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AIVITA Biomedical to Present at 2020 BIO CEO & Investor Conference

On February 11, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be featured as a presenting company at the BIO CEO & Investor Conference conference taking place February 10-11 at the New York Marriott Marquis in New York, N.Y (Press release, AIVITA Biomedical, FEB 11, 2020, View Source [SID1234554153]). Dr. Hans S. Keirstead, AIVITA’s Chairman and CEO, will present at the following time and location:

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Date: Monday, February 10, 2020
Time: 11:15 AM ET
Location: Ziegfeld Room

The BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies. Dr. Keirstead will be presenting details on AIVITA’s platform cancer technology, a next generation immunotherapy targeting the tumor-initiating stem cells, with strong clinical data evidencing 72% survival at 2-years, and 54% survival at 5-years post-treatment. AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

BrainCool AB completes recruitment in trial for FDA clearance of oral mucositis treatment

On February 11, 2020 BrainCool AB, a Swedish medical device innovator, and a world leader in medical cooling technology for therapeutic hypothermia (brain cooling) and oncology, is reported that it has completed patient recruitment in the Scandinavian multi-center pivotal trial of 180 patients to investigate the patented Cooral System for prevention of Oral Mucositis (OM), one of the most debilitating side-effects of both standard and high-dose chemotherapeutic oncology treatments (Press release, BrainCool, FEB 11, 2020, View Source [SID1234554152]).

In the United States (U.S.), BrainCool is conducting a De Novo 510 k regulatory process, with the aim of obtaining product and market clearance for the Cooral System in the U.S. by the Food and Drug Administration (FDA). The De Novo process was introduced by the FDA for instances where a device is novel and there is therefore no suitable predicate device to support a standard 510(k) submission. To qualify for the De Novo pathway, the new device must also present no more than moderate risk.

BrainCool has been granted FDA "Expedited Access Pathway" (EAP) status and will be given priority review for the Cooral System. EAP projects address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), or are eligible for de novo requests.

"With full patient recruitment for our pivotal trial, we are opening an important new door in cancer care and treatment," said Martin Waleij, CEO BrainCool AB. "Conclusive validation that cryotherapeutic intervention with the Cooral System can safely and effectively prevent the excruciating side-effects of oral mucositis is not just a major medical milestone, it’s actually a matter of life and death."

The Cooral System intra-oral cooling device includes a disposable and thermostatically controlled mouthpiece that fills with a hypothermic liquid, which circulates through the system’s channels. As the coolant gradually reaches and maintains a consistently controlled temperature, the system reduces blood flow and exposure of tissue to radiation or chemotherapeutic agents, thus preventing adverse mucosal erythema and ulcerative reactions.

Details of the Clinical Study and the Expedited Access Pathway (EAP)

The Nordic clinical trial of 180 patients has been selected by the U.S. FDA as part of the De Novo 510 process for obtaining market clearance in the U.S. Patients have been recruited over a period of two years across five important medical centers, including the lead site, Karolinska Universitetsjukhuset in Stockholm, Sweden.

Clinical data from the Nordic trial will be applicable for FDA submission. BrainCool is currently working on a module-based application wherein the first two modules contain quality routines for product development and manufacturing. The third and final module will contain clinical data from the completed Pivotal trial and will be submitted as soon as the results are available. Thereafter FDA will review the documentation and decide on a product and market approval.

About Oral Mucositis (OM)

Oral Mucositis significantly affects the quality of life for cancer patients in terms of pain, ability to eat, swallow and talk. The symptoms are often of such severity that they result in an interruption and curtailment of therapy. OM can also lead to dose reduction of the cancer therapy and treatment delays. In many cases these patients require hospitalization. OM has a direct and significant effect on the duration of disease remission and cure rates due to its dose-limiting toxicity. In some cases, risk for infection threatens survival, and there is a significant impact on quality of life and cost of care. The presence of OM is a major driver of health-care cost. Read more: View Source

IntelGenx Completes C$8.2 Million Equity Offering

On February 11, 2020 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is reported that it has closed its offering (the "Offering") of 16,317,000 units (the "Units") at a price of C$0.50 per Unit (the "Offering Price") for gross proceeds of C$8,158,500 (Press release, IntelGenx, FEB 11, 2020, View Source [SID1234554151]).

Each Unit consists of one share of common stock (the "Offered Shares") and one warrant (a "Warrant") entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share (a "Warrant Share"). The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Units were distributed under a short form prospectus dated January 27, 2020 filed by the Company in connection with the Offering and available on SEDAR at www.sedar.com and have been registered with the United States Securities and Exchange Commission pursuant to a Form S-1 Registration Statement that was declared effective on January 31, 2020 (the "Registration Statement"). The Offering was conducted, on a best efforts basis, by Echelon Wealth Partners Inc. (the "Agent"). In consideration for the services rendered by the Agent, the Company has paid the Agent an agency fee equal to 7% of the gross proceeds of the Offering and has issued the Agent a number of warrants (the "Agent Warrants") equal to 7% of the number of Units issued under the Offering, each Agent Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of C$0.75 per share until the third anniversary of the date of their issuance. After the payment of the Agent’s commissions and the reimbursement of certain of the Agent’s Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately C$7.4 million.

