On April 12, 2022 Chimeron Bio, an RNA company developing self-amplifying RNA (saRNA) vaccines and therapeutics designed on its proprietary ChaESAR RNA delivery platform, reported it has entered into a manufacturing agreement with FUJIFILM Diosynth Biotechnologies (FDB), a leading Contract Development and Manufacturing Organization (CDMO) with experience in the development and manufacture of recombinant biopharmaceuticals and viral gene therapies, to advance the Company’s Oncology portfolio to the clinic (Press release, Chimeron Bio, APR 12, 2022, View Source [SID1234612092]).

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Chimeron Bio selected FUJIFILM Diosynth Biotechnologies as its partner for the transfer and scale up of their drug substance manufacturing process. Drug substance manufacturing will be carried out in FUJIFILM Diosynth Biotechnologies’ state-of-the-art cGMP manufacturing facility in College Station, Texas. Materials from this partnership will help facilitate Chimeron’s IND-enabling work and entry into the clinic.

"We selected FUJIFILM Diosynth Biotechnologies as our manufacturing partner because of their proven track record in the advanced therapies space," said Jolly Mazumdar, chief executive officer, Chimeron Bio. "FDB really understands our ChaESAR platform and pipeline potential, making them the best partner to scale up our processes and help bring our ground-breaking approach for the treatment of underserved patients closer to reality."

"Chimeron’s ChaESAR platform has the potential to impact how we bring treatments and therapies to patients," said Gerry Farrell, chief operating officer, FUJIFILM Diosynth Biotechnologies, Texas site. "We are delighted to be the partner of choice to bring their technology into our GMP facility and produce Bulk Drug Substance to support their clinical trials."

About Chimeron’s ChaESAR platform

The ChaESAR platform is a self-assembling biosynthetic non-lipid nanoparticle (NLNP) comprising a self-amplifying RNA genome encased within a capsid with a surface ligand of choice.

On April 12, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of its study titled, "A machine learning algorithm with subclonal sensitivity reveals widespread pan-cancer human leukocyte antigen loss of heterozygosity," in Nature Communications (Press release, Personalis, APR 12, 2022, View Source [SID1234612091]).

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Human leukocyte antigen loss of heterozygosity (HLA LOH) allows cancer cells to escape immune recognition by deleting HLA alleles, causing the suppressed presentation of tumor neoantigens. Despite its importance in immunotherapy response, few methods exist to detect HLA LOH, and their accuracy is not well understood. Further, detecting HLA LOH accurately from sequencing data is of interest given the growing ubiquity of tumor molecular profiling.

The Personalis study details the development of DASH (Deletion of Allele-Specific HLAs), a novel machine learning-based algorithm to detect HLA LOH from paired tumor-normal sequencing data. Through validation with cell line mixtures and patient-specific digital PCR, the study demonstrates increased sensitivity of HLA LOH detection by DASH compared to previously published tools and paves the way for clinical utility. Using DASH for 610 patients across 15 tumor types, the study found that a large percentage of patients are impacted by HLA LOH, including patients with non-small cell lung cancer adenocarcinoma (NSCLC-A) (24 percent), cervical cancer (38 percent), and head and neck squamous cell carcinomas (HNSCC) (40 percent). Additionally, the study showed inflated HLA LOH rates compared to genome-wide LOH, and correlations between CD274 (PD-L1) expression and microsatellite instability status, suggesting that HLA LOH is a key immune resistance strategy.

"Accurate detection of HLA LOH is critical for its use as a biomarker for cancer immunotherapy. This study demonstrates DASH’s ability to sensitively detect subclonal events in samples with low tumor purity, enabling comprehensive profiling of widespread HLA LOH across tumor types," said Richard Chen, MD, chief medical officer and SVP of R&D for Personalis. "Integrated with Personalis’ NeXT Platform, these DASH-identified HLA LOH events are a key input to our composite, multi-omic biomarker, NEOPS, to better predict immunotherapy response."

On April 12, 2022 Radionetics Oncology, a pharmaceutical company focused on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications, reported the appointment of Nishan de Silva, M.D. as its Chief Executive Officer (Press release, Radionetics Oncology, APR 12, 2022, View Source [SID1234612089]). Dr. de Silva brings more than 20 years of experience in biotechnology operations, biopharmaceutical venture capital and healthcare consulting to Radionetics and joins a veteran leadership team leveraging a broadly enabling platform to expand the application of radiopharmaceuticals.

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The company’s technology platform uses small molecule targeting to deliver therapeutic radioisotopes to a broad range of cancers by binding selectively to peptide receptors that are overexpressed on many tumors. This platform has the potential to be impactful in nearly all solid tumors and Radionetics is rapidly advancing multiple candidates with the expectation of filing three INDs in the next two years.

"Nishan’s rich experience building companies, coupled with Radionetics’ deep scientific and drug development expertise, gives the company an ability to mobilize its robust technology platform to rapidly develop targeted small molecule radiopharmaceuticals in pursuit of precision treatments for cancer," said Scott Struthers, Ph.D., Chairman of Radionetics. "We are delighted to have Nishan take the helm and accelerate the company’s momentum in this exciting field of oncology therapeutics."

"Radionetics is pursuing a differentiated approach in an emerging therapeutic class that has the potential to upend current standards of care in radiation oncology," said Dr. de Silva. "The company’s focus on pursuing novel oncology targets using a small molecule approach with a platform that is agnostic to the type of radioisotope is very attractive. In addition, recent scientific advancements and significant improvements in the radiopharmaceutical supply chain are unlocking vast opportunities to deliver precise and powerful radiopharmaceuticals to patients as well as meaningful financial returns for investors. The strength of the Radionetics team and platform uniquely position the company for success and I’m excited to take on this leadership role."

