On April 25, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report first quarter financial results on Thursday, April 28, 2022, at 8:30 a.m. ET (Press release, GlycoMimetics, APR 25, 2022, View Source [SID1234612894]).

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The dial-in number for the conference call is (844) 413-7154 for domestic participants or (216) 562-0466 for international participants, with participant code 1068226. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers are able to connect.

A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1068226.

On April 25, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2022 (Press release, Chugai, APR 25, 2022, View Source [SID1234612893]).

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"The first quarter marked a strong start to 2022. Significant increases in both domestic and overseas sales resulted in record revenues and profits for the quarter. Domestic sales were driven by the supply of Ronapreve to the government and good penetration of our new products Enspryng, Polivy, and Evrysdi, while Hemlibra posted a remarkable increase in overseas sales. These products are on track to become our next growth drivers. In R&D, Vabysmo, a bispecific antibody in-licensed from Roche, obtained regulatory approval for two diseases that may potentially lead to vision loss. This unlocks Chugai’s first full-scale entry into ophthalmology. For Mitchga, the anti-IL-31 receptor A inhibitor created by Chugai, regulatory approval for itching associated with atopic dermatitis was obtained by Maruho, our partner for the Japanese market. Both of these products have novel modes of action, and I am very pleased that we can provide new treatment options based on innovation. We will continue to challenge ourselves to create innovative new drugs," said Dr. Osamu Okuda, Chugai’s President and CEO.

[First quarter results for 2022]

Chugai reported a significant growth in revenues and operating profit, achieving record highs for the first quarter (Core-basis).

Revenues increased by approximately 60% over the same period last year. Sales increased sharply by almost 90%, while royalties and other operating income decreased by approximately 30%. Domestic sales increased by approximately 70%. In the oncology field, sales remained almost flat over the same period last year. The contribution of the new product Polivy offset declines in mature products, including Avastin and Herceptin, due to NHI drug price revisions last year and biosimilars. In the primary field, sales almost tripled year-on-year due to the supply of Ronapreve to the government and the contribution of new products, Enspryng and Evrysdi. Overseas sales more than doubled given a five-hold growth of Hemlibra owing to the full-scale export to Roche at regular shipping price, and a 50% increase in Actemra, which obtained emergency use authorization and regulatory approval for severe COVID-19 in the U.S. and Europe, respectively, since last June. On the other hand, royalties and other operating income decreased by approximately 30%, mainly due to a significant decrease in royalty income related to the initial shipments of Hemlibra. Revenues on IFRS basis including Non-Core items totaled ¥360.6 billion (+113.6%), including the lump-sum income of ¥91.9 billion from the settlement agreement with Alexion Pharmaceuticals, Inc.

Cost to sales ratio rose by 4.8% points year-on-year to 47.0%, mainly due to a change in the product mix. Marketing and distribution, research and development, and general and administration expenses have all increased, resulting in an overall increase in operating expenses by almost 15%. Marketing and distribution expenses increased due to an increase in activities at overseas group companies and the effects of foreign exchange. Research and development expenses increased due to the progress of projects. General and administration expenses increased due to the enterprise tax and various expenses. As a result, Core operating profit totaled ¥98.9 billion (+51.2%).

The Company also made good progress in research and development. Chugai obtained regulatory approval in March 2021 for Vabysmo for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Vabysmo, in-licensed from Roche, is the first bispecific antibody in ophthalmology. Clinical development of RG6321, the port delivery system with ranibizumab in-licensed from Roche, was newly initiated also in the field of ophthalmology. In-house projects that will drive the company’s mid-to-long-term growth also progressed well, including Mitchga and several projects applying Chugai’s proprietary antibody engineering technologies. Maruho, the licensee of anti-IL-31 receptor A antibody Mitchga in Japan, obtained regulatory approval for the product in March for the treatment of pruritus associated with atopic dermatitis (only when existing treatment is insufficiently effective). As for the anti-C5 recycling antibody crovalimab, a phase III clinical trial conducted in China in paroxysmal nocturnal hemoglobinuria (PNH) met its primary endpoint. Application for regulatory approval will be filed in China ahead of other countries by the end of this year. Also, Roche started clinical development in sickle cell disease outside Japan.

Regarding development of treatments for COVID-19, WHO granted prequalification of Actemra for patients with severe or critical COVID-19 in February. Furthermore, in April, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental Biologics License Application (sBLA) for Actemra for the treatment of COVID-19 in hospitalized adults, granting priority review. In the U.S., Actemra has been used under the Emergency Use Authorization (EUA) since June 2021.

