On March 30, 2022 KYORIN Holdings, Inc. reported that its wholly owned subsidiary of KYORIN pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo, President & CEO: Shigeru Ogihara, "KYORIN Pharmaceutical") has entered into a collaboration research agreement with Lumen Bioscience, Inc. (Head office: Seattle, WA, CEO: Brian Finrow, "Lumen") to obtain a development candidate toward clinical study (Press release, Kyorin, MAR 30, 2022, View Source [SID1234611166]).

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Under the terms of the agreement, KYORIN Pharmaceutical and Lumen will promote the collaboration research to obtain a clinical candidate for targets in the disease areas of interest to Kyorin Pharmaceutical by utilizing Lumen’s spirulina genetic protein engineering technology.

Biologic drugs (including antibodies) have conventionally been produced from E. coli, yeast, or mammalian cells. Lumen is the first company to establish a scalable method for manufacturing biologic drugs by genetically engineering spirulina instead of using these conventional methods. Spirulina, which is a well-known and healthy food product, can solubly express therapeutic proteins like these at extraordinarily high levels within its cytoplasm. And because both spirulina itself is safe to eat, the entire biomass—including the therapeutic proteins within—can be consumed orally without the costly and inefficient downstream purification steps required with conventional approaches. This technology is expected to provide safe orally deliverable biologic drugs at much lower costs than current approaches.

KYORIN Pharmaceutical believes that this opportunity to collaborate with Lumen’s breakthrough technology will enhance our research capabilities

On March 30, 2022 Cipla Medpro and the wholly owned subsidiary of Cipla Limited reported that have finalised a partnership agreement with the global biotechnology company mAbxience, to get oncology and respiratory-related biosimilars to South Africa (Press release, mAbxience, MAR 30, 2022, View Source [SID1234611165]).

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These medicine products for the treatment of cancer are on the WHO Model List of Essential Medicines.

The mAbxience partnership will enable Cipla to continue its ethos of ensuring equitable access to affordable, life-saving medication. Most other biosimilar treatments, particularly in oncology, create a high-cost burden on the payer or patient and often are inaccessible to patients in need of this critical treatment.

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing approved reference biologic product, and is produced from living cells using biotechnology. Biosimilars, while being more affordable, are developed with equivalent efficacy, safety and quality of the reference biologic.

In 2018, Cipla paved the way for more affordable treatments in the fight against dreaded diseases with the launch of the first biosimilar drug, Filgrastim Teva, for oncology and haematology patients in South Africa. Cipla also recently launched a biosimilar for the treatment of immune-mediated inflammatory disease.

According to the Cancer Alliance report CA03/2021, South Africa faces a crisis in terms of affordable access to medicines, particularly in the treatment of cancer. Fatima Hassan of the Health Justice Initiative says most patients cannot afford the medicines and treatment because they are priced for first-world markets.

"Some also enjoy extended periods of exclusivity, which means they have little or no competition", Hassan added.

Challenging treatment pricing and accessibility

Cipla changed the face of the HIV/Aids pandemic during its most severe phase more than 20 years ago, by dramatically slashing the prices of antiretrovirals to less than $1 a day, in comparison to the prevailing yearly treatment cost of $12,000 per patient. This revolutionised HIV/Aids from being a perceived death sentence to a disease managed like any other chronic medical condition.

CEO of Cipla South Africa, Paul Miller, said: "Cipla is built on the foundation of ensuring affordable and accessible drugs to patients in need. Cipla has focused on oncology to help make an equally profound difference in patients’ lives. We want people to live a long and healthy life, and quality medication is not just the privilege for a few, but a right for everyone."

Recently, Cipla also received regulating approval for lenalidomide – a lifesaving drug proven to enhance the immune-system cells that identify and attack cancer cells – a development that addresses the disparity with regards to access to and affordability of this medication.

On March 30, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2022 financial results on Thursday, April 21, 2022, before the market opens (Press release, Quest Diagnostics, MAR 30, 2022, View Source,-2022 [SID1234611164]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-583-8095 for domestic callers or 203-369-3815 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 21, 2022 until midnight Eastern Time on May 5, 2022.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On March 30, 2022 Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions (Press release, Taiho, MAR 30, 2022, View Source [SID1234611161]). Futibatinib is an investigational, oral, potent, selective and irreversible small-molecule inhibitor of FGFR1, 2, 3 and 4. The FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of September 30, 2022.

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Each year, approximately 8,000 individuals in the U.S. are diagnosed with CCA,1 a rare cancer of the bile ducts of the liver, and approximately 0.3-6 people per 100,000 individuals live with CCA worldwide.2 CCA is mainly seen in people 65 years of age or older,3 and treatment options are limited. Within the CCA patient population, approximately 10-16% have tumors with FGFR2 gene rearrangements,4,5,6,7,8 including gene fusions, which can form a hybrid gene and promote tumor proliferation. It is this subset of patients with CCA that encompasses the NDA for futibatinib.

"Given the lack of an accepted standard chemotherapy following the failure of first-line treatment,9 futibatinib could represent a significant opportunity for a targeted therapy in this subset of patients with CCA, which has driven our pursuit with this investigational compound," said Volker Wacheck, Vice President, Clinical Development, Taiho Oncology, Inc. "We look forward to working with the FDA as they consider the application for futibatinib under priority review."

