Adagene Announces Authorization of Share Repurchase Program up to US$10 Million

On June 29, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported that its board of directors has authorized a share repurchase program under which, Adagene may repurchase up to US$10 million of its ordinary shares in the form of American depositary shares, subject to the relevant rules under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Company’s insider trading policy (such repurchase program, the "2022 Share Repurchase Program") (Press release, Adagene, JUN 29, 2022, View Source [SID1234616357]).

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The Company’s share repurchases, if any, under the 2022 Share Repurchase Program may be made from time to time on the open market at prevailing market prices, in open-market transactions, privately negotiated transactions or block trades, and/or through other legally permissible means, depending on market conditions and in accordance with the applicable rules and regulations. The timing and conditions of the share repurchases will be subject to various factors including the requirements under Rule 10b-18 and Rule 10b5-1 of the Exchange Act. The Company’s board of directors will review the 2022 Share Repurchase Program periodically and may authorize adjustments to its terms and size or suspend or discontinue the program. The Company expects to utilize its existing funds to fund repurchases made under this program.

The Company has disclosed certain details of the repurchases made in accordance with the prior share repurchase program in its annual report for the year ended December 31, 2021 filed with the SEC. See Item 16.E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers on page 212.

The 2022 Share Repurchase Program will be effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The 2022 Share Repurchase Program does not obligate Adagene to acquire any particular number of American depositary shares, and the 2022 Share Repurchase Program may be modified or suspended at any time at the management’s discretion.

Abbott Hosts Conference Call for Second-Quarter Earnings

On June 29, 2022 Abbott (NYSE: ABT) reported that it will announce its second-quarter 2022 financial results on Wednesday, July 20, 2022, before the market opens (Press release, Abbott, JUN 29, 2022, View Source [SID1234616356]).

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The announcement will be followed by a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

A case study shows contribution of Cellestia ’s CB-103 in achieving complete response in a relapse/refractor T-ALL patient

On June 29, 2022 Cellestia reported to share a case report of complete clinical response in a patient with relapsed and refractory T-ALL after treatment with Cellestia’s CSL-NICD inhibitor CB-103 thanks to the collaboration with the team of the Department of Hematology, University Hospital Basel (Press release, Cellestia Biotech, JUN 29, 2022, View Source [SID1234616354]). The study has been just published in a peer reviewed journal (eJHaem published by British Society for Haematology).

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ALX Oncology Receives U.S. FDA Orphan Drug Designation for Evorpacept for the Treatment of Patients with Acute Myeloid Leukemia

On June 29, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported that the U.S. Food and Drug Administration ("FDA") granted orphan drug designation ("ODD") to evorpacept, a next-generation CD47 blocker, for the treatment of patients with acute myeloid leukemia ("AML") (Press release, ALX Oncology, JUN 29, 2022, View Source [SID1234616353]).

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"Receiving orphan drug designation in AML, and previously in gastric cancer, from the FDA is an important regulatory milestone and reflects the FDA’s recognition of evorpacept’s potential to improve clinical outcomes in patients with these advanced cancers," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer, ALX Oncology. "In our ongoing Phase 1/2 ASPEN-05 study (NCT04755244), we are excited to evaluate the combination of evorpacept with venetoclax and azacitidine in patients with previously untreated AML who are not candidates for intensive induction therapy or with relapsed/refractory AML."

The FDA’s Office of Orphan Products Development grants ODD status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. ODD provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

About Acute Myeloid Leukemia

AML is an aggressive blood cell cancer that can rapidly progress and lead to death if not treated promptly. AML is the most common form of acute leukemia in adults, with an estimated 20,050 new cases and 11,540 deaths from AML in the United States in 2022. Due to advanced age and comorbidities at the time of diagnosis, a significant number of patients are not considered eligible for intensive and potentially curative therapies. Despite advances in available care, the estimated 5-year survival for patients in the United States with AML remains only 31%.

Chimeric Licenses Viral Vector Technology from University of Pennsylvania for CDH17 CAR T Program

On June 29, 2022 Chimeric Therapeutics Ltd (ASX:CHM) reported that it has expanded its licensing agreement with the University of Pennsylvania to include non-exclusive access to its lentiviral vector plasmid system, a viral vector technology critical for the manufacture of chimeric antigen receptor (CAR) T cells (Press release, Chimeric Therapeutics, JUN 29, 2022, View Source [SID1234616350]).

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Licensing of this technology will support Chimeric’s efforts to develop and commercialise its CHM 2101 CDH17 CAR T technology, offering improved safety as a third-generation technology.

The amended licence agreement with Pennsylvania University will allow CHM to manufacture clinical-grade lentiviral vector for use in its planned Phase 1 study of CHM2101 for gastrointestinal cancers.

Chimeric will also be able to cross-reference regulatory information on file with the US Food and Drug Administration (FDA) to support the filing of an investigational new drug (IND) designation for CHM 2101.

CDH17 CAR T technology
CHM 2101 (CDH17 CAR T) is based on a novel third-generation iteration of the CDH17 CAR T technology invented by the University of Pennsylvania.

The treatment is at a pre-clinical development stage, with plans for a Phase 1 clinical trial assessing neuroendocrine tumours, colorectal, gastroesophageal and gastric cancer already in the works.

Preclinical data has indicated a particular efficacy in solid tumours, having demonstrated the complete eradication of tumour cells with no relapse and no toxicity to normal tissue.