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.

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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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%.

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.

On July 28, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported that it has commenced an underwritten public offering of its common stock. All of the shares of common stock are being offered by Volition (Press release, VolitionRX, JUN 28, 2022, View Source [SID1234617284]). In addition, Volition intends to grant the underwriter in the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions. The final terms of the proposed offering will depend on market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Newbridge Securities Corporation is acting as the sole book-running manager of the offering.

The securities are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-259783) previously filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021 and declared effective by the SEC on November 8, 2021. The offering is being made only by means of a prospectus supplement and an accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. A preliminary prospectus supplement and an accompanying base prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering can also be obtained, when available, from Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected], or by telephone at (877) 447-9625. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall 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.