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Be Bio and Resilience Announce Strategic Collaboration to Manufacture Engineered B Cells, a New Class of Cellular Medicines

On May 19, 2022 Be Biopharma, Inc. ("Be Bio") and National Resilience, Inc. (Resilience) reported a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning (Press release, Be Biopharma, MAY 19, 2022, View Source [SID1234614878]).

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The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties.

"Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio. "Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs."

Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work.

"This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases."

About B Cells – A New Class of Cellular Medicines

Imagine what could "Be?" In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

Alchemab Announces Publication of AntiBERTa, an Antibody-Specific Machine Learning Model with Multiple Applications

On May 19, 2022 Alchemab Therapeutics, a biotechnology company focused on the discovery and development of naturally-occurring protective antibodies and immune repertoire-based patient stratification tools, reported the publication of research demonstrating the potential of AntiBERTa (Antibody-specific Bi-directional Encoder Representation and Transformers), a transformer neural network that reads the components of an antibody amino acid sequence, to deeply understand the structure and function of antibody sequences (Press release, Alchemab Therapeutics, MAY 19, 2022, View Source [SID1234614877]). The article, titled "Deciphering the language of antibodies using self-supervised learning" has been published online in the journal Patterns. AntiBERTa is a 12-layer transformer model that provides a contextualized numeric representation of antibody sequences and learns biologically relevant information.

"AntiBERTa forms the basis of Alchemab’s machine learning platform, providing a pre-trained model which is primed for multiple downstream tasks relevant to antibody drug discovery," said Jake Galson, Ph.D., Head of Technology at Alchemab. "We have already demonstrated the utility of AntiBERTa for binding-site prediction, and this is helping us to better identify convergent antibodies associated with disease resilience. We are excited to further progress our research and leverage our expertise to develop pioneering ways of treating diseases in the field of immunotherapy."

The study found that the B cell receptor (BCR) sequence representations separate according to mutational load and the underlying BCR V gene segments used. Importantly, there is distinct partitioning of BCRs derived from naïve versus memory B cells, suggesting that functionally important information is captured by the model. Finally, the model recognized pairs of positions within the BCR sequence that form contacts in three-dimensional space. These data demonstrate that AntiBERTa learns various characteristics of the BCRs, such as B cell origin, activation level, immunogenicity, and structure.

Dr. Jane Osbourn, PhD, Co-founder and Chief Scientific Officer of Alchemab, commented: "Our AntiBERTa technology has the potential to transform our ability to understand antibody structure and function and will inform our understanding of antibody paratopes, or the amino acid sequences comprising the site at which antibodies bind to antigens. It will also enable Alchemab to continue to build its unbiased platform to identify novel oncology and neurodegenerative targets. Alchemab’s novel approach learns from nature and naturally optimized antibodies and works backwards to uncover the most important targets and pathways involved in disease modulation. This approach has been very successful, leading to the identification of several novel oncology and neurodegenerative disease drug targets."

Data from Second Independent Multi-Center Study of Patients with High-Risk Cutaneous Squamous Cell Carcinoma Confirms Independent Risk-Stratification Performance of DecisionDx®-SCC

On Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data showing that DecisionDx-SCC can independently risk-stratify patients with cutaneous squamous cell carcinoma (SCC) and one or more risk factors according to their biologic risk of metastasis, consistent with findings in previous development and validation studies.1,2 The poster was presented at the 2022 American College of Mohs Surgery (ACMS) Annual Meeting (Press release, Castle Biosciences, MAY 19, 2022, View Source [SID1234614876]).

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile (GEP) test designed to use a patient’s tumor biology to predict individual risk of metastasis for patients diagnosed with SCC who have one or more high-risk factors. The test stratifies patients into one of three classes based on their biologic risk of metastasis: Class 1 (low risk), Class 2A (moderate risk) or Class 2B (high risk).

"Identifying which patients are at an increased risk of disease progression and metastasis is a challenge for clinicians who may see hundreds of cutaneous squamous cell carcinoma cases in their practices each year," said study author Sarah T. Arron, M.D., Ph.D., Mohs surgeon and dermatologist at Peninsula Dermatology in Burlingame, California. "Using DecisionDx-SCC to add a patient’s biologic risk to our existing clinical and pathologic risk-assessment methods can improve our decision-making and help us to personalize treatment for our patients."

