Monthly Archives: August 2021

SAN FRANCISCO and BERLIN, Aug. 02, 2021 (GLOBE NEWSWIRE) -- T-knife Therapeutics, Inc., a next-generation T-cell receptor company developing a pipeline of innovative therapeutics for solid tumor patients, today announced the successful completion of a $110 million Series B financing. The financing was led by Fidelity Management & Research Company, LLC., with participation from other new investors including, LSP, Qatar Investment Authority (QIA), Casdin Capital, Sixty Degree Capital, and CaaS Capital, along with existing investors RA Capital Management, Versant Ventures and founding investor Andera Partners. The company plans to use proceeds from the financing to expand its scientific team, increase manufacturing capacity and advance its pipeline of T-cell receptor (TCR) engineered T cell therapies (TCR-T).

Over the past year we have made substantial progress toward our goal of building a leading TCR-T company focused on delivering clinically meaningful benefits for patients with solid tumors, stated Thomas M. Soloway, Chief Executive Officer of T-knife. We are excited to have the support of this group of dedicated life sciences investors to help us fulfill our mission, and we welcome Dr. Karin Kleinhans of LSP to our board of directors.

T-knife has an elegant and differentiated approach to identifying potent, cancer-specific TCRs with naturally optimized affinity and specificity profiles, creating a next-generation platform for this promising therapeutic field, said Alex Mayweg, Chairman of T-knife and Managing Director at Versant Ventures. We are pleased to be progressing TK-8001 toward the clinic and to advance our broader portfolio of product candidates.

T-knife is leveraging its proprietary HuTCR transgenic mouse platform to discover and develop a portfolio of TCR-T programs to treat patients with solid tumors. T-knifes lead program, TK-8001, is a novel TCR-T product candidate targeting MAGE-A1 positive cancers. T-knife plans to begin enrolling patients in the TK-8001 IMAG1NE Phase 1/2 clinical study in the fourth quarter of 2021 and is planning to submit INDs/CTAs for additional product candidates in 2022.

"The field of TCR-T holds significant promise to change the treatment paradigm for many cancer patients, said Karin Kleinhans, PhD, Partner at LSP who joined T-Knifes board in connection with the Series B financing. We are highly encouraged by the progress being made at T-knife to advance its important next-generation therapies.

Olivier Litzka, Partner at Andera Partners, commented, As a founding investor, it is gratifying to witness the continued success at T-knife. The completion of the Series B financing is an important milestone that will enable us to execute on our vision of building a leading transatlantic immuno-oncology company.

About the HuTCR platformT cells play a key role in the immune response by directly recognizing and eliminating infected, foreign or altered cells, such as cancer cells. To do this, they use their T-cell receptors (TCRs) to scan the surface of other cells for foreign antigens presented on Human Leukocyte Antigen (HLA) complexes. Cancer cells can be recognized by mutated or viral antigens expressed only in the tumor, or self-antigens normally expressed during embryonic development and in non-somatic adult tissues. Genetic engineering of T cells with TCRs recognizing antigens aberrantly or over-expressed in cancers can redirect these T cells to the tumor, potentially offering curative responses to cancer patients.

The ability to identify potent cancer-specific TCRs has been limiting for the field of TCR-T. In the case of self-antigens, T cells bearing those TCRs are eliminated during T cell development to avoid recognition and attack of healthy tissues. For non-self tumor antigens, such as those derived from viral sequences or mutations, the very low T cell frequency in the blood has limited TCR discovery efforts.

To overcome these challenges, T-knife has developed transgenic mice (HuTCR mice) carrying the human TCR gene loci and expressing multiple human HLAs. Immunizing HuTCR mice with human tumor antigens, for which mice are not tolerant, allows for the identification of both CD4+ and CD8+ T cells with TCRs that have optimized affinity / specificity profiles capable of mediating significant anti-tumor activity. The TCRs from HuTCR mice are of higher affinity for tumor self-antigens than TCRs isolated from human donors and are naturally optimized to maintain a high specificity profile, making HuTCR mice a powerful high-throughput platform for rapidly generating TCRs with best-in-class potential.

About T-knife TherapeuticsT-knife is a next-generation T-cell receptor (TCR) company developing a pipeline of therapeutics for solid tumor patients. The company leverages its proprietary humanized T-cell receptor (HuTCR) mouse platform to produce fully human TCRs, naturally selected in vivo for optimal affinity and specificity.

T-knife is developing a pipeline of potential first/best-in-class TCR therapeutics against targets with high unmet medical need, including cancer testis antigens, viral antigens and commonly shared neoantigens. T-knife was founded by leading T-cell and immunology experts using technology developed at the Max Delbruck Center for Molecular Medicine together with Charit University Hospital in Berlin. For additional information, please visit the companys website at http://www.t-knife.com.

