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 [SID1234606748]).

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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 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported it has been named to the 2022 OTCQX Best 50, a ranking of top performing companies traded on the OTCQX Best Market last year (Press release, Nuvo Pharmaceuticals, JAN 24, 2022, View Source [SID1234606714]).

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The OTCQX Best 50 is an annual ranking of the top 50 U.S. and international companies traded on the OTCQX market. The ranking is calculated based on an equal weighting of one-year total return and average daily dollar volume growth in the previous calendar year. Companies in the 2022 OTCQX Best 50 were ranked based on their performance in 2021.

"We are very pleased to be included in the 2022 OTCQX Best 50 at #39," said Jesse Ledger, Miravo’s President and CEO. "This achievement comes as a result of the dedication and hard work Miravo employees have made during 2021, as we continued to execute on our strategic plan."

For the complete 2022 OTCQX Best 50 ranking, visit

View Source

The OTCQX Best Market offers transparent and efficient trading of established, investor-focused U.S. and global companies. To qualify for the OTCQX market, companies must meet high financial standards, follow best practice corporate governance, and demonstrate compliance with applicable securities laws.

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.

On January 24, 2022 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the presentation of results of two trials evaluating eryaspase in advanced pancreatic cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) on January 21, 2022 (Press release, ERYtech Pharma, JAN 24, 2022, View Source [SID1234607438]).

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Abstract # 581 – rESPECT: A Phase I dose-escalation study of eryaspase in combination with modified FOLFIRINOX in locally advanced and metastatic pancreatic ductal adenocarcinoma: Interim update (NCT04292743).

Dr Marcus Noel, MD, medical oncologist at Georgetown University Lombardi Comprehensive Cancer Center, Washington, DC, USA, and principal investigator of the rESPECT trial, presented an interim update of this Phase 1 trial evaluating eryaspase in combination with mFOLFIRINOX, a fluoropyrimidine- and irinotecan-based chemotherapy regimen, as first-line treatment for advanced pancreatic cancer.

To date, eleven patients have been enrolled with a mean age of 68. Three patients were enrolled at a dose level of 75 U/kg and eight at a dose level of 100 U/kg. The novel combination of mFOLFIRINOX plus eryaspase was well tolerated and no dose limiting toxicity (DLT) was observed. The maximum tolerated dose (MTD) has been declared with 5-FU 2400 mg/m2, Oxaliplatin 85 mg/m2, Irinotecan 150 mg/m2 and eryaspase 100 units/kg.

Among ten patients with imaging available to evaluate response, 5 (50%) had partial response (PR) and 5 (50%) had stable disease (SD), corresponding to a disease control rate (PR + SD) of 100%. One patient with locally advanced disease became eligible for resection after receiving therapy.

Dr Marcus Noel, MD, Principal Investigator of the rESPECT IST, commented: "The early results from the rESPECT study are highly encouraging for the combination of eryaspase and modified FOLFIRINOX in first-line pancreatic cancer, with the MTD now established and initial signs of clinical activity demonstrated. We plan to expand enrolment on rESPECT to further evaluate efficacy. Alongside a group of international experts, we are now in the process of potentially considering a larger study in light of both our experience with rESPECT to date and the results observed in patients treated with the combination of eryaspase and FOLFIRI in TRYbeCA-1."

Abstract # 518 – TRYbeCA-1: A randomized, Phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with advanced pancreatic adenocarcinoma (NCT03665441).

Prof. Pascal Hammel, MD, PhD, medical oncologist at University Paris-Saclay, Hôpital Paul Brousse (APHP), France, and co-principal investigator of the TRYbeCA-1 trial, presented the final results of this Phase 3 trial. The top-line results had been reported in October 2021.

As reported before, the trial did not meet primary efficacy endpoint of overall survival (OS). The median OS for patients treated with eryaspase plus chemotherapy was 7.5 months (95% CI, 6.5-8.3), compared to 6.7 months (95% CI, 5.4-7.5) for chemotherapy alone.

The prespecified subgroup of patients treated with eryaspase and FOLFIRI, a fluoropyrimidine- and irinotecan-based chemotherapy regimen, demonstrated a nominal increase in median OS of 2.3 months versus FOLFIRI alone, from 5.7 to 8 months (HR = 0.81; 95% CI, 0.6-1.1). The FOLFIRI treated patients represented approximately 42% of the patients in this trial.

The treatment was well tolerated, and the addition of eryaspase did not enhance the cytotoxicity of chemotherapy.

Following Prof. Hammel’s presentation, the discussant, Dr Nilofer Saba Azad, MD, Department of Oncology, Johns Hopkins Sidney Kimmel Cancer Center, concluded that TRYbeCA-1 was well designed with appropriate power and stratification factors. Furthermore, the study findings open the possibility for additional study of eryaspase in combination with FOLFIRI in neo-adjuvant, adjuvant and first-line settings.

"While it was initially disappointing to be unable to demonstrate an improvement in survival across the entire population in one of the largest prospective second-line pancreatic cancer studies conducted to date, TRYbeCA-1 has improved our understanding of pancreatic cancer in this setting, and importantly, has also identified a potential utility of the combination of eryaspase with fluoropyrimide- and irinotecan-containing regimens in this difficult to treat cancer. I look forward to furthering discussions with the pancreatic cancer community on future potential clinical trials with eryaspase," said Prof. Pascal Hammel, MD, PhD, Co-principal Investigator of the TRYbeCA-1 trial.

