On July 24, 2023 CG Oncology, Inc., reported completion of patient enrollment for BOND-003, a single arm, Phase 3, monotherapy study evaluating cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, CG Oncology, JUL 24, 2023, View Source [SID1234633398]).

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In the BOND-003 study there are 110 patients enrolled with BCG-Unresponsive High-Risk NMIBC across North America and the Asia-Pacific regions. The primary endpoint of the study is complete response (CR) at any time. Secondary endpoints include CR at 12 months, duration of response, progression-free survival, cystectomy-free survival, and safety. For more information about BOND-003, visit www.clinicaltrials.gov (NCT04452591).

"As a patient advocacy organization, it is exciting to see new treatments get closer to being available to bladder cancer patients with BCG-unresponsive disease, who have so few options available. Many will only have the option of bladder removal, which is not always available due to other health concerns," said Andrea-Maddox Smith, Chief Executive Officer, Bladder Cancer Advocacy Network (BCAN). "We have consistently advocated for increased funding for research and encouraged patients to seek out appropriate trials."

"We would like to thank all those who partnered with us to complete this study especially patients, care givers, physicians and health care teams in the United States and globally who helped us reach this important milestone," said Arthur Kuan, Chief Executive Officer, CG Oncology. "We are intensely focused on developing bladder-sparing therapeutics and are actively engaged in making cretostimogene available to patients as soon as possible."

About Cretostimogene Grenadenorepvec

Cretostimogene grenadenorepvec is an intravesically delivered oncolytic immunotherapy agent in a Phase 3 trial for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Cretostimogene grenadenorepvec is also in a Phase 2 study in combination with KEYTRUDA (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with cretostimogene grenadenorepvec in combination with OPDIVO (nivolumab).

About Bladder Cancer

More than 82,000 people are estimated to be diagnosed with bladder cancer this year. NMIBC is the most common form of bladder cancer, representing approximately 75% of cases. Four times more men are diagnosed with bladder cancer than women and is the fourth most common type of cancer in men in the United States.

On July 24, 2023 ARTBIO, Inc. (ARTBIO), a clinical-stage radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ART), and SpectronRx, a leading radiopharmaceutical developer and manufacturer, reported a global strategic partnership agreement to support manufacturing of components of ARTBIO’s AlphaDirect isotope isolation technology (Press release, ARTBIO, JUL 24, 2023, View Source [SID1234633397]).

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As part of the agreement, SpectronRx will be responsible for manufacturing a critical component of ARTBIO’s proprietary AlphaDirect technology. AlphaDirect is a first-of-its-kind system that delivers highly pure Pb212 from widely available raw materials. The multi-year agreement covers an initial technology transfer and development phase, followed by qualification and release of the technical components.

"We have a long history in managing complicated technology projects involving radioactive materials," said SpectronRx co-founder and CEO John Zehner. "We understand the importance of collaboration for companies developing new technologies aimed at creating radioligand therapies. SpectronRx is well-equipped and proud to partner with ARTBIO to develop and supply key components of AlphaDirect."

ARTBIO pioneered the AlphaDirect technology to create an optimized and proprietary Pb212 isotope isolation technology with unique advantages, including:

Benchtop format, which can be operated in facilities of any size.
Simple process with no fluid separation that results in 99.9%+ purity.
Streamlined supply chain with starting materials derived from accessible nuclear industry stockpiles that minimize uncertainty and cost.
SpectronRx will tap into its expertise for handling and producing rare medical radioisotopes such as Ac-225 (actinium-225) and Pb-212, along with its infrastructure for Radiopharmaceutical Contract Development (rCDMO) and Radiopharmaceutical Contract Manufacturing (rCMO). This unique combination and its extensive regulatory track record will enable ARTBIO to effectively improve and validate its manufacturing processes to get them ready for FDA and EMA review.

"We are pleased to partner with SpectronRx, a company with extensive experience and capabilities in managing nuclear chemistry projects," said Emanuele Ostuni, Ph.D., Chief Executive Officer of ARTBIO. "Handling high doses of radioactivity is an extremely complex process, and it was critical that we work with a partner that understands the specific requirements needed and can create a customized solution for our proprietary AlphaDirect technology. With SpectronRx’s expertise, we are a step closer to the establishment of the ARTBIO manufacturing network."

"ARTBIO’s technology has the potential to revolutionize the field of cancer treatment," added SpectronRx President Anwer Rizvi. "We are thrilled to be a part of their incredible journey."

