On June 24, 2019 Asieris, a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, reported the completion of enrollment for its APL-1202 Phase Ib trial in the US (Press release, Asieris Pharmaceuticals, JUN 24, 2019, View Source [SID1234537237]). This new drug is being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). APL-1202 is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor under clinical development in the world. It has novel mechanisms of action of inhibiting both tumor cell growth and angiogenesis. APL-1202 is currently in registration clinical trial in China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The primary objective of this Phase Ib clinical trial in the US is to evaluate the safety, tolerability, and PK characteristics of APL-1202 when dosed in combination with intravesical BCG. Enrolled subjects are NMIBC patients who have received at least one induction course of intravesical BCG. This trial is expected to complete all patient follow-up in September. Asieris is currently planning to launch a Phase II global clinical trial to evaluate the efficacy and safety of a combination of APL-1202 with BCG in NMIBC patients.

"We are very excited to have participated in the Phase I trial combining APL-1202 with BCG in patients with non-muscle invasive bladder cancer previously treated and who are resistant to BCG. This trial has the potential to significantly improve the care of patients with non-muscle invasive bladder cancer. This is a very exciting therapeutic option for our patients given its oral route of delivery," commented John P. Sfakianos, MD, Assistant Professor of Icahn School of Medicine at Mount Sinai and a leading investigator of this trial. "I am enthusiastic about the future studies involving this treatment".

"The completion of enrollment for our APL-1202 Phase Ib clinical trial in the US represents a remarkable milestone for APL-1202’s global clinical development. In a Phase II trial in China, APL-1202 as a single agent demonstrated encouraging clinical efficacy and safety. Its combination with intravesical chemotherapy is in a pivotal clinical trial in China. Intravesical BCG is the first-line therapy for NMIBC globally, and through the clinical trials of APL-1202 in combination with intravesical BCG, we hope to provide a better treatment for NMIBC patients in the world," Kevin Pan, co-founder, chairman and CEO of Asieris said.

Bladder Cancer is one of the most common malignant tumors. According to Globalcan, the incidence of bladder cancer in 2018 was 549,343, while mortality was 199,922. The majority of patients are male, and most of them reside in developed countries. Currently, the common treatment of NMIBC is Trans-Urethral Resection of Bladder Tumor (TURBT). Because of high tumor recurrence rate after TURBT, intravesical chemo- or immune-therapies are required after the procedure. At present, the choice of second-line treatment for relapsed patients is very limited. For high-risk NMIBC patients who have failed intravesical therapies, radical cystectomy is the standard treatment. No oral drugs have been approved for NMIBC to date.

On June 24, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Mirati, JUN 24, 2019, View Source [SID1234537236]). All of the shares are being offered by Mirati. In addition, Mirati expects to grant the underwriters of the offering a 30-day option to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cowen, Credit Suisse and Barclays are acting as joint book-running managers in the offering.

The securities 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 will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, or by telephone: (631) 592-5973, or by emailing [email protected]; from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd floor, New York, NY 10010, or by telephone: (800) 221-1037, or by emailing [email protected]; or 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].

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 June 24, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical stage biopharmaceutical company developing multifunctional biotherapeutics (the "Company"), reported the closing of its previously announced underwritten public offering (the "Offering") (Press release, Zymeworks, JUN 24, 2019, View Source [SID1234537235]). The Offering consisted of 7,013,892 common shares, including the exercise in full of the underwriters’ over-allotment option to purchase 1,458,336 additional shares, and, in lieu of common shares, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares. The common shares were offered at a price to the public of US$18.00 per common share and the pre-funded warrants were offered at a price of US$17.9999 per pre-funded warrant, for aggregate gross proceeds to the Company of approximately US$201.3 million, before deducting underwriting discounts and commissions and estimated Offering expenses.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use the net proceeds of the Offering to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, breast and other underserved cancers; to accelerate and expand the clinical development of ZW49 through its ongoing adaptive Phase 1 clinical trial and follow-on global studies; to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and for general corporate purposes.

J.P. Morgan Securities, LLC acted as active book-running manager for the Offering. Wells Fargo Securities, LLC and Stifel, Nicolaus & Company, Incorporated acted as passive book-running managers, Raymond James Ltd. acted as co-lead manager and Ladenburg Thalmann & Co. Inc. acted as co-manager.

