On January 21, 2020 Cell>Point reported, based on its sponsored chelator and therapeutic research conducted at the University of Texas M.D. Anderson Cancer Center on Platinum-Oncardia and 177Lu-Oncardia, and the positive results of its lung cancer imaging trials with 99mTc-Oncardia, that it will be moving forward with these two intra-nuclear therapeutics expanding its focus in theranostic medicine (Press release, CELLPOINT DIAGNOSTICS, JAN 21, 2020, View Source [SID1234553390]). The company believes that Oncardia (a proprietary organic formulation of ethylenedicysteine-glucosamine), which functions as an intra-nuclear compound, will provide an effective means to deliver highly targeted low dose therapy with minimal impact to collateral healthy cells. The research focus will involve studies to treat relapsed aggressive diffuse type B-cell lymphoma and lung cancer. Other cancer targets will likely eventuate from these initial studies.

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The research objective is to target cancers with Platinum or 177Lu (depending on the type of cancer) by delivering the therapy to the nucleus of the diseased cell to cause cell apoptosis. The cell nucleus contains the DNA and thus controls growth and reproduction. Oncardia targets the nucleus. The stability of Oncardia allows it to be used with a range of therapeutic isotopes and cold metals. Based on the affinity of hyperactive cancer cells to maintain metabolic activity using glucose or the transition of cells being depleted of glucose, Oncardia based therapeutic compounds should be effective in the treatment of a wide range of cancers.

Theranostic personalized medicine involves the combination of therapy and imaging to improve the detection, staging, treatment and assessment of the patient’s response to treatment. No two patients are identical and their responses to treatment for the same type of cancer will not necessarily be the same. Medical management in oncology is evolving from a generalized approach in the treatment of many forms of cancer to a more patient centric approach. Theranostic medicine should play a central role in this transformation.

On January 21, 2020 OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-999 for the treatment of Gastric Cancer (Press release, OBI Pharma, JAN 21, 2020, View Source [SID1234553356]). OBI-999 is a first-in-class antibody drug conjugate targeting Globo H, a glycolipid antigen. On December 26, 2019 OBI-999 was granted Orphan Drug Designation for Pancreatic Cancer.

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A Phase 1/2 clinical trial of OBI-999 has commenced enrollment at the University of Texas M.D. Anderson Cancer Center, with Dr. Apostolia M Tsimberidou as the Principal Investigator, in patients with locally advanced or metastatic solid tumors, including Gastric, Pancreatic, Colorectal and Esophageal Cancers (ClinicalTrials.gov Identifier: NCT04084366). The objective of the trial is to verify the safety and preliminary efficacy profile of OBI-999 in these patient populations.

Tillman Pearce, MD, CMO, OBI Pharma noted, "Advanced gastric cancer is an orphan disease where targeted therapies are lacking for the majority of patients. OBI-999 is an antibody-drug conjugate therapeutic targeting the cancer-associated glycolipid antigen, Globo H. OBI-999 incorporates a validated payload, MMAE, with a proprietary linker technology. It has demonstrated high effectiveness in xenograft models of metastatic gastric cancer that overexpress Globo H. Clinical development of this agent will be guided by evaluation of patients based on a validated Globo H immunohistochemistry assay, which will allow selection of patients whose tumors overexpress this tumor antigen for clinical investigation."

About Gastric Cancer

Gastric cancer (GC), or stomach cancer, is a disease in which malignant cancer cells form in the lining of the stomach. The majority of GC (90-95%) presents as adenocarcinomas arising from the mucosa layer. Some of the potential risk factors associated with GC include Helicobacter pylori infection, high intake of salt, low consumption of fruits and vegetables, obesity, heavy alcohol consumption, chronic atrophic gastritis and cigarette smoking.

GC is a deadly disease and an estimated prevalence in 2019 at 100,189 individuals in the US, with a low 5-year survivability of 31.0%. Current standard treatment options for patients with advanced or recurrent GC are associated with limited efficacy and unfavorable toxicity profile, especially for extended use or maintenance treatment in a patient population which is often already frail and cachectic.

About Orphan Drug Designation (ODD)

The orphan drug designation provides OBI Pharma with potential benefits, including market exclusivity upon regulatory approval is received, exemption of FDA application fees, and tax credits for qualified clinical trials. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for rare diseases or conditions that affect fewer than 200,000 people in the U.S.

