On January 24, 2022 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported that the first patients have been enrolled in both of the Phase 2 studies of OBI-999, an antibody drug conjugate (ADC) cancer therapy targeting Globo H, and OBI-3424, a prodrug targeting the enzyme aldo-keto reductase 1C3 (AKR1C3) (Press release, OBI Pharma, JAN 24, 2022, View Source [SID1234606757]).

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The Phase 2 cohort expansion part of the OBI-999-001 (ClinicalTrials.gov Identifier: NCT04084366) entitled "A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-999 in Patients with Advanced Solid Tumors" has now begun enrollment. The Phase 2 part of the study will enroll Globo H expressing patients with pancreatic, colorectal and other high Globo H expression solid tumors in more than ten medical centers in the United States and Taiwan.

The Phase 2 cohort expansion part of the OBI-3424-001 (ClinicalTrials.gov Identifier: NCT03592264) entitled "A Phase 1/2 Study of OBI-3424 in Subjects with Advanced Solid Tumors" has also begun enrollment. This study will enroll AKR1C3 expressing patients with pancreatic and other high AKR1C3 expressing solid tumors in select oncology medical centers in the United States.

OBI’s Chairman and Chief Executive Officer, Michael Chang, PhD, noted "OBI Pharma strives to develop novel therapeutics for cancer patients worldwide. Based upon the impressive Phase 1 safety study and preclinical data of OBI-999 and OBI-3424, we are excited to commence our Phase 2 efficacy and safety study in patients with high Globo H or AKR1C3 antigen expression in solid tumors. We would like to thank the commitment of our international investigators to bring these 1st-in-class cancer therapeutic products to potential patients in our ongoing study."

OBI anticipates completing the enrollment of both Phase 2 studies in the second half of 2023.

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In human Phase 1 study, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI-999 is currently in a Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) in medical centers in the US and Taiwan. OBI Pharma owns global rights to OBI-999.

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

OBI-3424 is currently in a Phase 2 trial (ClinicalTrials.gov Identifier: NCT03592264) in medical centers in the US. OBI owns global rights to OBI-3424 except the Asia Pacific region.

On January 24, 2022 EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, reported a research and development collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology by combining resources and expertise from both sides (Press release, EdiGene, JAN 24, 2022, View Source [SID1234606752]).

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The Haihe Laboratory of Cell Ecosystem, run by the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, is focused on conducting fundamental research, innovation, and translation in the cell ecosystem.

Under the agreement, both parties will jointly develop hematopoietic stem cell regenerative therapies, including the development of innovative genetically-modified hematopoietic stem cell therapies and the exploration of novel biomarkers to optimize quality control for stem cell production.

"With top-notch resources and industry-university-research cooperation, we’ll facilitate the development of cell-based medicine and therapies," said Professor Tao Cheng, Deputy Director of Haihe Laboratory of Cell Ecosystem and President of the Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences and Peking Union Medical College, a leading hematology researcher who has made a series of discoveries relating to the regulatory and regenerative mechanisms of hematopoietic stem cells. "Hematopoietic stem cells (HSCs) have the potential for long-term self-renewal and can differentiate into various types of mature blood cells. These stem cells can be harnessed to provide treatment for a broad range of diseases such as hematological tumors, autoimmune diseases, and hereditary blood disorders. We believe that this collaboration with EdiGene will accelerate the innovation and translation in the field of HSCs, thus enabling healthier patients with new therapies."

Professor Cheng was awarded the second prize of the National Natural Science Award 2020 as the first author of work on basic and translational research that advanced the development of adult hematopoietic stem cells for therapeutic applications.

EdiGene is scaling up clinical translation and development of the first gene-editing hematopoietic stem cell therapy in China following the 2021 approval by the China National Medical Products Administration its IND for its investigational therapy ET-01. "Our team has extensive experience in the development and translation of cutting-edge technologies including hematopoietic stem cell and gene editing," said Dong Wei, Ph.D., CEO of EdiGene. "This collaboration with Haihe Laboratory of Cell Ecosystem will further our exploration in the field of hematopoietic stem cells. The partnership with this leading academic institute and our translational know-how enable us to move forward in bringing more innovative treatment options to patients in China and around the world."

