On May 14, 2024 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held in Madrid, Spain and virtually, June 13-16, 2024 (Press release, Genmab, MAY 14, 2024, View Source [SID1234643221]).

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Presentations will include data from clinical trials evaluating the safety and efficacy of epcoritamab as a monotherapy and in combination with standard-of-care or other novel therapies across multiple patient populations. Three oral presentations will highlight data from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory follicular lymphoma (FL), from EPCORE NHL-5 evaluating epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as a potential first-line treatment regimen for patients with diffuse large B-cell lymphoma (and DLBCL), and from EPCORE CLL-1 evaluating epcoritamab in patients with Richter’s transformation (RT). All abstracts accepted for presentation have been published and may be accessed online via the EHA (Free EHA Whitepaper) Open Access Library.

"Building on the recent global regulatory approvals and pending regulatory decisions for epcoritamab, we look forward to presenting new data at EHA (Free EHA Whitepaper) 2024 that highlight the key progress that has been made developing epcoritamab as a potential core therapy across a variety of B-cell malignances," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we are committed to advancing and evolving the robust development program evaluating epcoritamab, as a monotherapy and in combination, across B-cell malignancies and settings."

The safety and efficacy of these investigational uses have not been established.

Abstracts accepted for presentation at EHA (Free EHA Whitepaper):

Clinical Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S163 Single-Agent Epcoritamab Leads to Deep Responses in Patients (pts) with Richter’s Transformation (RT): Primary Results from the EPCORE CLL-1 Trial Oral Friday, June 14, 14:45-16:00 CEST
S239 First Data from Subcutaneous Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for First-line Diffuse Large B-Cell Lymphoma (DLBCL): EPCORE NHL-5 Oral Friday, June 14, 14:45-16:00 CEST
S234 Epcoritamab Induces Deep Responses in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Safety and Pooled Efficacy Data from EPCORE NHL 1 Pivotal and Cycle (C) 1 Optimization (Opt) FL Cohorts Oral Saturday, June 15, 16:30-17:45 CEST
P1146 Epcoritamab with Rituximab + Lenalidomide (R2) in Previously Untreated (1L) Follicular Lymphoma (FL) and Epcoritamab Maintenance Therapy in FL: EPCORE NHL 2 Arms 6 and 7 Poster Friday, June 14, 18:00-19:00 CEST
P1151 Extended Follow-Up Beyond 2.5 Years Shows Long-Term Efficacy in Complete Responders Following Epcoritamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P1152 Epcoritamab + GemOx Induces Deep, Durable Responses in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma: Updated Results From the EPCORE NHL-2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P1161 Epcoritamab + R-DHAX/C Elicits Deep, Durable Responses in Transplant-Eligible Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Including High-Risk Disease Poster Friday, June 14, 18:00-19:00 CEST
PB2955 EPCORE FL-2: Phase 3 Trial of Epcoritamab with Rituximab and Lenalidomide (R2) vs Chemoimmunotherapy or R2 in Previously Untreated Follicular Lymphoma Electronic Publication Friday, June 14, 9:00 CEST
Outcomes Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1114 Patient-Reported Outcomes in Patients with Relapsed or Refractory Follicular Lymphoma Treated With Epcoritamab Poster Friday, June 14, 18:00-19:00 CEST
P1121 Matching-Adjusted Indirect Comparisons of Epcoritamab vs Mosunetuzumab or Odronextamab in Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies Poster Friday, June 14, 18:00-19:00 CEST
P1140 The Efficacy of Subcutaneous Epcoritamab vs Standard-of-Care (SCHOLAR-5) in Patients With Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies: An Indirect Treatment Comparison Poster Friday, June 14, 18:00-19:00 CEST
P1133 Comparative Effectiveness of Epcoritamab versus Real-World Usual Care in Relapsed/Refractory Follicular Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P2081 Logistical Challenges Associated with Chimeric Antigen Receptor T-Cell Therapy (CAR T) in Non-Hodgkin Lymphoma (NHL): A Survey of Healthcare Professionals Electronic Poster Friday, June 14, 9:00 CEST
Pharmacokinetic/Translational Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1244 Immune Correlates of Response to Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Dose Expansion in a Phase 1/2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P2059 Minimal Residual Disease (MRD), Pharmacokinetic (PK), and Pharmacodynamic (PD) Assessment of Epcoritamab 2-vs 3-step Step-up Dosing in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) Electronic Poster Friday, June 14, 9:00 CEST
P2060 Model-Based Cycle (C) 1 Optimization of Step-Up Dose Regimen For Epcoritamab in Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Electronic Poster Friday, June 14, 9:00 CEST
About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.

