milano Convention Centre
Presenting Author: Juan Pablo Alderuccio, MD, Associate Professor of Medicine and Hematologist at Sylvester Comprehensive Cancer Center, University of Miami
Abstract: PS1911

Title: Updated Safety Run-In Results From LOTIS-5: A Phase 3, Randomized Trial of Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Patients With R/R DLBCL/HGBL
Session: Poster Session 2
Session Date and Time: Saturday, June 14; 12:30-1:30 p.m. ET / 18:30 -19:30 CEST
Location: Poster Hall, Allianz MiCo, Milano Convention Centre
Presenting Author: Carmelo Carlo-Stella, MD, PhD, section chief of Lymphoid Malignancies and Cancer Therapeutics at Humanitas Clinical and Research Center (IRCCS)
Abstract: PS1957

Details of the ICML oral encore presentation are as follows:
Title: Initial Results From LOTIS-7: A Phase 1b Study of Loncastuximab Tesirine Plus Glofitamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Session: 13 – Aggressive B-Cell Lymphomas
Session Date and Time: Friday, June 20; 8:00 a.m.-9:30 a.m. ET / 14:00-15:30 CEST
Location: Room A, broadcast in Cinema Corso, Lugano Convention Centre, Palazzo dei Congressi
Presenting Author: Juan Pablo Alderuccio, MD, Associate Professor of Medicine and Hematologist at Sylvester Comprehensive Cancer Center, University of Miami
Abstract: 078

Additionally, a poster entitled, "Updated analysis of a phase 2 multicenter study of the loncastuximab in relapsed/refractory marginal zone lymphoma demonstrates high rate of complete responses" will be presented at ICML. This single-arm, open-label investigator-initiated study is being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope, and led by Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami.

About LOTIS-7
LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (BsAbs). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. Part 2 includes dose expansion in 2L/2L+ large B-cell lymphoma in the ZYNLONTA plus glofitamab arm at dose levels determined from Part 1 (120 µg/kg and 150 µg/kg of ZYNLONTA plus the approved dosing of glofitamab). Primary endpoints of the study include safety and tolerability. Secondary efficacy endpoints include ORR, DOR, CRR, PFS, RFS, and OS as well as pharmacokinetics and immunogenicity.

For more information about the LOTIS-7 trial, visit clinicaltrials.gov (NCT04970901).

About ZYNLONTA
ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On May 14, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the first quarter of 2025. Following the completion of the sale of INBRX-101 by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the current year (Press release, Inhibrx, MAY 14, 2025, View Source [SID1234653096]). Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company’s financial statements are the historical financial statements of the Former Parent.

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Upcoming Milestones

INBRX-109
Data from the registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma are expected during the third quarter of 2025; and
Initial data on the colorectal cancer expansion cohort are anticipated in the third quarter of 2025 with interim data from the Ewing sarcoma expansion cohort expected in the second half of 2025.
INBRX-106
Initial Phase 2 data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA (pembrolizumab) are expected during the fourth quarter of 2025; and
Interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer are expected during the fourth quarter of 2025.
Financial Results

