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New ARAMIS Phase III data to be presented at ASCO 2020: Nubeqa® (darolutamide) significantly improved overall survival with a favorable safety profile in men with non-metastatic prostate cancer

On May 14, 2020 Orion Corporation reported new ARAMIS Phase III data to be presented at ASCO (Free ASCO Whitepaper) 2020: Nubeqa (darolutamide) significantly improved overall survival with a favorable safety profile in men with non-metastatic prostate cancer (Press release, Orion , MAY 14, 2020, View Source [SID1234558050]).

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Darolutamide significantly reduced risk of death by 31 percent (HR=0.69, 95% CI 0.53-0.88; p=0.003) in men with non-metastatic castration-resistant prostate cancer (nmCRPC)
Darolutamide significantly delayed the time to pain progression, time to first initiation of cytotoxic chemotherapy, and time to first symptomatic skeletal event (SSE)
Darolutamide continues to demonstrate a favorable safety profile, with no new safety signals observed, even with a longer treatment duration, allowing men with nmCRPC to maintain their active lifestyle
ARAMIS data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program on Friday, May 29, and will be available on the ASCO (Free ASCO Whitepaper) website (View Source)
Abstract 5514
Darolutamide (Nubeqa) is shown to significantly improve overall survival (OS) and significantly delay the onset of cancer-associated symptoms, while minimizing the toxicity associated with treating men with non-metastatic castration-resistant prostate cancer (nmCRPC). These data from the pre-specified final OS analysis of the Phase III ARAMIS trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, which takes place from May 29-31, 2020.

Previously published results from the ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months for darolutamide plus androgen deprivation therapy (ADT) compared to 18.4 months for placebo plus ADT (p<0.001); however, OS data were not yet mature at the time of the MFS analysis.

"Men with nmCRPC typically do not have cancer symptoms. In selecting a treatment for these patients, my goal as a clinician is to improve their overall survival while limiting side effects and drug interactions," said Karim Fizazi, M.D., Ph.D., Professor of Medicine at the Institut Gustave Roussy, Villejuif, France. "These data add to the growing evidence for darolutamide as an effective treatment option with a favorable safety profile that extends patients’ lives and delays cancer symptoms and morbidities, without disrupting their daily activities."

Final OS Analysis Presented at ASCO (Free ASCO Whitepaper) Virtual Scientific Program
Men receiving darolutamide plus ADT demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003).

Darolutamide has a distinct chemical structure and inhibits the growth of prostate cancer cells while limiting the burden of side effects on patients’ everyday lives. With extended follow-up, darolutamide’s safety profile remains favorable, allowing men with nmCRPC to continue their daily lives without disruption. Consistent with the previously reported primary analysis results, darolutamide plus ADT showed a favorable tolerability confirmed by a longer-term safety analysis compared to ADT alone, without clinically relevant increases in rates of hypertension, falls or central nervous system (CNS) effects. In the follow-up analysis of secondary endpoints, all secondary endpoints were statistically significant. Darolutamide plus ADT significantly delayed time to pain progression, time to first initiation of cytotoxic chemotherapy and time to first symptomatic skeletal event (SSE) versus placebo plus ADT.

Under the brand name Nubeqa, darolutamide is developed jointly by Orion and Bayer, and indicated for the treatment of men with nmCRPC, who are at high risk of developing metastatic disease. The approvals of Nubeqa in the European Union (EU), U.S., Australia, Brazil, Canada, and Japan are based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus ADT compared to placebo plus ADT.

About the ARAMIS trial
The ARAMIS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial evaluating the safety and efficacy of oral darolutamide in patients with nmCRPC who are currently being treated with ADT and are at high risk for developing metastatic disease. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of darolutamide orally twice daily or placebo along with ADT. Patients with a history of seizure were allowed in the study.

About Nubeqa (darolutamide)
Darolutamide was approved in March 2020 in the European Union (EU) under the brand name Nubeqa for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Nubeqa has also received regulatory approval in the U.S., Australia, Brazil, Canada as well as Japan, and filings in other regions are underway or planned by Bayer.

Nubeqa is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The compound is also being investigated in a Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS). Information about these trials can be found at www.clinicaltrials.gov.

About castration-resistant prostate cancer (CRPC)
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2018, an estimated 1.2 million men were diagnosed with prostate cancer, and about 358,000 died from the disease worldwide. Prostate cancer is the fifth leading cause of death from cancer in men. Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system. It mainly affects men over the age of 50, and the risk increases with age.

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location. However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.

Prostate cancer that is confined to the prostate region which is treated with ADT but keeps progressing without showing metastases, even when the amount of testosterone is reduced to very low levels in the body, is known as non-metastatic castration-resistant prostate cancer (nmCRPC). In men with progressive nmCRPC, a rapid prostate specific antigen (PSA) doubling time has been consistently associated with reduced time to first metastasis and death. About one-third of men with nmCRPC go on to develop metastases within two years.

Xenetic Biosciences, Inc. Reports First Quarter 2020 Financial Results and Provides Corporate Update

On May 14, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported its financial results for the quarter ended March 31, 2020 and provided a corporate update (Press release, Xenetic Biosciences, MAY 14, 2020, View Source [SID1234558049]).