During his career, Dr. de Silva has built multiple companies, bringing novel pharmaceuticals through financing and clinical development. Prior to joining Radionetics, Dr. de Silva was the CEO at AFYX Therapeutics where he led a successful Phase 2 clinical trial program for a first-ever sponsor-conducted study in oral lichen planus. He also raised the financing to enable the achievement of that key value creating milestone and led the development and implementation of new IP strategies to ensure the program’s exclusivity position. Before AFYX Therapeutics, Dr. de Silva served as President and Chief Operating Officer for Poseida Therapeutics, a leading gene therapy and gene editing therapeutics-focused company. There, he oversaw clinical, regulatory, technical operations, finance, business development and human resources functions through direct reporting relationships. Dr. de Silva played a key leadership role in raising over $100 million in capital, and he oversaw the advancement of the company’s lead asset from preclinical concept through successful establishment of clinical proof-of-concept in a Phase 1/2 clinical trial in multiple myeloma.

Dr. de Silva holds a B.A. summa cum laude in biology from Harvard University, an M.D. from The University of Pennsylvania School of Medicine and an M.B.A. with Distinction in healthcare management from The Wharton School.

Dr. de Silva joins the founding Radionetics management team, which includes Yu-Fei (Frank) Zhu, Ph.D., Deborah Slee, Ph.D., Brett Ewald, Ph.D., and Ana Kusnetzow, Ph.D. In addition to his CEO role, he will serve as a director on the company’s board. Since launching in October 2021, Radionetics has added eight new members to the team and plans to more than double over the coming year.

On April 12, 2022 OncoNano Medicine, Inc. reported positive results from the company’s ON-BOARD pH-sensitive nanoparticle platform (Press release, OncoNano Medicine, APR 12, 2022, View Source [SID1234612088]). The data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, demonstrate that the clinically validated ON-BOARD platform has the potential to be a universal tool for tumor specific activation and the efficient delivery of proteins for an improved therapeutic index.

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"Our ON-BOARD micelle platform is designed to efficiently carry a broad range of payloads to the tumor microenvironment. Capable of being tuned to deliver either small molecules or biologics, the ON-BOARD platform has the potential to be a universal tool for targeted delivery of therapeutics to a range of cancers," said Tian Zhao, Ph.D., Vice President of Research & Development for OncoNano Medicine, Inc. "We are pleased with the positive data from our research efforts to encapsulate therapeutic antibodies with our ON-BOARD delivery technology and look forward to the further development of protein payloads with an improved therapeutic index."

A variety of biosimilar monoclonal antibodies including those of atezolizumab, cetuximab, pembrolizumab, trastuzumab and ipilimumab were encapsulated by the ON-BOARD platform. The findings indicate that ON-BOARD demonstrated:

Encapsulation of antibodies without additional modification of the original antibody
Encapsulation efficiency ranging from 50-100%
Formulations characterized as uniformly distributed particles < 100nm in size with good stability
Over a 100-fold activation window between the acid-activated and intact formulations based on in vitro assessment by cell-based reporter assays
pH-dependent activation that was further confirmed by affinity and binding assay
Tumor specific accumulation that was demonstrated by a biodistribution study
Presentation Overview

TITLE:
Encapsulating therapeutic antibodies for tumor specific activation and delivery using a clinically validated pH-sensitive nanoparticle platform

PRESENTER:
Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine

On April 12, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal (Press release, Personalis, APR 12, 2022, View Source [SID1234612087]).

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The patent, US Patent No. 11,299,783, entitled "Methods and Systems for Genetic Analysis," was issued on April 12, 2022. The ‘783 patent claims novel methods for a partially personalized assay, combining both tumor-informed and prespecified (tumor naïve) content. Tumor-informed methods can provide high sensitivity for detection of MRD. They can also support tracking of variants specific to an individual patient’s cancer, such as those targeted by specific therapies or which are thought to elicit an immune response. Prespecified, tumor-naïve content can include variants not detected on initial sequencing of a tumor, but which may emerge and confer drug resistance as a tumor evolves. It can also include driver mutations of a second primary tumor, which may arise independently during the course of the initial cancer. The ‘783 patent is a member of a patent family that broadly describes Personalis’ foundational work relating to the development of personalized assays for disease identification and tracking.

Personalis’ recently introduced NeXT Personal platform leverages many elements of the ‘783 patent. It is unique among MRD assays in that it combines a highly sensitive measurement of tumor burden with simultaneous tracking of thousands of tumor variants, both tumor-informed and prespecified, in a single panel design.

The issuance of the ‘783 patent adds to Personalis’ growing intellectual property portfolio that includes multiple early families related to personalized genetic testing. Overall, Personalis has 19 issued US and foreign patents, spanning 16 distinct families, relating to advanced genomic sequencing and analysis solutions. In addition, the company has over 25 pending US and foreign patent applications that relate to its existing advanced cancer detection platforms and novel research areas, including methods for interpreting genetic data generated by its platforms.

"Cancer is very complex and dynamic," said John West, CEO and co-founder of Personalis. "Our NeXT Personal approach combines detection, quantification, and detailed characterization of a patient’s tumor in a single, integrated data stream. As the cost and turnaround time of both DNA sequencing and DNA synthesis have rapidly improved, sensitive and detailed monitoring over a patient’s entire clinical trajectory has become affordable, and we believe that it will become the new standard of care."