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The NDA is based on data from the pivotal Phase 2b FOENIX-CCA2 trial in 103 patients with locally advanced or metastatic unresectable intrahepatic (inside the liver) CCA, harboring FGFR2 gene rearrangements including fusions who had received one or more prior lines of systemic therapy. Patients in the trial received futibatinib 20 mg once daily until disease progression or unacceptable toxicity. The trial’s primary endpoint was an objective response rate (ORR), which was 41.7% as assessed by independent central review. The key secondary endpoint of duration of response (DOR) demonstrated a median of 9.7 months (72% of responses ≥6 months). Common treatment-related adverse events (TRAEs) in the trial were hyperphosphatemia (85%), alopecia (33%) and dry mouth (30%). The only serious adverse reaction reported in more than one patient enrolled in the FOENIX-CCA2 trial was migraine (1.9%).

Results from the trial were presented in 2021 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting. Based on these data, the FDA granted Breakthrough Therapy Designation (BTD) for futibatinib for the treatment of patients with previously treated locally advanced or metastatic CCA in 2021.

"This is a very important step towards our goal to deliver futibatinib to patients awaiting potential new treatment options," said Teruhiro Utsugi, Senior Managing Director at Taiho Pharmaceutical. "The Taiho group, working as one, will continue to do its utmost to deliver this agent to those in need."

About Futibatinib
Futibatinib (TAS-120) is an investigational, oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4 being studied as a potential treatment for patients with advanced solid tumors with FGFR1-4 genetic aberrations, including cholangiocarcinoma, who were previously treated with chemotherapy or other therapies. Futibatinib selectively and irreversibly binds to the ATP binding pocket of FGFR1-4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumor cell proliferation and increased tumor cell death in tumors with FGFR1-4 genetic aberrations.

On March 28, 2022 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinicalstagecompany developing therapeutics designed to treat diseases in areas of high unmet need, reported the peer-reviewed publication of a Phase 1, multicenter, open-label, dose-escalation studyinvestigating the therapeutic potential of intravenous VCN-01 oncolytic adenovirus with or withoutstandard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) in patients with advanced solidtumors (Press release, VCN Biosciences, MAR 30, 2022, View Source [SID1234611126]). The data, published in the Journal for ImmunoTherapy of Cancer, suggests that treatment withVCN-01 is feasible and has an acceptable safety profile, with encouraging biological and clinical activity.These findings provide valuable dose-finding context and inform the clinical development strategy forVCN-01.

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"The results in this publication support VCN-01 administration intravenously at doses ≥3.3x1012vp/patient, resulting in viral exposure in the primary tumor and liver metastases, replication within thetumor, and the potential to remodel the tumor matrix to further promote tumor inflammation," saidManel Cascallό, Ph.D., General Director of Synthetic Biologics’ European Subsidiary. "These clinical dataunderscore VCN-01’s differentiated mechanism of action and were used to inform our Phase 2 study inpatients with metastatic pancreatic adenocarcinoma, which is expected to initiate in the second half of2022. More broadly, these results will help guide our rapidly advancing clinical program for VCN-01 andfurther support the development of our novel OV platform."

In the Phase 1, multicenter, open-label, dose-escalation study (NCT02045602), researchers evaluatedthe administration of a single dose of VCN-01 alone, in patients with solid tumors (Part I), or incombination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with locally advanced ormetastatic, unresectable, pancreatic adenocarcinoma (Parts II and III). In Part II, the VCN-01 wasadministered on the same day as the first dose of chemotherapy (Concomitant Regimen) and in Part IIIthe VCN-01 was administered 7-days prior to the first dose of chemotherapy (Sequential Regimen). Theobjective was to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)and dose-limiting toxicity (DLT) of the intravenous delivery of the replication-competent VCN-01adenovirus.

Overall, systemic VCN-01 was well tolerated in the patient population. The most common treatmentrelatedadverse events (AEs) were pyrexia, flu-like symptoms and increases in liver transaminases. These AEs were dose-dependent, reversible and consistent with AEs previously described for other adenovirusbasedproducts. In Part II, transient increases in neutropenia and thrombocytopenia were observedwhen VCN-01 in combination with gemcitabine/nab-paclitaxel was administered using the ConcomitantRegimen, and one patient suffered a fatal episode of enterocolitis and thrombocytopenia. The AE profilewas significantly reduced in Part III when VCN-01 and gemcitabine/nab-paclitaxel was administeredusing the Sequential Regimen, and was similar to the observed AE profile when VCN-01 wasadministered alone. There were no dose limiting toxicities observed in patients administered VCN-01using the Sequential Regimen. The investigators determined the RP2D was 1×1013 viral particles(vp)/patient in Part I and Part III, and 3.3×1012 vp/patient in Part II.

The Phase 1 study provided encouraging clinical results and further confirmed the proposed VCN-01mechanism of action. In patients with pancreatic adenocarcinoma, overall response rates were 50%(Part II) and 50% (Part III). VCN-01 viral genomes were detected in tumor tissue in five out of six biopsies(primary pancreatic tumor and liver metastases) on day eight. A second peak of virus concentrations inplasma and increased serum hyaluronidase levels suggest replication after IV injection in all patients.Higher peaks of hyaluronidase serum levels were associated with maximum tumor shrinkage andincreased levels of immune biomarkers (IFNγ, sLAG3, IL-6, IL-10) were found in sera after VCN-01administration. Several markers of tumor inflammation (including CD8 infiltration and indoleamine 2, 3-dioxygenase [IDO] upregulation) were described in tumor biopsies indicating that VCN-01 promotes achange in the tumor immune environment.

Synthetic Biologics anticipates the initiation of multiple international studies, including a Phase 2 clinicaltrial of intravenous VCN-01 in combination with SoC chemotherapy using the Sequential Regimen as afirst-line therapy in newly diagnosed metastatic pancreatic adenocarcinoma patients in the fourthquarter of 2022, as well as a Phase 2/3 pivotal trial of intravitreal VCN-01 as either an adjunct tochemotherapy or a potential rescue therapy in pediatric patients with advanced retinoblastoma in early2023.