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.

On May 9, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported its business update for the first quarter of 2022, reporting continued progress on its oral vaccine candidates (Press release, Aviragen Therapeutics, MAY 9, 2022, View Source [SID1234614017]).

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"We continue to make progress on our pipeline of potentially game changing oral tablet vaccine programs, with norovirus studies that will report results in the second quarter as well as our Phase II study for our COVID-19 program that will report results from the first part of the planned two-part study in the third quarter," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "Vaxart’s oral vaccine technology may address many public health challenges, including rapidly emerging COVID-19 variants because the cross-reactive nature of mucosal IgA response increases the likelihood of variant coverage."

Recent Business Highlights

Preclinical and Clinical

COVID-19 Vaccine Developments

In February 2022, Vaxart’s COVID-19 non-human primate study was published by bioRxiv. The study demonstrates that Vaxart’s S-only COVID-19 vaccine candidate, now being studied by Vaxart in Phase II trials, generated antibodies to the original COVID-19 virus strain and to the Beta, Delta, Alpha and Gamma variants of SARS-CoV-2 in the serum and nasal mucosa of non-human primates (NHPs).
Vaxart’s S-only candidate is believed to be the first vaccine candidate to demonstrate neutralizing antibody responses in mucosal sites, which is where primary infection occurs.
The candidate also induced a 1000-fold increase in nasal IgA responses to the variants, which may reduce community transmission.
In April 2022, an article was published in Vaccines that highlights the potential of Vaxart’s oral tablet vaccine platform to transform vaccine strategies for respiratory viral pathogens.
The article discusses one of the chief advantages of oral vaccines, which is to induce an immune response in the mucosa, the first line of defense against invading respiratory pathogens.
The article also outlines how Vaxart’s oral tablet vaccine candidates are very well suited to transform global vaccination strategies by potentially removing cold-chain requirements and the necessity of administration by healthcare professionals, enabling rapid deployment of new vaccines to address novel pathogens.
Vaxart now expects data from the dose selection portion of its two part dose-ranging and preliminary efficacy Phase II clinical trials of its oral tablet COVID-19 vaccine candidate to be available in the third quarter of 2022. This is an open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects.
Norovirus Vaccine Developments

Vaxart has dosed all subjects in its Phase IB placebo-controlled, dose-ranging, repeat dose trial of its oral norovirus vaccine candidate in elderly subjects aged 55 to 80 years. This study is designed to evaluate the safety and immunogenicity of Vaxart’s GI.1 vaccine candidate and results will be available in the second quarter of 2022.
Vaxart launched a Phase II GI.1 norovirus challenge study in January 2022 to evaluate the safety and clinical efficacy of its oral vaccine candidate. This double blind, placebo-controlled study uses a safe, well-characterized challenge with norovirus GI.1 of volunteers vaccinated with our monovalent norovirus vaccine candidate. The study will yield data on efficacy, safety, and immune correlates of protection, with data expected to be reported in the first quarter of 2023.
2022 Planned Clinical Milestones

Data from the first part of Vaxart’s two-part Phase II trial of its COVID-19 vaccine candidate is expected to be available in the third quarter of 2022.
Vaxart’s international Phase IB and Phase II COVID-19 trials, including a placebo-controlled efficacy trial in India, are anticipated to begin this year.
Results from Vaxart’s Phase IB trial of its norovirus vaccine candidate in elderly subjects are expected in the second quarter of 2022.
Financial Results for the Three Months Ended March 31, 2022

Vaxart ended the first quarter with cash, cash equivalents and available-for-sale debt securities of $157.0 million, compared to $182.7 million as of December 31, 2021. The decrease was primarily due to $25.1 million of cash used in operations.
The Company reported a net loss of $25.1 million for the first quarter of 2022, compared to $16.0 million for the first quarter of 2021. Net loss per share for the first quarter of 2022 was $0.20, compared to a net loss of $0.14 per share in the first quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development expenses.
Revenue for the first quarter of 2022 was $85,000, compared to $506,000 in the first quarter of 2021. The decrease was due to lower royalty revenue from sales of Inavir in Japan.
Research and development expenses were $18.2 million for the first quarter of 2022, compared to $10.1 million for the first quarter of 2021. The increase was mainly due to increases in headcount and related costs and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
General and administrative expenses were $6.7 million for the first quarter of 2022, compared to $5.9 million the first quarter of 2021. The increase was mainly due to an increase in headcount and related costs.

