On May 9, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on its proprietary tRNA synthetase biology platform, reported first quarter 2022 results and provided a corporate update (Press release, aTyr Pharma, MAY 9, 2022, View Source [SID1234614113]).

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"We are pleased with the start of 2022 and the continued progress throughout the first quarter for our efzofitimod clinical program in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "With the receipt of U.S. Food and Drug Administration (FDA) orphan drug designation and a positive End-of-Phase 2 meeting with the FDA, we are on track to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of this year."

"The second quarter is shaping up to be an important period, as we prepare to present the clinical data for the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis at the upcoming American Thoracic Society (ATS) International Conference and anticipate the potential publication of a related manuscript. We are focused on preparation for the planned registrational study so that the balance of the year may center upon initiating the study in the U.S. and Europe and supporting our partner Kyorin Pharmaceutical with the anticipated launch of the study in Japan."

First Quarter 2022 and Subsequent Period Highlights

Announced posters accepted for presentation for efzofitimod in pulmonary sarcoidosis at the upcoming ATS 2022 International Conference. The posters will present clinical data from the recently completed Phase 1b/2a study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety, tolerability and consistent dose response for efzofitimod on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.
Announced a company reception at the upcoming ATS 2022 International Conference in San Francisco, CA, on Monday, May 16, 2022. The event, which will convene sarcoidosis medical experts, principal investigators, advocacy organizations, analysts and investors, will review results from the Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis and discuss an outlook for the planned registrational study that the company expects to initiate in the third quarter of 2022.
Received FDA orphan drug designation for efzofitimod for the treatment of systemic sclerosis (SSc, or scleroderma), a chronic, progressive autoimmune disease in which many patients may develop associated ILD, known as SSc-ILD. Orphan drug designation is granted to support the development of medicines for patients with unmet needs for rare disorders affecting fewer than 200,000 people in the U.S. and provides certain benefits, including the potential for seven years of market exclusivity following regulatory approval. The company expects to explore the potential expansion of its efzofitimod clinical program into other forms of ILD with high unmet medical need.
Presented preclinical research in a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting characterizing the effects of ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate, in highly aggressive tumor subtypes, including triple-negative breast cancer. The findings suggest that ATYR2810 reduces metastasis and enhances chemosensitivity by downregulating key genes linked to these processes. The company expects to initiate a phase 1 study of ATYR2810 in cancer patients in the second half of 2022.
First Quarter 2022 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents and investments as of March 31, 2022, were $98.7 million.
R&D Expenses: Research and development expenses were $8.9 million for the first quarter of 2022, which consisted primarily of product development and manufacturing costs for the efzofitimod and ATYR2810 programs.
G&A Expenses: General and administrative expenses were $3.5 million for the first quarter of 2022.
Shares Outstanding: Common shares outstanding were 28,056,249 as of March 31, 2022.
Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. EDT / 2:00 p.m. PDT to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the U.S., or 209-905-5951 internationally and using conference ID 9273437. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About Efzofitimod

aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr intends to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of 2022.

On May 9, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has extended and expanded its partnership with Bristol Myers Squibb (NYSE:BMY) in targeted protein degradation, originally signed in 2018 (Press release, Evotec, MAY 9, 2022, View Source [SID1234614065]). The initial collaboration has proven to be highly productive in generating a promising pipeline of molecular glue degraders. Based on this success, Bristol Myers Squibb and Evotec extend and expand this partnership for an additional 8 years with the goal to further broaden and deepen the strategic alliance.

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Molecular glue degraders are small, drug-like compounds that induce interactions between an E3 ubiquitin ligase and a molecular target. This induced interaction results in ubiquitination and subsequent degradation of the recruited protein leading to long-lasting therapeutic effects. Bristol Myers Squibb is a leader in this field based in particular on its unique library of cereblon E3 ligase modulators (CELMoD). Under the terms of the agreement, both parties will leverage all of Evotec’s proprietary EVOpanOmics and EVOpanHunter platforms as well as AI/ML-based drug discovery and development platforms.

Evotec receives an upfront payment of $ 200 m and expects to obtain further performance-based, near-term and programme-based milestone payments, resulting in a deal potential of $ 5 bn with additional tiered royalties on product sales.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: "Bristol Myers Squibb is the pioneer and industry-leader in the field of molecular glue degraders. Molecular glues are one of the most exciting new modalities as they can be developed into highly selective and potent degraders of high-value therapeutic targets, even reaching molecular targets which have been deemed undruggable by conventional means. We are extremely excited about the opportunity to significantly extend and expand our strategic partnership with Bristol Myers Squibb into 2030 and possibly beyond."

On May 9, 2022 Cardinal Health (NYSE:CAH) and URAC, the nation’s largest independent health care accreditation organization, reported an agreement to help customers of Cardinal Health pursue accreditation for their specialty pharmacies and practices (Press release, Cardinal Health, MAY 9, 2022, View Source [SID1234614064]).