Contact T-knife Therapeutics, Inc.Camille Landis Chief Business Officer / Chief Financial Officerinfo@t-knife.com

Sylvia WheelerWheelhouse Communicationsswheeler@wheelhouselsa.com

Dr. Ludger Wess / Ines-Regina Buthakampioninfo@akampion.com

Read the original here:
T-knife Therapeutics Announces $110 Million Series B Financing to Advance Pipeline of T-cell Receptor - GlobeNewswire

DetailsCategory: More NewsPublished on Wednesday, 04 August 2021 13:50Hits: 298

HOUSTON, TX, US AI August 04, 2021 I Excel Diagnostics and Nuclear Oncology Center (EDNOC), a premier Diagnostic Imaging and Radioligand Therapy center in Houston, Texas announces approval of its physicians sponsored Investigational New Drug (IND) application for providing Targeted Alpha Therapy (TAT) with 225Ac-PSMA I&T for metastatic Castration-Resistant Prostate Cancer (mCRPC). We are glad to be able to make this game-changing drug available to our patients suffering from mCRPC. Excel Diagnostics and Nuclear Oncology Center has been a pioneer in bringing new targeted Radioligand Therapies such as Lu-177 DOTATATE, and Lu-177 PSMA to serve our patients in the United States. The addition of 225Ac-PSMA I&T is in continuation of our mission to address unmet needs in the field of Nuclear Oncology said Dr. Ebrahim Delpassand, Chairman and Medical Director of EDNOC and Co-Principal Investigator of the trial. PSMA is an established prostate cancer target. Highly encouraging results have been reported by using Targeted Alpha Therapy (TAT) Radiopharmaceuticals in conditions such as neuroendocrine, prostate, or hematological malignancies. These breakthroughs have brought a significant amount of hope to our patients suffering from different types of advanced cancers. said Dr. Rodolfo Nuez, Director of Nuclear Medicine Department at EDNOC and Co-Principal Investigator of the trial. We are pleased to be able to facilitate the availability of 225Ac-PSMA I&T by manufacturing this drug at RadioMedix. We firmly believe that the menu of targeted Radioligand Therapies will only increase in the future. RadioMedix with its wide range of capabilities, from drug discovery to scale-up commercial manufacturing, is ready to meet this challenge said Dr. David Ranganathan, Director of CMC and Regulatory affairs at RadioMedix.

About Excel Diagnostics and Nuclear Oncology Center (EDNOC)

EDNOC is a premier outpatient facility offering a full spectrum of diagnostic imaging, nuclear medicine and Radioligand therapies. In addition to our comprehensive and state-of-the-art imaging services, we have assembled a staff of highly skilled technical and medical professionals to meet and exceed the demanding standards of the industry. EDNOC is fully capable of conducting sponsored clinical research trials in the field of diagnostic and therapeutic nuclear medicine. All our research staff is GCP Trained and CITI certified consisting of highly trained, board-certified investigators, study coordinators, patient recruiters, and support staff. At Excel, you will find areas designed to safely handle and administer radiopharmaceuticals, patient care areas, and physician interpretation resources. The Excel Clinical Research Department (ECRD) is a dedicated department to assist investigators in their clinical trials. Our team is fully trained regarding rules and regulations of conducting human research, FDA requirements, and IRB compliance. We offer our expertise in conducting clinical research to a variety of academic institutions and pharmaceutical companies. ECRD works closely with CROs & IRBs, to support sponsored clinical trials in the field of oncology radiopharmaceuticals. In April of 2020, Excel passed FDA inspection of one of its investigational drugs with no deficiencies or citations. For more information, please visit us at: http://www.exceldiagnostics.com

About RadioMedix

RadioMedix, Inc. is a clinical-stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is developing radiopharmaceuticals for PET imaging and therapy (alpha and beta-labeled). RadioMedix has also established contract service facilities for academic and industrial partners including drug discovery and probe development core facility, a small animal molecular imaging facility for pre-clinical evaluation of radiopharmaceuticals, and cGMP and analytical suites for late-stage human clinical trials, and post-approval commercial manufacturing. To learn more, visit http://www.radiomedix.comand LinkedIn. For more information about this press release, please contact:This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it.

SOURCE: RadioMedix

Here is the original post:
Excel Diagnostics and Nuclear Oncology Center Announces FDA Authorization of IND for 225Ac-PSMA I&T Targeted Alpha Therapy for Castration Resistant...