Seattle Genetics Initiates Phase 1 Trial of SGN-CD352A for Patients with Relapsed or Refractory Multiple Myeloma

Seattle Genetics | January 05, 2017

Seattle Genetics, Inc. (NASDAQ: SGEN), a global biotechnology company, today announced enrollment of the first patient in a multicenter phase 1 clinical trial of SGN-CD352A for patients with relapsed or refractory multiple myeloma (MM). SGN-CD352A is an investigational CD352-targeted antibody-drug conjugate (ADC) utilizing Seattle Genetics’ proprietary ADC technology, an engineered cysteine antibody (EC-mAb) stably linked to a highly potent cytotoxic agent called a pyrrolobenzodiazepine (PBD) dimer. CD352 is broadly expressed on B-cell cancers including multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin lymphoma, while exhibiting low expression on normal white blood cells.

Spotlight

Accurate diagnosis is the cornerstone of medicine; it is essential for informed care and promoting patient and family well-being. However, families with a rare genetic disease (RGD) often spend more than five years on a diagnostic odyssey of specialist visits and invasive testing that is lengthy, costly, and often futile, as 50% of patients do not receive a molecular diagnosis.


Other News
INDUSTRY OUTLOOK

Curocell, Breaks Ground on 'CAR-T Manufacturing GMP Facility'

Curocell, Inc. | December 24, 2021

Curocell, currently on PhaseⅠCAR-T Therapy clinical trial with CRC01 has recently broken ground for the new CAR-T Center in Dungok Residential & Industrial Area in Daejeon International Science & Business Belt. The GMP Facility for commercial manufacturing CAR-T Cell therapy and R&D Center for further pipeline development are constituting the 17,325 square-meter site of CAR-T Center. By the first half of 2023, construction is expected to be completed and in 2024, when the CAR-T Center is fully operational, supply of advanced cure should be possible for patients in pain. Also, Curocell is expecting to expand their business to global market by in-housing all processes of CAR-T therapy development and production. About CRC01 (anbalcabtagene autoleucel) CRC01, recognized CD19 and is based on OVIS™, a first-in-class CAR-T platform. OVIS™ technology downregulates PD1 and TIGIT expression on CAR-T cells. Through overcoming the immune suppression by PD-1 and TIGIT ligands, OVIS™ CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. Phase II clinical trial of CRC01 will start in South Korea in the first half of 2022. About Curocell Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS™ technology with the goal of improving clinical efficacy of CAR-T therapies.

Read More

CELL AND GENE THERAPY

Genomics Testing Companies and Laboratories Combine Efforts to Establish the CardioGenomic Testing Alliance

CardioGenomic | March 23, 2022

Several leading genomics companies and laboratories, including Illumina, Fulgent Genetics, Invitae, GeneDx, and PerkinElmer Genomics, have formed the CardioGenomic Testing Alliance (CGTA), a collaborative group aimed at raising awareness and utilization of genomic testing in cardiology. CGTA will inform healthcare providers and other stakeholders to the value of such testing to assure adherence to existing guidelines from professional medical societies, inform medical management and cascade testing, and improve clinical outcomes. The companies forming this coalition believe in extensive clinical utility of cardiogenomic testing. Their combined efforts to increase awareness and utilization of cardiogenomic testing will show the positive outcomes genetic testing can have on patients." Melissa Dempsey, genetic counselor at Illumina and CGTA chairwoman. Genomic testing in cardiology is a powerful tool that can identify those at-risk for specific cardiac conditions, such as arrhythmias, cardiomyopathies, and congenital heart malformations. According to the American Heart Association, "genetic testing is informative and useful for the clinical management of various inherited cardiovascular diseases such as cardiomyopathies, arrhythmic disorders, thoracic aortic aneurysms and dissections, and familial hypercholesterolemia."1 Sudden cardiac arrest can often be the first symptom of an inherited cardiac condition.2 The Sudden Arrhythmia Death Syndromes (SADS) Foundation reports that up to 49% of victims of sudden cardiac death had a significant family history that should have triggered diagnostic testing, and cascade genetic testing reveals an average of 8.9 additional affected family members.3 Genetic testing is one of the essential steps in the diagnosis and treatment of families with SADS conditions." Alice Lara, president of the SADS Foundation. Despite evidence and major professional society recommendations, utilization and awareness of cardiogenomic testing remains low. CGTA will strive to inform healthcare providers about the current guidelines for the appropriate use of genetic testing in cardiology. Working with key stakeholders, CGTA will identify logistical barriers to testing and develop educational resources to address these barriers for providers and for the public.