The securities described above were offered in Canada pursuant to Zymeworks’ final prospectus supplement, dated June 19, 2019 (the "Canadian Supplement"), to its Canadian final base shelf prospectus, dated March 6, 2019 (the "Base Prospectus"), and in the United States pursuant to Zymeworks’ final prospectus supplement, dated June 19, 2019 (the "U.S. Supplement", together with the Canadian Supplement, the "Supplements"), to its U.S. shelf registration statement on Form S-3, as amended, including a prospectus dated January 31, 2019 (the "Registration Statement"). The Supplements were filed in Canada and the United States on June 20, 2019.

The Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as the NYSE.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement can be found on SEDAR at www.sedar.com, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also 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; Wells Fargo Securities, LLC, Attention; Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected]. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

This news 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 province, 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 province, state or jurisdiction.

On June 24, 2019 Minerva Biotechnologies, a biopharmaceutical company focused on developing immunotherapies for cancer and cellular therapies in regenerative medicine, reported that the U.S. FDA (Food and Drug Administration) has approved their IND (Investigational New Drug) application to conduct clinical trials with huMNC2-CAR44, an autologous CAR T cell therapy for solid tumors (Press release, Minerva Biotechnologies, JUN 24, 2019, View Source [SID1234537234]). huMNC2-CAR44 targets MUC1* (muk one star), a cleaved form of MUC1 present on over 75% of solid tumor cancer cells. Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7AB binds to and dimerizes its truncated extracellular domain.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Minerva intends to commence clinical trials in breast cancer before the end of 2019. "We are delighted that we will soon be able to begin human clinical trials for metastatic breast cancer," said Minerva CEO Dr. Cynthia Bamdad. "Over 95% of breast cancers are positive for MUC1*, and this cancer immunotherapy has the potential to bring hope to the many thousands of patients battling this terrible disease."

Minerva’s chimeric antigen receptor (CAR) technology genetically engineers the patient’s own immune cells to recognize and kill specific types of cancer cells. The homing device on the CAR is an antibody that can distinguish the tumor-associated cleavage product, MUC1*, from the normal, full-length MUC1. Previous attempts to make cancer therapeutics that target MUC1 have failed, we believe, because they have targeted the a portion of full-length MUC1, which on tumor cells is cleaved, then shed and released form the cancer cell surface. Minerva has an extensive patent portfolio covering the part of MUC1 that remains on cancer cells (MUC1*) which is a powerful growth factor receptor, its activating ligands, and next generation CAR T technology.

Contacts
Press Release Contact:
Minerva Biotechnologies
Matt Britz
617-221-8897

Investor Contact:
Minerva Biotechnologies
Ron Axelrod
617-785-9491
[email protected]

On June 24, 2019 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) reported that the European Patent Office will grant Oncology Venture a patent on the LiPlaCis Drug Response Prediction (DRP) (Press release, Oncology Venture, JUN 24, 2019, View Source [SID1234537233]). The LiPlaCis DRP covers 205 genes and predicts the response in individual patients to the anti-cancer drug LiPlaCis based on a pre-treatment biopsy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at the tumor site. Oncology Venture’s drug specific diagnostic tool DRP selects the patients who are expected to benefit from the treatment. LiPlaCis is showing strong results in an ongoing Phase 2 study in patients with metastatic breast cancer.

The patent from the European Patent Office provides key intellectual property protection in Europe.

"The patent approval is an important value driver in the development of LiPlaCis, since our AI powered DRP technology is instrumental for the strong results we have seen so far in the ongoing Phase 2 study. Together with the well-defined regulatory route towards marketing approval, as announced earlier this month, the new patent provides us with an exceptionally solid platform for the ongoing partnering process", says Peter Buhl Jensen, M.D., CEO of Oncology Venture.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49

For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

About the Drug Response Predictor – DRP Companion Diagnostic
Oncology Venture uses its multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patient’s biopsies.
DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 37 clinical studies that were examined and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis and its DRP to track, match and treat patients with metastatic breast cancer.
The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by Oncology Venture for Personalized Medicine. The DRP is used by Oncology Venture for drug development.