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.

On March 30, 2022 IGM Biosciences, Inc. (NASDAQ: IGMS) reported the pricing of its underwritten public offering of 8,695,653 shares of its non-voting common stock at a price to the public of $23.00 per share (Press release, IGM Biosciences, MAR 30, 2022, View Source [SID1234611125]). IGM expects to receive total gross proceeds of approximately $200.0 million from this offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM. In addition, IGM has granted the underwriters a 30-day option to purchase up to an additional 1,304,347 shares of its voting common stock at the public offering price, less underwriting discounts and commissions. All of the shares in the offering will be sold by IGM. The offering is expected to close on or about April 1, 2022, subject to satisfaction of customary closing conditions.

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J.P. Morgan, BofA Securities, Stifel, and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on August 9, 2021 and declared effective on August 19, 2021. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; BofA Securities, Attention: Prospectus Department, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255, or via email: [email protected]; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attn: Syndicate, or by phone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

On March 29, 2022 SYNSIGHT, a biotech company specialized in RNA-targeting small molecules drugs, reported a $1.5 million fundraising (Press release, SYNSIGHT, MAR 29, 2022, View Source [SID1234644755]). The financing was led by an international investor.

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SYNSIGHT is pleased to announce today a $1.5 million fundraising This financial opportunity was realized with a Chinese investor who well recognized SYNSIGHT’s potential, which is completed by financial help from Region Ile-de-France and BPIfrance.

This fundraising will allow SYNSIGHT to accelerate its growth and development. The company will continue to refine its innovative platform and expand the drug discovery platform potentials. Thus, SYNSIGHT’s advantage in RNA targeting will be even enhanced.

The fundraising will also advance the SYNSIGHT pipelines and expand its portfolio. Noted that the SYNSIGHT pipelines are innovative targets which could only be treated by SYNSIGHT’s indoor innovative platform mentioned above, these targets (neurogenerative, oncology and infectious diseases related) were considered to be undruggable since the lack of breakthrough RNA target platform.

The fundraising will allow SYNSIGHT to expand its team and welcome new experts: senior project manager, AI research scientist, senior cell biologist and High-Content Screening engineer.