Read More

CELL AND GENE THERAPY

Bicycle Therapeutics Announces Continued Clinical Progress and Updates to Management Team

Bicycle Therapeutics | January 06, 2022

Bicycle Therapeutics plc, a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide technology, announced continued progress in its ongoing Phase I/II clinical trials of BT8009, BT5528 and BT7480. “Last quarter, we reported interim clinical results from ongoing trials of two of our Bicycle toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced the first patient dosed in the Phase I clinical trial of BT7480, our first tumor-targeted immune cell agonist to enter the clinic. In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. We look forward to presenting interim BT8009 Phase I results at a medical meeting and initiating the BT5528 expansion cohorts this year. We are also pleased with our progress advancing BT7480 in the ongoing Phase I clinical trial and look forward to sharing additional details regarding the potential for Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted oncology therapeutics.” Kevin Lee, Ph.D., Chief Executive Officer Bicycle Toxin Conjugates® (BTCs) BT8009 and BT5528 In the ongoing Phase I portion of the Phase I/II clinical trial of BT8009, a second-generation BTC™ targeting Nectin-4, four out of 11 patients were previously reported to have a partial response under Response Evaluation Criteria in Solid Tumors version 1.1, including one out of four (25%) in the 2.5mg/m2 dose and three out of seven (43%) at the 5.0 mg/m2 cohorts. All four patients previously reported as responders have since received at least one subsequent scan, and all have been confirmed as ongoing RECIST 1.1 responses. One patient in the 5.0 mg/m2 cohort, who previously was reported to have a partial response with an 89% tumor reduction, has now received two subsequent scans, which each showed that total tumor volume has been reduced by 100%, constituting a confirmed complete response. All four patients previously reported to have a RECIST 1.1 clinical response remain on therapy. The tolerability profile of the 2.5mg/m2 and 5.0 mg/m2 cohorts remains consistent with that previously reported. Dose escalation in the BT8009 Phase I trial remains ongoing, with patients currently being dosed at 7.5mg/m2 weekly or every-other-week. Bicycle intends to present interim Phase I results from the ongoing clinical trial at a medical meeting this year. The Phase I/II trial of BT5528, Bicycle’s second-generation BTC targeting EphA2, is also ongoing, with plans remaining on track to initiate the expansion cohorts this year, with an expected recommended Phase II dose of 6.5mg/m2 every-other-week. Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™) BT7480 Bicycle also initiated a Phase I clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137, in the fourth quarter of 2021, and dose escalation in that trial remains ongoing. BT7480 and other Bicycle TICAs, including a novel NK-cell-engaging molecule, were the subjects of four posters at SITC in November 2021. Management Team Updates Bicycle is also announcing the expansion of and transition in its management team. Michael Skynner, Ph.D., the company’s Chief Operating Officer has been appointed to the newly created position of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing the growth of Bicycle’s proprietary phage display discovery platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr. Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who has served as the company’s Vice President, Human Resources and Communications since January 2021, has assumed the COO role. Mr. Milnes previously led human resources and communications at multinational energy and mineral companies. Both Dr. Skynner and Mr. Milnes are based in the United Kingdom. “We are delighted to announce our recent management team appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the COO role. Mike has been an invaluable contributor to Bicycle’s success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical progress, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline and on identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic focus. I am confident that Mike can help us achieve these objectives.” Dr. Lee added, “I am similarly enthusiastic about Alistair’s appointment as COO and believe his operational experience and track record of successfully identifying, recruiting, and retaining key talent at large, multinational companies will be instrumental in helping guide Bicycle through our next phase of growth.” About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA.

Read More

MEDTECH

Salipro Biotech Receives European Patent for Antigen production

Salipro Biotech | February 09, 2022

Swedish biotech company Salipro Biotech AB announced that the European Patent Office has granted a further European Patent to the company, No. EP 3 043 814 B1 entitled "Antigen and method for production thereof", following the approval of the US-member of this patent family already in 2018 under US Patent 10,159,729 B2. The patents cover the composition-of-matter, methods and uses of the company's novel antigen technology, strengthening Salipro Biotech's proprietary platform technologies for the discovery and development of next-generation therapeutics against challenging drug targets such as GPCRs, ion channels and transporters. "We're constantly increasing our collaborations, partnerships and licensing agreements with major pharma companies on a wide range of challenging drug targets. Expanding our already strong patent portfolio further will enable us to increase the value of such collaborations for our partners as well as moving towards building our own discovery pipeline." Maria Knudsen, Business Development Director at Salipro Biotech AB Jens Frauenfeld, CEO, comments: "We're excited about this important milestone that provides additional protection for our core technologies. The market for therapeutic antibodies, vaccines and biologics is ever expanding. Securing these patents protects our innovative platform and further strengthens our position by supplementing our foundational and follow-up patents that have already been granted to Salipro Biotech in many countries, including US, EU, China and Japan." About Salipro Biotech AB Salipro Biotech AB is a privately held biotech company focused on unlocking challenging drug targets for the development of next-generation therapeutics. The company is headquartered in Stockholm, Sweden with a fully owned IP portfolio that covers the Salipro® platform technology for the stabilization of membrane proteins.

Read More

Spotlight

Accurate diagnosis is the cornerstone of medicine; it is essential for informed care and promoting patient and family well-being. However, families with a rare genetic disease (RGD) often spend more than five years on a diagnostic odyssey of specialist visits and invasive testing that is lengthy, costly, and often futile, as 50% of patients do not receive a molecular diagnosis.

Resources