TAP Partner News During ASH: Dec 2022

Current and former TAP partners presented new data during the 2022 American Society of Hematology (ASH) meeting that took place from December 10-13^th.

Deepening Response of Bexmarilimab in Combination with SoC in Hematological Malignancies: BEXMAB Study Update

TURKU, FINLAND / BOSTON, MA - December 5, 2022 - 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 a further update on the Company's Phase I/II BEXMAB study, investigating bexmarilimab, Faron's wholly owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

BioNTech and Ryvu Therapeutics Enter into Global Collaboration to Develop and Commercialize Immuno Modulatory Small Molecule Candidates

MAINZ, Germany and KRAKOW, Poland – November 30, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Ryvu Therapeutics S.A. (Warsaw Stock Exchange: RVU, “Ryvu”), a clinical-stage company developing oncology therapeutics today announced that the companies have entered into a multi-target research collaboration for several small molecule immunotherapy programs as well as an exclusive license agreement for Ryvu’s STING agonist portfolio as standalone small molecules.

X4 Pharmaceuticals Announces Positive Top-Line Results from 4WHIM Global, Pivotal Phase 3 Trial of Once-Daily, Oral Mavorixafor in WHIM Syndrome

BOSTON, Nov. 29, 2022 -  X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with diseases of the immune system, today announced positive top-line results from the global, pivotal Phase 3 clinical trial (4WHIM) of its lead investigational therapy, mavorixafor, a novel CXCR4 antagonist, in people with WHIM syndrome. 4WHIM met its primary endpoint and a key secondary endpoint, with mavorixafor achieving clinical and statistical superiority over placebo. Following achievement of these key trial endpoints, the company is now preparing to meet with U.S. regulatory authorities in the first half of 2023 to discuss next steps in advancing mavorixafor further towards a submission for regulatory approval and commercialization as the potential first treatment for people with WHIM syndrome.

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy

BERKELEY, CA, Nov. 29, 2022 - 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 CB-010 Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed or refractory large B cell lymphoma (LBCL) and Fast Track designation for relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout, is being evaluated in the company’s ongoing ANTLER Phase 1 clinical trial in patients with r/r B-NHL, which can enroll three LBCL subtypes: diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL), and high-grade B cell lymphoma (HGBL). CB-010 is the first allogeneic anti-CD19 CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to improve the persistence of antitumor activity by limiting premature CAR-T cell exhaustion.

Caribou Biosciences Announces FDA Clearance of IND Application for CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma

BERKELEY, Calif., Nov. 21, 2022 - Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-011, a genome-edited allogeneic anti-BCMA CAR-T cell therapy with immune cloaking. The CaMMouflage Phase 1 clinical trial, a multicenter, open-label study to evaluate the safety and efficacy of a single dose of CB-011 in adult patients with relapsed or refractory multiple myeloma, is expected to initiate patient enrollment for treatment in early 2023.

TAP Partner News During SITC: Nov 2022

Current and former TAP partners presented new data during the 2022 The Society for Immunotherapy of Cancer (SITC) meeting that took place from November 8-12^th.

Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies

WALTHAM, Mass. September 21, 2022 – Immunitas Therapeutics (“Immunitas”), a precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for IMT-009, a fully human monoclonal antibody against a novel immuno-oncology target CD161. 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).

Sesen Bio and Carisma Therapeutics Announce Merger Agreement

CAMBRIDGE, Mass. & PHILADELPHIA - Sep. 21, 2022-- Sesen Bio, Inc. (Nasdaq: SESN) and Carisma Therapeutics Inc. (Carisma), a privately held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Carisma is pioneering the development of chimeric antigen receptor macrophage (CAR-M) therapies and is believed to be the only company developing CAR-M therapies with demonstrated proof of mechanism and safety data in clinical trials. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol “CARM”.

Kymera Therapeutics Receives FDA Orphan Drug Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Cutaneous T-Cell Lymphoma

WATERTOWN, Mass., Sept. 15, 2022 - 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 orphan drug designation to KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL).

Faron Pharmaceuticals announces the private placement of EUR 5 million to limited number of investors, including LLS TAP

TURKU, FINLAND / BOSTON, MA, June 28, 2022 - 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, today announces that it has conducted a placement to raise EUR 5 million to a limited number of institutional investors and other investors including The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP). Upon receipt of these proceeds, the Company expects to have sufficient working capital into Q1 2023.

Kymera Therapeutics Doses First Patients in Phase 1 Oncology Trials of STAT3 and IRAKIMiD Degraders KT-333 and KT-413

WATERTOWN, Mass., June 15, 2022 - Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, has recently dosed the first patients in separate Phase 1 clinical trials evaluating the STAT3 degrader KT-333 and the IRAKIMiD degrader KT-413. The KT-333 trial includes patients with relapsed/refractory liquid and solid tumors, including T cell lymphomas and leukemia, and the KT-413 study is enrolling patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma (DLBCL).