In 2021, EdiGene initiated a Phase I multicenter clinical trial of ET-01, its gene-editing hematopoietic stem cell therapy for transfusion-dependent β-thalassemia. EdiGene has enrolled the first patient at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Currently, the clinical trial is being conducted in Tianjin and Guangdong-Hong Kong-Macao Greater Bay Area (Greater Bay Area). EdiGene also presented its latest research on new surface markers and migration of hematopoietic stem cells at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2021.

On January 24, 2022 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported that the Hong Kong Department of Health (DH) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy (Press release, Innovent Biologics, JAN 24, 2022, View Source [SID1234606751]).

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Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Hong Kong market, marking a new milestone following the successful approval of Pemazyre in Taiwan in June 2021 and the New Drug Applicant(NDA) acceptance by China’s NMPA in July 2021.

The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The major efficacy outcome measure was overall response rate (ORR) determined by an independent review committee Per RECIST V1.1. As data cut of (April 4th,2020), a total of 108 subjects with FGFR 2 fusion/rearrangement was enrolled in the study and received 13.5mg pemigatinib per day, the ORR was 37.0% (95% CI: 27.94%, 46.86%), including 4 complete responses. The median duration of response (DOR) was 8.08 months with responses lasting ≥ 6 months in 26 of the 40 (66.0%) responding patients and ≥ 12 months in 15 (37.5%) patients. The safety analysis, including 147 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common (58.5%) treatment-emergent adverse event (TEAE). TEAEs grade 3 or higher were reported in 68.7% of patients; the most frequent of which were hypophosphatemia (14.3%), arthralgia (6.1%), stomatitis 6.1%), hyponatremia (5.4%), abdominal pain (5.4%) and fatigue (5.4%).

For more information FIGHT-202, please visit View Source or https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30109-1/fulltext.

Dr. Yongjun Liu, President of Innovent, stated: "The approval of Pemazyre in Hong Kong, following the approval in Taiwan earlier this year, further broadens Innovent’s product portfolio and market coverage. Currently Innovent has developed a robust pipeline of 26 clinical assets and more than 80 projects in preclinical stage, along the way we have established strategic collaborations with a dozen of global and regional partners. We look forward to launching more innovative drugs to help fulfill unmet needs, overcome current therapeutic limitation and improve the life quality of patients."

"Cholangiocarcinoma is the second most common malignancy originated in the liver with a high incidence in Asia. This cancer is usually not diagnosed until it has already developed into an advanced unresectable and/or metastatic stage. There are limitations on current treatment options, which call for innovative drugs that could greatly enhance disease control as well as provide better life quality," stated Dr. Hui Zhou, Senior Vice President of Innovent. "Data from previous clinical trials of Pemazyre in participants with advanced cholangiocarcinoma with FGFR2 fusion that have progressed after at least one prior line of systemic therapy has not only shown satisfactory safety results but also revealed compelling efficacy signals. In addition, Pemazyre is an orally administered medication that could improve convenience and patient compliance. The approval is a new milestone for Innovent; we look forward to hearing good news from NMPA as well and to bringing the therapeutic benefit of Pemazyre in the treatment of eligible patients with cholangiocarcinoma in the Greater China market."

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas has been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including Pemazyre, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemazyre (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.

In June 2021, Taiwan Food and Drug Administration (TFDA) approved Pemazyre (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.

In July 2021, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for Pemazyre(pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement.

In Jan 2022, the Hong Kong Department of Health (DG) approved Pemazyre(pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

On January 24, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that, it has successfully completed the dosing of first patient in phase Ib/IIa trial at the stage of dose expansion of its anti-CTLA-4 antibody (HBM4003) in combination therapy with toripalimab (anti-PD-1 antibody) for patients suffering from advanced melanoma and other solid tumors (Press release, Harbour BioMed, JAN 24, 2022, View Source [SID1234606750]).

