On January 11, 2024 Xcell Biosciences, Inc. (Xcellbio), a platform technology company focused on cell and gene therapy applications, reported a collaboration with ElevateBio, LLC (ElevateBio), through which the companies aim to explore novel approaches to improving therapeutic potency of cell and gene therapies (Press release, Xcell Biosciences, JAN 11, 2024, View Source [SID1234639210]). As part of this collaboration, ElevateBio becomes the first member of Xcellbio’s beta program for its new AVATAR Foundry device. In addition, Michael Paglia, Chief Technology Officer at ElevateBio’s BaseCamp, has joined Xcellbio’s Scientific Advisory Board.

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ElevateBio is a technology-driven company commercializing its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate the development of genetic medicines. The company’s integrated ecosystem combines its BaseCamp process development and current Good Manufacturing Practice (cGMP) manufacturing business with its technology stack that includes gene editing, cell engineering technologies, and viral and non-viral delivery.

"At BaseCamp, we work with industry partners to design the best process for their product and recognize the importance of emerging technologies that will revolutionize how cell and gene therapies are manufactured," said Mr. Paglia. "I am excited to join the Xcellbio advisory board and look forward to joining Brian and the team on the collaboration with BaseCamp."

As part of this collaboration, ElevateBio BaseCamp scientists will have access to Xcellbio’s AVATAR incubator system for cell therapy research and development as well as two new platforms: the AVATAR Ai system for measuring the potency of cell therapies and the AVATAR Foundry system for cGMP cell therapy manufacturing. The AVATAR and AVATAR Foundry systems are used to metabolically reprogram therapeutic cells to improve their potency and persistence in the tumor microenvironment (TME), while the AVATAR Ai provides real-time analysis of tumor cytotoxicity under TME conditions. These collaborative efforts should streamline manufacturing protocols for cell and gene therapies.

Brian Feth, co-founder and CEO at Xcellbio, commented: "We are delighted to collaborate with ElevateBio, a true leader in the cell and gene therapy field, and we look forward to one day having a collective impact in how these important treatments are used to improve healthcare. We also welcome Mike to our advisory board and are eager for his contributions to our own R&D programs in that capacity."

The beta program for Xcellbio’s AVATAR Foundry system is now open. To learn more, meet with the Xcellbio team at Advanced Therapies Week taking place in Miami from January 16-19 or visit View Source

On January 11, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, reported that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma (Press release, Indapta Therapeutics, JAN 11, 2024, View Source [SID1234639209]). The patients were treated at the University of Texas MD Anderson Cancer Center and NEXT Oncology, Virginia.

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The first patient received a single dose of IDP-023. The second patient has received the first of three planned doses of IDP-023. Subsequent cohorts of patients will receive three doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive treatment with IDP-023 in combination with the monoclonal antibodies rituximab and daratumumab, respectively.

"We are excited to transition to a clinical stage company," said Dr. Mark Frohlich, CEO of Indapta. "Based on the encouraging clinical activity of NK cells demonstrated by others and the superior activity of IDP-023 compared to conventional NK cells in preclinical models, we are looking forward to evaluating the safety and clinical activity of IDP-023 in this Phase 1 trial."

Indapta also announced that it has successfully manufactured sufficient IDP-023 to supply the Phase 1 clinical trial through the second half of 2024. "We are very pleased with the high yields we are achieving in our GMP production runs," added Frohlich. "The recent improvements in our manufacturing process together with additional planned process changes should position us well for a competitive cost of goods by the time of product launch."

Indapta’s Differentiated G-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "G minus" NK cells, or "g-NK" that markedly improve the cancer killing power of monoclonal antibody (mAb) therapy, without the need for genetically engineering the cells. G-NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells. Indapta’s off-the-shelf g-NK cell therapy is further differentiated from other NK cell therapies in that it is a cryopreserved product with low variability.

