On January 16, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that the Japanese Pharmaceuticals and Medical Device Agency (PMDA) has approved the therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic with Pfizer’s VIZIMPRO (dacomitinib) for EGFR gene mutation-positive, inoperable or recurrent non-small cell lung cancer (Press release, Qiagen, JAN 16, 2019, View Source [SID1234532684]). The therascreen EGFR RGQ PCR Kit is registered in more than 40 countries globally. This marks the first companion diagnostic approval for QIAGEN in Japan.

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"As precision medicine becomes the standard of care in oncology, we are pleased to provide benefits to more lung cancer patients with our clinically proven therascreen EGFR RGQ PCR Kit. Our collaboration with Pfizer has made great strides already and will continue to improve personalized healthcare for patients around the world," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics for QIAGEN. "In addition to detecting a comprehensive panel of EGFR mutations, the therascreen EGFR kit offers laboratories an efficient workflow on the Rotor-Gene Q MDx, the real-time PCR module in our widely-used QIAsymphony family of instruments."

QIAGEN is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. QIAGEN has an unmatched depth and breadth of technologies from NGS to PCR for companion diagnostic development and has been the market leader in companion diagnostics working under master collaboration agreements with more than 25 pharmaceutical companies developing companion diagnostic tests for their drug candidates. For more details surrounding QIAGEN’s companion diagnostics and their claims please visit www.qiagen.com. For additional information on Pfizer’s VIZIMPRO (dacomitinib) please visit www.pfizer.com.

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 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will hold a conference call on January 24, 2019 at 1:30 p.m. Pacific / 4:30 p.m. Eastern to discuss its plan for 2019, including the commercialization path and timeline for Cchek, its artificial intelligence based cancer diagnostic test, and the clinical path of its CAR-T based ovarian cancer therapeutic program (Press release, Anixa Biosciences, JAN 16, 2019, View Source [SID1234532668]).

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"We are pleased with the advances made with both of our programs to date, and are excited about where these programs are headed this year. We believe 2019 will be a transformative year for Anixa and we look forward to sharing our plans on this conference call," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences.

To access the call, please dial (866) 342-8591 five minutes prior to the start time.

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.