The poster, titled "Performance of the prognostic 40-gene expression profile (40-GEP) test for high-risk cutaneous squamous cell carcinoma (cSCC) in a second independent cohort," highlights data from a second, independent, multi-center study of high-risk SCC patients, consisting of 598 novel patient samples from 43 contributing centers. The poster can be viewed here. With the cohort of patients in this study, combined with the cohort of patients from the first validation study (n=420), the ability of DecisionDx-SCC to independently stratify risk has been confirmed in a total of 1,018 patients.

Kaplan-Meier analysis showed a statistically significant difference in metastasis-free survival (MFS) rates between DecisionDx-SCC Class 1, Class 2A and Class 2B results (p<0.0001, log-rank), demonstrating the ability of the test to risk-stratify patients according to their biologic metastatic risk. As demonstrated by univariate Cox regression analysis, DecisionDx-SCC Class 2A, Class 2B, traditional high-risk clinicopathologic risk factors, American Joint Committee on Cancer Eighth Edition (AJCC8) T3/T4 stages and Brigham and Women’s Hospital (BWH) T2b/T3 stages were all statistically associated with metastatic risk. A DecisionDx-SCC Class 2B result had the highest hazard ratio, 10.71, which was the strongest predictor of metastasis among the analyses. Further, multivariate Cox regression analysis demonstrated that DecisionDx-SCC independently and significantly contributed to risk stratification of patients when combined with traditional high-risk clinicopathologic factors (p<0.05 for Class 2A and 2B), BWH (p<0.001 for Class 2A and p<0.002 for Class 2B) or AJCC8 (p<0.001 for Class 2A and 2B) staging. This reinforces that the test’s results provide risk-stratification value on their own and can add clinical value when used as a complement to other risk-prediction systems.

Overall, the study data confirm what previous development and validation studies1,2 have substantiated: DecisionDx-SCC can accurately classify risk for metastasis in SCC patients with one or more risk factors and provides significant prognostic information independent from current risk prediction methods. Additionally, the study data further support the use of DecisionDx-SCC test results in combination with other risk-assessment and staging systems to guide more refined and risk-aligned patient care.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

Mevion Selected to Equip Proton Center in Southern China

On May 19, 2022 Mevion Medical Systems reported that it has been selected to install a MEVION S250i Proton Therapy System with HYPERSCAN Pencil Beam Scanning (PBS) in a comprehensive hospital in Southern China (Press release, Mevion Medical Systems, MAY 19, 2022, View Source [SID1234614875]).

Proton therapy is a superior form of radiation therapy that can reduce the amount of unnecessary radiation exposure to surrounding healthy tissue and sensitive organs at risk. HYPERSCAN PBS improves on these benefits by using Mevion’s unique Adaptive Aperture pMLC to enable faster and sharper delivery of therapeutic radiation to tumors while sparing healthy tissue.

The MEVION S250i Proton Therapy System’s leading-edge clinical capabilities, combined with its compact, affordable design, and industry-leading ramp-up time, have changed the landscape of proton therapy. Mevion received US FDA 510(k) clearance for the system in 2017 and is actively seeking regulatory approval from the National Medical Products Administration (NMPA) in China.

"We are proud to be selected to equip a new proton center in Southern China," said Tina Yu, Ph.D., CEO and President of Mevion Medical Systems. "It confirms Mevion’s leading position as a trusted compact proton therapy provider and marks another milestone of our growth in China."

According to Global Cancer Observatory, there were over 4.5 million cancer cases in China in 2020. However, only 3 proton centers are currently in clinical operation in Mainland China, leaving a substantial number of patients without access to this advanced cancer-fighting technology. As the innovator of the single-room system, Mevion’s approach allows for an expedited project timeline, efficient center operation, and financial success, all of which will benefit the underserved China market.

Akebia Therapeutics to Present at H.C. Wainwright Global Investment Conference

On May 19, 2022 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported that John Butler, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference, which will take place as a hybrid event May 23–26, 2022 (Press release, Akebia, MAY 19, 2022, View Source/news-releases/news-release-details/akebia-therapeutics-present-hc-wainwright-global-investment" target="_blank" title="View Source/news-releases/news-release-details/akebia-therapeutics-present-hc-wainwright-global-investment" rel="nofollow">View Source [SID1234614874]).

An audio replay of the fireside chat will be available through the Investors section of Akebia’s website at View Source starting on May 24th and for approximately 90 days following the conference.