On March 30, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the pricing of its previously announced underwritten public offering of 53,333,334 shares of its common stock and pre-funded warrants to purchase 18,095,238 shares of its common stock, together with accompanying warrants to purchase 35,714,286 shares of its common stock (Press release, Geron, MAR 30, 2022, View Source [SID1234611167]). The combined offering price to the public of each share of common stock and accompanying warrant is $1.05. The combined offering price to the public of each pre-funded warrant and accompanying warrant is $1.049. The common stock and pre-funded warrants will be sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $1.45 per share and expires five years from the date of issuance; however, such term will be shortened upon achievement of a regulatory milestone.

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All of the securities in the offering are being sold by Geron. The gross proceeds to Geron from this underwritten public offering are expected to be approximately $75.0 million, before deducting the underwriting discount and other estimated offering expenses payable by Geron. The offering is expected to close on or about April 1, 2022, subject to the satisfaction of customary closing conditions.

Geron currently intends to use the net proceeds from this public offering, together with its existing cash, cash equivalents, restricted cash and marketable securities to fund potential regulatory filings in the United States and European Union for imetelstat in lower risk myelodysplastic syndromes (MDS), assuming top-line results in the IMerge Phase 3 clinical trial are supportive, and to support toward the completion of the IMpactMF clinical trial in refractory myelofibrosis and the planned exploratory studies in new indications, including IMproveMF and investigator-led trials in acute myeloid leukemia and higher risk MDS, the preclinical work in lymphoid malignancies and the discovery research program related to next generation telomerase inhibitors.

Stifel and Baird are acting as joint book-running managers for the offering. Needham & Company is acting as lead manager for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock, pre-funded warrants and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement relating to the offering may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected] or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Avenue, Milwaukee, Wisconsin 53202, by telephone at 800-792-2473 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, 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 prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

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.