On May 14, 2024 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of March 31, 2024 and revenues for the first three months of 2024 (Press release, Genfit, MAY 14, 2024, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2024-financial-information [SID1234643220]).

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Cash position

As of March 31, 2024, the Company’s cash and cash equivalents amounted to €74.0 million compared with €128.6 million as of March 31, 2023, and €77.8 million as of December 31, 2023.

The stability in cash and cash equivalents between December 31, 2023, and March 31, 2024 takes into account changes in accounts receivables (notably the receipt of the €13.3 million milestone invoiced to Ipsen in December 2023) offset by our continued research and development efforts, notably for:

UNVEIL-IT, our Phase 2 clinical trial evaluating VS-01 in Acute-on-Chronic Liver Failure (ACLF);
our cholangiocarcinoma program evaluating GNS561;
our ACLF program evaluating NTZ; and
our non-clinical trial of SRT-015 in ACLF.
We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements until approximately the fourth quarter of 2025. This is based on current assumptions and programs and does not include exceptional events. This estimation includes our expectations to receive future milestone revenue in 2024, subject to approval by applicable regulatory authorities and US and European commercial launches of elafibranor in Primary Biliary Cholangitis (PBC) by Ipsen, representing a total of approximately €75.2 million.

Revenues

Revenues for the first three months of 2024 amounted to €1.1 million compared to €5.0 million for the same period in 2023.

This revenue for the first three months of 2024 was generated under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 ELATIVE clinical trial until the complete transfer of the responsibility of the trial to Ipsen.

Of the €5.0 million in revenues for the first three months of 2023, €4.1 million in revenue was attributable to the partial recognition of the €40.0 million deferred income per IFRS 15 in accordance with the Collaboration and Licensing Agreement signed with Ipsen in 2021. €0.8 million was attributable to re-billings made in accordance with this agreement. €0.1 million in revenue was generated from the services rendered by GENFIT to Ipsen in accordance with the Transition Services Agreement signed in 2022.

On May 14, 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 first quarter ended March 31, 2024, and provided a corporate update (Press release, Sellas Life Sciences, MAY 14, 2024, View Source [SID1234643219]).

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"SELLAS had a very productive and successful first quarter of 2024," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We reported strong preliminary data from the Phase 2a study of SLS009 in r/r AML showing high anti-leukemic activity in the selected optimal dose regimen of 30 mg BIW, including a 100% response rate in patients with ASXL1 mutation. Based on these results we are expanding the cohort to participants bearing the ASXL1 mutation. This mutation is prevalent in AML, as well as solid tumors including colon cancer, and is associated with poor prognosis. We strongly believe in SLS009’s potential and hope to deliver its promise to this heavily pretreated, underserved patient population. The data thus far are indeed extremely encouraging both in terms of safety and efficacy."

Dr. Stergiou continued: "We are also excited with the ongoing progress in the Phase 3 REGAL study of GPS. Based on its recent efficacy and safety assessment, the IDMC recommended the trial continue without modification. We look forward to the next IDMC meeting, scheduled for June, during which the Committee will review data from all enrolled 127 patients and the most recent information regarding the number of events required for triggering the interim analysis. Furthermore, with the recent financing, we were able to strengthen our balance sheet as we expect further significant catalysts throughout 2024."

