On January 16, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported the pricing of an underwritten public offering of 1,612,903 shares of its common stock at a price to the public of $62.00 per share (Press release, Mirati, JAN 16, 2019, View Source [SID1234532685]). The aggregate gross proceeds from this offering are expected to be approximately $100.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati. The offering is expected to close on or about January 22, 2019, subject to customary closing conditions. Mirati has also granted the underwriters a 30-day option to purchase up to an additional 241,935 shares of common stock in connection with the public offering. All of the shares are being sold by Mirati.

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Mirati expects to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical development of sitravatinib and MRTX849, the preclinical development of its KRAS G12D inhibitor and the development of other preclinical programs, and for working capital.

J.P. Morgan Securities LLC, Citigroup Global Markets Inc., Cowen and Company, LLC, Barclays Capital Inc. and Credit Suisse Securities (USA) LLC are acting as joint book-running managers in the offering.

The shares of common stock described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these 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 January 16, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the first patient has been dosed in a phase III clinical trial (ORIENT-16) that is to evaluate Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection), in combination with capecitabine and oxaliplatin, as first-line treatment for patients with advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ) (Press release, Innovent Biologics, JAN 16, 2019, View Source [SID1234532687]).

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The ORIENT-16 study is a randomized, double-blind, multi-center, phase III trial conducted in China to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic GC or GEJ. The phase III study will enroll 650 patients. The study follows a phase Ib study that evaluated Tyvyt (sintilimab injection) in combination with chemotherapy in patients with gastric cancer.

"Over the past decade, the treatment of various malignant tumors has progressed rapidly. From traditional chemotherapy to targeted molecular therapy and immunotherapy, the prognosis of cancer patients has been improved remarkably. However, breakthroughs in the treatment of gastric cancer have been few. With the exception of trastuzumab in first-line use for HER-2 positive patients, several phase III clinical trials have failed successively. Based on the efficacy signals and the safety profile from previous trials, we hope to validate the therapeutic potential of sintilimab in combination with chemotherapy in ORIENT-16, a phase III trial," said Dr. Jianming Xu, a professor from the Chinese PLA General Hospital.

"Gastric cancer is the second most common malignant tumor in China. The development of new agents for the treatment of advanced gastric cancer has been stagnant, and unmet clinical need is huge. Based on the encouraging efficacy signal we have observed in our phase Ib study, we have decided to conduct ORIENT-16, a phase III study in first-line gastric cancer. Our goal is to provide more effective cancer treatment options for the benefit of these patients and for their families," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1（Programmed Cell Death-1 Ligand-1, PD-L1 pathway）and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

About ORIENT-16 Study

The ORIENT-16 study is a randomized, double-blind, multi-center, phase III trial which evaluates the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced, recurrent or metastatic GC or GEJ. Patients will receive Tyvyt (sintilimab injection) or placebo in combination with capecitabine and oxaliplatin, followed by Tyvyt (sintilimab injection) or placebo and capecitabine until disease progression. Participants will be randomly assigned in a 1:1 ratio into the experimental or control groups. The study will enroll 650 patients. The primary endpoints are overall survival in both the entire population and in PD-L1 positive population of patients.

About Advanced, Recurrent or Metastatic Gastric Cancer (GC)

Gastric cancer is one of the most common malignant tumors worldwide, ranking fifth in incidence and third in cancer-related deaths. More than half of the cases and deaths from gastric cancer occur in China. Many patients have advanced disease at the initial diagnosis and have little opportunity for therapy with curative intent. The prognosis of patients with advanced and metastatic gastric cancer is poor with an overall survival less than 12 months.

On January 16, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company dedicated to developing innovative treatments for patients suffering from cancer and autoimmune/inflammatory diseases, reported it has entered into a definitive securities purchase agreement for the sale of units consisting of shares of common stock and warrants to purchase common stock, as described below, in a private placement expected to result in gross proceeds to the Company of approximately $25.3 million, before deducting placement agent commissions and other offering expenses (Press release, Alpine Immune Sciences, JAN 16, 2019, View Source [SID1234532670]). The private placement is being led by Decheng Capital with participation from existing investors OrbiMed Advisors, Frazier Healthcare Partners, Alpine BioVentures, and BVF Partners L.P. Effective on the closing of the private placement, the Company expects to appoint Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, to the Alpine Board of Directors.

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Pursuant to the terms of the securities purchase agreement, at the closing of the private placement, Alpine will issue units representing an aggregate of approximately 4.7 million shares of common stock and warrants to purchase an aggregate of approximately 1.8 million shares of common stock. The aggregate purchase price of each unit, which consists of one share of common stock plus a warrant to purchase 0.39 shares of common stock, is $5.37. The warrants to purchase common stock will have a per share exercise price of $12.74 and will be exercisable at any time on or after the closing date and through the fifth anniversary of the closing date. The price per unit was based in part upon the average of the last five closing prices of the common stock on the Nasdaq Global Market.

The private placement is expected to close on or about January 18, 2019, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by Alpine with the Securities and Exchange Commission ("SEC").

Alpine intends to use the net proceeds to fund development of lead programs ALPN-101 in autoimmune and inflammatory indications and ALPN-202 in cancer.

Piper Jaffray & Co. acted as sole placement agent in the transaction.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Alpine has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable in connection with the private placement and upon exercise of the warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

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."