On October 4, 2022 The Cancer Research Institute (CRI), a nonprofit organization spearheading transformative research in immunotherapy to control and potentially cure all cancers, reported its commitment to the U.S. Hispanic cancer community with on-demand free access to the 2022 CRI Virtual Immunotherapy Patient Summit in Spanish on cancerresearch.org/conferencia (Press release, Cancer Research Institute, OCT 4, 2022, View Source [SID1234621711]).

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Cancer immunotherapy uses the body’s own immune system to treat, control, and even eliminate cancer. The second annual CRI Virtual Immunotherapy Patient Summit in Spanish included the most up-to-date research from leading immunotherapy experts working in the field to help impact and improve cancer patient care. In fact, 97% of participants who responded to the post-event survey, found the summit to be very valuable and/or valuable and felt that the explanations were easy to understand and very helpful.

Moderated by Ana Patricia Gámez, TV host and entrepreneur, the Summit contained informative sessions and fireside chats with experts and doctors like Kurt Schalper, M.D., Ph.D., associate professor of pathology and medicine (Medical Oncology), Yale School of Medicine, and director of the Translational Immuno-Oncology Laboratory, Yale Cancer Center. Panels led by Teresa Rodríguez, host of Univisionarios (Univision News) and Carolina Sarassa, correspondent for Aquí y Ahora and co-anchor of Univision’s noon newscast Edición Digital included the voices of leading experts like Antoni Ribas, M.D., Ph.D., professor of medicine, surgery, and molecular and medical pharmacology at the University of California Los Angeles (UCLA), director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center, and the chair of the Melanoma Committee at SWOG Cancer Research Network, speaking to the need for information and participation in clinical trials for a future immune to cancer for all patients.

An early diagnosis can change a patient’s cancer journey and overall outcome. Unfortunately, Hispanic men and women are less likely to be diagnosed at an early stage. CRI is leading the charge to help close the immunotherapy information gap for the U.S. Hispanic cancer community by providing in-language research, information, and direct access to clinical trial consultations, where a professional navigator will walk patients and their families through their immunotherapy clinical trial options.

On October 4, 2022 ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent and next generation therapeutic radiopharmaceuticals (RPT), reported to provide the following business update (Press release, ImaginAb, OCT 4, 2022, View Source [SID1234621701]).

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Summary:

ImaginAb has made significant progress this year in its clinical development plans as it pursues the goal to achieve regulatory approval of CD8 ImmunoPET imaging agent across multiple geographies and increases the number of partnerships using this technology.

In January 2022, ImaginAb announced a major expansion of its pipeline with four active programs focused on the development of Radiopharmaceutical Therapies (RPT).

CD8 ImmunoPET Progress:

ImaginAb continues the clinical development of CD8 ImmunoPET with a target to file a Biologics License Application (BLA) submission in the next two years. The clinical development program consists of company and investigator-sponsored studies.

Phase I IBM study:

In August 2021, ImaginAb completed its Phase I IBM study showing utility of CD8 ImmunoPET to detect disease pathology in Inclusion Body Myositis (IBM) patients.

Phase IIa ‘BOT’ study:

In December 2021, ImaginAb completed recruitment of its Phase IIa ‘baseline-on treatment’ (BOT) study and in July 2022 it concluded the 12-month follow-up process of subjects and has now entered the data analysis stage. Preliminary analyses are encouraging, and initial findings will be shared at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference being held in Boston, in November 2022.

Phase IIb ‘iPREDICT’ study:

ImaginAb formally launched its Phase IIb ‘iPREDICT’ study to measure CD8 ImmunoPET imaging predictivity and prognosis, building on the data from its promising Phase IIa ‘BOT’ study. The study aims to enrol 80 patients over 22 sites across US, Australia, and Europe, focusing on many cancer types including Melanoma, Merkel Cell, Renal Cell, Non-Small Cell Lung Cancer and selected solid tumors. Data is anticipated in 2024. In this study, Roche is providing access to atezolizumab (Tecentriq) to Non-Small Cell Lung Cancer Patients.