Pipeline Highlights

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: Reached planned enrollment of patients in the United States, Europe, and Asia, following the predetermined statistical analysis plan. The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC scheduled its next meeting in June 2024 to review the safety and efficacy data from all enrolled 127 patients.

SLS009: highly selective and specific CDK9 inhibitor

Announced Positive Phase 2 Data of SLS009 in r/r AML: The preliminary data showed 62% and 67% anti-leukemic activity at all dose levels and in the 30 mg BIW cohort, respectively, with a favorable safety profile. A 100% overall response rate (CR/CRi/MLFS) was achieved in patients with ASXL1 mutation in the 30 mg BIW cohort to date. Enrollment is ongoing at the 30 mg BIW cohort with ASXL1 mutation.
IP Protection: Based on the SLS009 efficacy data in r/r AML patients with ASXL1 mutation, SELLAS filed a provisional patent application. The ASLX1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options.

Phase 1b/2 clinical trial in combination with BTK inhibitor, Brukinsa (zanubrutinib), in r/r DLBCL: GenFleet Therapeutics (Shanghai), Inc. entered into a clinical trial collaboration and supply agreement with BeiGene Switzerland GmbH and dosed the first patient in March 2024. The trial is an open-label single-arm multicenter Phase 1b/2 study to be conducted in two parts. In the Phase 1b portion, 6-18 patients will be enrolled and in the Phase 2 portion, approximately 45 patients will be enrolled. This study is being conducted in China and is funded by GenFleet which intends to focus on DLBCL as its lymphoma target with SLS009.

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 throughout 2H 2024.
Financial Results for the First Quarter 2024:
R&D Expenses: Research and development expenses for the quarter ended March 31, 2024 were $5.1 million, compared to $7.2 million for the same period in 2023. The decrease was primarily due to the timing of a clinical drug supply purchase in the prior period and decreases in consultants, personnel related expenses due to changes in headcount, and licensing fees.
G&A Expenses: General and administrative expenses for the first quarter of 2024 were $4.5 million, as compared to $4.1 million for the same period in 2023. The slight increase was primarily attributed to the initial recognition of a one-time severance charge in the first quarter of 2024, partially offset by decreases in outside services and public company costs and other personnel related expenses.
Net Loss: The net loss was $9.6 million for the first quarter of 2024, or a basic and diluted loss per share of $0.21, as compared to a net loss of $11.1 million for the first quarter of 2023, or a basic and diluted loss per share of $0.47.
Cash Position: As of March 31, 2024, cash and cash equivalents totaled approximately $18.4 million.

On May 14, 2024 FogPharma, a clinical-stage biopharmaceutical company dedicated to delivering a new class of therapies that go beyond the limits of currently available medicines using its Helicon peptide platform, and ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of 212Pb alpha radioligand therapies (ARTs), reported a collaboration to co-develop Helicon-enabled ARTs (HEARTs) to transform outcomes for patients with multiple types of cancer (Press release, FogPharma, MAY 14, 2024, View Source [SID1234643218]).

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ARTBIO and FogPharma will co-develop novel HEARTs against multiple targets, leveraging FogPharma’s field-leading Helicon platform of tunable stabilized α-helical peptides and ARTBIO’s AlphaDirect platform for the development of ARTs using the best-in-class isotope, 212Pb. ARTs with 212Pb have the ideal clinical profile due to a short half-life that delivers maximal energy into tumors with high stability and the ability to image with SPECT/CT. The synergy of these two powerful platforms offers promising potential to create next-generation ARTs with properties ideal for precise delivery to tumors.