ImCheck Closes Upsized EUR 96 Million (USD 103 Million) Financing to Advance Clinical Program of First-in-human Gamma-delta T Cell Activating Antibody and Accelerate Development of Disruptive Immunotherapeutic Pipeline

Marseille, France, June 13, 2022 – ImCheck Therapeutics announced today the close of a EUR 96 million (USD 103 million) financing, co-led by Earlybird and Andera Partners. The Series C round (EUR 80 Million - USD 86 Million) and the last outstanding tranche of Series B converted in Series C shares (EUR 16 Million - USD 17.2 Million) solidifies ImCheck’s financial position and leadership in the gamma-delta T cell space. Invus and The Leukemia & Lymphoma Society Therapy Acceleration Program^® also joined the round as new investors.

TAP Partner News During EHA: June 2022

Current and former TAP partners presented new data during the 2022 European Hematology Association (EHA) meeting that took place from June 9-12^th.

TAP Partner News During ASCO: June 2022

Current and former TAP partners presented new data during the 2022 American Society of Clinical Oncology (ASCO) meeting that took place from June 3-7^th.

Kymera Therapeutics Receives FDA Orphan Drug Designation for KT-333, a First-in-Class, Investigational STAT3 Degrader for the Treatment of Peripheral T-Cell Lymphoma

WATERTOWN, Mass., June 01, 2022 - 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 FDA has granted orphan drug designation to KT-333 for the treatment of Peripheral T-cell Lymphoma (PTCL). KT-333 is a first-in-class degrader of the transcriptional regulator STAT3. STAT3 activation has been shown to be a key modulator of disease in PTCL, and there are currently no approved therapies for PTCL that target this pathway.

Caribou Biosciences Announces Positive Initial Data for CB-010 Anti-CD19 Allogeneic CAR-T Cell Therapy

BERKELEY, Calif., May 12, 2022 - Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced initial results demonstrating a 100% overall response rate (ORR) and 80% complete response rate (CR) in cohort 1 (n=5 evaluable) from its ANTLER Phase 1 trial for CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). These initial data are scheduled to be shared at the European Hematology Association (EHA) 2022 Hybrid Congress, being held in Vienna, Austria, June 9-17, 2022.

TAP Partner News During AACR: April 2022

Current and former TAP partners presented new data during the 2022 American Association of Cancer Research (AACR) meeting that took place from April 8-13^th.

Yescarta® Receives U.S. FDA Approval as First CAR T-cell Therapy for Initial Treatment of Relapsed or Refractory Large B-cell Lymphoma (LBCL)

SANTA MONICA, Calif. April 1, 2022 - Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta^® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. 

Immune-Onc Therapeutics Receives FDA Fast Track Designation for IO-202, the First Anti-LILRB4 Myeloid Checkpoint Inhibitor, for the Treatment of Relapsed or Refractory AML

PALO ALTO, CA, February 17, 2022 - Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The Company received Orphan Drug Designation for IO-202 for the treatment of AML in 2020.

Secura Bio Announces Final Patient Enrolled in PRIMO Study and Inclusion of COPIKTRA® (duvelisib) in NCCN Guidelines for PTCL

SUMMERLIN, Nev., Feb. 9, 2022 - Secura Bio, Inc. announced that it completed enrollment on February 1, 2022, in the PRIMO study. PRIMO is evaluating COPIKTRA (duvelisib) for the treatment of adult patients with relapsed or refractory (r/r) Peripheral T-cell Lymphoma (PTCL) and has enrolled a total of 157 patients. Primary endpoint analysis is expected later in 2022.

Shortly following the presentation of interim data from the PRIMO study at ASH, COPIKTRA was included in the National Comprehensive Cancer Network^® T-Cell Lymphoma Guidelines^® (Version 1.2022, 12/22/21) as a Category 2A designated option for the treatment of all subtypes of r/r PTCL.

Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors

January 31, 2022 - Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for IO-202, a first-in-class antibody targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3), for the treatment of solid tumors. IO-202 is currently in Phase 1 clinical development for the treatment of AML and chronic myelomonocytic leukemia (CMML).

Moderna and Carisma Establish Collaboration to Develop in vivo Engineered Chimeric Antigen Receptor Monocytes (CAR-M) for Oncology

CAMBRIDGE, Mass. and PHILADELPHIA, Jan. 10, 2022 - Moderna Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Carisma Therapeutics Inc., a biopharmaceutical pioneer in engineered macrophage-based therapeutics, today announced that the two companies have entered into a strategic collaboration agreement to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.

Affimed Announces Completion of Enrollment in REDIRECT, the Registration-Directed Study of AFM13 in PTCL

Heidelberg, Germany, January 6, 2022 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has completed enrollment in the REDIRECT study (NCT04101331), a registration-directed phase 2 open-label, multicenter, global study investigating the efficacy and safety of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL). Affimed expects to report topline data from the REDIRECT study in the second half of 2022.