Phase IIb iCiT study:

ImaginAb started recruitment in June 2022, which is being performed in conjunction with Memorial Sloan Kettering Cancer Center (MSKCC) and funded by the Melanoma Research Alliance and ImaginAb with the goal to collect whole tumor samples to provide additional supportive evidence for diagnostic performance and explore utility of CD8 ImmunoPET in the neoadjuvant setting.

ImaginAb supports the exploration and expanded use of CD8 ImmunoPET by exploring alternative indications and provision of funding to investigator-initiated studies.

COVID-19:

In June 2022, University of California Davis presented preliminary data regarding the utility of CD8 ImmunoPET in imaging COVID-19 patients.

CD8 ImmunoPET Partnership Agreements:

Over the last year, ImaginAb has signed multiple partnership agreements with several biotech and pharma companies to license its technology, demonstrating third party endorsement and establishing ImaginAb’s pioneering CD8 ImmunoPET technology as integral to immuno oncology clinical trials in countries all over the world. ImaginAb has publicly disclosed and announced the following partnerships:

Multi-year license agreement with Bayer to use CD8 ImmunoPET imaging agent in its oncology trials at clinical sites across multiple countries
License agreement with international biotechnology company, Genmab A/S, to utilize CD8 ImmunoPET in its clinical trials, accessing ImaginAb’s global supply chain
Signed agreements with two leading iCRO’s allowing them to provide ImaginAb technology more widely to pharma and biotech customers.
Agreement to supply global, industry-leading imaging CRO company, Invicro LLC, with CD8 ImmunoPET for use in pharma and biotech clinical and preclinical studies
Partnership expansion enabling the world’s largest oncology-focused imaging CRO, Imaging Endpoints, to supply CD8 ImmunoPET direct to biopharma for use in clinical trials in oncology, IBM, and COVID-19.
Exclusive Territorial Licensing Agreement:

In May 2022, ImaginAb signed an exclusive license agreement with DongCheng Pharmaceutical Group, the second largest radiopharmaceutical company in China, to utilize and commercialise CD8 ImmunoPET in pharma and biotech clinical trials in China. ImaginAb has agreed to receive substantial milestone and royalty payments.

CD8 ImmunoPET Global Manufacturing Agreements:

Having entered into multiple productive clinical supply and global manufacturing agreements (GMA) this year, ImaginAb has established a leading global network for manufacturing and distributing its CD8 ImmunoPET imaging agent. These GMA agreements include:

Turkey-based radiopharmaceuticals company, Monrol, to supply, manufacture and distribute CD8 and radiopharmaceutical isotopes for ImaginAb’s iPREDICT study and other partner pharma studies
PharmaLogic, the fastest growing radiopharmaceutical manufacturer in North America, to manufacture and distribute CD8 ImmunoPET for ImaginAb. On September 12th, 2022, the GMP contract manufacturing organization (CMO) successfully delivered the first tracer dose to a US clinical site. The production launch increased ImaginAb’s manufacturing and distribution capacity in North America, providing additional flexibility in clinic scheduling for injection and scan for immune-oncology clinical trials.
DuChemBio, South Korea’s leading radiopharmaceutical company, agreed to supply, manufacture, and distribute CD8 ImmunoPET to pharma sponsored trials in South Korea and other Asian countries which are new to ImaginAb.
RadioPharmaceutical Therapy (RPT) Progress: ImaginAb announced in summer 2021 that it had active programs developing RPT agents based on its proprietary minibody and cys-dibody platforms. In less than one year, the team have identified potential clinical candidates for two cancer targets and is currently initiating IND enabling studies. To support this work and to secure isotope supply for clinical studies and commercialization, ImaginAb announces the following supply agreement:

Next-generation nuclear technology company, SHINE Technologies, agree to supply (n.c.a.) lutetium-177 for the clinical development of ImaginAb’s investigational radiopharmaceuticals
Commenting on ImaginAb’s progress this year, Ian Wilson, Chief Executive Officer of ImaginAb, said:

"The leadership team at ImaginAb is excited to be making progress with our own clinical studies as we pursue our goal to file BLA submissions for 89Zr crefmirlimab berdoxam across multiple geographies, in addition we have expanded our pipeline further into the radiopharmaceutical therapy field.