"Our AI-enabled Helicon platform provides an unprecedented level of chemical flexibility and diversity for modifying the crucial chemical and biological properties of peptides, a capability that we have leveraged to address previously undruggable protein:protein interactions inside the cell. We are thrilled to begin our collaboration with ARTBIO, wherein we extend the use of our Helicons to bind extracellular proteins and use our Helicons to finely tune distribution and elimination properties, paving the way for a new safe and effective category of targeted radioligand therapy," stated Mathai Mammen, M.D., Ph.D., CEO of FogPharma. "Our aim is to revolutionize outcomes for cancer patients in critical need."

"Alpha radioligand therapy, and 212Pb in particular, has shown tremendous promise as a new class of radiopharmaceuticals. This collaboration with FogPharma enables ARTBIO to advance next-generation therapeutics specifically designed to treat solid tumors," said Emanuele Ostuni, Ph.D., CEO of ARTBIO. "FogPharma has a shared vision of radically changing the current treatment paradigms for cancers, and together we will fuse science, technology, and collective passion to improve patient outcomes."

The partners will contribute equally to the collaboration across research, development and commercialization phases; additional financial terms are undisclosed.

On May 14, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the first quarter ended March 31, 2024 (Press release, Delcath Systems, MAY 14, 2024, View Source [SID1234643217]).

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Recent Business Highlights
During and since the first quarter, Delcath:

Recognized over $2.0 million of revenue from sales of HEPZATO KIT (melphalan/Hepatic Delivery System) and $1.1 million in CHEMOSAT sales through March 31, 2024;

Updated U.S. center activation guidance from 15 active centers to a total of 20 active centers by the end of 2024;

Activated four treating centers during the first quarter with an additional two centers in April. A further five centers are accepting patient referrals in anticipation of activation;

Raised $7.0 million in a private placement transaction with certain accredited investors comprised of existing investors, Delcath senior executives, and members of its Board of Directors;

Appointed Martha S. Rook, Ph.D, an experienced industry leader with more than 25 years of academic and industry experience, as Chief Operating Officer;

Received a permanent, product-specific J-code (J9248) and transitional pass-through payment status for HEPZATO KIT from the Centers for Medicare & Medicaid Services (CMS) which became effective on April 1, 2024;

Executed an amendment with Synerx Pharma, LLC and Mylan Teoranta for Delcath’s supply of melphalan hydrochloride which extends the term of the original agreement to December 31, 2028; and

Announced the publication of results from the pivotal Phase 3 FOCUS study of HEPZATO KIT in patients with unresectable metastatic Uveal Melanoma on May 4, 2024, in the journal Annals of Surgical Oncology.
"We continue to make steady progress in the training and activation of new treatment centers which is a testament to both the emerging role of HEPZATO in the treatment of patients with metastatic uveal melanoma and the capability and dedication of our field force," said Gerard Michel, Delcath’s Chief Executive Officer. "We are committed to expanding the availability of HEPZATO to patients in need and I am confident that we will reach our goal of 20 treating centers by the end of 2024."

First Quarter 2024 Results
Cash, cash equivalents and investment totaled $27.2 million as of March 31, 2024, which includes a $7.0 million private placement financing which closed on March 19, 2024.

Total revenue for the quarter ended March 31, 2024 was $3.1 million compared to $0.6 million for the same period in the prior year from our sales of HEPZATO in the U.S. and CHEMOSAT in Europe.

Research and development expenses for the quarter ended March 31, 2024, were $3.7 million compared to $4.6 million for the same period in the prior year. The change in research and development expenses is primarily due to a decrease in clinical trial activities and expenses related to the FDA inspection offset by an increase in personnel related expenses.

Selling, general and administrative expenses for the quarter ended March 31, 2024, were $8.8 million compared to $4.2 million for the same period in the prior year. The increase primarily relates to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date:

Tuesday, May 14, 2024

Time:

8:30 AM Eastern Time

Participant Numbers

Toll Free:

1-833-630-1960

International:

1-412-317-1841

Webcast:

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Conference Replay

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End Date:

May 21, 2024