On March 20, 2019 Xynomic Pharmaceuticals, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corporation (Nasdaq: BCAC), jointly reported that Xynomic and its collaborators will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2019 Annual Meeting to be held in Chicago from May 31, 2019 – June 4, 2019 (Press release, Xynomic Pharmaceuticals, MAR 20, 2019, View Source [SID1234534943]). The presentation will show Phase 1 data of XP-105 (also known as BI 860585), Xynomic’s Phase 2 ready, ATP-competitive, third generation mTORC1/2 Inhibitor, used alone or in combination with exemestane or paclitaxel in patients with advanced solid tumors. XP-105 is a potent dual inhibitor designed to overcome mTORC1 inhibition resistance. An oral presentation titled "A Dose Escalation Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of mTORC1/2 Inhibitor XP-105 (BI 860585) as Monotherapy and in Combination with Exemestane or Paclitaxel in Patients (pts) with Advanced Solid Tumors" will be presented by Dr. Filippo G. De Braud, a lead investigator at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. This Phase 1 trial enrolled a total of 90 patients; 41 were in Arm A where XP-105 was used as a monotherapy (the "monotherapy arm"), 25 were in Arm B where XP-105 was used in combination with exemestane (the "exemestane combination arm"), and 24 were in Arm C where XP-105 was used in combination with paclitaxel (the "paclitaxel combination arm"). Combination regimens showed higher activity as compared to monotherapy. In the monotherapy arm, stable disease ("SD") was reported in 8 pts (20%), with a median duration of 11 months. In the exemestane combination arm, 4 (16%) partial responses ("PR") were reported. In the paclitaxel combination arm, 1 complete response ("CR") and 4 PRs were reported (OR rate 21%). Disease control rate (CR/PR/SD) was 20%, 28%, and 58% in the monotherapy, XP-105/exemestane, and XP-105/paclitaxel arms, respectively. In the XP-105/paclitaxel combination the most frequent drug-related adverse events ("AEs") were diarrhea and fatigue (58.3% each), hyperglycaemia (54.2%), and anaemia (50%). Grade ≥3 AEs were hyperglycaemia, fatigue, diarrhea, anaemia, and leukopenia.

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In addition, Xynomic will sponsor an investigator meeting on Friday, March 22, 2019 in Athens, Greece. The investigator meeting will bring together European Union ("EU") physicians, care providers and clinical research coordinators. The participants are from current and prospective clinical trial sites in the potentially pivotal Phase 3 clinical trial of testing Xynomic’s abexinostat, in combination with pazopanib, against renal cell carcinoma. The participants will be presented with trial design, protocol, and study management as a part of the preparation of the trial start and patient recruitment.

Furthermore, Xynomic’s board of directors has appointed Ms. Jinwei Coco Kou as the Interim Chief Accounting Officer. Ms. Kou is responsible for overseeing all accounting functions such as ledger accounts, financial statements, and cost control systems. Before joining Xynomic, Ms. Kou had extensive experience in internal controls, multinational operations and corporate finance of high-tech companies. From 2017-2018, Ms. Kou was the Chief Financial Officer at Salion Food Condiment Company Limited (a company approved for listing by the Hong Kong Stock Exchange). From 2008-2016, she was a Managing Director at Marcum Bernstein & Pinchuk LLP, one of the largest independent public accounting and advisory services firms in the United States, with multinational offices. From 2005-2008, Ms. Kou worked for Deloitte Touche Tohmatsu. Ms. Kou is a CPA in both the United States and China. Ms. Kou holds a Bachelor degree in Economics majoring in Finance, and a Master’s degree in Economics majoring in Risk Management and Insurance, both from Peking University. Ms. Kou holds an Executive MBA degree jointly granted by Columbia Business School, London Business School and Hong Kong University Business School.

On March 20, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, being held March 29 – April 3, in Atlanta, Georgia (Press release, Dynavax Technologies, MAR 20, 2019, View Source [SID1234534546]).

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Abstract Number and Title: #8304, "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)"

Poster Session Title: Phase I-III Trials in Progress: Part 3

Session Date and Time:Tuesday, April 2, 2019, 1 – 5 p.m. ET

Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17, Poster Board Number: #18

Permanent Abstract Number: CT224

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.

On March 20, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that it has commenced a proposed underwritten public offering of common stock of the Company, together with warrants to purchase shares of common stock (Press release, Oragenics, MAR 20, 2019, View Source [SID1234534524]). In addition, the Company expects to grant the underwriter of the offering, a 30-day option to purchase additional shares of common stock and/or warrants at the public offering price, less underwriting discounts and commissions. The 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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H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016. A preliminary prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, at the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus also may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, email: [email protected].