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. OBI-999 is currently in a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) to test its safety and efficacy as an oncology ADC therapy. In pre-clinical xenograft animal models in multiple tumor types (gastric, pancreatic, lung and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI Pharma owns global rights to OBI-999.

On January 21, 2020 Advaxis, Inc. (Nasdaq: ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported it has entered into a definitive agreement with two institutional investors for the purchase and sale of 10,000,000 shares of the Company’s common stock at an offering price of $1.05 per share, for gross proceeds of $10.5 million before deducting fees and other estimated offering expenses, pursuant to a registered direct offering (the "Offering") (Press release, Advaxis, JAN 21, 2020, View Source [SID1234553374]). The Company has also agreed to issue to those investors, in a concurrent private placement, unregistered common share purchase warrants to purchase 5,000,000 shares of the Company’s common stock. The warrants will be exercisable on the six-month anniversary of issuance and will have a five-year term and an exercise price of $1.25 per share.

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The Company expects to use the net proceeds from the Offering to fund its continued research and development initiatives in connection with its product pipeline including, but not limited to, in its ADXS-HOT program and potential new studies for its ADXS-PSA drug candidate, and for general corporate purposes. The Offering is expected to close on or about January 23, 2020, subject to the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), and an additional registration statement on Form S-3 filed pursuant to Rule 462(b) under the Securities Act, which became effective upon filing on August 30, 2018. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. Copies of the Supplement, the Base Shelf Prospectus and the Registration Statement may also be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected].

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 21, 2020 SHINE Medical Technologies LLC, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and GE Healthcare reported the production of patient dose quantities of the therapeutic isotope lutetium-177 (Lu-177) (Press release, Shine Medical Technologies, JAN 21, 2020, View Source;pk_kwd=shine-iocb-deliver-lu-177-doses-to-ge [SID1234553393]). The lot passed GE Healthcare’s quality control testing, including internationally recognized radionuclide purity (RNP) standards. The delivery of Lu-177 in this quantity and purity demonstrates the suitability of the IOCB technology for Lu-177 production. It is a major step toward commercial production of the therapeutic isotope by SHINE.

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Last May, SHINE entered an agreement with IOCB Prague that granted the company exclusive access to IOCB Prague’s novel technology, which is used to separate lutetium from enriched ytterbium targets. The technology enabled the production of the non-carrier-added (nca) Lu‑177 supplied to GE Healthcare. The isotope was produced in collaboration with the Nuclear Physics Institute in Czechia. The Nuclear Physics Institute and IOCB Prague are members of the Czech Academy of Sciences.

Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers. The isotope is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule.

"Non-carrier-added Lu-177 at the dosage and purity delivered to us bodes well for the potential to provide physicians and patients with a vital, highly effective therapeutic isotope," said Charles Shanks, GE Healthcare’s principal engineer, Life Sciences. "Lu-177 is one of the key drivers of growth in the medical isotope market. It represents a major opportunity to better serve the market."

"The delivery of patient dose quantities of Lu-177 to GE Healthcare is a significant step forward for SHINE Therapeutics," said Katrina Pitas, the vice president and general manager of SHINE Therapeutics. "Together with our collaborators from the Czech Academy of Sciences, we have demonstrated the capability to produce Lu-177 at a very high standard of purity. We look forward to continuing to work with GE Healthcare to move Lu-177 closer to commercialization and the patients who will benefit from it most."

"Producing clinically relevant doses of any therapeutic radionuclide is not easy and we have demonstrated that our technology can meet the challenge for nca Lu-177," said Dr. Miloslav Polasek of IOCB Prague. "I am very grateful to the SHINE, IOCB and NPI teams for the progress we are making together."

On January 21, 2020 Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported the commencement of a proposed underwritten public offering of 8,000,000 shares of its common stock by certain selling shareholders (Press release, Adaptive Biotechnologies, JAN 21, 2020, View Source [SID1234553523]). In addition, certain selling shareholders expect to grant the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock in the offering. Adaptive will not receive any of the proceeds from the sale of the shares of its common stock being offered by the selling shareholders. The proposed offering is subject to 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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J.P. Morgan, Goldman Sachs & Co. LLC and BofA Securities are acting as joint lead book-running managers for the offering. Cowen, Guggenheim Securities and William Blair are acting as book-running managers for the offering. BTIG is acting as co-manager for the offering.

A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) but has not yet become effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time the registration statement becomes effective. The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to this offering may 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]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected].

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