BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Cutaneous T-cell Lymphoma

Lund, Sweden – April 29, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of adults with relapsed or refractory mycosis fungoides and Sézary syndrome, subtypes of cutaneous T-cell lymphoma (CTCL). Fast Track Designation (FTD) is intended to facilitate the development and review of drugs that treat serious conditions.

Solu Therapeutics Closes $41M Series A Financing and Announces First Patient Dosed in Phase 1 Clinical Trial of STX-0712 in Patients with CMML

BOSTON, Mass – April 9, 2024 – Solu Therapeutics, a biotechnology company pioneering therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, today announced the successful completion of a $41 million Series A financing that included participation from five new investors including The Leukemia & Lymphoma Society Therapy Acceleration Program®. The company also announced initiation of treatment of the first patient in its first-in-human Phase 1 clinical trial evaluating STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies. 

Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline

Paris, March 20, 2025. Sanofi and Dren Bio, Inc., a private clinical-stage biopharmaceutical company, have entered into a definitive agreement under which Sanofi has agreed to acquire DR-0201, a targeted bispecific myeloid cell engager (MCE) that has shown robust B-cell depletion in pre-clinical and early clinical studies. Under the terms of the merger agreement, Sanofi will acquire DR-0201 through the acquisition of the Dren Bio affiliate Dren-0201 for an upfront payment of $600 million and potential future payments totaling $1.3 billion upon achievement of certain development and launch milestones. 

BioInvent Receives FDA Orphan Drug Designation for BI-1808 for the Treatment of T-cell Lymphoma

Lund, Sweden – March 20, 2025 – BioInvent International AB (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BI-1808, a first-in-class anti-TNFR2 antibody for the treatment of T-cell Lymphoma (TCL).

Kura Oncology and Kyowa Kirin Announce Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs

SAN DIEGO, Feb. 05, 2025 - Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. today announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). Topline data for KOMET-001 has been submitted for presentation at an upcoming medical conference in the second quarter of 2025, and Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025.

BioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin's lymphoma

Lund, Sweden – January 8, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), in non-Hodgkin's lymphoma (NHL).

Vittoria Biotherapeutics Announces Dosing of First Patient in Phase 1 Clinical Trial of VIPER-101

PHILADELPHIA, Dec. 19, 2024 - Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company specializing in the development of innovative cell therapies for hard-to-treat diseases, today announced that in November, the first patient was dosed in its Phase 1 clinical trial of VIPER-101. VIPER-101 is an enabled autologous cell therapy designed to treat relapsed and/or refractory (r/r) T cell lymphoma, a severe disease with limited treatment options.

Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the FDA

MANNHEIM, Germany, Dec. 05, 2024 - Affimed N.V. (Nasdaq: AFMD) (“Affimed”), a clinical-stage immuno-oncology company, today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed’s innate cell engager (ICE^®) acimtamig and Artiva Biotherapeutic’s AlloNK^® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma. The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial.

Rgenta Therapeutics Announces Strategic Alliance with GSK to Develop RNA-Targeted Small Molecule Splice Modulators

WOBURN, Mass., Dec. 4, 2024 - Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA for oncology and neurological disorders, announced today that it has entered into a multi-year, multi-target strategic research alliance with GSK. The alliance aims to advance the discovery and development of novel RNA-targeted small molecule splice modulators for multiple disease areas including oncology.

Kura Oncology and Kyowa Kirin Announce Global Strategic Collaboration to Develop and Commercialize Ziftomenib in Acute Leukemias

SAN DIEGO and TOKYO, Nov. 20, 2024 - Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced they have entered into a global strategic collaboration to develop and commercialize ziftomenib, Kura’s selective oral menin inhibitor, being investigated for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies.

TAP Partner News During ASH: Dec 2024

Current and former TAP partners presented new data during the 2024 American Society of Hematology (ASH) annual meeting that took place from December 7-10.

Vittoria Biotherapeutics Completes $25 Million in Private Financing to Propel Groundbreaking Cell Therapy Candidates

PHILADELPHIA, Nov. 12, 2024 - Vittoria Biotherapeutics, Inc., a clinical-stage immunotherapy company specializing in the development of innovative cell therapies for hard-to-treat diseases, today announced the successful completion of a $25 million private financing round. This funding is a $10 million extension to its previous $15 million financing secured in November 2023.

Ryvu Therapeutics Announces Dosing of the First Patient in Phase 2 Study of RVU120 for the Treatment of Anemia in Patients with Lower-Risk Myelodysplastic Syndromes

Krakow, Poland – September 19, 2024 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the first patient has been dosed in the REMARK study, a Phase II clinical trial investigating RVU120 as a monotherapy for the treatment of patients with LR-MDS. 

ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in First-Line Acute Myeloid Leukemia

Marseille, France, September 18, 2024 – ImCheck Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ICT01 in combination with azacitidine and venetoclax for the treatment of acute myeloid leukemia (AML) patients 75 years or older, or who have comorbidities that preclude use of standard intensive induction chemotherapy. Based on encouraging results from the Phase 1 dose-escalation portion of the EVICTION study evaluating ICT01 monotherapy in relapsed/refractory hematological malignancies, ImCheck initiated in October 2023 a randomized dose-optimization cohort (NCT04243499), evaluating two doses of ICT01 in combination with azacitidine and venetoclax, the current standard of care for newly diagnosed patients with AML who are deemed unfit for induction chemotherapy.

