Therapy Acceleration Program
2020 News
Therapy Acceleration Program
2020 News
News from 2020
TAP Partner News During ASH: December 5-8 2020
Current and former TAP partners show off data during the virtual 2020 American Society of Hematology (ASH) meeting that took place from December 5-8th.
Affimed Announces Publication of Final Study Results of AFM13 in Combination with anti-PD-1 therapy in Blood
Heidelberg, Germany, November 19, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the Phase 1b study of AFM13, a CD30/CD16A innate cell engager (ICE®), in combination with KEYTRUDA was published in Blood, the renowned Journal of the American Society of Hematology.
Promising Preclinical Combinations of AFM13 and Natural Killer Cells Presented at SITC
Heidelberg, Germany, November 9, 2020 - 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 preclinical data – generated through a collaboration with The University of Texas MD Anderson Cancer Center and Washington University School of Medicine – will be the focus of an oral presentation at the virtual Annual Meeting of the Society for Immunotherapy of Cancer (SITC), identifying promising combinations of Innate Cell Engager (ICE®) AFM13 with cytokine-activated adult blood or cord blood natural killer (NK) cells against CD30-positive hematological malignancies.
Sanofi offers to acquire Kiadis for €308 million
Paris, France and Amsterdam, The Netherlands, 2 November 2020 – Kiadis’ proprietary platform is based on allogeneic or ‘off-the-shelf' NK-cells from a healthy donor. NK-cells seek and identify malignant cancer cells and have broad application across various tumor types. The platform has the potential to make products rapidly and economically available for a broad patient population across a wide range of indications. Kiadis’ NK cell-based medicines will be developed alone and in combination with Sanofi’s existing platforms.
NexImmune Establishes Research Initiative with City of Hope to Focus on Novel Immunotherapeutic Approaches to Acute Myeloid Leukemia
GAITHERSBURG, MD - October 27, 2020 - NexImmune, a clinical-stage biotechnology company developing unique non-genetically-engineered T cell immunotherapies, announced today that it has signed a research initiative related to its AIM nanoparticle technology with City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases.
OncoPep Strengthens Pipeline with Addition of Multi-Tumor Antigen Adoptive T Cell Therapy
BOSTON – October 15, 2020 – OncoPep, Inc. today announced a licensing agreement with MANA Therapeutics for use of its EDIFY™ platform for the development of an autologous multitumor antigen adoptive T cell therapy for the treatment of multiple myeloma and solid tumors, as an additional T cell focused immunotherapeutic for its product pipeline.
X4 Pharmaceuticals Announces FDA Fast Track Designation Granted to Mavorixafor for the Treatment of WHIM Syndrome
BOSTON, Oct. 08, 2020 - X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases resulting from dysfunction of the CXCR4 pathway, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead asset, mavorixafor, for the treatment of adult patients with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, inherited, primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene.
First Patient Dosed in NexImmune Phase 1/2 Clinical Trial of NEXI-002 in Multiple Myeloma
GAITHERSBURG, MD -- October 6, 2020 – NexImmune, a clinical-stage biotechnology company developing a portfolio of unique non-genetically-engineered T cell immunotherapies, announced today that it has dosed the first patient in its Phase 1/2 clinical trial for NEXI-002. NEXI-002 is a patient-derived cellular product that contains populations of naturally-occurring CD8+ T cells directed against several multiple myeloma-specific antigen targets. It is the second clinical product NexImmune has generated with its AIM nanoparticle technology.
Affimed Doses First Patient in Phase 1 Clinical Trial of Natural Killer Cells in Combination with AFM13
Heidelberg, Germany, October 6, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the first patient was successfully dosed with allogeneic cord blood-derived natural killer (cbNK) cells preloaded with AFM13 and has moved on to the AFM13 monotherapy phase of the treatment cycle.
Verastem Oncology Announces Closing of Duvelisib Sale to Secura Bio
BOSTON - Sep. 30, 2020 - Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced that it has completed the sale of Verastem's COPIKTRA (duvelisib), a marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, Inc.
NexImmune Completes Dosing of First Cohort in Phase 1/2 Clinical Trial of NEXI-001 in Relapsed AML
GAITHERSBURG, MD - September 23, 2020 – NexImmune, a clinical-stage biotechnology company developing unique non-genetically-engineered T cell immunotherapies, announced today that it has completed dosing of the first safety cohort (n=3) in its Phase 1/2 clinical trial for NEXI-001, representing a significant milestone for the Company. NEXI-001 is a cellular product that contains populations of naturally-occurring CD8+ T cells directed against multiple AML-specific antigen targets, and it is the first clinical product generated by the Company’s AIM nanoparticle technology.
Magrolimab Receives FDA Breakthrough Therapy Designation for Treatment of MDS
September 15, 2020 - FOSTER CITY, Calif. - Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS). Breakthrough Therapy designation is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy.
Kiadis announces IND approval for COVID-19 clinical trial with off-the-shelf K-NK cells
Amsterdam, The Netherlands, September 14, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical-stage biopharmaceutical company developing innovative cell-based medicines for the treatment of life-threatening diseases, today announces a collaboration with the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital to develop Kiadis-NK cells (K-NK cells) as a post-exposure pre-emptive therapy for COVID-19.
X4 Announces Publication of Mavorixafor Clinical Data in ‘Blood’
CAMBRIDGE, Mass., Sept. 02, 2020 - X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel therapies targeting diseases resulting from dysfunction of the CXCR4 pathway, today announced the publication of comprehensive safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy data of mavorixafor from an ongoing Phase 2, open-label, dose-escalation and extension study in adult patients with genetically confirmed WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome. The manuscript was published in Blood, the official journal of the American Society of Hematology.
