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:

View Source

Conference Replay

US Toll Free:

1-877-344-7529

International Toll:

1-412-317-0088

Replay Access Code:

9490444

End Date:

May 21, 2024

On May 14, 2024 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that John Butler, Chief Executive Officer, will participate in a fireside chat at the 2nd Annual HCW Bioconnect Investor Conference on Monday, May 20th, 2024 at 3:00 p.m. ET (Press release, Akebia, MAY 14, 2024, View Source/news-releases/news-release-details/akebia-therapeutics-present-2nd-annual-hcw-bioconnect-investor" target="_blank" title="View Source/news-releases/news-release-details/akebia-therapeutics-present-2nd-annual-hcw-bioconnect-investor" rel="nofollow">View Source [SID1234643261]).

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The 2nd Annual HCW Bioconnect Investor Conference will take place in New York, NY on May 20, 2024.

A webcast of the presentation can be accessed through the "Investors" section of Akebia’s website at View Source for 30 days following the conference.

On May 14, 2024 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage biopharmaceutical company advancing novel therapies in immunology and oncology by targeting myeloid cell inhibitory receptors, reported the company will present Phase 1b interim data for IO-202 in patients with chronic myelomonocytic leukemia (CMML) at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting held virtually and in Madrid, Spain, June 13 – 16 (Press release, Immune-Onc Therapeutics, MAY 14, 2024, View Source [SID1234643277]).

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Promising early responses, including 4 out of 5 efficacy evaluable patients achieving complete remission (CR), were observed in the Phase 1b expansion study of hypomethylating agents-naïve CMML patients using the preliminary recommended Phase 2 dose of IO-202 in combination with azacitidine (AZA). Hypomethylating agents, including AZA, are the only FDA-approved treatment option for CMML, with only a 7-17% CR rate.1 Phase 1b interim data demonstrate that IO-202 is well tolerated in combination with azacitidine. All patients who achieved CR exhibited high baseline LILRB4 expression on bone marrow blasts, supporting the mechanism of action of IO-202 as a targeted therapy with antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Study enrollment is ongoing, and additional clinical data will be presented at EHA (Free EHA Whitepaper).

"CMML is an incurable cancer with a poor prognosis and limited treatment options. We are highly encouraged by the early complete responses seen in our evaluable patient pool," said Charlene Liao, Ph.D., chief executive officer of Immune-Onc. "We believe that the addition of IO-202 to the standard of care treatment, such as azacitidine, has the potential to change the treatment landscape of CMML."

Poster presentation details:

Abstract Number: P792 (here)
Title: Targeting LILRB4 (ILT3) Using IO-202 in Patients with Chronic Myelomonocytic Leukemia (CMML): Interim Efficacy, Safety, and Mechanism of Action Data from the Phase 1b Expansion Cohort
Presenter: Ahmed Aribi, M.D., assistant professor, Division of Leukemia, City of Hope in Duarte, CA
Session Title: Myelodysplastic Syndromes – Clinical
Session Date and Time: Friday, June 14, 6-7 p.m. CEST

ABOUT CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)

CMML is a rare form of blood cancer, occurring in 4 of every 1,000,000 people in the United States each year, 1 or about 1,100 annual cases.2 CMML is characterized by the presence of a high monocyte count (>1×109/L peripheral monocytes with monocytes ≥ 10% of white blood count) along with dysplastic features in the bone marrow.1 Current FDA-approved therapies for CMML are all hypomethylating agents, including azacitidine, only achieving a 7%-17% complete response rate.1

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune-modulatory transmembrane protein found on monocytes and monocyte-derived cells. LILRB4 is expressed on certain hematologic cancer cells, such as myelomonocytic leukemia blasts, and on certain pathogenic cells involved in autoimmunity and inflammatory processes.

About IO-202

IO-202 is a first-in-class IgG1 antibody with specific, high-affinity binding to LILRB4 and depletes LILRB4 positive cells via antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. As such, IO-202 is a targeted therapy with broad potential in blood cancers and autoimmune and inflammatory diseases.

IO-202 has completed the dose escalation part of the first-in-human, multicenter, open-label Phase 1 study in the U.S., and the data was presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in 2023. This Phase 1 trial has advanced to the dose expansion stage to evaluate IO-202 in combination with azacitidine (NCT04372433) in patients with newly diagnosed chronic myelomonocytic leukemia (CMML) who have not received any hypomethylating agents (HMA).

The U.S. Food and Drug Administration granted IO-202 Fast Track Designations for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory CMML, respectively. The FDA has also granted IO-202 Orphan Drug Designations for the treatment of AML and CMML, respectively.

On May 14, 2024 Instylla, Inc., a privately held clinical-stage company focused on developing liquid embolics for peripheral vascular embolotherapy, reported the completion of patient enrollment in the ongoing Instylla HES Hypervascular Tumor Pivotal Study (Press release, Instylla, MAY 14, 2024, View Source [SID1234643193]).

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The Instylla HES Hypervascular Tumor Pivotal Study is a prospective, multicenter, randomized clinical study to evaluate the safety and effectiveness of Instylla’s Embrace Hydrogel Embolic System (HES) compared with standard of care transcatheter arterial embolization or transcatheter arterial chemoembolization for the vascular occlusion of hypervascular tumors. A wide variety of tumors were treated in the study including primary and metastatic liver tumors, metastatic bone tumors, and renal tumors.
Dr. Nadine Abi-Jaoudeh, the study’s National Principal Investigator and Chief of Interventional Radiology at the University of California, Irvine, said, "Congratulations to all the investigators, study coordinators, and the Instylla team on the completion of enrollment for the Instylla HES Hypervascular Tumor Pivotal Study. This marks an exciting milestone in the field of embolization of hypervascular tumors. We hope the study will be positive and demonstrate that this next-generation liquid embolic technology will improve the lives of our patients who have to navigate their challenging clinical conditions. We want to thank all the patients that participated."

"Enrollment completion represents a significant milestone for Instylla and cancer patients diagnosed with hypervascular tumors," said Amar Sawhney, CEO of Instylla, Inc. and Managing Director of Incept, LLC. "We look forward to continuing to work with the study investigators to maintain the high quality of patient follow-up as we continue on our pathway to a PMA for Embrace HES."

About Embrace Hydrogel Embolic System:
Embrace HES is an investigational device intended to embolize hypervascular tumors in vessels ≤ 5 mm. Embrace HES consists of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during embolization. The Embrace HES embolization uses no organic solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG).

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.