On March 28, 2019 OBI Pharma, Inc. (TPEx: 4174), a leader in Glycosphingolipid Immuno-Oncology therapeutics targeting the Globo Series antigens (Globo H, SSEA-3 and SSEA-4), reported that data highlighting OBI-888 (Globo H mAb) and OBI-999 (Globo H ADC) mechanism of action, anti-tumor efficacy and pharmacokinetics profile in multiple cancer types, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from March 29–April 3, 2019 in Atlanta, Georgia (Press release, OBI Pharma, MAR 28, 2019, View Source [SID1234534694]).

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Title: Anti-tumor efficacy and potential mechanism of action of a novel therapeutic humanized anti-Globo H antibody, OBI-888
Session: PO.IM02.16 – Therapeutic Antibodies 1
Date/Time: March 31, 2019 from 1:00 PM – 5:00 PM EST
Location: Section 23
View Source!/6812/presentation/2395

Title: Specificity, biodistribution, tumor targeting, and pharmacokinetics of a novel humanized anti-Globo H antibody, OBI-888, for cancer immunotherapy
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3113

Title: Novel Globo H targeting antibody-drug conjugate with binding specificity and anti-tumor efficacy in multiple cancer types
Session: PO.ET07.01 – Targeted Therapies
Date/Time: April 3, 2019 from 8:00 AM – 12:00 PM EST
Location: Section 14
View Source!/6812/presentation/3114

Preclinical studies showed that OBI-888’s mechanism of action involves antibody-induced tumor lysis which may have substantial therapeutic potential. OBI-888 is currently in a Phase 1 clinical study in solid tumor patients at the MD Anderson Cancer Center in Houston, Texas (USA). For OBI-999, preliminary pharmacological studies in established animal tumor models showed potent and long lasting anti-tumor activity in multiple cancer types, including breast, pancreatic, lung and gastric cancer. A US FDA IND submission is planned for 2019. OBI Pharma owns global rights to OBI-888 and OBI-999.

About OBI-888

OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 types of epithelial cancer. This Globo H targeting antibody has been shown to induce tumor-killing via antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP) and complement-dependent cytotoxicity (CDC).

OBI-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated with no adverse effects observed in all the doses tested.

About OBI-999

OBI-999 is an antibody-drug conjugate (ADC) treatment for cancer. 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. Preliminary pharmacological studies and animal verification have already been completed and showed impressive and long lasting anti-tumor efficacy in multiple cancer types, including breast, pancreatic, lung and gastric cancer. It is currently undergoing Chemistry Manufacturing Control (CMC) planning and toxicology study design.

On March 28, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis (OM), reported it will present and meet with investors at Spring Investor Summit on April 1, 2019 at 1:00 PM ET as part of Track 1 at The Essex House in New York City (Press release, Oragenics, MAR 28, 2019, View Source [SID1234534714]).

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Interested investors may request a one-on-one meeting at Spring Investor Summit by registering for the meeting at www.microcapconf.com, or contacting conference administrators at [email protected].

On March 28, 2019 Precision BioSciences (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported the pricing of its initial public offering of 7,900,000 shares of common stock at a public offering price of $16.00 per share, for total gross proceeds of $126.4 million, before deducting underwriting discounts and commissions and expenses payable by Precision (Press release, Precision Biosciences, MAR 28, 2019, View Source [SID1234534733]). In addition, Precision has granted the underwriters a 30-day option to purchase up to 1,185,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Precision. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "DTIL" on Thursday, March 28, 2019. The offering is expected to close on April 1, 2019, subject to customary closing conditions.

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J.P. Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays are acting as joint book-running managers for the offering.

A registration statement relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 27, 2019. This offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to this offering may be obtained by contacting: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (866) 803-9204 or email: [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone: (866) 471-2526, facsimile: (212) 902-9316, or email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone: (877) 547-6340 or email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone: (800) 603-5847.

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.

On March 28, 2019 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) reported that it has entered into a research collaboration with Glycostem Therapeutics BV to explore the potential synergies of using Phio’s self-delivering RNAi technology (sd-rxRNA) in combination with Glycostem’s proprietary Natural Killer-cell (NK-cell) generation technology (oNKord) to develop cellular immunotherapies for cancer treatment with enhanced efficacy and/or safety (Press release, Phio Pharmaceuticals, MAR 28, 2019, View Source [SID1234534695]).

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The companies’ research teams will collaborate and examine the applicability of Phio’s sd-rxRNA technology to be integrated into Glycostem’s processes to produce NK-cells with the ultimate goal to further improve Glycostem’s cellular immunotherapies for the treatment of cancer patients.

Dr. Jan Spanholtz, CSO of Glycostem commented, "One of the research focuses of Glycostem is novel oNKord products with improved functions. Towards that goal we have already established several collaborations, and we are glad to expand our efforts in this field in collaboration with Phio Pharmaceuticals. We believe their proprietary self-delivering RNAi technology can provide new and more effective ways for expanding and differentiating NK-cells. In addition, their technology can help overcome immune checkpoints or other immunosuppressive roadblocks that NK-cells may encounter, which may further enhance the efficacy and safety of our cellular therapies."

Dr. Gerrit Dispersyn, President and CEO of Phio Pharmaceuticals, added, "We are excited to partner with Glycostem, a leading cellular immunotherapy company. Their focus on safe and cost-effective allogeneic approaches with the promise of providing ‘off-the-shelf’ cellular products very much aligns with our vision on the use of innovative technology to create a next generation of very powerful adoptive cell therapies against various cancers."

On March 28, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the European Medicines Agency (EMA) has granted a meeting with the Company’s European subsidiary, IPIX Pharma Ltd., to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, MAR 28, 2019, View Source [SID1234534715]).

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The purpose of such meetings is for the EMA to provide guidance on the appropriate tests and studies in the development program for a medicine. Receiving formal scientific advice helps ensure health authority alignment regarding appropriate testing to support an eventual marketing-authorization application in Europe.

The meeting with IPIX Pharma has been scheduled by EMA for mid-April 2019 and will serve to complement the regulatory feedback and advice obtained by the Company from the already completed End-of-Phase 2 Meeting held with the U.S. Food and Drug Administration (FDA). At this meeting, an acceptable Phase 3 development pathway was agreed upon by the FDA and the Company to advance Brilacidin for the prevention of SOM in HNC.

"We are extremely pleased to have been granted this scientific meeting with the EMA, particularly in such rapid fashion," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "New and effective treatments that not only help mitigate, but actually prevent the occurrence of oral mucositis, have been long sought-after. Currently there is no approved drug to decrease the incidence of Severe Oral Mucositis in Head and Neck Cancer. We look forward to advancing Brilacidin toward potential regulatory approval, both in Europe and the United States, as we refine key aspects of our planned Phase 3 program in oral mucositis."

About Brilacidin Phase 2 Results in Treating Severe Oral Mucositis

The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving an aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is the standard of care. In this patient population, the incidence of SOM was reduced to 25.0% in the modified Intent-to-Treat (mITT) population, versus 71.4% of patients on placebo. In the Per Protocol (PP) patient group, incidence of SOM dropped to 14.3% for patients receiving Brilacidin-OM, compared to 72.7% among those receiving placebo.

The completed Phase 2 study met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM.

Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs currently in clinical development.

View Source
About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs to decrease the incidence of Severe OM (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and on a worldwide basis, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop SOM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.