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Ixaka to present in vivo gene delivery platform for CAR-T and related bioproduction challenges at 6th CAR TCR Summit

On August 31, 2021 Ixaka Ltd, an integrated cell and gene therapy company, reported that Dr Cecile Bauche, Chief Scientific Officer, will present its in vivo gene delivery platform and the key bioproduction challenges associated with advancing an in vivo CAR-T therapy into the clinic at the 6th CAR TCR Summit on Tuesday, 31 August, 2021 at 2.30pm ET / 11.30am PT (Press release, Ixaka, AUG 31, 2021, View Source [SID1234587059]).

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Ixaka’s nanoparticle-based in vivo gene delivery technology is a highly promising platform for the development of in vivo CAR-T therapies. Dr Bauche will present on the different components of the platform and then the lessons learned from progressing Ixaka’s lead program for CD19 haematological malignancies (CELTIC) towards first-in-man clinical studies. The presentation will discuss how lentiviral vector design and bioproduction are key for in vivo gene delivery platforms and outline the anticipated regulatory pathway and associated quality controls. Dr Bauche will also chair a discussion on the development of relevant animal models for developing cell therapies at 4.00pm ET / 1.30pm PT.

"Our nanoparticle-based in vivo gene delivery technology is ideally positioned to deliver on the promise of in vivo CAR-T therapies to transform cancer treatment without the need for costly dedicated manufacturing sites for T-cell modification. The CAR TCR Summit is now one of the key events in the industry calendar, with leaders from the entire field represented. We are therefore delighted to share our latest insights from the development of an in vivo anti-CD19 CAR T-cell therapy based on a chemically encapsulated lentiviral vector," commented Dr. Cecile Bauche, Vice President & Chief Scientific Officer, at Ixaka.

A further five posters will also be presented at the conference covering a range of applications of the nanoparticle-based in vivo gene delivery platform. In addition to further detail on the CELTIC program, progress with proprietary anti-CD3 aptamers, selected by Ixaka as targeting agents, will be made available.

Endevica Bio Reports TCMCB07 Preserves Lean Body Mass in Preclinical Cancer Cachexia Study

On August 31, 2021 Endevica Bio, a company developing best-in-class peptide drug candidates with better safety and efficacy properties, reported that new data from a recent preclinical study with its lead compound TCMCB07 at the 6th Cancer Cachexia Conference in August 27-29, 2021 (Press release, Endevica Bio, AUG 31, 2021, View Source [SID1234587058]). The study was conducted by researchers at Oregon Health & Science University. The results were presented in a poster titled "Melanocortin-4 receptor antagonist TCMCB07 preserves lean muscle mass during cancer cachexia."

The researchers evaluated efficacy of TCMCB07 with subcutaneous administration in two recently developed mouse cachexia models of orthotopic pancreatic cancer and head and neck cancer. The data demonstrate that TCMCB07 can preserve lean mass as well as attenuate muscle wasting and body weight loss during cancer cachexia. The authors concluded that TCMCB07 is a promising drug candidate with universal effects on treating cancer cachexia.

TCMCB07 is a first-in-class melanocortin ¾ antagonist peptide designed to help people with cachexia to live longer by enabling greater tolerability of treatment and improved quality of life. Discovered by Endevica Bio founder and CEO, Dr. Kenneth Gruber, the compound reduces catabolism and energy expenditure via inhibiting the hypothalamic melanocortin signing and brain inflammation. TCMCB07 can effectively cross the blood-brain barrier when administering it peripherally.

"Even with only modest improvements in food intake in mouse cancer cachexia models, TCMCB07 significantly improves the maintenance of lean body mass," said Dr. Xinxia Zhu, Staff Scientist and the study lead investigator in the Marks Lab at Oregon Health & Science University "This is an important point because general appetite stimulants do not effectively ameliorate cachexia."

"Given that there are no approved drug therapies for cachexia in the United States, these data are incredibly promising and give us confidence that TCMCB07 may be effective as a treatment for cachexia caused by any type of cancer," said Russ Potterfield, Executive Chairman of Endevica Bio. "We are looking forward to studying TCMCB07 further and commencing clinical trials in the beginning of 2022."