We have had a transformational year which has seen ImaginAb complete many key development milestones. We currently have licensing agreements with more than fourteen different customers and repeat business from existing customers including Astra Zeneca, Pfizer and Boehringer Ingelheim, enable use of our product in their clinical trials. We look forward to continuing our progress into 2023."

On October 4, 2022 Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported the tuck-in acquisition of Circularis, a biotechnology company with a proprietary circular RNA and promoter screening platform (Press release, Ginkgo Bioworks, OCT 4, 2022, View Source [SID1234621700]). When circularized, RNA is much longer-lived in cells, improving its robustness as a potential therapeutic modality. The Circularis platform also allows ultra-high-throughput screening of promoters and other enhancers. Ginkgo is excited to welcome the Circularis team and platform to enable new solutions across bioproduction, RNA therapeutics, cell therapy, and gene therapy partnerships.

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In recent years, Ginkgo has significantly expanded its work in cell and gene therapy, including a program to improve adeno-associated virus (AAV) manufacturing in partnership with Biogen, and a program to develop AAV capsids with altered tropism and immunogenicity in partnership with Selecta Biosciences. The field of nucleic acid therapeutics is a promising novel therapeutic modality, and Ginkgo has worked on programs across the space, including with Moderna and Aldevron, and is actively engaged in improving circular RNA efficacy and manufacturing yields.

The Circularis platform strengthens Ginkgo’s platform for development of cell and gene therapies, providing the capability to rapidly identify novel promoters with appropriate strength and tissue-specificity designed into customer specific delivery modalities. Leveraging Ginkgo’s ability to explore large numbers of genetic designs, these promoter libraries can be explored in combination with modified therapeutic payloads and capsids to provide gene therapy developers a solution that works across any range of cell or organism models. Similarly, the Circularis platform will give Ginkgo the ability to rapidly identify context-specific promoters for cell therapy applications, such as those that modulate gene expression in the tumor microenvironment.

"Circularis has built an exceptional platform to screen gene expression regulatory elements, a need across the cell and gene therapy space," said Narendra Maheshri, Head of Mammalian Foundry at Ginkgo Bioworks. "We are excited to leverage the strong expertise of the Circularis team to further develop circular RNA methods for therapeutic use, and can’t wait to incorporate this technology into existing and upcoming cell programs across therapeutic applications as well as more broadly."

"Circularis was founded because we saw a need for better tools to control gene regulation in a range of species. Our team is incredibly proud of what we’ve built, and the opportunity to scale it on the Ginkgo platform means we’re a major step closer to realizing this technology’s potential," said Mat Falkowski, Chief Executive Officer at Circularis. "We are excited to bring the power of the Ginkgo platform to both Circularis’ already existing customer base and future partners."

On October 4, 2022 ImpediMed Limited (ASX.IPD) reported the signing of a Global Strategic Commercial Partnership and pilot program with GenesisCare (Press release, ImpediMed, OCT 4, 2022, View Source [SID1234621699]). The pilot program will consist of an initial roll out of five (5) SOZO units to establish lymphedema screening services for breast cancer patients in centers across the United States. These units are scheduled to be installed over the coming quarter. Upon successful completion of the pilot program, GenesisCare will evaluate a staged expansion to additional sites in the United States and globally.

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GenesisCare is a global care leader with more than 6,000 highly trained healthcare professionals employed at more than 300 locations across four countries. They are the one of largest providers of cancer care in USA, Australia, Spain, and the UK. In the US, GenesisCare operates radiation oncology treatment centers and integrated medical offices, including 120 radiation oncology centers. Additionally, GenesisCare operates a further 40 centers in Australia, 17 in Spain, and 14 in the UK.

