TAP Partner News During EHA: June 2021

Current and former TAP partners presented new data during the virtual 2021 European Hematology Association (EHA) meeting that took place from June 11-17^th.

TAP Partner News During ASCO: June 2021

Current and former TAP partners presented new data during the virtual 2021 American Society of Clinical Oncology (ASCO) meeting that took place from June 4-8^th.

MorphoSys to Acquire Constellation Pharmaceuticals

PLANEGG/MUNICH, Germany & CAMBRIDGE, Mass. Jun. 2, 2021- MorphoSys AG (FSE: MOR; NASDAQ: MOR) (“MorphoSys”), and Constellation Pharmaceuticals, Inc., (NASDAQ: CNST) (“Constellation”) today announced that they have entered into a definitive agreement whereby MorphoSys will acquire Constellation for $34.00 per share in cash, which represents a total equity value of $1.7 billion.

Meet the Researcher: Charlene Liao, PhD

In honor of Asian American and Pacific Islander Heritage Month in May, LLS is highlighting the stories of volunteers, healthcare professionals, researchers, patients, survivors, and advocates from across our community. Recently, we caught up with Charlene Liao, Ph.D., Co-Founder, President, and Chief Executive Officer of Immune-Onc Therapeutics, a new LLS Therapy Acceleration Program® (LLS TAP) partner.

BioTheryX Announces $92M Series E Financing to Accelerate Development of Targeted Protein Degradation Pipeline and Technology Platform in Oncology

SAN DIEGO, May 20, 2021 - BioTheryX, Inc., a clinical-stage company focused on degrading proteins to create life-saving cancer medicines, today announced a $92 million Series E financing.

The proceeds from the financing will be used to advance multiple molecular glues, PHM-based PROTACs and monovalent degraders, including BTX-1188, toward clinical development.  BioTheryX also plans to advance the clinical development of its lead multi-kinase inhibitor, BTX-A51, for the treatment of acute myeloid leukemia, myelodysplastic syndromes and solid tumors.

Affimed Announces Publication of Preclinical Data in Clinical Cancer Research Supporting Therapeutic Potential of AFM13 in Combination with Natural Killer Cells

Heidelberg, Germany, May 13, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company announced today the publication of preclinical in vitro and in vivo research of its lead innate cell engager (ICE®), AFM13 (CD16A/CD30), combined with healthy donor-derived NK cells in Clinical Cancer Research, and supports use of AFM13 combined with NK cells as a promising therapy for CD30-positive hematological malignancies.

LLS TAP announces five new investments supporting next generation immunotherapies

RYE BROOK, N.Y., April 22, 2021 /PRNewswire/ -- The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP) today announced five new investments aimed at speeding the development of new and improved immunotherapies for the treatment of blood cancers. LLS has dedicated more than $100 million over the past several decades, through both grants and TAP investments, to advancing pioneering approaches that harness cellular immunotherapies to fight blood cancers.

Immune-Onc Receives California Institute for Regenerative Medicine Award to Conduct Clinical Trial in AML

APRIL 20, 2021 - Today the governing Board of the California Institute for Regenerative Medicine (CIRM) awarded $6.0 million to Immune-Onc Therapeutics to conduct a clinical trial for patients with acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML).

Kymera Therapeutics Honored by Boston Business Journal as a 2021 Best Places to Work Company

WATERTOWN, Mass., April 19, 2021 - 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 Boston Business Journal (BBJ) has named Kymera Therapeutics to its 2021 Best Places to Work, an exclusive ranking of the Massachusetts companies that have built outstanding work environments for their people.

Sanofi Completes Kiadis Acquisition

April 16, 2021 - Sanofi and Kiadis announce today the successful completion of Sanofi’s acquisition of Kiadis, a clinical-stage biopharmaceutical company developing next generation, ‘off-the-shelf’, NK cell-therapies.

TAP Partner News During AACR: April 10-15 2021

Current and former TAP partners show off data during the virtual 2021 American Association for Cancer Research (AACR) meeting that took place from April 10-15th.

FDA Approves Vyxeos for Secondary Acute Myeloid Leukemia in Children

DUBLIN, March 30, 2021 - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. 