BioInvent Announces Positive Efficacy Data in CTCL Cohort of Patients with Single Agent BI-1808 from the Phase 2a anti-TNFR2 program

Lund, Sweden – September 9, 2024 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced additional positive preliminary efficacy data from its ongoing Phase 2a dose expansion study of BI-1808 as a single agent in the CTCL cohort of patients.

Caribou Biosciences Announces the FDA has Granted Fast Track Designation to CB-012 in Relapsed or Refractory AML

BERKELEY, Calif., Sept. 03, 2024 - Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-012 for relapsed or refractory acute myeloid leukemia (r/r AML). CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy, is being evaluated in the company’s ongoing AMpLify Phase 1 clinical trial in patients with r/r AML.

ImCheck Awarded EUR 20.18 Million from the French Government Through the France 2030 Investment and Innovation Plan

Marseille, France, August 29, 2024 – ImCheck Therapeutics announced today that it has received EUR 20.18 million in non-dilutive funding as part of the “i-Démo” call for projects under the France 2030 Plan operated by Bpifrance on behalf of the French government.

The funding will support the development of the company’s most advanced drug candidate, ICT01, a γ9δ2 T cell-activating monoclonal antibody, currently in a Phase I/IIa clinical trial program in various solid cancer and hematologic malignancy indications. The funding also supports ImCheck’s ICT41 pathogen-agnostic infectious disease candidate, which is moving toward clinical development.

FDA Grants Fast Track Designation for Bexmarilimab in r/r MDS

TURKU, Finland, August 26, 2024 - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been granted Fast Track Designation for the treatment of relapsed or refractory myelodysplastic syndrome  (r/r MDS) in combination with azacitidine by the USA Food and Drug Administration (the FDA).

Dren Bio Announces Strategic Collaboration with Novartis to Develop Novel Targeted Myeloid Engagers for Cancer

FOSTER CITY, CA, July 24, 2024 - Dren Bio, Inc. (“Dren Bio” or the “Company”), a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, today announced that it has entered into a strategic collaboration with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS). The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform.

Faron Announces Positive FDA Feedback Regarding Registration Study Plan in MDS

TURKU, Finland, July 1, 2024 - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provides information on the result of its formal Type D Scientific Advice Meeting with the USA Food and Drug Administration (the FDA) regarding the registrational study plan for its drug candidate bexmarilimab in relapsed and refractory high risk MDS (r/r MDS).

Breaking Data Presented at ASCO 2024 Showcase Breadth of The Leukemia & Lymphoma Society Therapy Acceleration Program Impact on Key Blood Cancer Research

RYE BROOK, N.Y., May 30, 2024 – Four companies supported by The Leukemia & Lymphoma Society Therapy Acceleration Program (LLS TAP) are presenting new data from clinical studies across four different types of blood cancers at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO). In addition, each company is studying a unique approach to blood cancer treatment. This exemplifies LLS’s commitment to explore every avenue of scientific discovery for the benefit of patients with all types of blood cancer.

Kura Oncology Completes Enrollment in Registration-Directed Trial of Ziftomenib in NPM1-Mutant AML

SAN DIEGO, May 14, 2024 -  Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that it has completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a registration-directed clinical trial of the Company’s menin inhibitor, ziftomenib (KO-539), in patients with relapsed or refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). The Company expects to report topline data from the trial in early 2025.

X4 Pharmaceuticals Announces FDA Approval of Mavorixafor, First Drug Indicated in Patients with WHIM Syndrome

BOSTON, April 29, 2024 - X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has approved XOLREMDI™ (mavorixafor) capsules for use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.

Kura Oncology Receives Breakthrough Therapy Designation for ziftomenib in NPM1-mutant AML

SAN DIEGO, April 22, 2024 - Kura Oncology, a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that its investigational drug, ziftomenib, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML).

MorphoSys Enters into Business Combination Agreement to be Acquired by Novartis for € 2.7 Billion

PLANEGG/MUNICH, Germany – February 5, 2024 – MorphoSys AG today announced the company entered into a Business Combination Agreement with Novartis based on Novartis’ intention to submit a voluntary public takeover offer for all outstanding MorphoSys shares for € 2.7 Billion equity value.

As part of the Business Combination Agreement with Novartis, Novartis seeks to obtain exclusive, worldwide rights to develop and commercialize pelabresib, an investigational BET inhibitor across all indications. The development of pelabresib was funded in part by The Leukemia & Lymphoma Society.

Rgenta Therapeutics Joins The Leukemia & Lymphoma Society Therapy Acceleration Program

CAMBRIDGE, Mass., Jan. 30, 2024 /PRNewswire/ -- Rgenta Therapeutics ("Rgenta" or the "Company") today announced that it was selected by The Leukemia & Lymphoma Society (LLS) as a new Therapy Acceleration Program^® (TAP) portfolio company, and provided with strategic funding to support preclinical and clinical advancement of the Company's therapeutics in hematologic malignancies utilizing its RNA-targeting small molecule platform to target MYB, an oncogenic transcription factor.