On January 16, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1B clinical trial investigating the Company’s ROOT OF CANCER technology in patients with metastatic melanoma (Press release, AIVITA Biomedical, JAN 16, 2019, View Source [SID1234532688]). The trial marks the first time AIVITA’s cancer immunotherapy technology will be tested in combination with checkpoint inhibitors.

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"As our non-responding patients all have elevated checkpoint levels, this combination therapy is a natural extension of our technology, and indeed, checkpoint inhibitors," said Dr. Robert O. Dillman, Chief Medical Officer at AIVITA. "Now that the limitations of anti-PD-1 therapy have been realized, many experts are touting the advantages of adding a personalized vaccine to an anti-PD-1 approach."

AIVITA’s open-label, single-arm, phase 1B treatment study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AV-MEL-1 in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients.

AIVITA’s personalized patient-specific platform cancer technology uniquely and selectively targets the patient’s tumor-initiating cells, which seed tumor growth, metastases and tumor recurrence. Previously, this treatment was tested in two Phase 2 trials in patients with advanced melanoma and approved for Phase 3 testing. These clinical studies demonstrated the efficacy of the approach in a randomized trial, yielding a 72% 2-year survival rate and a 54% 5-year survival rate.

AIVITA’s ROOT OF CANCER technology is currently the subject of two ongoing multi-center Phase 2 trials in the USA, one in patients with a primary diagnosis of advanced ovarian cancer and another in patients with newly diagnosed glioblastoma. The Company is also applying to commercialize the treatment of melanoma patients in Japan and is considering Japanese strategic partners for this program, having just received an enabling approval of its manufacturing, quality systems and safety by Japan’s PMDA.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who will be randomized in a 2:1 ratio to receive either the autologous dendritic cell vaccine 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.

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

AIVITA’s glioblastoma Phase 2 single-arm study is active and will enroll approximately 55 patients to receive the treatment candidate.

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).

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

On January 16, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry (Press release, Massive Bio, JAN 16, 2019, View Source [SID1234532689])." will be presented by Selin Kurnaz, PhD., a lead investigator, at the ASCO (Free ASCO Whitepaper)-Gastrointestinal Cancers Symposium on January 19, 2019 in San Francisco, California, USA.

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The poster, Abstract # TPS717, is available at View Source, and discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry which can be found at ClinicalTrials.Gov View Source, is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We are very excited to be among the highly selected group of clinical trials and registries to be presented at the largest GI Oncology meeting in the United States. It is our goal to continue to promote precision oncology approaches at the point-of-care and enable easy access to clinical trials at scale to all cancer patients, while reducing operational complexities and costs. We are the first oncology dedicated company that has achieved the ability to combine patient centricity, technology and sub-specialist expertise while consistently delivering quadruple better results than national averages in clinical trial enrollment," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

Massive Bio has also expanded its Patient Contact and Clinical Research Center and opened a second location in Newtown, Pennsylvania, in addition to its main headquarters in New York City. This center is staffed with a team of oncology nurse navigators, patient advocates and research coordinators and focuses on Massive Bio’s growing portfolio of clinical trials and patient support services. The center is designed to have 24/7 customer support, patient pre-screening and real-world analytics capabilities to further guide and assist patients enrolling in all-phases of clinical trials.

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "We are very pleased to have our patient support division grow both in New York and Pennsylvania, and continue to be trusted by some of the world’s top CROs, pharmaceutical companies, patient advocacy groups, and the many patients who are reaching out to our call center directly every day". Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "We look forward to constantly exceeding our clients’ expectations of our services and professionalism while helping patients explore all of their treatment options from access to clinical trials through new and innovative therapies, which may have not previously been considered for all cancer patients."

On January 16, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in its Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-601 in patients with selected solid tumors that are locally advanced or metastatic (Press release, ADC Therapeutics, JAN 16, 2019, View Source [SID1234596066]).

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ADCT-601 is an ADC composed of a humanized monoclonal antibody against human AXL, conjugated using GlycoConnect site specific conjugation technology to a pyrrolobenzodiazepine (PBD) dimer toxin. In preclinical studies, ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in multiple cancer-derived models with different levels of AXL expression, and was stable and well tolerated.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "AXL is a novel and ideal target for an ADC approach, as it is overexpressed in many solid tumor types. We look forward to exploring the effect of ADCT-601 on patients with selected advanced solid tumors who have failed or are intolerant to any established therapy. With five ADCs in eight ongoing clinical trials for multiple indications, we believe our highly targeted therapies have the potential to meaningfully improve outcomes for patients with solid tumors and hematological cancers."

The open-label, multicenter, single-arm trial will include a Phase Ia dose-escalation part followed by a Phase Ib dose-expansion part. The dose-escalation part is designed to determine the maximum tolerated dose of ADCT-601. The identified dose will be evaluated in the dose-expansion part. Approximately 75 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03700294).

About ADCT-601

ADCT-601 is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human AXL, conjugated using GlycoConnect technology to a linker with a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to an AXL-expressing cell, ADCT-601 is internalized into the cell where enzymes release the PBD-based warhead. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and ultimately killing the cancer cell. ADCT-601 is being evaluated in a Phase I clinical trial in patients with advanced solid tumors (NCT03700294).

On January 16, 2019 ISA Pharmaceuticals B.V., a clinical-stage immuno-oncology company, reported that its Chief Scientific Officer Prof. Cornelis Melief will give a talk at the upcoming Keystone Cancer Vaccines Conference in Vancouver, BC, Canada, January 20-24, 2019 (Press release, ISA Pharmaceuticals, JAN 16, 2019, View Source [SID1234532675]).

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The talk titled "Therapeutic HPV16 Vaccination Is Effective as Monotherapy in Pre-Malignant Disease, but Requires Combination Treatment in HPV16-Induced Cancers" is scheduled for Thursday, January 24, 2019, at 17:00 as part of the session "Immune Monitoring of T Cells" (17:00-18-45, Pacific Ballroom).

The data will outline the T cell response to ISA Pharmaceuticals´ therapeutic vaccine ISA101 and the resulting clinical activity. ISA101 is directed against the HPV16 oncoproteins E6/E7 and is the Company´s clinical-stage lead compound. It is being developed to treat HPV16-induced cancers such as cervical cancer and head-and-neck cancer.

On January 16, 2019 Kitov Pharma Ltd. (NASDAQ/TASE:KTOV), an innovative biopharmaceutical company, reported that it has entered into definitive agreements with institutional investors providing for the issuance of 3,428,572 American Depositary Shares (ADS) at a purchase price of $1.75 per ADS in a registered direct offering (Press release, Kitov Pharmaceuticals , JAN 16, 2019, View Source [SID1234532769]).

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Kitov will also issue unregistered warrants to purchase up to 2,571,430 ADSs. The warrants will have a term of 5.5 years, be exercisable immediately following the issuance date and have an exercise price of $2.00 per ADS. The offering is expected to result in gross proceeds of approximately $6 million.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The closing of the sale of the securities is expected to take place on or about January 18, 2019, subject to satisfaction of customary closing conditions.

The ADSs described above were offered pursuant to a shelf registration statement on Form F-3 (File No. 333-215037), which was declared effective by the United States Securities and Exchange Commission (the "SEC") on December 14, 2016. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

When filed with the SEC, copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained at the SEC’s website at View Source Copies of the prospectus supplement and accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing [email protected].

The warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or a 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 the registration or qualification under the securities laws of any such state or jurisdiction.