Therapy Acceleration Program
Therapy Acceleration Program
Kymera Therapeutics Receives U.S. FDA Fast Track Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Relapsed/Refractory CTCL and PTCL
WATERTOWN, Mass., Sept. 18, 2023 - Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to KT-333 for the treatment of R/R Cutaneous T-cell Lymphoma (CTCL) and R/R Peripheral T-cell Lymphoma (PTCL).
KT-333 is a highly selective degrader of STAT3 in development for the treatment of multiple STAT3-dependent pathologies, including hematological malignancies and solid tumors. STAT3 is a transcriptional regulator that has been linked to numerous cancers as well as to inflammatory and autoimmune diseases. In 2022, KT-333 received FDA orphan drug designation for the treatment of both CTCL and PTCL.
Affimed Receives FDA Fast Track Designation for AFM13 in Combination with ALLONK® for the Treatment of Patients with Relapsed/Refractory Hodgkin Lymphoma
Mannheim, Germany, September 12, 2023 – Affimed N.V., a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the FDA has granted fast track designation to the combination of its innate cell engager (ICE®) AFM13 with AlloNK® for the potential treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL). The combination treatment is entering Phase 2 development and will be investigated in Affimed’s LuminICE-203 study (NCT05883449), which received IND-clearance earlier this year; the study also includes an exploratory cohort of CD30-positive peripheral T-cell lymphoma patients.
Faron Updates Positive Clinical Data from Phase I/II BEXMAB Study of Bexmarilimab in Relapsed/Refractory AML and MDS
July 19, 2023 - TURKU, Finland / BOSTON, Massachusetts - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces new positive clinical data from the Company's ongoing Phase I/II BEXMAB study. The BEXMAB study (NCT05428969) investigates bexmarilimab, Faron's wholly owned immunotherapy asset, in combination with standard of care (SoC) in the aggressive hematological malignancies of relapsed/refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The data reported here builds on earlier positive results presented on June 9, 2023 at the European Hematology Association (EHA) 2023 Hybrid Congress.
Caribou Biosciences Reports Positive Clinical Data from Dose Escalation of CB-010 ANTLER Phase 1 Trial in r/r B-NHL
BERKELEY, Calif., July 13, 2023 - Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported long-term follow-up data from the dose escalation portion of the ongoing ANTLER Phase 1 trial. The data set includes all 16 patients treated in dose escalation with CB-010, an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
BERKELEY, Calif., July 06, 2023 - Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that Pfizer Inc. (NYSE: PFE) has made a $25 million equity investment in the company. Caribou will use the proceeds of this investment to advance CB-011, an immune cloaked allogeneic CAR-T cell therapy currently being evaluated in the CaMMouflage Phase 1 clinical trial in patients with relapsed or refractory multiple myeloma (r/r MM).
Kymera Therapeutics Announces Updated Clinical Data from the Phase 1 Trials of STAT3 Degrader KT-333 and IRAKIMiD Degrader KT-413
WATERTOWN, Mass., June 09, 2023 - Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today announced new data demonstrating that its oncology programs KT-333 and KT-413 continue to demonstrate substantial target knockdown in ongoing Phase 1a dose escalation clinical trials, with no dose limiting toxicities (DLTs) observed. The data were shared in the online abstract book of the International Conference on Malignant Lymphoma (ICML), taking place from June 13-17, 2023, in Lugano, Switzerland.
Current and former TAP partners presented new data during the 2023 European Hematology Association (EHA) meeting that took place from June 8-11.
Immune-Onc Therapeutics Announces IO-202 Granted Fast Track Designation by FDA for the Treatment of Relapsed or Refractory CMML
PALO ALTO, CA, June 7, 2023 – Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage oncology company dedicated to the discovery and development of novel biotherapeutics by targeting inhibitory receptors on myeloid cells, today announced that the FDA granted Fast Track designation for IO-202 for the treatment of R/R CMML, which follows the R/R AML Fast Track designation received in 2022.
Current and former TAP partners presented new data during the 2023 American Society for Clinical Oncology (ASCO) meeting that took place June 2-6 in Chicago, IL.
Affimed Announces IND Clearance for a Phase 2 Clinical Trial Investigating AFM13 and AB-101 Combination Therapy
Heidelberg, Germany, May 23, 2023 – Affimed N.V. announced today that the U.S. Food and Drug Administration (FDA) has cleared its IND application for the combination of AFM13, its first-in-class tetravalent bispecific innate cell engager (ICE®) and AB-101, Artiva Biotherapeutics Inc.’s (“Artiva”) clinical-stage, cryopreserved, off-the shelf, non-genetically modified, allogeneic cord blood-derived natural killer (NK) cells to initiate the Phase 2 clinical trial, AFM13-203 (LuminICE-203), expected to start in the third quarter of 2023.
Current and former TAP partners presented new data during the 2023 American Association of Cancer Research (AACR) meeting that took place from April 14-19.
Biotheryx Announces Research Collaboration and License Agreement with Incyte for Discovery of Targeted Protein Degraders for Novel Oncology Targets
SAN DIEGO, CA., April 5, 2023 - Biotheryx, Inc., a biopharmaceutical company discovering and developing a portfolio of first-in-class protein degraders with a focus on validated targets in cancer and inflammatory disease, today announced it has entered into a Research Collaboration and License agreement with Incyte to discover and develop targeted protein degraders for novel oncology targets.
