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SCG Cell Therapy Announces HSA Clinical Trial Approval Of TCR-T Cell Therapy For Liver Cancer

On May 9, 2022 Singapore-based SCG Cell Therapy Pte Ltd ("SCG"), a leading biotechnology company, reported that Singapore’s Health Sciences Authority (HSA) has cleared the company’s Investigational New Drug (IND) application for clinical trials for SCG101 – an autologous T-cell receptor (TCR) T-cell therapy (Press release, SCG Cell Therapy, MAY 9, 2022, View Source [SID1234614172]). SCG101 is being developed to treat hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) – the most common form of liver cancer.

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The treatment has recently secured IND approval from China’s National Medical Products Administration (NMPA), making it the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-regional IND approval in the field of cell therapy across Singapore and China.

"The multi-country IND approval for SCG101 is a key milestone for SCG’s cell therapy pipeline, proving our capability to fulfil regulatory requirements in the target markets", said Frank Wang, Chief Executive Officer of SCG Cell Therapy. "Globally, liver cancer has the second-highest cancer-mortality rate accounting for over 700,000 deaths each year. Four in five new HCC cases are diagnosed in the Asia Pacific. Singapore is known as a medical centre of excellence in Southeast Asia and is one of the world’s top medical tourism destinations. This milestone pushes forward our mission to advance cell therapy to patients in need and strengthens our position as a key global player", Frank added.

"In Singapore, liver cancer is the third most common cause of cancer-related death. There are significant challenges with the available treatment options in meeting patient needs. SCG101 offers a novel treatment option for patients," said Dr Yong Wei Peng, Principal Investigator of the study and Senior Consultant at the Department of Haematology-Oncology at the National University Cancer Institute, Singapore.

"Cell therapy is one of the most promising and rapidly advancing treatments for chronic and life-threatening diseases such as cancer. SCG101, an individualised cancer treatment which is manufactured locally at Cell Therapy Facility of Singapore Health Sciences Authority (HSA-CTF), offers potential new hope to such cancer patients in Singapore," said Dr Toh Han Chong, Principal Investigator at National Cancer Centre Singapore.

According to Grand View Research, the global T-cell therapy market is expected to reach USD 20.3 billion by 2028, expanding at a CAGR of 20.2% from 2021 to 2028.

With SCG101, the function of T-cells is activated by recognising peptide fragments – short chains of amino acids – of pathogen-derived proteins in the form of complexes of peptides and MHC molecules (major histocompatibility complex) on the cell surface via the TCR. SCG101 specifically recognises the epitope of the hepatitis B virus surface antigen (HBsAg), which redirects T-cells specificity against the HBV antigens. With the specific HLA typing, SCG101 can recognise both HBsAg membrane antigen and HBsAg intracellular antigen. Therefore, SCG101 eliminates HBsAg-positive HCC cells and also eradicates HBV cccDNA (covalently closed circular DNA).

T-cells are important white blood cells of the immune system and play a central role in the adaptive immune response. TCRs are molecules on the surface of T-cells that allow the immune system to distinguish the body’s own healthy cells from diseased pathogen-infected or tumour cells.

In November 2021, SCG Cell Therapy announced a collaboration with the Cell Therapy Facility of Singapore’s Health Sciences Authority (HSA-CTF) for the evaluation and validation of SCG’s proprietary cell therapy manufacturing process for the development of new treatment options for patients with HBV related HCC.

The validation process of SCG101 was performed in the Good Manufacturing Practice (GMP)-certified facility at HSA-CTF and is fully compliant with current GMP (cGMP) requirements.

10-Q – Quarterly report [Sections 13 or 15(d)]

BeiGene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

10-Q – Quarterly report [Sections 13 or 15(d)]

Eagle Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Adamis Pharmaceuticals Schedules First Quarter 2022 Financial Results Conference Call and Business Update

On May 9, 2022 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported that it will host an investor conference call on Monday, May 16, 2022 at 2 p.m. Pacific Time to discuss its financial and operating results for the first quarter 2022 as well as provide a business update (Press release, Adamis Pharmaceuticals, MAY 9, 2022, View Source [SID1234614115]). The company’s press release concerning its first quarter 2022 financial results is expected to be available after 1 p.m. Pacific Time on May 16, 2022, and on its website.

Dennis J. Carlo, Ph.D., President and CEO of Adamis, will host the call along with other members of the management team. The call is open to the public and will provide an update on recent developments, events that have taken place during the year, and certain goals for future periods. Forward-looking statements concerning expectations regarding future company performance may be made during the conference call.

A live audio webcast of the conference call will also be available via this link, with a replay available shortly after the live event.

aTyr Pharma Announces First Quarter 2022 Results and Provides Corporate Update

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]).

"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.