On November 1, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported that it will release its third quarter 2019 financial results after market close on November 7, 2019 (Press release, IntelGenx, NOV 1, 2019, View Source;Conference-Call-to-Follow/default.aspx [SID1234550178]).

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An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Date: Thursday, November 7, 2019

Time: 4:30 p.m. ET

Conference dial-in: (833) 231-8269

International dial-in: (647) 689-4114

Conference ID: 5068946

On November 1, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be presenting at the following regenerative medicine and investor conferences in November (Press release, AIVITA Biomedical, NOV 1, 2019, View Source [SID1234550179]):

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Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting
Oral Presentation
Presenter: Dr. Daniela Bota, MD, PhD, University of California, Irvine; AIVITA GBM Principal Investigator
Title: Phase II trial of therapeutic vaccine consisting of autologous dendritic cells loaded with autologous tumor cell antigens from self-renewing cancer cells in patients with newly diagnosed glioblastoma
Time: November 6-10, 2019
Location: Gaylord National Hotel & Convention Center, National Harbor, MD

The Regenerative Medicine Consortium of the Gulf Coast Consortia for Biomedical Sciences
Oral Presentation
Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEO
Title: Clinical and Commercial Application of Scaled Human Stem Cell Derivates
Time: November 8, 4:00 PM CT
Location: Bioscience Research Collaborative, Houston, TX

NYC Oncology Investor Conference
Oral Presentation
Presenter: Dr. Hans S. Keirstead, AIVITA Chairman and CEO
Title: AIVITA Corporate Presentation
Time: November 12, 4:50 PM – 5:10 PM
Location: Rockefeller Center, New York, NY

Society for NeuroOncology Annual Meeting
Poster Presentation
Title: Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with newly diagnosed glioblastoma.
Time: November 20-24, 2019
Location: JW Marriott Desert Ridge, Phoenix, AZ

On November 1, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the closing of its public offering of 5,134,750 shares of its common stock, at a public offering price of $28.00 per share, which includes the exercise in full of the underwriters’ option to purchase 669,750 additional shares of common stock (Press release, Y-mAbs Therapeutics, NOV 1, 2019, View Source [SID1234550198]). The aggregate gross proceeds to Y-mAbs, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company, were approximately $143.8 million. All of the shares of common stock were offered by the Company. Y-mAbs’ common stock is listed on The Nasdaq Global Select Market under the ticker symbol "YMAB."

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Morgan Stanley, J.P. Morgan and BofA Securities acted as the joint book-running managers for the offering. Wedbush PacGrow and H.C. Wainwright & Co. acted as co-managers for the offering.

A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the Securities and Exchange Commission (SEC) on October 30, 2019. A final prospectus supplement relating to the offering was filed with the SEC on October 31, 2019. Copies of the final prospectus relating to the offering are available on the SEC’s website at www.sec.gov. The prospectus and prospectus supplement relating to the offering may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014; J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by telephone at (866) 803-9204; or BofA Securities, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected].

The shares of common stock described above are being offered by Y-mAbs pursuant to its shelf registration statement on Form S-3 (Reg. No. 333-234034), including a base prospectus, that was filed with the SEC on October 1, 2019 and declared effective by the SEC on October 15, 2019. The securities are being offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. 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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 31, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has concluded an End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, OCT 31, 2019, View Source [SID1234550100]). The purpose of the meeting was to review the Phase II study data with the FDA and to present Can-Fite’s proposed Phase III study design to the regulatory agency.

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The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval. The Phase III study will enroll patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line therapy. This design leverages the previously announced Phase II trial data, which showed promising efficacy signals in this population. The FDA’s guidance will be incorporated into the Phase III study’s final protocol.

"Namodenoson is a novel approach to treating advanced liver cancer with an orally bioavailable drug specifically targeting the tumor cells, a unique mechanism that contributes to the favorable safety profile. We are very pleased with this outcome from our meeting with the FDA. With the FDA’s guidance, we plan to now finalize our Phase III study protocol for this unmet advanced liver cancer indication," stated Dr. Michael Silverman, Can-Fite’s Medical Director.

Can-Fite’s completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with CPB7 cirrhosis, the largest subpopulation of the study, even though the Phase II study did not achieve its primary endpoint of overall survival in the whole population.

DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries. According to the American Cancer Society, in the U.S. liver cancer incidence has tripled since 1980, with an estimated 42,000 cases diagnosed and 32,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being developed as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On October 31, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported a regulatory and clinical update on IDE196 following receipt of meeting minutes from an End‑of‑Phase 1 (EOP1) meeting with the FDA (Press release, Ideaya Biosciences, OCT 31, 2019, View Source [SID1234550157]). IDE196 is being evaluated for the treatment of MUM and other solid tumors harboring activating GNAQ or GNA11 (GNAQ/11) mutations in its ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385).

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"Following FDA feedback from the EOP1 meeting, we plan to initiate the Phase 2 single-arm, potentially registration-enabling clinical trial of IDE196 monotherapy. This arm of our clinical trial will target enrollment of 60 evaluable MUM patients with blinded independent central review (BICR)‑determined overall response rate (ORR) as the primary endpoint," said Bao Truong, Vice President, Head of Regulatory Affairs at IDEAYA Biosciences. "We look forward to the continued clinical advancement of IDE196 in MUM and in our broader tissue-type agnostic basket trial to treat other solid tumors that harbor activating GNAQ/11 mutations, including in cutaneous melanoma and colorectal cancer," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.

Regulatory and Clinical Program Highlights for IDE196:

FDA EOP1 meeting minutes indicate that the proposed single-arm Phase 2 IDE196 clinical trial may be adequate to support a new drug application (NDA) seeking Accelerated Approval of IDE196 monotherapy for the treatment of MUM
Phase 2 dose selection, and the single-arm, potentially registration‑enabling Phase 2 part of the Phase 1/2 clinical trial is anticipated to be initiated in Q4 2019
This Phase 2 clinical trial will target enrollment of 60 evaluable MUM patients with the primary endpoint of overall response rate (ORR) as determined by blinded independent central review (BICR), supported by BICR‑determined duration of response (DOR) as a secondary endpoint
The 13-week GLP-compliant toxicology studies in 2 species is scheduled to initiate in November 2019, in support of FDA requirement that results of these studies be submitted prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
An immediate release tablet formulation for IDE196 is on-track for introduction in the clinic in Q1 2020, as a potential registration and commercial formulation
Interim data for GNAQ/11 Phase 1/2 basket trial expected in Q2/Q3 2020
Confirmed Complete Response observed at month 31 in one patient previously reported with confirmed Partial Response in the ongoing IDE196 monotherapy clinical trial conducted by Novartis (ClinicalTrials.gov Identifier: NCT02601378)
"We are grateful for the regulatory feedback from the FDA on our single-arm trial design, providing an opportunity for a potential Accelerated Approval path for IDE196 monotherapy in MUM, a high unmet medical need and a solid tumor indication where there are no FDA approved therapies. We are also encouraged to see continued progress in our tissue-type agnostic GNAQ/11 Phase 1/2 basket trial to treat solid tumor patients beyond MUM," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.