On May 9, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the first quarter ended March 31, 2022 and provided an update on recent developments (Press release, IGM Biosciences, MAY 9, 2022, View Source [SID1234614001]).

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"IGM took a major step in expanding the scope and support of our research pipeline of IgM antibodies with the recent closing of an exclusive worldwide collaboration agreement with Sanofi for the creation, research and development of agonist IgM antibodies against three oncology targets and three autoimmune/inflammation targets," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We have also made significant progress in the clinical development of our wholly-owned pipeline of IgM antibodies with the start of our two Phase 2 studies for our T cell bispecific antibody, IGM-2323, and the continuation of our Phase 1 trial of IGM-8444. In addition to continued progress in these ongoing clinical trials, we also expect to file INDs for our targeted IL-15 IgM antibody, IGM-7354, and our CD38 x CD3 bispecific IgM antibody, IGM-2644, this year."

Corporate Updates

Closing of collaboration agreement with Sanofi. IGM announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), has expired in connection with the Company’s previously announced exclusive worldwide collaboration agreement with Sanofi. In connection with the closing of the collaboration agreement, Sanofi will pay IGM a $150 million upfront payment. The agreement is for the creation, development, manufacture, and commercialization of IgM antibody agonists against three oncology targets and three autoimmune/inflammation targets. In addition to the $150 million upfront payment, IGM is eligible for over $6 billion in aggregate development, regulatory and commercial milestones, a 50:50 profit share in certain major market countries and tiered royalties in the rest of world for oncology targets, and tiered royalties for autoimmune/inflammation targets.

Completed underwritten public offering of common stock. In April 2022, IGM closed a public offering of its common stock with gross proceeds of $230 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM.
Pipeline Updates

IGM-2323 (CD20 x CD3)

Phase 2 studies. IGM previously announced the initiation of two Phase 2 studies to assess the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL).
IGM-8444 (DR5)

Clinical development of IGM-8444. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase I study of IGM-8444 in multiple combinations in subjects with relapsed and/or refractory solid and hematologic cancers.
IGM-7354 (IL-15 x PD-L1)

IND application expected to be filed this year. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s targeted IL-15 IgM antibody, in solid tumors this year.
IGM-2644 (CD38 x CD3)

IND application expected to be filed this year. IGM expects to file an IND for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma this year.
First Quarter 2022 Financial Results

Cash and Investments: Cash and investments as of March 31, 2022 were $187.5 million, compared to $229.5 million as of December 31, 2021.
The March 31, 2022 cash and investments balance does not include the $230.0 million in gross proceeds, before deducting the underwriting discounts and commissions and other offering expenses payable by IGM, received in connection with IGM’s 2022 public offering, which closed in April.
The March 31, 2022 cash and investments balance also does not include the $150.0 million upfront payment that IGM is expected to receive from Sanofi during the second quarter of 2022 under the terms of the collaboration agreement announced in March 2022.
Research and Development (R&D) Expenses: For the first quarter of 2022, R&D expenses were $38.9 million, compared to $23.6 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the first quarter of 2022, G&A expenses were $13.1 million, compared to $8.1 million for the same period in 2021.
Net Loss: For the first quarter of 2022, net loss was $51.9 million, or a loss of $1.53 per share, compared to a net loss of $31.6 million, or a loss of $0.95 per share, for the same period in 2021. The net loss included non-cash stock-based compensation expense of $11.5 million and $5.5 million for the first quarter of 2022 and 2021, respectively.
2022 Financial Guidance

IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses of $250 million to $260 million including estimated non-cash stock-based compensation expense of approximately $50 million. IGM expects to end 2022 with a balance of over $390 million in cash and investments.