On February 6, 2020 Epic Sciences, Inc. reported it will present two abstracts at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium to be held in San Francisco, February 13-15, 2020 (Press release, Epic Sciences, FEB 6, 2020, View Source [SID1234553968]). The abstracts feature two analyses of the PROPHECY trial cohort. One abstract evaluates the androgen-receptor splice variant 7 (AR-V7) in CTCs as a predictor of resistance to anti-androgen therapy. The second abstract reports new data on CTC-based biomarkers of chromosomal instability and small-cell neuroendocrine transformation and their association to resistance to anti-androgen therapy.

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"This analysis of PROPHECY builds on previous evidence demonstrating AR-V7 as a predictive biomarker, reinforcing the clinical utility of AR-V7 to guide treatment decisions for patients with metastatic prostate cancer and improve patient outcomes," said Rick Wenstrup, MD, chief medical officer at Epic Sciences. "Further, the research also demonstrated that CTC phenotypes of both chromosomal instability and small-cell neuroendocrine identify AR-V7 negative patients who are resistant to anti-androgen therapy. We believe patient selection strategies based on CTC phenotypes to identify patients more or less likely to respond to the various drug classes in prostate cancer will help in optimizing drug sequencing and associated treatment outcomes for patients."

Epic demonstrated its expertise in the development of blood-based tests that predict therapy response with the launch of the Oncotype Dx© AR-V7 Nucleus Detect test, commercially available and reimbursed by Medicare. The test, which is offered in the U.S. through Epic’s partnership with Exact Sciences for patients with mCRPC, assists physicians in choosing between androgen receptor-directed therapies or taxane chemotherapy.

Following are the details for the two poster sessions:

Title: AR-V7 and prediction of benefit with taxane therapy: Final analysis of PROPHECY
First Author: Andrew Armstrong, MD
Date and Time: Thursday, February 13, 2020 11:30 AM-1:00 PM and 5:30 PM-6:30 PM
Poster Session: A
Abstract: 184
Poster Board: H20

Title: Association of circulating tumor cell chromosomal instability with worse outcomes in men with mCRPC treated with abiraterone or enzalutamide
First Author: Landon Brown, MD
Date and Time: Thursday, February 13, 2020 11:30 AM-1:00 PM and 5:30 PM-6:30 PM
Poster Session: A
Abstract: 183
Poster Board: BOARD H19

On February 6, 2020 Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that members from the Replimune management team will participate in fireside chats and host investor meetings at the following two conferences (Press release, Replimune, FEB 6, 2020, View Source [SID1234553918]).

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Guggenheim Healthcare Talks Forum – Oncology Day 2020
Date: Thursday, February 13, 2020
Presentation Time: 2:30 pm ET
Location: St. Regis in New York, NY

9th Annual SVB Leerink Global Healthcare Conference
Date: Tuesday, February 25, 2020
Presentation Time: 11:00 am ET
Location: Lotte New York Palace in New York, NY

On February 6, 2020 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has entered into an amendment of its collaboration, license and option agreement with Aurigene Discovery Technologies, Ltd. (Aurigene) (Press release, Curis, FEB 6, 2020, View Source [SID1234553937]). Under the terms of the amended agreement, Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, an orally available, dual inhibitor of VISTA and PDL1, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer (nsNSCLC). In turn, Aurigene receives rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. Curis retains U.S., E.U., and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia.

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In 2019, Aurigene presented clinical data from a Phase 2a basket study of CA-170 in patients with multiple tumor types, including those with nsNSCLC. In the study, CA-170 demonstrated promising signs of safety and efficacy in nsNSCLC patients compared to various anti-PD-1/PD-L1 antibodies.

"We are pleased to announce this amendment which leverages our partner Aurigene’s expertise and resources to support the clinical advancement of CA-170, as well as maintain our rights to CA-170 outside of Asia," said James Dentzer, President and Chief Executive Officer of Curis. "Phase 2a data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference last fall supported the potential for CA-170 to serve as a therapeutic option for patients with nsNSCLC. We look forward to working with our partner Aurigene to further explore this opportunity."

"Despite recent advancements, patients with localized unresectable NSCLC struggle with high rates of recurrence and need for expensive intravenous biologics. The CA-170 data presented at ESMO (Free ESMO Whitepaper) 2019 from Aurigene’s Phase 2 ASIAD trial showed encouraging results in Clinical Benefit Rate and Prolonged PFS and support its potential to provide clinically meaningful benefit to Stage III and IVa nsNSCLC patients, in combination with chemoradiation and as oral maintenance" said Kumar Prabhash, MD, Professor of Medical Oncology at Tata Memorial Hospital, Mumbai, India.

Murali Ramachandra, PhD, Chief Executive Officer of Aurigene, commented, "Development of CA-170, with its unique dual inhibition of PD-L1 and VISTA, is the result of years of hard-work and commitment by many people, including the patients who participated in the trials, caregivers and physicians, along with the talented teams at Aurigene and Curis. We look forward to further developing CA-170 in nsNSCLC."

On February 6, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported the closing of its previously announced registered direct offering of 197,056 shares of common stock, at a purchase price of $8.83 per share, priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, FEB 6, 2020, View Source [SID1234553953]). Additionally, the Company issued to the investors unregistered warrants to purchase up to an aggregate of 197,056 shares of common stock.

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

The warrants have an exercise price of $8.71 per share of common stock, are exercisable immediately and will expire five and one-half years following the date of issuance.

Gross proceeds to Phio, before deducting placement agent fees and other offering expenses, are approximately $1.74 million. The Company intends to use the net proceeds from the offering to fund the development of its immuno-oncology programs, other research and development activities and for general working capital needs.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 6, 2020 Kleo Pharmaceuticals, Inc., an immuno-oncology company developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, reported that it has received Investigational New Drug (IND) authorization to proceed from the U.S. Food and Drug Administration (FDA) to initiate a safety and tolerability clinical study combining KP1237, a CD38-targeting antibody recruiting molecule (ARM), with patients’ own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients (Press release, Kleo Pharmaceuticals, FEB 6, 2020, View Source [SID1234553969]).

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The single-arm study will be conducted in 25-30 patients with exploratory endpoints that assess the MRD (minimal residual disease) conversion rate at 90-100 days after transplantation. Recent clinical trials have identified MRD negativity post-transplant as a potential surrogate of long-term remission in MM. The trial is expected to begin enrollment in the first half of 2020, and topline data are expected in the second half of 2021.

"We are excited to have clearance to initiate a clinical trial in the US that addresses a significant unmet medical need in newly diagnosed, post-transplant multiple myeloma patients," said Kleo CEO Doug Manion, MD. "Approximately 30,000 individuals are diagnosed with multiple myeloma in the United States each year, with at least 1/3 of those patients undergoing autologous stem cell transplants."

In this trial, KP1237 is being investigated as a "cell homing" molecule to target the patient’s activated NK cells to the CD38-expressing tumor. Current anti-CD38 therapeutic antibodies kill NK cells and are not approved for use in this clinical settingi.

Nonclinical efficacy data presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that CD38-ARMs are able to kill multiple myeloma cells by antibody-dependent cellular cytotoxicity without depleting CD38-expressing immune cells. Nonclinical data also demonstrated that the CD38-ARM molecule did not induce complement-dependent cytotoxicity (CDC) suggesting it is not likely to cause CDC in humans. Kleo’s 2019 ASH (Free ASH Whitepaper) posters can be viewed here and here.