On July 24, 2023 Cognizant (NASDAQ: CTSH) reported an expansion of its relationship with Gilead Sciences (NASDAQ: GILD) (Press release, Gilead Sciences, JUL 24, 2023, View Source [SID1234633396]). Gilead is a leading biopharmaceutical company advancing innovative medicines to prevent and treat life-threatening diseases. Under the agreement, Cognizant will manage Gilead’s global IT infrastructure, platforms, applications and advanced analytics, and lead initiatives designed to accelerate its digital transformation. The agreement includes renewal and expansion of Cognizant services for a total expected value of $800 million over the next five years. This collaboration is aimed at enabling Gilead to streamline various parts of its business with the goal of faster time to market of various medicines for life-threatening diseases, including HIV, viral hepatitis, and cancer.

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The pharmaceutical industry has traditionally been slower to adopt digital transformation journeys compared with other industries. Gilead is an industry leader in embracing digital transformation in its business, having partnered with Cognizant for more than three years to adopt cutting-edge technologies designed to drive better business outcomes. This includes supporting enabling technologies for running business operations, new product launches and improving IT processes for efficient research, manufacturing, and commercialization of its products.

"Over the past three years, Cognizant has demonstrated quality delivery, adaptability and dedication to Gilead’s success," said Marc Berson, Senior Vice President and Chief Information Officer at Gilead Sciences. "Through this collaboration, Cognizant has provided critical expertise to progress our digital transformation journey while enabling stable, secure operations. This has allowed us to advance research and commercialization of transformative treatments for some of the world’s most challenging diseases. We look forward to expanding this partnership to advance to the next phases of our capability roadmap."

Building on the company’s collaboration, Cognizant will continue to support Gilead in the following:

Enhance the internal and external client experience: BioPharma customers often need special and time-sensitive assistance to support their projects. With IT infrastructure, IT security and IT platform services, Cognizant expects to enable Gilead to provide a more consistent and seamless experience to over 18,000 internal users across 40+ countries globally.

Expand cloud operations: Cognizant will continue to support Gilead’s shift to cloud-computing environments as appropriate in collaboration with the hyperscalers. In addition, Cognizant will also help Gilead continue to modernize the business applications on such Cloud Platforms.

Digitally transform the business: Cognizant anticipates leveraging the power of Generative AI (GenAI) and AI automation to help enhance Gilead’s customer service experience and assist it in driving greater manufacturing efficiencies. The GenAI advances should enable Gilead to provide greater visibility and transparency about the company’s treatments to patients and internal employees globally. The company will leverage Cognizant’s Neuro IT service for AI automation innovation, which should help the company to bring products to market more efficiently. In addition, Cognizant will build applications and operate services that introduce new or enhanced technologies enabling efficient and differentiated business capabilities.

Data and Analytics Services: Cognizant will continue to provide support for all enterprise data and analytics platforms across all business functions, including the introduction of the latest and most relevant technologies to support differentiated business outcomes.
"We’re excited about this expanded partnership with Gilead, one of the pharmaceutical industry leaders in adapting advanced technologies to better deliver transformative treatments for patients world-wide," said Surya Gummadi, Executive Vice President and President, Cognizant Americas. "Working together our teams will be leveraging the latest technologies from automation to cloud computing, and Generative AI to help Gilead bring its products to market faster, more efficiently, and with higher customer satisfaction."

On July 24, 2023 AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic engineered CAR-T cell therapies, reported that the European Medicines Agency (EMA) has approved the company’s Clinical Trial Application (CTA) application for AVC-201 for the treatment of relapsed/refractory Acute Myeloid Leukemia (AML) and other selected hematologic malignancies positive for CD123 (NCT05949125) (Press release, AvenCell Therapeutics, JUL 24, 2023, View Source [SID1234633395]). AVC-201 is a CRISPR-engineered allogeneic switchable CAR-T candidate designed to target and eliminate cells expressing receptor CD123, which is known to be overexpressed in nearly all acute myeloid leukemias, and several other hematological malignancies.

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The phase 1 study, which includes up to 35 patients, will be conducted at multiple sites in Germany. The primary objective of the trial is to assess the safety profile of AVC-201 and to determine the maximum tolerated dose. Secondary measures will include efficacy, safety, and CAR-T persistence.

"We are excited to build on the early success and promising activity and safety of our ongoing switchable autologous clinical program in AML (AVC-101) by now including what we believe is the most scientifically-compelling allogeneic technology in the industry," said Andrew Schiermeier, AvenCell’s President & CEO. "With the application of both platform technologies, we are the first company in this space to completely separate the manufacture of cells from the ultimate patients and cancer indications they will be targeted to. This modular approach allows for unparalleled future flexibility and reduction in cycle times, massive scaling of supply, and meaningful reductions in cost of goods, all of which will dramatically advance the field of cell therapy for patients."

