On January 31, 2019 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, reported the closing and funding of its previously announced public offering of 15,217,392 shares of its common stock ("Common Stock") at a public offering price of $0.23 per share (Press release, Cancer Genetics, JAN 31, 2019, View Source [SID1234533043]). The Company’s Chairman, John Pappajohn; board director, Ted Cannon; Chief Financial Officer, Glenn Miles; and President and Chief Executive Officer, John A. Roberts, each purchased shares in the offering. The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses are approximately $3.5 million.

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!

H.C. Wainwright & Co. acted as the sole placement agent for the offering.

Cancer Genetics intends to use the net proceeds from this offering to pay any amounts required by its lenders and if any proceeds remain available, to pay certain costs previously incurred in connection with its ongoing strategic initiatives and to fund working capital and other general corporate purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 5, 2017. A prospectus supplement describing the terms of the offering was filed with the SEC on January 29, 2019, and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press 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 state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On January 31, 2019 Repare Therapeutics, Inc., a privately held precision oncology company pioneering synthetic lethality to develop novel therapeutics that target specific vulnerabilities of tumors in clearly defined patient populations, reported that it has entered into an exclusive strategic research, development and commercialization partnership with ONO Pharmaceutical Co., Ltd., for Repare’s small molecule Polθ inhibitor program in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU.

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!

"We’re excited to have ONO as a discovery and development partner," said Lloyd M. Segal, President and CEO of Repare. "This relationship will support our drive to and through the clinic in this important new area of precision oncology therapeutic development."

"ONO identified Repare Therapeutics as the partner of choice for bringing in a potential first-in-class and best-in-class Polθ inhibitor to our portfolio," said Gyo Sagara, President, Representative Director and CEO of ONO. "We are excited to work with Repare for the benefit of cancer patients."

Under the terms of the agreement, ONO will provide an up-front payment and research service payments potentially totaling US $15M, plus additional cost-sharing through IND. Beyond IND, significant clinical, regulatory and commercial milestones are also included in the agreement, with a potential total of US $160M. ONO will also pay to Repare high single-digit to low double-digit tiered royalties based on net sales of the products. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and the EU.

Polθ inhibitor opportunity

DNA Polymerase θ (Polθ) is a unique, multifunctional DNA polymerase essential to repairing DNA breaks, especially in homologous recombination deficient (HRD) cells. HRD, including deficiency in the BRCA1 and BRCA2 genes, is a clinically important feature across a variety of important tumor types, including breast, ovarian, prostate and pancreatic cancers. Polθ gene expression is low in normal cells but elevated across a broad range of tumor types, including those with HRD. Currently, HRD tumors may be treated with Poly(ADP-ribose) Polymerase (PARP) inhibitors, which represent a rapidly growing, multi-billion dollar global market. A significant fraction of patients does not initially respond to PARP inhibitor treatment, and the vast majority of treated patients eventually develop PARP inhibitor resistance. A Polθ inhibitor has potential as both a mono-therapy across multiple tumor types and in combination with PARP inhibitors, where its distinct mechanism of action may help address both forms of PARP resistance. Additional clinical populations may also be attractive for combination treatment with a Polθ inhibitor, including possible combinations with chemotherapy, radiotherapy and Immuno-Oncology agents.

On January 31, 2019 AVEO Oncology (NASDAQ: AVEO) reported that it has accepted the recommendation of the U.S. Food and Drug Administration (FDA) not to submit a New Drug Application (NDA) for tivozanib (FOTIVDA) with the preliminary overall survival (OS) results from the Phase 3 TIVO-3 trial (Press release, AVEO, JAN 31, 2019, View Source [SID1234532989]). The FDA indicated that these preliminary OS results do not allay their concerns about the potential detriment in OS outlined in the complete response letter dated June 6, 2013. The Company now plans to make a NDA filing decision following the availability of more mature OS results.

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!

As disclosed in November 2018, a preliminary analysis of the secondary endpoint of OS in the TIVO-3 trial showed a hazard ratio (HR) > 1. The Company previously planned to conduct the final OS analysis in August 2019. Due to the longer-than-expected median OS in both arms, and following discussions with the FDA, the Company plans to designate the August 2019 OS analysis as interim. Results of this analysis are expected to be reported in the fourth quarter.

Since initially conducting the preliminary analysis of the OS endpoint in November 2018, the Company has identified the survival status of a group of patients that were previously lost to follow up. With the identification of these OS events, the October 4, 2018 preliminary OS HR was revised from 1.06 to 1.12. The Company has not performed any OS analyses beyond the preliminary October 4, 2018 data cut-off date.

AVEO intends to present detailed results of the TIVO-3 study, the Company’s Phase 3 randomized, controlled, multi-center, open-label study comparing tivozanib to sorafenib in 350 subjects with highly refractory advanced or metastatic Renal Cell Carcinoma (RCC) during an oral session at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) being held February 14-16, 2019 in San Francisco.

"We are hopeful that the positive PFS outcome will translate into an improved hazard ratio when we evaluate a more mature interim OS outcome in the fourth quarter of 2019," said Michael Bailey, president and chief executive officer of AVEO. "We look forward to continuing to work with the FDA to determine tivozanib’s benefit-risk profile as a single agent in RCC patients."

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3, and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

On January 31, 2019 Invenra and WARF (Wisconsin Alumni Research Foundation) reported they have entered into a collaboration to discover and develop a bispecific antibody therapeutic for the treatment of neuroblastoma, a cancer that is the third most common childhood cancer, after leukemia and brain tumors (Press release, Invenra, JAN 31, 2019, View Source [SID1234532990]). The collaboration will use Invenra’s proprietary SNIPERTM technology to allow for precise targeting of the cancer cells while sparing normal nerve cells, and potentially alleviating unwanted toxicities and pain related side effects. The idea for the therapeutic candidate came out of a collaboration between Invenra and University of Wisconsin, Madison Professor, Dr. Paul Sondel, a pediatric oncologist who treats these children in his practice.

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!

"Invenra’s SNIPERTM technology should enable creation of antibody-based therapies that are specifically able to target tumor cells while not binding to normal tissues. We are excited to be working with Invenra to initiate this approach by directing it towards improving treatment for pediatric neuroblastoma," notes Sondel.

Roland Green, Ph.D., Chief Executive Officer and Co-Founder of Invenra states, "We are very excited about this program and the potential it has for helping these children with neuroblastoma. This program also has the potential to treat patients with a variety of other cancers such as glioblastoma (a form of brain cancer), melanoma and small cell lung cancer (SCLC). This collaboration is a good example of the benefits that can come from partnerships between the UW-Madison and industry."

On January 31, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the company will host a conference call and live webcast on Thursday, February 14, 2019 at 8:00 a.m. ET to report its fourth quarter and full year 2018 financial results and other business highlights (Press release, Agios Pharmaceuticals, JAN 31, 2019, http://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-fourth-quarter-and-full-year-2018 [SID1234533007]).

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!

A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 9886713. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.