Cash and Cash Equivalents. As of March 31, 2025, Inhibrx had cash and cash equivalents of $216.5 million, compared to $152.6 million as of December 31, 2024. The Company’s cash balance increased following the receipt of $100.0 million in gross principal in January 2025 under a loan and security agreement (the "2025 Loan Agreement") entered into with Oxford Finance LLC ("Oxford").
R&D Expense. Research and development expenses were $36.9 million during the first quarter of 2025, compared to $63.9 million during the first quarter of 2024. The decrease in research and development expenses was primarily due to a decrease in clinical trial expenses and contract manufacturing expenses following the spin-off of our INBRX-101 program in the second quarter of 2024.
G&A Expense. General and administrative expenses were $6.0 million during the first quarter of 2025, compared to $10.0 million during the first quarter of 2024. The decrease in general and administrative expenses was primarily due to:
a decrease in non-cash stock option expense as a result of fewer stock options outstanding in the current period under the Company’s new 2024 Omnibus Incentive Plan following the termination of its prior plan in connection with the spin-off;
a decrease in professional service expenses in the current period as a result of higher legal and accounting services in the prior period to support the spin-off transaction and the conclusion of legal proceedings.
Other Income (Expense). Other expense was $0.4 million during the first quarter of 2025, compared to other expense of $4.9 million during the first quarter of 2024. Other expense consists of interest expense incurred on the Company’s outstanding third-party debt during each period, offset in part by interest income earned on the Company’s sweep and money market account balances. The Company incurred less interest expense during the first quarter of 2025 as compared to the first quarter of 2024 due to a lower principal balance under its 2025 Loan Agreement as compared to its prior borrowings with Oxford which were extinguished as a result of the spin-off transaction.
Net Loss. Net loss was $43.3 million during the first quarter of 2025, or $2.80 per share, basic and diluted, compared to a net loss of $78.7 million during the first quarter of 2024, or $5.77 per share, basic and diluted.

On May 14, 2025 AbbVie (NYSE: ABBV) and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, reported a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology and oncology (Press release, AbbVie, MAY 14, 2025, View Source [SID1234653095]).

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siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates the expression of genes. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.

The strategic collaboration will leverage ADARx’s RNA discovery expertise and proprietary siRNA technology, which has the potential to enable sustained and precise mRNA silencing. AbbVie will contribute its expertise in antibody engineering, antibody drug conjugates (ADCs) and tissue delivery approaches as appropriate, to augment ADARx’s discovery efforts.

"siRNA is a promising genetic medicine approach for silencing disease-causing genes, but challenges still remain in targeting and delivering siRNA effectively," said Jonathon Sedgwick, Ph.D., senior vice president and global head, discovery research, AbbVie. "We are very pleased to collaborate with ADARx, leveraging their proprietary RNA technology alongside our antibody, ADC, and therapeutic area research and development expertise to bring siRNA forward as a potential novel therapeutic modality alongside our other established approaches. Together, we’re committed to developing innovative solutions for difficult-to-treat diseases across neuroscience, immunology and oncology."

"This collaboration with AbbVie further validates the differentiated RNA technology that we have developed at ADARx and has the potential to unlock tremendous clinical and commercial potential across multiple disease areas. AbbVie’s research and development expertise combined with its global commercial reach make them the ideal strategic collaborator to accelerate these programs for the potential benefit of patients worldwide," said Zhen Li, Ph.D., co-founder, president and chief executive officer of ADARx. "In addition to this strategic collaboration with AbbVie, ADARx continues to advance a deep pipeline of wholly-owned clinical-stage programs that span complement-mediated, cardiovascular and thrombotic diseases and various preclinical discovery programs including in obesity and neurodegeneration."

Under the terms of the agreement, ADARx will receive a $335 million upfront payment and will be eligible to receive several billion dollars in additional contingent payments including option-related fees and milestone payments, as well as tiered royalties.

On May 14, 2025 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that preclinical data will be presented on its lead program, RGT-61159, at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress, which will be held from June 12-15, 2025, in Milan, Italy (Press release, Rgenta Therapeutics, MAY 14, 2025, View Source [SID1234653094]).