Cachexia, a serious clinical consequence also known as "wasting syndrome," is estimated to be prevalent in approximately 50-80% of those with advanced cancer and it is estimated to be the cause of death for up to 40% of cancer patients.

RayzeBio Expands Leadership Team With Susan Moran, M.D., as Chief Medical Officer; Kimberly Ma, M.S., as SVP of Clinical Operations; and Nicholas Smith, Ph.D., as SVP of Chemistry Innovation

On August 31, 2021 RayzeBio, Inc., a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported that three senior management team members across clinical development and research have joined the company (Press release, RayzeBio, AUG 31, 2021, View Source [SID1234587057]).

Susan Moran, M.D., M.S.C.E. – Chief Medical Officer. With over 20 years of clinical experience in industry and academia, Susan has successfully led programs from IND clearance to full regulatory approval. Prior to RayzeBio, Susan led the clinical efforts that led to FDA approval of Truseltiq for cholangiocarcinoma.
Kimberly Ma, M.S. – Senior Vice President of Clinical Operations. Kim has vast experience in clinical operations having spent over 17 years in CRO, pharmaceutical and biotech companies leading efforts in oncology clinical trials from Phase 1 to Phase 3. Most recently, she oversaw a global Phase 3 program in breast cancer.
Nicholas Smith, Ph.D. – Senior Vice President of Chemistry Innovation. For over 20 years, Nick has developed small molecules across multiple therapeutic areas with a particular interest in oncology. He has led the discovery and development of several novel cancer therapies that have entered clinical evaluation and have progressed to approval.
"I am thrilled to have Susan, Kim and Nick join our efforts to discover, develop and ultimately commercialize innovative radiopharmaceutical products for cancer," said Ken Song, M.D., President and CEO of RayzeBio. "Each of them has had successful careers in their respective disciplines and will undoubtedly propel us to the next phase of our company’s growth."

Dr. Moran further added, "I am incredibly excited to join this outstanding team to help move RayzeBio’s investigational therapies into the clinic. As a field, we’ve witnessed the clinically meaningful impact that radiopharmaceuticals can have, and I am very optimistic that this next generation of potent, targeted radiopharmaceuticals will provide further benefits for patients living with cancer."

Massive Bio, Inc. to Partner With Veterans Prostate Cancer Awareness and Self-Care Catalysts to Accelerate Clinical Trial Enrollment and Digital Health Solutions

On August 31, 2021 Massive Bio reported it has entered a partnership with Veterans Prostate Cancer Awareness (VPCa), and Self-Care Catalysts to increase clinical trial and real-world evidence research participation in prostate cancer (Press release, Massive Bio, AUG 31, 2021, View Source [SID1234587056]). This will help put Massive Bio in a position to attract new patients and will provide Veterans Prostate Cancer Awareness and Self-Care Catalysts with new ways to help their members fight cancer. "Today there are over 500,000 Veterans with prostate cancer in the VHA system, over 16,000 of those are fighting a metastatic form of the disease where clinical trials can help. The partnership between Massive Bio, VPCa, and Self-Care Catalysts provide the patient search and navigation tool to effectively guide thousands of Veterans to new treatments and clinical trials," stated Mike "Bing" Crosby, Founder & CEO of VPCa.

Massive Bio is known in the healthcare industry for its SYNERGY-Artificial Intelligence (AI) clinical trial matching program, as well as its Virtual Tumor Board. Massive Bio is a leader in AI-enabled patient-centric clinical trial enrollment whose mission is to provide cancer patients access to clinical trials regardless of their location or financial situation. "We are very excited for our partnership with VPCa, and Self-Care Catalysts," stated Selin Kurnaz, Co-Founder and CEO of Massive Bio. "Teaming up with both parties to provide prostate cancer patients with more access to clinical trials is an exciting development for our companies." "Our partnership with Veterans Prostate Cancer Awareness and Massive Bio brings together an unprecedented platform to drive real-world evidence research and outcome," said Grace Castillo-Soyao, Founder and CEO of Self Care Catalysts.