Before you invest, you should read the preliminary prospectus supplement and the accompanying prospectus in the registration statement and other documents Oragenics has filed or will file with the SEC for more complete information about Oragenics and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s 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.

On March 20, 2019 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, reported that it has entered into a research and development collaboration with Dana-Farber Cancer Institute (Boston, MA) to evaluate and develop gut microbiome-derived antigens as potential cancer immunotherapies (Press release, Enterome, MAR 20, 2019, View Source [SID1234534522]).

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Enterome is developing an innovative approach to cancer immunotherapy, based on the concept of "molecular mimicry," whereby microbiome-derived bacterial antigens show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs). Based on this similarity, bacterial antigens ("onco-mimics") mimic key tumor antigens that are highly expressed by tumors to trigger tumor-specific cytotoxic T cell immune responses.

Enterome has developed a discovery platform to identify such onco-mimics from the human gut microbiome and has advanced EO2401 as its first clinical candidate. EO2401 comprises several microbiome-derived antigens that mimic antigens highly expressed by brain tumors and is targeting first clinical trials in 2019 as a potential new immunotherapy for recurrent glioblastoma multiforme (GBM) for which no curative treatments exist.

The collaboration brings together Enterome’s ability to identify potential TAAs and TSNAs as well as to generate bacterial onco-mimics for the selected TAAs and TSNAs with the complementary translational expertise from the research groups at Dana-Farber Cancer Institute led by Dr. David Reardon at the Center for Neuro-Oncology and Dr. Paul Kirschmeier at the Belfer Center for Applied Cancer Science. Drs. Reardon’s and Kirschner’s groups are focused on driving innovative research programs and clinical trials to improve cure rates in patients with brain and spinal cancers, with a particular focus on immunotherapies.

Through this collaboration Enterome will have access to knowledge, scientific expertise and preclinical models at Dana-Farber Cancer Institute that are intended to support the in vivo validation and further development of Enterome’s immunotherapy approach for the treatment of cancer.

"We are delighted to have signed this collaboration with one of the most esteemed cancer research institutions in the US," said Pierre Belichard, CEO of Enterome. "Drs. Reardon and Kirschmeier are accomplished and renowned clinician-scientists in their respective fields and their groups have pioneered novel approaches to cancer therapy, particularly in the brain. We believe that this collaboration will be highly productive in further validating our onco-mimic immunotherapy approach and enable us to develop our pipeline of new candidates for multiple cancer indications."

On March 20, 2019, Constellation Pharmaceuticals, Inc. (the "Company") reported that it has entered into a Loan and Security Agreement (the "Loan Agreement") by and among the Company, the several banks and other financial institutions or entities from time to time parties thereto (the "Lenders") and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and the Lenders (in such capacity, the "Agent"), pursuant to which a term loan of up to an aggregate principal amount of $40.0 million is available to the Company (Filing, 8-K, Constellation Pharmaceuticals, MAR 20, 2019, View Source [SID1234534519]). The Loan Agreement provides for an initial term loan advance of $20.0 million, which funded on March 20, 2019, and, at the Company’s option, three additional term loan advances of $10.0 million, $5.0 million and $5.0 million, respectively, subject to certain terms and conditions, including the achievement of certain milestones, and, with respect to the final $5.0 million tranche, approval by the Lenders’ investment committees.

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The term loan bears interest at an annual rate equal to the greater of 8.55% and the prime rate of interest plus 2.55%. The Loan Agreement provides for interest-only payments until April 30, 2021, and repayment of the aggregate outstanding principal balance of the term loan in monthly installments starting on May 1, 2021 and continuing through April 1, 2023 (the "Maturity Date"). In addition, the Company paid a fee of $255,000 upon closing and is required to pay a fee of 6.35% of the aggregate amount of advances under the Loan Agreement at maturity. At the Company’s option, the Company may elect to prepay all or a portion of the outstanding advances by paying the entire principal balance (or such portion thereof) and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid: 2% if an advance is prepaid during the first 12 months following the applicable advance date, 1% if an advance is prepaid after 12 months but prior to 24 months following the applicable advance date, and 0.5% if an advance is prepaid any time after 24 months following the applicable advance date but prior to the Maturity Date.

In connection with the Loan Agreement, the Company granted the Agent a security interest in all of the Company’s personal property now owned or hereafter acquired, excluding intellectual property (but including the rights to payment and proceeds from the sale, licensing or disposition of intellectual property), and a negative pledge on intellectual property. The Loan Agreement also contains certain events of default, representations, warranties and non-financial covenants of the Company.