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Presentation Details:

Title: RGT-61159, a Potent and Selective Small Molecule MYB RNA Inhibitor, Showed Significant Anti-Tumor Activity as Monotherapy or in Combination with Standards of Care in Several Leukemia Disease Models Harboring AML Most Common Genetic Lesions.
Presenting Author: Patricia Soulard
Session title: Poster Session 2
Session date and time: Saturday, June 14 (18:30 – 19:30 CEST)
Abstract #: PS1424

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of the oncogenic MYB protein and potential cell death of the cancer cells that overexpress the MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemia (AML), T-cell acute lymphoblastic leukemia (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer. Rgenta is evaluating RGT-61159 in an ongoing multi-center, open-label Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is designed to evaluate safety, tolerability, pharmacokinetics, target engagement, and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

On May 14, 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 updated, positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) in an abstract accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress taking place June 12-15 in Milan, Italy, and virtually (Press release, Enliven Therapeutics, MAY 14, 2025, View Source [SID1234653093]). Updated data will be presented during an oral presentation at the conference on Friday, June 13, at 5 p.m. CEST/11 a.m. ET. Enliven management will host a webcast and conference call to discuss the data on Friday, June 13, at 7:30 p.m. CEST/1:30 p.m. ET.

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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 CML. Data presented at EHA (Free EHA Whitepaper) will be from the ongoing ENABLE Phase 1a/1b clinical trial, which enrolled patients with CML that have failed, are intolerant to, or are not a candidate for, available therapies known to be active for treatment of their CML (NCT05304377).

"We are strongly encouraged by the consistent efficacy, safety and tolerability data from the ongoing ENABLE trial in heavily pretreated patients with CML," said Helen Collins, M.D., Chief Medical Officer of Enliven. "These data continue to demonstrate the potential for ELVN-001 to achieve a best-in-class profile compared to the available active-site TKIs. We look forward to providing additional updates at the EHA (Free EHA Whitepaper) Congress in June."

Abstract Highlights

Patient Demographics

As of the cutoff date of January 21, 2025, 74 patients have been enrolled in the ongoing Phase 1 trial across dose levels from 10-160 mg daily and the vast majority of patients (82%) remain on study with a median treatment duration of ~26 weeks.
Patients enrolled continue to be heavily pretreated, with 66% having received three or more prior tyrosine kinase inhibitors (TKIs), including ponatinib (45%) and asciminib (57%).
Updated Efficacy

Of the enrolled patients, 36 with typical transcripts and without T315I mutations were evaluable for molecular response by 24 weeks.
16 of 36 (44%) evaluable patients were in major molecular response (MMR) by 24 weeks, with 7 of 27 (26%) achieving and 9 of 9 (100%) maintaining MMR.
Of those resistant to their last TKI, 10 of 25 (40%) were in MMR by 24 weeks.
Of those previously treated with asciminib or ponatinib, 9 of 25 (36%) were in MMR by 24 weeks, including one with a known asciminib resistance mutation (A337T).
All patients who achieved or maintained MMR were still in MMR at the time of data cutoff.
These data continued to compare favorably to precedent Phase 1 MMRs for approved BCR::ABL1 TKIs, particularly given the more heavily pre-treated patient population in the ELVN-001 clinical trial.
Updated Safety

ELVN-001 remains well-tolerated across all doses, consistent with its selective kinase profile.
Dose interruptions and reductions occurred in less than 10% and less than 5% of patients, respectively.
The maximum tolerated dose was not reached.
Details of the oral presentation are as follows:
Title: ENABLE: A Phase 1a/1b Study of ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with previously treated CML
Presenter: Andreas Hochhaus, M.D.
Session Title: s425 Novel approaches of CML treatment
Location: Coral 2
Abstract Number: S165
Presentation Date/Time: June 13, 5 p.m. CEST / 11 a.m. ET

The abstract is available on the EHA (Free EHA Whitepaper) website. Following the presentation, a copy will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.

Webcast and Conference Call Information
Enliven will host a conference call with management on June 13, 2025, at 7:30 p.m. CEST/1:30 p.m. ET. To access the call, please dial +1 (800) 803-6955 (domestic) or (240) 220-9050 (international), and reference participant ID 631-128-259 at least 10 minutes prior to the start time and ask to be joined to the Enliven call. Accompanying slides and a link to the webcast will be available in the Investors section of the Enliven website at View Source To participate in the live event, please register using this link. An archived webcast will be available following the event.

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.

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.