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As the first heavy chain only fully-human antibody on clinical stage in the world, HBM4003 showed its good safety profile and strong efficacy on its monotherapy study of phase I trial. HBM is making all efforts to push forward to the studies of this product in combination therapy as treatment for multiple solid tumors, including melanoma, NSCLC, HCC, NET/NEC.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combo-therapy.

On January 24, 2022 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported that strong financial results for the fourth quarter and record-high earnings for the fiscal year of 2021 (Press release, Samsung BioLogics, JAN 24, 2022, View Source;fiscal-year-2021-financial-results-301466346.html [SID1234606749]).

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John Rim, CEO of Samsung Biologics, stated, "With a steep increase in demand for medicines due to the prolonged COVID-19 pandemic, there was a great need for CDMO capabilities around the world to ensure a reliable supply of high-quality biological products. By successfully managing all potential impact from the pandemic with strong business continuity and operational excellence, Samsung Biologics achieved solid growth and increased sales in an extraordinary year and made meaningful progress in building momentum around our long-term business and capacity. Our fourth-quarter financial performance demonstrates our ability to execute a robust and resilient approach to maintaining business continuity while adapting at every level to the needs of our clients and partners. Our concerted efforts have enabled us to achieve our financial targets and lay a foundation to deliver future growth. As we look towards 2022, we remain fully committed to delivering high-quality, life-saving treatments to our partners and patients around the world."

FOURTH QUARTER & FISCAL YEAR 2021 RESULTS

Fourth quarter 2021 revenue was KRW 444.3 billion, an increase of 18% from KRW 375.3 billion reported for the fourth quarter in the previous year, attributable to increased utilization of Plants 1 and 3, and sales activities bringing in new contracts.

Fourth quarter 2021 operating profit was KRW 128.8 billion, 39% higher than the prior-year period leveraging steady sales growth.

Fourth quarter 2021 net profit reached KRW 79.3 billion, a decrease of KRW 16.9 billion from KRW 96.2 billion in the fourth quarter a year ago, and fourth quarter 2021 operating margin was 29% due to increased utilization across all plants and improved product mix.

Samsung Biologics demonstrated strong operational excellence and business agility in 2021 with Plants 1, 2, and 3 in stable operations, and laid a strong mRNA business foundation through signing strategic partnership agreements with Moderna for fill and finish and Greenlight Biosciences for the manufacturing of mRNA vaccines. Samsung Biologics also launched its newest CDO process platform, S-CellerateTM, which offers an expedited process for the development and commercialization of monoclonal antibodies.

FISCAL YEAR 2022 OUTLOOK

At the JP Morgan Healthcare Conference, the company addressed the three core pillars of its multidimensional growth plan, which includes increasing manufacturing capacity, enhancing portfolio diversification, and expanding facilities overseas.

In addition to steadily securing client pre-sales, Plant 4 construction is expected to complete six months ahead of schedule, commencing operations to support 10KL production capacity in Q4 2022 and 15KL by mid-2023. Upon its full completion, the company is expected to hold a total of 620KL of capacity, reaffirming its position as the world’s largest CDMO.

As part of its growth plan, Samsung Biologics is planning to start the construction of a new facility, Plant 5 in 2022 where it will offer multi-modal product services including cell and gene therapies and next-gen vaccines utilizing mRNA, pDNA and viral vectors, all at a single site. This is in addition to the mRNA vaccine drug substance (DS) manufacturing suite, which is expected to be ready for cGMP operations at its existing facility in Songdo within the earlier part of this year.

The company is further venturing into securing additional land within Songdo for the construction of future plants and an Open Innovation Center, as well as overseas in multiple locations to maximize both its manufacturing capacity to produce large-scale biologics and be in closer proximity to its global clients, further expanding its global footprint beyond its San Francisco R&D center.

With the increasing importance of sustainability, Samsung Biologics will continue to prioritize its ESG commitments through steady improvement in lowering operational GHG emissions and participating various climate change initiatives including the Sustainable Markets Initiative in the lead up to COP27.

For more details on performance and financials, please refer to the Earnings Release.