The Company has granted the Agent an over-allotment option exercisable, in whole or in part, at the sole discretion of the Agent, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the date hereof, to offer and sell up to an additional number of Units representing 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the Warrants and the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants and the Agent Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 15 days of the closing of the Offering.

The Warrants will be listed on the TSXV under the symbol "IGX.WT" and will commence trading effective at the opening of the market on Thursday, February 13, 2020.

The Company intends to use the net proceeds from the Offering for its Phase 2A Montelukast Study and general working capital requirements.

U.S. FDA LIFTS CLINICAL HOLD ON PHASE 2 AML TRIAL; PLACES PARTIAL HOLD ON THE TRIAL FOR THE USE OF A REAGENT FROM AN ALTERNATIVE VENDOR UNTIL FINAL DATA AND CERTIFICATE OF ANALYSIS ARE ACCEPTED BY FDA

On February 11, 2020 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Marker’s planned trial investigating safety and efficacy of its novel MultiTAA T cell therapy in patients with post-transplant acute myeloid leukemia (AML) (Press release, Marker Therapeutics, FEB 11, 2020, View Source [SID1234554150]).

Marker previously announced on November 12, 2019, that the FDA placed the trial on clinical hold. The FDA requested additional information and technical specifications for two legacy reagents supplied by third parties used in the MultiTAA-specific T cell manufacturing process. The technical specifications and data requested by the FDA could not be produced by the original suppliers. The Company identified alternative suppliers, satisfying the Agency’s request.

Based on data Marker provided, the FDA permitted the Company to initiate its AML trial, beginning with a safety lead-in portion. The FDA placed a partial clinical hold on the trial for the use of the MultiTAA-specific T cell product manufactured using one of the reagents supplied by the alternative supplier, until the final data and certificate of analysis for the reagent are reviewed and accepted by the Agency. The safety lead-in portion of the trial is expected to enroll approximately six patients as part of the amended trial design. Three patients will be dosed with MultiTAA-specific T cells manufactured using the legacy reagent, and three patients will be dosed with T cells manufactured using the reagent from the alternative supplier.

Marker currently estimates that the alternative supplier will deliver the final reagent, along with the final data and certificate of analysis required by the FDA, by the end of the second quarter of 2020. Marker anticipates to complete enrollment of the first three patients and submission of the final technical specifications and comparability data of the new reagents to the FDA during the second half of 2020, thereby satisfying the requirements for lifting the partial hold on the clinical trial. Given this expected timing, Marker does not currently expect the partial clinical hold to significantly impact site and patient enrollment of the AML trial.

The safety lead-in will be followed by the 160-patient randomized portion of the study at approximately 20 transplant centers. Group 1 will comprise 120 adjuvant (disease-free) patients, with the primary endpoint of relapse-free survival of patients receiving MultiTAA-specific T cell therapy versus a control group. Group 2 will comprise 40 active disease patients in a single arm, with primary endpoints of complete remission and duration of complete remission.

"With a clear path identified for getting our study of MultiTAA-specific T cell therapy underway in patients with AML, we’re focused on addressing the remaining requirements from the FDA and enrolling up to 20 clinical centers to conduct our Phase 2 trial," stated Peter L. Hoang, President and CEO of Marker Therapeutics. "We appreciate the productive dialogue with the FDA throughout the process and look forward to advancing MultiTAA-specific T cell therapy for patients with post-transplant AML in a randomized and multicenter clinical trial."

Immune Therapeutics Inc. Provides Updates and Guidance on Reverse Stock Split and Name Change

On February 11, 2020 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases reported an update on the pending 1000 to 1 reverse stock split and name change of Immune Therapeutics (Press release, Immune Therapeutics, FEB 11, 2020, View Source [SID1234554149]).

Immune Therapeutics originally submitted the reverse and name request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded to FINRA’s requests for further information multiple times, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company’s control.

Michael K. Handley, CEO of Immune, said, "We are disappointed in the delay in processing the reverse and name change and remain fully committed to the restructuring and success of IMUN. I would personally like to thank all of our shareholders for their patience in this process. We realize this delay has eroded share value, and confidence however, based on the extensive review by FINRA, we are optimistic that their approval could be given soon, at which time we will certainly inform shareholders immediately. Immune would like to thank our shareholders for standing behind us, as we continue to work in your interests with a commitment to the reverse and merger with Aletheia as soon as possible."