Indapta’s g-NK are capable of releasing dramatically more immune activating cytokines and cancer-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2020, View Source)

On January 11, 2024 GenFleet Therapeutics, a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, reported that U.S. Food and Drug Administration (FDA) has recently granted another two designations for SLS009 (GFH009) (Press release, GenFleet Therapeutics, JAN 11, 2024, View Source [SID1234639208]). GFH009 (highly selective CDK9 inhibitor) so far has received both fast track and orphan drug designations from the FDA for the treatment of adult patients with relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and r/r acute myeloid leukemia (AML). At present, two phase II studies are actively underway in China and the US, focusing on the treatment of r/r PTCL and r/r AML respectively. Numerous subjects in GFH009 studies achieved complete or partial responses, and superior safety profile & efficacy of GFH009 was observed in previous studies.

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GenFleet is conducting a multi-center, open-label, single-arm study of GFH009 for the treatment of r/r PTCL in close to 40 sites in China. The study is currently progressing into Phase II, following the completion of safety confirmation in Phase Ib. During the dose escalation portion of Phase I, the data demonstrated significant reduction in expression of proto-oncogenes such as MYC, MCL1 among patients with hematological malignancies including PTCL; clinical responses were observed in four PTCL patients, and one of these PTCL patients has been under continuous treatment for over 66 weeks.

GenFleet’s partner Sellas Life Sciences is currently undertaking a Phase II trial in the US for SLS009 (GFH009) in combination with venetoclax and azacitidine for treating r/r AML patients. The first patient enrolled at the safety dose level has achieved complete response. No dose-limiting toxicities were observed; significant anti-leukemic effects, marked by a decrease of 50% or more in bone marrow blasts, were observed in a substantial number of subjects.

"Leading projects in GenFleet’s pipeline made significant strides in registrational efforts over the past year. GFH925 was granted with NDA acceptance, priority review and two breakthrough therapy designations in China; GFH009 received FDA fast track and orphan drug designations for two indications. The forward-thinking strategy in GenFleet’s pipeline buildup brings immense challenge as well as opportunities for our innovation. We appreciate recognition of supervisory bodies and collaborative efforts of business partners both in China and the US. As we step into new year, we are looking forward to more registrational advancements of our pipeline." stated by Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.

Fast Track Designation is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Programs with FTD are eligible for more frequent interactions with FDA to discuss the candidate’s development plan, as well as a rolling review of NDA or BLA to facilitate Accelerated Approval and Priority Review if relevant criteria are met. Besides, the benefits provided by ODD include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

About CDK9 and GFH009

As a family of serine & threonine kinases, the cyclin-dependent kinase (CDK) family plays an important role in cell cycle regulation and transcription; CDK9 activity is inversely correlated with the overall survival rate of patients with multiple tumors. Data from phase I trial and the preclinical research of GFH009 were posted at the 2002 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). GFH009 monotherapy is well tolerated with preliminary clinical activity in patients with relapsed/ refractory lymphomas.

According to preclinical research, GFH009 reduces the expression of downstream oncogenes required for rapid cellular division and protein expression through specific, short-lived inhibition of CDK9. With more than 100 times selectivity over other CDK subtypes, this depletion via GFH009 inhibition of CDK9 likely deprives oncogene-addicted cancer cells of crucial survival signals, leading to senescence and death. GFH009 also exhibits strong anti-proliferative activities in multiple human cell lines, effectively inhibits the growth of tumor in various xenograft models and significantly improves survival of tumor bearing animals.

GenFleet received IND approval in 2020 for the GFH009 monotherapy to proceed into phase I trial treating patients with r/r hematological malignancies. In 2022, GenFleet and SELLAS Life Sciences Group (Nasdaq: SLS) entered into an exclusive license agreement across all therapeutic and diagnostic uses worldwide outside of Greater China (the Chinese mainland, Hong Kong, Macau and Taiwan).

On January 11, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that Liz Barrett, President and CEO, will participate in a fireside chat at the upcoming B. Riley Virtual Healthcare Conference on January 18th beginning at 12:00 p.m. ET (Press release, UroGen Pharma, JAN 11, 2024, View Source [SID1234639207]).

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To access the event, please RSVP to your B. Riley Securities sales representative. Following the event, a replay of the fireside chat will be available at the "Events and Presentations" section of UroGen’s investor website for approximately 30 days.

On January 11, 2024 Immunome presented its corporate presentation (Presentation, Immunome, JAN 11, 2024, View Source [SID1234639205]).

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