Dr Iman El-Hariry, MD, PhD, Chief Medical Officer at ERYTECH, added: "I would like to thank all investigators and patients who are participating and have participated in the rESPECT and the TRYbeCA-1 studies. Pancreatic cancer remains very difficult to treat with few treatment options, but we have been encouraged by the clinical activity observed with eryaspase in both trials. We continue to evaluate the path forward for potential further clinical development focused on evaluating eryaspase in combination with fluoropyrimidine-and irinotecan-based chemotherapy. Meanwhile, the company is currently preparing a BLA to seek approval for eryaspase for the treatment of ALL patients who developed hypersensitivity to E. coli-derived asparaginase, based on the results of a Phase 2 clinical trial sponsored by the NOPHO group1. The Company intends to submit the BLA in the first quarter of 2022, subject to completion of remaining data requested by the FDA."

On January 24, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of new data that suggest the company’s Percepta Genomic Sequencing Classifier (GSC) can accelerate delivery of curative therapy for patients with high-risk lung nodules and inconclusive bronchoscopy results (Press release, Veracyte, JAN 24, 2022, View Source [SID1234606715]). The findings, from a prospective, randomized decision impact study published in BMC Pulmonary Medicine, also show that the test can increase physician confidence in clinical decision-making and decrease unnecessary diagnostic procedures.

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While many physicians use bronchoscopy to evaluate potentially cancerous lung nodules, results from the non-surgical procedure are often inconclusive, which can lead to diagnostic uncertainty and treatment delays. Veracyte developed the Percepta GSC to aid in the diagnosis of patients who have suspicious lung nodules and inconclusive bronchoscopy results. Clinical guidelines and data suggest patients with nodules identified as high-risk for lung cancer should be considered for immediate curative therapy (ablative therapy and/or surgery); however, studies have shown that physicians frequently opt for conservative management such as further surveillance or additional diagnostic procedures in these patients.

"Determining how to manage high-risk lung nodule patients who’ve had a non-diagnostic bronchoscopy is clinically challenging," said Sonali Sethi, M.D., FCCP, Interventional Pulmonology, Cleveland Clinic, and lead author of the paper. "The findings from our study suggest that, by accurately up-classifying patients’ risk of malignancy from ‘high’ to ‘very high,’ this tool can help provide objective data that inform a more aggressive treatment approach in appropriate cases and increase physician confidence in their decision-making."

The Percepta GSC stratifies the risk of primary lung cancer to guide patient management when bronchoscopy is inconclusive. In the current, prospective, randomized decision-impact study, researchers evaluated whether a Percepta GSC result that up-classified a nodule’s pre-bronchoscopy risk of malignancy (ROM) from "high" (>60%) to "very high" (>90%) led to an increase in the rate of referral for surgical or ablative therapy without additional intervening procedures and to an increase in physician confidence in patient management.

Using patient cases from the Percepta GSC validation cohort, researchers selected 37 cases that had a high ROM pre-bronchoscopy, a non-diagnostic bronchoscopy, and a Percepta GSC result that up-classified ROM from "high" to "very high." They presented these cases to 101 U.S.-based pulmonologists in three formats: a pre-post cohort where each case was presented without and then with a Percepta GSC result, and two independent cohorts where each case was presented either with or without a GSC result. Researchers then surveyed the physicians regarding subsequent patient management steps and confidence in their clinical decision.

The study found that Percepta GSC test results significantly increased the rate of recommendation for curative therapy (in alignment with current guideline recommendations) without additional, intervening procedures. Physicians who received the Percepta GSC result recommended surgical resection or ablative therapy more than twice as often as those who did not receive the test result (45% vs. 17%, respectively, p<0.001). Among the pre-post cohort, the rate of recommendation increased from 17% to 56% (p<0.001) following review of the Percepta GSC result. Additionally, pulmonologists’ confidence in decision-making following a non-diagnostic bronchoscopy increased with the Percepta GSC up-classification. Prior to receiving the Percepta GSC result, 70% of physicians reported confidence level in their decision was at a 6 or 7 on a 7-point scale. This increased to 76% of physicians upon receipt of the Percepta GSC "very high" result, with a statistically significant increase at the highest possible level of 7 (from 21% to 31%; p=0.0017).

"Both pulmonologists and patients are often confronted by a great deal of uncertainty when faced with a non-diagnostic bronchoscopy," said Giulia Kennedy, Veracyte’s global chief scientific officer and chief medical officer. "These findings reinforce the clinical value and benefits of Veracyte’s Percepta GSC, suggesting that the test could help improve outcomes for early-stage lung cancer patients by supporting recommended treatment approaches, reducing diagnostic delays and preventing unnecessary procedures."

About the Percepta Genomic Sequencing Classifier (GSC)

The Percepta GSC is an RNA sequencing-based risk-stratification test designed to aid patient management in cases where a lung nodule is present and bronchoscopy results are unclear. The Percepta GSC is based on novel "field of injury" science, which identifies genomic changes that correlate with lung cancer risk in current or former smokers using a brushing to collect cells from the patient’s main lung airway during a standard bronchoscopy, without the need to sample the lesion directly. Previous analyses demonstrated the test’s accuracy in "down-classifying" patients at low risk of lung cancer and in "up-classifying" patients at high risk of the disease.1

About Lung Cancer

Lung cancer kills more than 1.8 million people worldwide each year.2 Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to 6 percent when it is found at a later stage.3 Lung nodules are typically the first sign of lung cancer, but most lung nodules are benign. Each year in the U.S., an estimated 1.6 million lung nodules are found incidentally on CT scans and, with recently expanded recommendations from the U.S. Preventive Services Task Force, an estimated 15 million Americans are eligible for annual lung cancer CT screening.