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Leveraging insights from operating 70 outpatient pharmacies in 19 states, Cardinal Health offers pharmacies and medically integrated dispensaries a full range of solutions through its Specialty Pharmacy Services including consultative support, assessments and new facility openings, as well as providing leadership and day-to-day management. As part of the agreement with URAC, Cardinal Health customers will receive special pricing for new URAC accreditations, which validate that a pharmacy meets the most rigorous standards in the industry and demonstrates the value of the clinical services it provides.

"Hospitals across the country continue to face challenges in minimizing the costs and complexity of specialty medications. Many are searching for ways to better manage this growing area of outpatient pharmaceutical spend more effectively," said Peter J. Siavelis, senior vice president and general manager of Acute Care Distribution and Services at Cardinal Health. "Our agreement with URAC will further strengthen our commitment to providing the guidance and support needed to help hospitals and health systems determine the right path for their pharmacies."

URAC accreditation also serves as a framework for ensuring quality within an organization by identifying areas for improvement through performance analysis and education.

"Because of their role in serving patients with complex, chronic illnesses, pharmacies are a critical and growing resource within the health care landscape," said Jeffrey Carr, URAC’s vice president of business development. "We’re pleased to offer Cardinal Health preferred pricing for new accreditation to its customers nationwide, further validating the high-quality care they provide and their commitment to improving patient outcomes."

Cardinal Health helps hospitals and health systems determine the right outpatient pharmacy approach for their facilities based on their unique goals and needs. These services also extend to federally qualified health centers, independent physician practices, independent pharmacies and dispensing clinicians. Visit cardinalhealth.com/accreditedspecialtypharmacy to learn more.

On May 9, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported a poster presentation on IBIO–101, the Company’s monoclonal antibody candidate for the treatment of solid tumors (Press release, iBioPharma, MAY 9, 2022, View Source [SID1234614063]). The presentation will take place at Frontiers in Cancer Immunotherapy 2022 by the New York Academy of Sciences from May 9-11.

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Preclinical evaluation of IBIO-101, produced with iBio’s FastPharming and GlycaneeringSM Systems, showed equivalent efficacy and potency compared with this IL-2 sparing anti-CD25 antibody made using traditional mammalian cell culture methods (RTX-003 from RubrYc Therapeutics, Inc.). Additionally, iBio’s proprietary afucosylation technology enabled the engineering of a more potent version without incremental intellectual property access costs. The Company now plans to advance its Glycaneered anti-CD25 monoclonal antibody for the depletion of regulatory T cells ("Tregs") to the clinic next year.

Dillon Phan, PhD, iBio’s Vice President and Head of Early Research and Development, will present the poster, titled "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer", which highlights:

A CD25 epitope-survey using a novel artificial intelligence/machine learning platform to identify one epitope and corresponding antibodies with particularly high antibody-dependent cellular cytotoxicity ("ADCC") activity.
The production of a Glycaneered version of IBIO-101, which significantly increased effector function resulting from afucosylation using a deltaXT/FT N. benthamiana host compared with a fucoslyated form of the molecule.
Binding of IBIO-101 specifically to CD25+ cancerous cells with high affinity.
Preserved IL-2 signaling to effector T cells via pSTAT5.
Potent ADCC activity in killing cancer cells.

On May 9, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the termination of its collaboration and license agreements with Bavarian Nordic that leverage Bavarian Nordic’s MVA-BN (Modified Vaccinia Ankara – Bavarian Nordic) technology to develop potential vaccines against the hepatitis B virus and human papillomaviruses (Press release, Janssen Pharmaceuticals, MAY 9, 2022, View Source [SID1234614062]). Janssen remains committed to its strong collaboration with Bavarian Nordic in the quest to prevent and cure infectious diseases – with collaborations in HIV and Ebola still ongoing.

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No clinical studies in hepatitis B have been initiated by Janssen utilizing the MVA-BN technology.

Janssen will continue to prioritize investigation of its hepatitis B combination therapies using alternative investigational vaccine platforms and therapeutics within its broad portfolio and has multiple studies ongoing. Hepatitis B remains a critical global health issue, affecting an estimated 296 million people worldwide, and claiming nearly 900,000 lives every year.[1] Through its diverse scientific approach, Janssen is determined in its pursuit of a functional cure* for chronic hepatitis B to improve health outcomes for those living with the disease.

There has been widespread uptake of effective, preventive vaccines against human papillomaviruses.[2] Due to this and the prioritization of other programs, Janssen will not be focusing R&D efforts on a therapeutic vaccine against human papillomaviruses at this time.

Janssen is committed to the research and development of transformational vaccines and therapeutics to prevent and cure infectious diseases with high unmet need. Janssen’s infectious diseases and vaccines projects span all stages of development, from discovery through late development, addressing major global health threats including COVID-19, HIV, RSV, influenza, multi-drug resistant bacterial infections and Ebola.

For more information on Janssen’s commitment to battling infectious diseases, visit www.janssen.com/infectious-diseases-and-vaccines/IDV-News/.

*A functional cure for chronic hepatitis B is defined as a loss of viral markers (hepatitis B surface antigen [HBsAg] and hepatitis B viral DNA) that is sustained after cessation of treatment.