2022 Q1 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

On April 25, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported that it has acquired from Erytech Pharma its state-of-the-art, commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for $44.5 million (Press release, Catalent, APR 25, 2022, https://www.catalent.com/catalent-news/catalent-acquires-commercial-scale-cell-therapy-development-and-manufacturing-facility-in-princeton-new-jersey-from-erytech/ [SID1234612892]). The deal includes an exclusive long-term supply agreement for Catalent to support Erytech’s lead product candidate eryaspase (GRASPA), a red blood cell-derived product, which is currently in late-stage development for the treatment of acute lymphoblastic leukemia.

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The 30,900-square-foot facility is located within the University Square Campus Park and houses 16 suites positioned for production of products in a cGMP-compliant manner, as well as laboratories for analytical, quality control and microbiology testing. The site will become a strategic campus for development as well as clinical- and commercial-scale manufacturing of cell therapies, and is located within easy reach of Catalent’s facilities around Baltimore, Maryland, where the company develops and manufactures viral vectors and plasmid DNA. It will also work in collaboration with Catalent’s existing U.S. clinical-scale cell therapy facility in Houston, Texas.

Concurrent with the acquisition, Catalent has agreed to terms to lease an adjacent 23,000-square-foot building that could be used for additional laboratory or cGMP capabilities, and another building on the campus for potential future expansions. All staff at the site will transfer to Catalent’s employment, and Catalent is developing its plans for its future recruitment needs.

Under the supply agreement, Catalent will continue to manufacture eryaspase (GRASPA) at the site. It will also support the development of Erytech’s pipeline of encapsulated red blood cell-based therapeutics for severe forms of cancer and orphan diseases.

"This acquisition is strategically important to Catalent’s commitment to support the development and clinical and commercial supply of cell therapies to meet rapidly growing demand," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. "The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allow Catalent to expand rapidly to create a U.S. campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world."

"In Catalent we have found a great partner for the manufacturing of our innovative red blood cell-derived products," said Gil Beyen, Chief Executive Officer at Erytech. "Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics, and we believe this win-win strategic partnership will meet our long-term manufacturing needs in the United States. Erytech will now further focus its resources on seeking regulatory approval of GRASPA and on the development of potentially transformative therapeutics for serious diseases."

Catalent’s cell and gene therapy network includes six U.S. facilities across Maryland and Texas, a European center of excellence in Belgium, and its cell innovation facility in Germany. These sites offer a range of small- and large-scale clinical and commercial manufacturing, as well as fill/finish capabilities.

ABOUT CELL & GENE THERAPY
Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.

On April 25, 2022 AstraZeneca reported it’s Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) (Press release, AstraZeneca, APR 25, 2022, View Source [SID1234612891]). A supplemental BLA (sBLA) has also been submitted for Imfinzi in this indication. This novel dose and schedule of the combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).

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The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for their regulatory decision, is during the fourth quarter of 2022 following the use of a priority review voucher.

Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1,2 Approximately 26,000 people in the US present with advanced, unresectable HCC each year.3

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The HIMALAYA Phase III trial showed an unprecedented three-year overall survival in this setting with a single priming dose of tremelimumab added to Imfinzi, highlighting the potential for this regimen to improve longer-term survival outcomes. Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel approach to patients in the US as soon as possible."

The BLA for tremelimumab and sBLA for Imfinzi are based on final results from the HIMALAYA Phase III trial presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

In this trial, patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 96.02% confidence interval [CI] 0.65-0.93; p=0.0035).4 Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.4

The safety profiles of the STRIDE regimen and for Imfinzi alone were consistent with the known profiles of each medicine, and no new safety signals were identified.

Imfinzi and tremelimumab were granted Orphan Drug Designation in the US for the treatment of HCC in January 2020.

As part of its extensive clinical development programme in gastrointestinal (GI) cancers, AstraZeneca is further assessing Imfinzi across multiple liver cancer settings, including locoregional HCC (EMERALD-1, EMERALD-3) and adjuvant HCC (EMERALD-2).

Notes

Liver Cancer
About 75% of all primary liver cancers are HCC.1 Between 80-90% of all patients with HCC also have cirrhosis.5 Chronic liver diseases are associated with inflammation that over time can lead to the development of HCC.5

More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.6 A critical unmet need exists for patients with HCC who face limited treatment options.6 The unique immune environment of liver cancer provides clear rationale for investigating medications that harness the power of the immune system to treat HCC.6

HIMALAYA
HIMALAYA was a randomised, open-label, multicentre, global Phase III trial of Imfinzi monotherapy and the STRIDE regimen, comprising a single priming dose of tremelimumab 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks versus sorafenib, a standard-of-care multi-kinase inhibitor.

The trial included a total of 1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localised to the liver and surrounding tissue).