About AVC-201
AVC-201 is a CRISPR-edited Chimeric Antigen Receptor ("CAR")-T Cell therapy that embodies two discrete technology platforms. The first leverages AvenCell’s "UniCAR" universal/switchable technology which is comprised of a two-component system. Engineered T Cells are transduced with a "universal" receptor that is completely biologically inert (expressing human La peptide), and are only activated when bound to a second biologic molecule ("targeting module") which directs the T cells to a cancer antigen of interest (in this case, CD123). The presence or absence of the targeting module in circulation allows for exquisite "on" and "off" control, respectively, of the therapeutic activity. The second technology platform consists of an in-licensed allogeneic cell engineering technology developed by Intellia Therapeutics which allows for unrelated donors to provide cells for patients. These cells are uniquely engineered via CRISPR/Cas9 to avoid GvHD and rejection via the host/patient immune system by either innate or adaptive mechanisms.

About AVC-201 Clinical Program
AvenCell’s Phase I study (NCT05949125) is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AVC-201 in adults with relapsed or refractory AML and other CD123 positive hematological malignancies. The study is an open-label, single-ascending dose design used to identify two dose levels of AVC-201 that will be further evaluated in a subsequent Phase 2 study.

About Acute Myeloid Leukemia (AML)
AML typically develops from mutations in the DNA of early blood-forming cells, leading to the disruption of normal cell maturation and proliferation. This results in a buildup of immature cells in the bone marrow, crowding out healthy cells and impairing their ability to function properly. AML accounts for a significant proportion of all leukemia cases. In the United States, it is estimated that approximately 21,000 new cases of AML will be diagnosed in 2023, while on a global scale, the incidence of AML is estimated to be around 2-8 cases per 100,000 people annually. Treatment for AML usually involves chemotherapy to destroy cancer cells, and more recently available targeted therapies directed against specific mutations (e.g. IDH, FLT3.) While a majority of AML cells express the receptor CD123, several previous attempts to target this receptor therapeutically have failed due to the difficulty in managing toxicity. Stem cell transplant continues to be considered the only curative option. The survival rate of AML can vary depending on several factors, including age, overall health, specific genetic mutations, response to treatment, and other individual characteristics. However, the overall five-year survival rate for AML is around 25-30%.

On July 24, 2023 HDT Bio Corp., a clinical stage private company developing advanced RNA vaccine products to treat and prevent infectious diseases and cancer, reported the publication of preclinical data demonstrating that the company’s AMPLIFY vaccine platform, comprised of self-replicating RNA (repRNA) and LION formulation technology, holds a more favorable safety profile and increased durability and localization compared to repRNA vaccines delivered by lipid nanoparticles (LNPs), similar to those used to deliver currently-available RNA vaccines for COVID-19 (Press release, HDT Bio, JUL 24, 2023, View Source [SID1234633394]). The data were published in the journal Molecular Therapy, in an article entitled, "A localizing nanocarrier formulation enables multi-target immune responses to multivalent replicating RNA with limited systemic inflammation."

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"While RNA vaccines have greatly curtailed the COVID-19 pandemic, legitimate safety concerns have arisen that must be taken into consideration," said Steve Reed, Ph.D., Chief Executive Officer of HDT Bio. "The findings of this study demonstrate that our LION delivery system offers unique properties that greatly improve upon the safety, immunogenicity and efficacy of the type of lipid nanoparticles that are currently in use. This is a clear demonstration that AMPLIFY is a next-generation platform with the potential to transform immunizations worldwide."

The key findings of the publication, conducted in a mouse model, are summarized below.

Intramuscular administration of repRNA with LION technology (repRNA/LION) restricted RNA expression to the muscle, whereas repRNA with LNPs (repRNA/LNP) was observed broadly throughout the body;
repRNA/LNP triggered both local and systemic innate immune/inflammatory responses, whereas repRNA/LION restricted innate immune activity to the local injection site, but did not trigger a systemic inflammatory response;
repRNA/LION induced a comparable antibody and T cell response to repRNA/LNP, despite the absence of a systemic response;
In a multivalent vaccine design repRNA/LION induced potent neutralizing antibody responses to each antigen.
The publication can be found on the Molecular Therapy website and on the Publications page of the HDT Bio website.