"Over the course of the first quarter, we continued to make encouraging progress towards securing academic collaborations, the next major milestone for us in advancing the XCART platform," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Additionally, despite the fact that the COVID-19 health pandemic carries on, we have been fortunate to not have experienced any significant operational impacts and have maintained a cash runway expected to fund our projected operational and development efforts through mid-2021. We are excited for the year ahead and to further unlock the value that the XCART technology platform holds."

XCART Platform Technology Overview: Significantly differentiated, proprietary approach to personalized CAR T therapy for the treatment of multiple tumor types of B-cell Non-Hodgkin lymphomas, an area of significant unmet need, with the potential to address an initial global market opportunity of over $5 billion annually.1 Xenetic believes XCART has the potential to transform CAR T therapy.

The Company announced in February 2020 the appointments of Greg MacMichael, Ph.D. and Maksim Mamonkin, Ph.D. to its Scientific Advisory Board, each of whom brings with them extensive knowledge in cell therapy engineering and design, cell therapy manufacturing, and CMC expertise and capabilities. Both Dr. MacMichael and Dr. Mamonkin are actively engaged with the Company to advance the development of the XCART technology platform.

Xenetic is actively engaged in ongoing discussions to advance the development of XCART through one or more collaborations with academic or development partners.

Expected 2020 Milestones

Enter into academic site collaborations
INTERACT meeting with the United States Food and Drug Administration ("FDA")
Advance IND-enabling studies
Explore opportunities for Orphan Drug designation
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlights:

Exclusive License Agreement with Takeda Pharmaceuticals Co. Ltd. ("Takeda") in the field of coagulation disorders. Takeda currently has one active development program underway utilizing the PolyXen platform technology.
Royalty payments expected to continue to grow as the relevant product launch continues to be rolled out by the sublicensee.
Summary of Financial Results for First Quarter 2020

Net loss for the three months ended March 31, 2020 was approximately $1.2 million compared to a net loss of approximately $1.3 million for the same period in 2019. As of March 31, 2020, working capital was $9.2 million compared to $9.7 million as of December 31, 2019. The decrease in working capital was primarily due to the Company’s net loss for the three months ended March 31, 2020. The Company ended the quarter with approximately $9.4 million of cash.

TG Therapeutics Announces Proposed Public Offering of Common Stock

On May 14, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company dedicated to developing medicines for patients with B-cell mediated diseases ("TG Therapeutics"), reported that it intends to offer and sell 6,000,000 shares of its common stock in an underwritten public offering (Press release, TG Therapeutics, MAY 14, 2020, View Source [SID1234558048]). 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. TG Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.

TG Therapeutics intends to use the net proceeds of the public offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes.

J.P. Morgan Securities LLC, Jefferies LLC Evercore Group L.L.C., and Cantor Fitzgerald & Co. are acting as joint book-running managers for the proposed offering.

The public offering of common stock is being made pursuant to an automatically effective shelf registration statement previously filed with the SEC on September 5, 2019. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus related to the offering will be filed with the SEC and available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, 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, or email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at [email protected]; Evercore Group L.L.C, Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: [email protected]; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: [email protected].

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.

Surface Oncology to Present at the American Society of Clinical Oncology Annual Meeting

On May 14, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that data from the Phase 1 study of SRF231, a fully human, high-affinity anti-CD47 antibody, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting, to be held virtually May 29-31 (Press release, Surface Oncology, MAY 14, 2020, View Source [SID1234558047]).

A summary is provided below; the full poster will be placed on Surface Oncology’s website following the presentation.

Presentation Type: e-poster (Abstract: 3064 / Poster: 128)
Title: Results of a first-in-human Phase 1 study of SRF231, a fully human, high-affinity anti-CD47 antibody
Lead Author: Amita Patnaik
Session: Developmental Therapeutics – Immunotherapy

In 2018, Surface Oncology deprioritized the SRF231 clinical program and is concluding its Phase 1 study.

SELLAS Life Sciences Reports First Quarter 2020 Financial Results and Provides Business Update

On May 14, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported financial results for the first quarter of 2020 and provided a business update (Press release, Sellas Life Sciences, MAY 14, 2020, View Source [SID1234558046]).

"The first quarter of 2020 brought unprecedented times with the onset of the COVID-19 global pandemic. Our key priorities are to focus on the health and safety of our patients, investigators, employees and other stakeholders as well as diligently executing our business operations. We have been fortunate to be able to continue to progress our clinical development program for galinpepimut-S (GPS), including our Phase 3 REGAL study in acute myeloid leukemia (AML), our Phase 1/2 basket study in combination with pembrolizumab (KEYTRUDA), and our Phase 1 trial in combination with nivolumab (Opdivo) in malignant pleural mesothelioma (MPM) despite the uncertainty and disruption caused by the pandemic. Our activities around the REGAL study, including those for additional site activations in the United States and Europe, have continued unabated. Screening is continuing in the basket study and dosing of enrolled patients is continuing in the MPM Phase 1 study," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Additionally, we are continuing our business development efforts to pursue out-licensing opportunities for further clinical development of nelipepimut-S (NPS)."