Kymera Therapeutics Announces Upsized Initial Public Offering
WATERTOWN, Mass., Aug. 20, 2020 - Kymera Therapeutics, Inc. (NASDAQ: KYMR), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics that selectively degrade disease-causing proteins by harnessing the body’s own natural protein degradation system, today announced the pricing of its upsized initial public offering, expected to be approximately $173.7 million.
Verastem Agrees to Sell Duvelisib Rights to Secura Bio
BOSTON - Aug. 10, 2020 - Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, announced that it has entered into a definitive agreement to sell its global commercial and development rights to COPIKTRA (duvelisib), its marketed oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma, to Secura Bio, Inc., an integrated biopharmaceutical company dedicated to the worldwide commercialization of significant oncology therapies.
BioTheryX Announces $35 Million Series D Financing
SAN DIEGO, CA, July 28, 2020 — BioTheryX, Inc., a clinical stage biotechnology company harnessing the power of protein modulation to treat difficult diseases, today announced it has closed a $35 million Series D financing. Proceeds from the financing will be used to accelerate the timeline of the BTX-A51 Phase 1 clinical trial, continue IND-enabling studies for therapeutic candidates utilizing both PHMs™ and PHM®-based PROTACs (proteolysis targeting chimeras), and support more rapid development of the Company’s preclinical pipeline.
Cobomarsen Received Orphan Drug Designation from the U.S. FDA for the Treatment of T-cell Lymphoma
BOULDER, Colo., July 23, 2020 - miRagen Therapeutics, Inc. (NASDAQ: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, today announced that the Food & Drug Administration (FDA) has granted orphan drug designation to cobomarsen, for the treatment of T-cell lymphoma. Cobomarsen is an inhibitor of miR-155 currently being developed by miRagen in two clinical programs to address different types of T-cell lymphoma, including a Phase 2 trial for cutaneous T-cell lymphoma (CTCL) and a Phase 1 trial for adult T-cell leukemia/lymphoma (ATLL).
Ryvu Therapeutics Raises Over $36 Million
Krakow, Poland – July 22, 2020 – Ryvu Therapeutics [RVU], a clinical stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, has successfully raised over USD 36 million (PLN 143 million) of new capital. Ryvu Therapeutics plans to allocate the acquired funds primarily to the SEL120 project, including the development of the compound in new therapeutic indications in the area of solid tumors, AML/MDS as well as to the development of its preclinical projects.
EHA News - Constellation Announces MANIFEST Trial Clinical Updates
CAMBRIDGE, Mass., June 12, 2020 - Constellation Pharmaceuticals, Inc. (Nasdaq: CNST) announced that three posters relating to the MANIFEST clinical trial of CPI-0610 in myelofibrosis (MF) were published online in association with the European Hematology Association (EHA) annual meeting. The data in these posters are based on a data cutoff of April 17, 2020, and reflect an analysis of clinical activity in 51 first-line (1L) and 73 second-line (2L) patients.
EHA News - Kiadis Announces New K-NK Cell Therapy Data
Amsterdam, The Netherlands, June 12, 2020 – Kiadis Pharma N.V. (“Kiadis” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company, announced that new data related to its K-NK cell therapy platform will be presented today at the virtual edition of the 25th European Hematology Association (EHA) Congress.
ASCO News - Magrolimab in Combination with Azacitidine Demonstrates Durable Activity in Untreated MDS & AML
May 29, 2020 - FOSTER CITY, Calif. - Gilead Sciences, Inc. (Nasdaq: GILD) today announced updated results from a single-arm, open-label Phase 1b trial of magrolimab, an investigational anti-CD47 monoclonal antibody, in combination with azacitidine in previously untreated patients with higher-risk myelodysplastic syndrome (MDS) and previously untreated patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, including patients with TP53-mutant AML, a high unmet need population. Results continue to support the clinical activity of magrolimab and azacitidine.
Stemline Therapeutics to be Acquired by Menarini Group
FLORENCE, Italy and NEW YORK, May 04, 2020 - Menarini Group, a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics Inc., a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, (Nasdaq: STML) today announced a definitive agreement under which Menarini Group will acquire Stemline in a transaction valued up to $677 million.
Affimed Announces FDA Granted Orphan Drug Designation
Heidelberg, Germany, April 1, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma.
Ryvu Therapeutics receives Orphan Drug Designation from FDA
Krakow, Poland – 28 March 2020 – Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation to Ryvu’s SEL120, for the treatment of patients with acute myeloid leukemia. SEL120 is an oral, selective inhibitor of CDK8 kinase which is implicated in the development of hematological malignancies and solid tumors.
Kymera Therapeutics Announces $102 Million Series C Financing
Cambridge, Mass (March 12, 2020) – Kymera Therapeutics Inc., a biotechnology company pioneering targeted protein degradation to invent breakthrough protein degrader medicines for patients, today announced the closing of a $102 million Series C financing. Kymera also received a strategic investment from The Leukemia & Lymphoma Society‘s Therapy Acceleration Program® (TAP) directed toward advancing the company’s work to treat blood-based cancers.
Gilead to Acquire Forty Seven for $4.9 Billion
FOSTER CITY, Calif. & MENLO PARK, Calif., March 2, 2020 - Gilead Sciences, Inc. (Nasdaq: GILD) and Forty Seven, Inc. (Nasdaq: FTSV) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for approximately $4.9 billion.