On June 10, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the completion of target patient enrollment in the Clovis-sponsored Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca(rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO (nivolumab), as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer (Press release, Clovis Oncology, JUN 10, 2020, View Source [SID1234560970]). ATHENA is the first front-line switch maintenance study designed to show PARP monotherapy and PARP/PD-1 combination therapy in one study design.

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"The completion of target patient enrollment in the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step toward developing additional therapeutic options for women with advanced ovarian cancer," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "This was a tremendous effort by trial investigators, our collaborators and our dedicated Clovis team to complete target enrollment in this 1,000-patient study in under two years. Most important, we are grateful to all of the patients who participated in this study."

ATHENA is a Phase 3, randomized, multinational, double-blind, placebo-controlled, four-arm trial evaluating Rubraca and Opdivoas maintenance treatment following response to front-line treatment in newly-diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. The primary endpoint is investigator assessed progression-free survival (PFS); secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.

Target enrollment for the ATHENA trial was 1,000 ovarian cancer patients. Patients were enrolled at clinical trial centers in 24 countries including North America, Europe and Asia.

Topline data for the Rubraca monotherapy versus placebo arm in all study populations is expected in the second half of 2021 and, if supportive, would serve as the basis of an sNDA for the maintenance treatment of front-line, newly-diagnosed, advanced ovarian cancer patients. Topline data for the combination of Rubraca and Opdivo versus Rubraca monotherapy in all study populations are expected a year or more later and, if supportive, would serve as the basis of an sNDA for the combination therapy in front-line, newly-diagnosed ovarian cancer. In each of these, the primary efficacy analysis will evaluate two prospectively defined molecular sub-groups in a step-down manner: first, HRD-positive patients, including BRCA-mutant patients; and the intent-to-treat population, or all patients treated in ATHENA.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

On June 10, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering (Press release, Mustang Bio, JUN 10, 2020, View Source [SID1234561005]). Mustang expects to grant the underwriters a 30‐day option to purchase up to an additional 15 percent of the shares of common stock offered in the public offering. All of the shares of common stock are being offered by the Company. Mustang intends to use the net proceeds from the offering primarily for the continued development of its product candidates, the potential in‐license, acquisition, development and commercialization of other pharmaceutical products and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, 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.

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Cantor Fitzgerald & Co. is acting as the sole book running manager for the offering.

A shelf registration statement on Form S‐3 (File. No. 333-233350) (the "Registration Statement") relating to the shares of common stock being offered was filed with the U.S. Securities and Exchange Commission ("SEC") and was declared effective on September 30, 2019. Copies of the preliminary prospectus supplement and accompanying prospectus, when available, may be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by e-mail at [email protected]; or the on the SEC’s website at View Source

The offering will be made only by means of a prospectus. A final prospectus supplement to the base prospectus describing the terms of the offering will be filed with the SEC. This press release shall not constitute an offer to sell or a solicitation of an offer to buy securities of the Company, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale is not permitted.

On June 10, 2020 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that its scientific cofounders, Christopher Natale, PhD, Vice President of Research at Linnaeus and Todd Ridky, MD, PhD, Assistant Professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania, presented their findings on a new therapeutic target for pancreatic cancer in the journal Cellular and Molecular Gastroenterology and Hepatology (View Source) (Press release, Linnaeus Therapeutics, JUN 10, 2020, View Source [SID1234561057]).

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The peer-reviewed article, entitled "Pharmacologic Activation of G Protein-Coupled Estrogen Receptor Inhibits Pancreatic Ductal Adenocarcinoma" was authored by Natale et al. Using a small molecule agonist of the G protein-coupled estrogen receptor (GPER), the authors demonstrated that GPER activation inhibits the growth of multiple pancreatic ductal adenocarcinoma cancer (PDAC) models and has combinatorial effects with immune checkpoint inhibitors. The authors also demonstrated that GPER protein can be detected in a large percentage of clinical specimens, suggesting that GPER may represent a new therapeutic target for PDAC.

"It’s exciting to learn that the anticancer activity we observed with GPER agonists in our first studies in melanoma models extends to pancreatic cancer and many other cancer types and that these agents have a therapeutic synergy with modern immunotherapy. We are eager to continue working to identify new cancer types that could be targeted using GPER agonists," said Dr. Natale. "We are excited to see if these data translate to our current phase 1/2 clinical trial in patients with advanced cancer.

About LNS8801

LNS8801 is an orally bioavailable and highly specific agonist of GPER whose activity is dependent on the expression of GPER. GPER activation suppresses well-known tumor-associated genes, such as c-Myc and PD-L1. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. LNS8801 monotherapy has shown significant antitumor activity, including inducing complete responses that are immune to rechallenge. LNS8801 also has shown effects when combined with targeted therapies and immunotherapies. LNS8801 is currently in a phase 1/2 clinical trial in patients with advanced cancer at six comprehensive cancer centers in the United States.