Oxford BioDynamics Awarded US FNIH Grant to Apply EpiSwitch® Immune Health Test for Improved Prediction of Patient Response to Immune Checkpoint Inhibitor (ICI) Cancer Therapies

On August 31, 2021 Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing targeted clinical diagnostic tests for immune health utilizing its EpiSwitch 3D genomics technology, reported that it has been awarded an FNIH Partnership for Accelerating Cancer Therapies (PACT) Grant to use the EpiSwitch diagnostic platform for accurate prediction of a patient’s response to Immune Checkpoint Inhibitors (ICIs) from a routine blood sample (Press release, Oxford Biodynamics, AUG 31, 2021, View Source [SID1234587054]).

The grant worth $910,000 (RFA #2021-PACT001) is executed by the Foundation for the National Institutes of Health (FNIH), a US not-for-profit organization managing the precompetitive collaboration between the National Institutes of Health (NIH), National Cancer Institute (NCI), US Food and Drug Administration (US-FDA), and 12 leading pharmaceutical companies comprising AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Genentech/Roche, Gilead, GlaxoSmithKline, Janssen, Novartis (NIBR), Sanofi, and Pfizer, as part of the Beau Biden Cancer Moonshot Initiative accelerating cancer research. PACT seeks to provide a systematic approach to cancer biomarker investigation in clinical trials by supporting development of standardized assays.

Immuno-oncology (IO) focuses on using an individual’s immune system to help fight their cancer using a class of drugs, ICIs, to target either of the immune regulatory proteins PD-1 or PD-L1. At present, of those deemed eligible to receive an ICI, less than 30% will benefit from these drugs[1]. Unfortunately, a similar number will experience significant and sometime fatal side effects when these therapies are used[2].

Current testing modalities cannot predict who will and won’t respond and generally require an invasive tumor biopsy. Development of a predictive test, one that only requires a small blood sample, will help oncologists to successfully deploy these drugs as well as enable the pharmaceutical companies to further understand and develop IO therapies to expand their benefits.

In Q4 2021, OBD expects to launch the "EpiSwitch ICI Response Test" as an LDT to allow access for oncologists who want to use it immediately and to start shaping the market.

The test, which is a predictive diagnostic of likely response in cancer patients considered for monotherapy treatment with immune checkpoint inhibitors, has been in full development since 2018. More than 800 blood samples from multiple cohorts of patients have been analyzed, including several studies where the outcomes were blinded to validate the predictive abilities of this technology. The aim of the test is to help oncologists deploy ICI drugs more successfully as well as enable pharmaceutical companies to further understand and develop IO therapies to expand their benefits.

The two-year $910,000 PACT Grant awarded to OBD will fund extended application of this technology to the analysis of primary and acquired resistance to ICI in several trials, including over 186 longitudinal samples from an observational trial, encompassing at least 4 separate ICI therapies and 7 common cancer types. The project will further validate this first-generation immune health assay for predicting response as well as monitoring resistance to ICI monotherapies. It will also evaluate key differences in predictive profiles of the patients treated with a combination therapy of ICI and an epigenetic drug.

In awarding the PACT grant, the reviewers highlighted the strengths of OBD’s success in applying the EpiSwitch platform for biomarker discovery, the prior experience of the team, the clinical practicality of non-invasive EpiSwitch testing from blood and the high relevance of the 3D genomic epigenetic modality.

OBD’s EpiSwitch 3D genomics platform is well-known amongst the consortium’s pharmaceutical companies and has been used for practical patient stratification in prognostic, predictive and early diagnostic applications across immuno-oncology, autoimmune and neurodegenerative indications[3-6].

Dr Stacey Adam, Associate Vice President, Research Partnerships at the FNIH, said:
"The PACT partners are pleased to support the development of a novel epigenetic biomarker platform that can be used in a non-invasive manner and across various clinical settings, thereby allowing for better assignment of patients to specific immunotherapies to treat their cancer."

Dr Jon Burrows, CEO of Oxford BioDynamics, said:
"The recognition of the EpiSwitch platform by the consortium of US federal agencies and top pharmaceutical stakeholders marks another significant validation of OBD’s ability via 3D genomics technology to address the clinical challenges of personalized medicine, cancer treatment and immune health."