First Quarter 2020 and Recent Pipeline Highlights

Galinpepimut-S (GPS) Program

In April 2020, SELLAS announced the formation of the Steering Committee for its Phase 3 REGAL clinical trial of GPS in patients with AML who have achieved complete remission after second-line anti-leukemic therapy (CR2). The Steering Committee currently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the multi-center Phase 3 REGAL study and Chair of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology – Baylor Charles A. Sammons Cancer Center.
In February 2020, SELLAS announced positive follow-up data from its Phase 1/2 study of GPS in CR2 AML patients. The final data show a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS compared to 5.4 months in patients treated with best standard care (p-value < 0.02). GPS therapy continued to be well-tolerated throughout the study.
In February 2020, SELLAS announced the enrollment of the first patient in an investigator-sponsored clinical trial of GPS in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab (Opdivo), in patients with MPM.
In January 2020, SELLAS announced that it commenced patient screening for its pivotal Phase 3 REGAL study of GPS in patients with AML in CR2.
Nelipepimut-S (NPS) Program

In March 2020, SELLAS announced preliminary antigen-specific immune response data from a Phase 2 randomized investigator-sponsored trial of NPS in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. Preliminary data show an 11-fold increase in a CD8 cytotoxic T-lymphocytes immune response in patients who received a single dose of NPS compared to baseline. The final data is being further analyzed by the National Institute of Health, MD Anderson Cancer Center and the study principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and Women’s Cancer Center, and will be presented at an upcoming medical conference.
In March 2020, SELLAS announced that final results from the efficacy and safety data analysis of the Phase 2b independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin) +/- NPS targeting HER2 low-expressing breast cancer patient cohorts, including patients with triple negative breast cancer (TNBC), were recently published in the peer reviewed journal, Clinical Cancer Research. With regard to the TNBC patient cohort, the data analysis shows:
– Disease-free survival (DFS) landmark rate at 24 months for patients treated with NPS plus trastuzumab (n=53) was 92.6% compared to 70.2% for those treated with trastuzumab alone (n=44), a clinically and statistically significant improvement.
– There was a statistically significant reduction of 71.9% (p=0.01) in the frequency of clinically detected recurrences in patients treated with the combination (NPS plus trastuzumab) versus trastuzumab alone.
– The combination was generally well-tolerated and there were no clinicopathologic differences between the study groups.
In February 2020, SELLAS announced that it had finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment, following feedback from a Type C review with the FDA. SELLAS is actively pursuing out-licensing opportunities to fund and conduct the future clinical development of NPS.
Recent Corporate Highlights

In April 2020, SELLAS retained PCG Advisory Inc., a leading investor relations and digital strategies firm, to serve as an advisor for investor relations and strategic communications.
In February 2020, SELLAS announced the appointment of Dragan Cicic, MD, as Senior Vice President, Clinical Development.
First Quarter 2020 Financial Results

Cash Position: As of March 31, 2020, cash and cash equivalents totaled approximately $6.7 million, compared to $2.6 million as of March 31, 2019. Net cash used in operating activities was $6.8 million for the three months ended March 31, 2020, compared to $5.0 million for the three months ended March 31, 2019. Net cash provided by financing activities was $6.3 million for the three months ended March 31, 2020, which was attributable to $6.0 million in net proceeds from a registered direct offering of shares of common stock and warrants to purchase common shares in a concurrent private placement consummated in January 2020, and $0.3 million from the collection of a stock subscription receivable. During the three months ended March 31, 2019, the Company generated $2.2 million of net cash from financing activities from the exercise of certain common stock warrants.

R&D Expenses: Research and development expenses were $1.9 million for the first quarter of 2020, as compared to $1.9 million for the three months ended March 31, 2019. While relatively unchanged from the previous year quarter, for the three months ended March 31, 2020 there was a $0.2 million increase in clinical trial expenses, a $0.1 million increase in manufacturing related expenses for GPS due to the Company’s ongoing basket trial of GPS in combination with pembrolizumab and the Phase 3 REGAL study of GPS as a monotherapy in AML, and a $0.1 million increase in other research and development expenses, partially offset by a $0.2 million decrease in personnel related expenses due to reduced headcount and a $0.2 million decrease in licensing fees.

G&A Expenses: General and administrative expenses were $2.2 million for the three months ended March 31, 2020, as compared to $2.5 million for the three months ended March 31, 2019. The $0.3 million decrease was primarily due to a $0.3 million decrease in legal fees, a $0.2 million decrease in accounting fees, and a $0.1 million decrease in personnel related expenses due to reduced headcount. These decreases were partially offset by a $0.2 million increase in premiums for directors and officers liability insurance and a $0.1 million increase in outsourced consulting and public company costs.

Net Loss: Net loss attributable to common stockholders was $4.2 million for the first quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66, as compared to a net loss attributable to common stockholders of $5.0 million for the first quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $11.12.