On June 9, 2020 NanOlogy, LLC, a clinical-stage oncology company, reported initiation of a clinical trial of IT NanoPac (submicron particle paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in NSCLC and SCLC (Press release, NanOlogy, JUN 9, 2020, View Source [SID1234560917]). The trial follows FDA allowance of an investigational new drug (IND) application for IT NanoPac in neoplasms of the lung. A second IND was also allowed by FDA for a nebulized inhaled form of NanoPac in NSCLC. Five INDs have been established for NanoPac allowing progress of clinical trials via multiple routes of targeted administration for a variety of solid tumors including pancreatic, prostate, ovarian, peritoneal, and now lung.

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Clinical Trial of NanoPac in Lung Cancer
The first study to proceed will be a Phase 2a dose-rising and expansion trial (NCT04314895) evaluating the safety and tolerability of up to 3 monthly IT injections of NanoPac delivered via EBUS-TBNI, concurrent with standard of care therapy, in patients with primary or recurrent NSCLC or SCLC. In addition to safety and pharmacokinetics (PK), the study will measure progression free survival, overall survival, and tumor response determined from CT scan imaging. Blood and biopsy samples will be evaluated for immune effect through flow cytometry and multiplex immunohistochemistry analysis. The trial will begin at two clinical sites: Parkview Healthcare Institute in Fort Wayne, Indiana and University of Florida Health Cancer Center in Gainesville, Florida. More clinical sites will follow. The first subject is expected to be enrolled in August 2020.

Preclinically, a nebulized inhaled form of NanoPac was retained in lung tissue for more than 14 days in a PK model and caused tumor regression and immune cell infiltration in an orthotopic model of NSCLC. Clinical plans for inhaled NanoPac are under development.

Other Clinical Experience with Targeted Delivery of NanoPac
To date, approximately 70 patients have received targeted injections of NanoPac across clinical trials in the prostate and pancreas. Another 30 patients have received intraperitoneal NanoPac for peritoneal and ovarian cancers. NanoPac has been well tolerated in these study subjects with no confirmed drug-related serious adverse events reported. Along with safety and tolerability, signs of activity have also been observed across the clinical programs.

NanOlogy Submicron Particle Therapeutic Platform
The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (US 10,507,195) both valid until 2036 in the US and pending globally. In addition to lung cancer, NanOlogy clinical programs are advancing in pancreatic, genitourinary, peritoneal, ovarian, and dermal cancers.

About Lung Cancer
In 2020, an estimated 228,820 new cases of lung cancer will be diagnosed in the U.S. and 135,720 people will die from the disease. Lung cancer is by far the leading cause of cancer deaths in the U.S. responsible last year for 22% of all cancer-related deaths (SEER). Globally, lung cancer is also the most common form of cancer and the deadliest accounting for an estimated 2.1 million annual new cases and 1.8 million deaths (GLOBOCAN 2018).

On June 9, 2020 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported that the company will present new preclinical data for its folate receptor alpha targeting antibody-drug conjugate, STRO-002, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II being held June 22-24, 2020 (Press release, Sutro Biopharma, JUN 9, 2020, View Source [SID1234560953]).

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Additionally, Sutro’s partner Merck KGaA, Darmstadt, Germany, will be presenting preclinical data from the collaboration’s pre-Development Candidate, M1231, a first-in-class bispecific antibody-drug conjugate targeting EGFR and MUC1.

Presentation Details:

Title:

STRO-002, an anti-FolRα ADC, demonstrates immune-modulating properties and potentiates PD-L1 blockade

Abstract Number:

2250

Session Title:

Immune Mechanisms Invoked by Therapies 2

Date/Time:

June 22, 2020, 9:00 a.m. – 6:00 p.m. EDT

Presenter:

Trevor Hallam, Ph.D.

Title:

M1231: A first-in-class bispecific antibody-drug conjugate targeting EGFR and MUC1

Abstract Number:

5686

Session Title:

Emerging Mechanisms of Resistance to Targeted Therapies

Date/Time:

June 24, 2020, 10:05 a.m. – 10:15 a.m. EDT

Presenter:

Jan Anderl, Ph.D.

The abstracts can be found on the AACR (Free AACR Whitepaper) website. The Sutro virtual poster presentation will be on the AACR (Free AACR Whitepaper) website on June 22, 2020, and will be also accessible through the Clinical/Scientific Presentation and Publication Highlights page of the News section of Sutro’s website at www.sutrobio.com on the day of the poster presentation