ImpediMed is pleased to announce a Global Strategic Commercial Partnership and SOZO pilot program with GenesisCare.

GenesisCare focuses on a culture of care that is patient focused and performance driven. Their vision is to provide care that focuses on the individual as well as the condition. They personalize treatment by designing individualized care experiences that get the best possible life outcomes with a goal of delivering exceptional service in a way that enhances every aspect of a patient’s cancer journey.

"GenesisCare is dedicated to providing exceptional care utilizing the latest and best tools and technologies for our patients during both treatment and survivorship," said GenesisCare Global Chief Medical Officer, Wally Curran, MD. "Lymphedema places physical, emotional, and financial burden on cancer survivors, and it is often identified later in the course of treatment or care. Just as we seek to find breast cancer at the earliest possible time through screening, we can identify lymphedema earlier using SOZO and ImpediMed’s lymphedema prevention program, with the hope of improving our patients’ quality of life in survivorship."

"We are proud to partner with organizations like GenesisCare that are committed to bringing innovative technologies and solutions to their patients," said David Anderson, Interim CEO of ImpediMed. "Our team will work closely with the five pilot sites to ensure successful implementation of SOZO within their existing workflows. These initial programs will create the template to bring lymphedema prevention services to more cancer patients across the globe."

Over the past year, ImpediMed announced a strategy of expanding its engagement with key corporate accounts and large integrated delivery networks (IDNs). As a part of a proven land and expand strategy, SOZO programs start small and then expand once workflows are established. The Company has almost a quarter of US SOZO’s now operating in IDN and corporate accounts and expects this number to significantly grow as reimbursement becomes widely available.

About Lymphedema
Lymphedema is a side effect of cancer treatment. It currently affects about 1-in-3 patients who have undergone surgery, radiation, or chemotherapy, each of which may compromise the lymphatic system. Lymphedema is characterized by abnormal swelling that generally occurs in one of the arms or legs, and sometimes both arms and both legs. Patients with lymphedema also have a greater risk of getting infections. Cuts or small breaks in the skin can lead to serious complications and hospitalizations. Currently, no cure for lymphedema exists. By the time patients experience swelling, the condition is typically irreversible. However, new research indicates that prevention is possible if lymphedema is caught early. For more information, visit www.preventlymphedema.com.

On October 4, 2022 Applied BioMath (www.appliedbiomath.com), the industry-leader in providing model-informed drug discovery and development (MID3) support to help accelerate and de-risk therapeutic research and development (R&D), reported a continuation of their collaboration with Celsius Therapeutics for the development of a systems pharmacology model of a monoclonal antibody for the treatment of inflammatory bowel disease (IBD) (Press release, Applied BioMath, OCT 4, 2022, View Source [SID1234621698]).

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In this continued collaboration, Applied BioMath will develop an in vitro and human systems pharmacology model to support human dose predictions.

"We chose to continue our work with Applied BioMath due to the scientific excellence and collaborative approach we experienced in our previous project," said Jeanne Magram, PhD, CSO at Celsius Therapeutics. "The model results will provide critical insight as we prepare for IND filing."

Applied BioMath offers software and services to help de-risk and accelerate drug R&D. Their solutions, which focus on quantitatively integrating knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms, are leveraged across the entire R&D spectrum from early research through to clinical trials. Their approach involves working with clients to develop the appropriate mathematical strategy for each unique project, with common strategies encompassing systems pharmacology, mechanistic modeling, bioinformatics, biosimulation, and clinical pharmacology.

"We are proud to continue working with Celsius Therapeutics to provide support for their program," said John Burke, PhD, Co-founder, President and CEO at Applied BioMath. "MID3 helps define better human dose predictions by providing a holistic approach of integrating available knowledge, preclinical data, and competitor or comparator data."