MorphoSys Completes Enrollment of Phase 3 MANIFEST-2 Study of Pelabresib in Myelofibrosis with Topline Results Expected by End of 2023
Planegg/Munich, Germany, April 4, 2023 - MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that enrollment is complete for MANIFEST-2, the ongoing Phase 3 study exploring the efficacy and safety of pelabresib, an investigational BET inhibitor, in combination with ruxolitinib versus ruxolitinib alone in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-naïve). The topline data are now expected by the end of 2023, earlier than previously anticipated.
Caribou Biosciences Announces FDA Granted Fast Track Designation to CB-011, an Allogeneic CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma
BERKELEY, Calif., April 04, 2023 - 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) has granted Fast Track designation to CB-011, which is being developed for relapsed or refractory multiple myeloma (r/r MM). CB-011 is being evaluated in the company’s ongoing CaMMouflage Phase 1 clinical trial in patients with r/r MM.
Caribou Biosciences Initiates Dose Expansion Portion of CB-010 ANTLER Phase 1 Trial in Second-line LBCL Patients
BERKELEY, Calif., March 29, 2023 - Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced initiation of the dose expansion portion of the CB-010 ANTLER Phase 1 trial in second-line patients with large B cell lymphoma (LBCL) following the recent completion of dose escalation. CB-010 is an allogeneic cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
Caribou Biosciences Announces Dosing of First Patient in the CaMMouflage Phase 1 Trial of CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma
BERKELEY, Calif., March 29, 2023 - Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced the first patient has been dosed with CB-011 at dose level 1 (50x106 CAR-T cells) in the CaMMouflage Phase 1 trial for adults with relapsed or refractory multiple myeloma (r/r MM). CB-011 is an allogeneic anti-BCMA CAR-T cell therapy designed to improve antitumor activity by reducing T and natural killer (NK) cell-mediated rejection.
March 15, 2023, Krakow, Poland - Ryvu Therapeutics SA (WSE:RVU), a biotechnology company whose mission is to discover and develop new therapies in the field of oncology, was named the Stock Exchange Company of the Year in a competition organized by the largest business daily in Poland - Puls Biznesu. The results of the competition highlight the Company's achievements and potential for further development.
In addition to winning in the main category, Ryvu was ranked first in the following categories: Investor Relations, Development Prospects and Innovation. The Listed Company of the Year ranking is the oldest and one of the most prestigious competitions of this type on the Polish capital market.
PHILADELPHIA – March 7, 2023 – Carisma Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, and Sesen Bio, Inc. (“Sesen Bio”), announced today the closing of their previously announced merger. The combined company will operate under the name Carisma Therapeutics Inc. and shares of its common stock will commence trading under the ticker symbol “CARM” on March 8, 2023 on the Nasdaq Global Market.
Kura Oncology Announces First Patients Dosed in Phase 2 Registration-Directed Trial of Ziftomenib in NPM1-mutant AML
SAN DIEGO, Feb. 09, 2023 - 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 the first patients have been dosed in its KOMET-001 Phase 2 registration-directed trial of ziftomenib, the Company’s novel menin inhibitor, in patients with NPM1-mutant relapsed or refractory acute myeloid leukemia (AML).
Faron Announces Results of Placing, Including Additional Investment by The Leukemia & Lymphoma Society Therapy Acceleration Program®
TURKU, FINLAND / BOSTON, MA - January 27 2023 - Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces today that the Bookbuild, announced on 26 January 2023, is now closed. The Company has raised aggregate gross proceeds of approximately EUR 12.0 million in the Placing. The Placing was supported by new investors and existing shareholders such as local long-only institutional investors and family offices, Mr. Timo Syrjälä and The Leukemia & Lymphoma Society Therapy Acceleration Program®. With these proceeds and the current level of activities the Company has sufficient working capital into Q3 2023.
BioInvent Selected to The Leukemia & Lymphoma Society’s Therapy Acceleration Program and Receives $3 Million Strategic Equity Investment
Lund, Sweden – January 17, 2023 – 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 it has been selected as partner of The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP), aimed at advancing the company’s program to treat blood cancers. The partnership will include access to the unique scientific, clinical and drug development expertise of LLS as well as a strategic capital equity investment from LLS TAP of USD 3 million.
January 16, 2023 - TURKU, FINLAND / BOSTON, MA - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces objective responses in 3 out of 5 patients dosed in the first doublet cohort of the Company's Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron's wholly-owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.
Immune-Onc Therapeutics Announces Close of Series B Extension Financing, Bringing Total Round to $131 Million
PALO ALTO, CA, January 5, 2023 - Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints today announced the close of an additional $25 million through a Series B extension, for a total of $131 million in Series B financing. This extension was led by existing investor Triwise Capital and with participation from new investors including Proxima Ventures, among others. In addition, the company has received continued strategic capital investments from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP) and Wuxi Biologics HealthCare Venture.
WALTHAM, Mass., January 4, 2023 – Immunitas Therapeutics (“Immunitas”), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced the first patient has been dosed in a Phase 1/2a clinical trial evaluating use of novel cancer immunotherapeutic IMT-009 in solid tumors and hematologic malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D) for treatment of patients with advanced solid tumors or lymphomas. The trial will subsequently transition into Phase 2 to assess the safety and efficacy of IMT-009 as a monotherapy and in combination with another anticancer agent.