The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia. The primary endpoint is overall survival (OS) for STRIDE versus sorafenib and key secondary endpoints included OS for Imfinzi versus sorafenib, objective response rate and progression-free survival (PFS) for STRIDE and for Imfinzi alone.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy, and is the global standard of care in this setting based on the PACIFIC Phase III trial.

Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial. In 2021, updated results from the CASPIAN trial showed Imfinzi plus chemotherapy tripled patient survival at three years versus chemotherapy alone.

In the past year, Imfinzi has demonstrated clinical benefit in multiple additional cancer settings with positive Phase III trials in advanced biliary tract cancer (TOPAZ-1), unresectable advanced liver cancer (HIMALAYA) and metastatic NSCLC (POSEIDON).

As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with small cell lung cancer, NSCLC, bladder cancer, several gastrointestinal cancers, ovarian cancer, endometrial cancer, and other solid tumours.

Tremelimumab
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.

Beyond HIMALAYA, tremelimumab is being tested in combination with Imfinzi across multiple tumour types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

Tremelimumab is also under review by global regulatory authorities in combination with Imfinzi and chemotherapy in 1st-line metastatic NSCLC based on the results of the POSEIDON Phase III trial, which showed the addition of a short course of tremelimumab to Imfinzi plus chemotherapy improved both overall and progression-free survival compared to chemotherapy alone.

AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines spanning a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new diagnoses leading to approximately 3.6 million deaths.7

Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic, and colorectal cancers.

Imfinzi (durvalumab) is being assessed in combinations including with tremelimumab in HCC, biliary tract, oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings. In January 2022, results of the TOPAZ-1 Phase III trial in 1st-line advanced biliary tract cancer demonstrated a significant improvement in OS with Imfinzi plus standard-of-care chemotherapy versus chemotherapy alone.

The Company aims to understand the potential of Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate, in the two most common GI cancers, colorectal and gastric cancers. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Lynparza (olaparib) is a first-in-class PARP inhibitor with a broad and advanced clinical trial programme across multiple GI tumour types including pancreatic and colorectal cancers. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada).

AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumour immune response. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.

The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumour types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.

In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On April 25, 2022 The University of Tokyo (President: Teruo Fujii, Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.; hereafter "Astellas") reported that entered the second phase of their collaboration for co-creating innovative new medicines and medical solutions, called the Astellas Alliance Acceleration Program (AAAP), today (Press release, Astellas Pharma, APR 25, 2022, View Source,-Astellas-Enter-Second-Phase-of-Strategic-Partnership-for-Co-creation-of-Innovative-New-Medicines-and-Medical-Solutions [SID1234612890]).

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In its first phase, from September 2020 to March 2022, AAAP established a base for its collaborative relationship at the university’s Institute for Life Science Research and Education, and the University of Tokyo Center of Innovation. During this period, medical and pharmaceutical researchers from the two university organizations and drug discovery researchers from Astellas nurtured an environment for open-minded discussions, and as a result, several new research projects were identified and launched successfully.

In the second phase, the University of Tokyo will expand its partnership involvement to include all of its institutions. Furthermore, a newly appointed AAAP-dedicated project manager will be stationed at the university to facilitate the collaboration. These additional initiatives will allow the strategic partners to build new research projects, by combining the University of Tokyo’s cutting-edge scientific research with Astellas’ drug discovery know-how.

"Encouraged by our close collaboration during the first phase, we are delighted to start the second phase encompassing the breadth of research at the University of Tokyo. We hope that comprehensive knowledge of the life sciences from the university will further lead to innovative drug discovery projects," said Hidenori Ichijo, DDS, Ph.D., a professor at the university’s Graduate School of Pharmaceutical Sciences and a member of the AAAP Steering Committee.

Professor Yuichi Tei / Ungil Chung, M.D., Ph.D., of the university’s Graduate School of Engineering and Graduate School of Medicine, also a member of the AAAP Steering Committee, said: "In this phase, we will further pursue interdisciplinary collaboration, such as in the fields of engineering and the life sciences, by tapping into the broad range of research at the University of Tokyo."

"I am pleased with this AAAP second phase agreement," said Yoshitsugu Shitaka, Ph.D., Chief Scientific Officer at Astellas. He added: "By leveraging the power of the more extensive and closer collaboration, we expect to accelerate the co-creation of innovations that contribute to our activities from early drug discovery research to clinical development."

The University of Tokyo aims to find solutions to society’s problems and contribute to the development of industry by promoting the creation of value through dialogue and empathy with society. Astellas is committed to the creation of innovative medical solutions to turn innovative science into VALUE for patients under its business philosophy of "contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products." By sharing a common vision and challenges, the University of Tokyo and Astellas will work closely to promote innovation.