Immune-Onc Therapeutics Announces $73 Million Financing to Advance its Portfolio of Novel Immunotherapies in Blood Cancers and Solid Tumors

PALO ALTO, CA, March 30, 2021 - Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints today announced the closing of a $73 million Series B1 and B2 financing. The round was led by Oceanpine Capital and the company also received a strategic capital investment from The Leukemia & Lymphoma Society’s Therapy Acceleration Program® (LLS TAP), directed toward advancing the company’s work to treat blood cancers.

CARISMA Therapeutics Announces First Patient Dosed in Landmark Clinical Study Evaluating Engineered Macrophages

PHILADELPHIA, March 18, 2021 - CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company spun out of the University of Pennsylvania (Penn) and focused on discovering and developing innovative immunotherapies, announced that the first patient has been dosed in the Phase 1 multi-center clinical trial for CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M).

Publication of CPX-351 Clinical Data in 'Blood Advances': Phase 3 Post-Hoc Analyses

March 16, 2021 - CPX-351 (Vyxeos, daunorubicin and cytarabine liposome for injection) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine approved by the US Food and Drug Administration in 2017 and the European Medicines Agency in 2018 for the treatment of adults with newly diagnosed t-AML or AML with myelodysplasia-related changes (AML-MRC).  In the primary analysis of data from the pivotal randomized phase 3 study in older adults with newly diagnosed high-risk/sAML, induction followed by consolidation with CPX-351 demonstrated a significantly improved median overall survival.  After 5 years of follow-up, survival benefit was maintained.

Affimed Announces Continuation of REDIRECT, a Registration-directed Study of AFM13 in PTCL, after Positive Preplanned Interim Futility Analysis

Heidelberg, Germany, March 10, 2021 - Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today its decision to continue enrollment in the REDIRECT trial (NCT04101331), which is evaluating AFM13 as a monotherapy for the treatment of patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).

Immune-Onc Building Broad Pipeline of Myeloid Checkpoint Inhibitors

February 26, 2021 - Congrats to new TAP partner, Immune-Onc for being featured in BioCentury as an Emerging Company.

Caribou Biosciences Raises $115M Series C Financing to Advance Next-Generation CRISPR Technologies and Allogeneic Cell Therapy Pipeline

Berkeley, CA, March 3, 2021 – Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome editing biotechnology company, announced the successful completion of an oversubscribed $115 million Series C financing including a strategic investment by The Leukemia & Lymphoma Society Therapy Acceleration Program® (LLS TAP). Proceeds from the financing will be used to further develop the Company’s proprietary, next-generation CRISPR technology platform and to advance the Company’s pipeline of allogeneic immune cell therapies for oncology with a major focus on blood cancers.

Carisma Therapeutics Completes Series B Financing Totaling $59 Million

PHILADELPHIA, March 1, 2021 - CARISMA Therapeutics Inc., a biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced the second closing of its Series B equity financing, bringing the total amount raised in this round to $59 million and CARISMA's total capital raised to date to nearly $121 million. The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program® (TAP) also participated in the second closing of Carisma's Series B equity financing to support one or more CAR macrophage cell therapy programs for hematological malignancies.

Kymera Therapeutics Initiates Dosing in Phase 1 Trial of KT-474, a First-in-Class IRAK4 Protein Degrader

WATERTOWN, Mass., March 02, 2021 - Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, announced that the Company recently initiated dosing of the Phase 1 clinical trial evaluating KT-474 in adult healthy volunteers and patients with atopic dermatitis or hidradenitis suppurativa. KT-474 is a potential first-in-class, highly active and selective, orally bioavailable IRAK4 degrader being developed for the treatment of toll-like receptor (TLR)/interleukin-1 receptor (IL-1R)-driven immune-inflammatory diseases and potentially other indications.

NexImmune Announces Closing of Upsized Initial Public Offering

GAITHERSBURG, Md., Feb. 17, 2021 - NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent and durable immune response, announced the closing of its previously announced upsized initial public offering where the gross proceeds to NexImmune from the offering were approximately $126.5 million.

This is the first time LLS has participated in an initial public offering through an investment with our Therapy Acceleration Program® (TAP) venture philanthropy initiative.

European Commission Approves ELZONRIS for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

FLORENCE, January 21, 2021 – The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the European Commission (EC) has granted a marketing authorization, for ELZONRIS (tagraxofusp) as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare, aggressive hematologic malignancy with dismal outcomes.

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.