Genprex Announces Centralized Institutional Review Board Approval for Acclaim-1 Clinical Trial in Non-Small Cell Lung Cancer

On May 5, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Company has received centralized Institutional Review Board (IRB) approval of the clinical trial protocol for its upcoming Acclaim-1 clinical trial in non-small cell lung cancer (NSCLC) (Press release, Genprex, MAY 5, 2021, View Source [SID1234579219]). Acclaim-1 is an open-label, multi-center Phase 1/2 clinical trial that combines the Company’s lead drug candidate, REQORSA immunogene therapy, with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with mutated epidermal growth factor receptors (EGFRs), whose disease progressed after treatment with Tagrisso.

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"The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of individuals participating as subjects in clinical research," said Rodney Varner, President and Chief Executive Officer of Genprex. "With this centralized IRB approval, we have achieved another significant clinical milestone. We remain focused on completing our preparations for the Acclaim-1 clinical trial, and look forward to its commencement."

An IRB is a U.S. Food and Drug Administration (FDA) registered constituted group of medical professionals that are responsible for reviewing and monitoring biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. IRB group review serves an important role in the protection of the rights, safety and welfare of human research subjects.

A centralized IRB review process involves an agreement under which multiple study sites in a multicenter trial can rely on the review of a centralized IRB, other than the IRB affiliated with each individual research site. The goal of the centralized process is to increase efficiency and decrease duplicative efforts, while enabling the central IRB to take responsibility for all aspects of IRB review at each site participating in the centralized review process.

In January 2020, the Company received FDA Fast Track Designation for its Acclaim-1 patient population. Genprex has recently completed the manufacturing and scaled-up clinical grade production of REQORSA to supply drug product for its upcoming Acclaim clinical trials.

The Company expects to conduct the Acclaim-1 clinical trial at approximately 15 U.S. clinical sites with participation of approximately 92 patients (with up to 18 patients in the Phase 1 component and up to 74 patients in the Phase 2 component). An interim analysis will be performed after 25 clinical events (i.e., disease progression or death). Additional information on the Acclaim-1 clinical trial can be found by visiting ClinicalTrials.gov.

Infinity to Present at New York Academy of Sciences’ Frontiers in Cancer Immunotherapy 2021

On May 5, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic that addresses a fundamental biologic mechanism of immune suppression in cancer, reported that the Company will have a presentation summarizing recent eganelisib clinical data will be followed by a Q&A session at the New York Academy of Sciences’ Frontiers in Cancer Immunotherapy 2021 virtual symposium taking place on May 12-14, 2021 (Press release, Infinity Pharmaceuticals, MAY 5, 2021, View Source [SID1234579218]).

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Presentation Details:

Title:
Eganelisib (IPI-549) Activity as a Macrophage Reprogramming Therapeutic Candidate in 1L Metastatic TNBC, 2L Metastatic Urothelial Cancer and Other Solid Tumors

Date:
Wednesday, May 12

Time:
1:26 pm Eastern Time

The presentation can be accessed in the Investors/Media section of Infinity’s website at www.infi.com and will be available on Infinity’s website for 30 days following the event.

Leidos To Participate In The Goldman Sachs Industrials And Materials Conference 2021

On May 5, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will participate in the Goldman Sachs Industrials and Materials Conference 2021 webcast (Press release, Leidos, MAY 5, 2021, View Source [SID1234579217]).

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Jim Reagan, Chief Financial Officer, will participate in a question and answer "fireside chat" on Tuesday, May 11, 2021 at 10:30 a.m. ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for one year afterward.

CrownBio Acquires OcellO B.V. to Expand Its Preclinical In Vitro Drug Development Service Offerings

On May 5, 2021 Crown Bioscience (CrownBio), a JSR Life Sciences company and leader in preclinical services that help biopharmaceutical companies accelerate new drug development programs reported that it has acquired OcellO B.V., a privately owned contract research organization located in the Netherlands (Press release, Crown Bioscience, MAY 5, 2021, View Source [SID1234579216]). Through the acquisition, CrownBio will expand its portfolio of in vitro services, integrating OcellO’s expertise in high content imaging alongside CrownBio’s in vitro and in vivo screens and immunotherapy assessment services. Financial terms are not being disclosed.

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"CrownBio and OcellO believe that the key to improving clinical research success is to utilize more patient-relevant models and assays that can generate reliable efficacy data as early as possible in the drug development process," said Armin Spura, PhD, Chief Executive Officer of CrownBio. "This acquisition brings together the complementary strengths of our two companies, enhancing our in vitro services portfolio and offering customers the ability to better evaluate multiple drug combinations and targets, across a wider range of tumor and cancer types, with improved predictability and clinical relevance moving from in vitro to in vivo phases of drug discovery."

The acquisition establishes CrownBio as the only global source licensed to offer customers specialized Hubrecht Organoid Technology (HUB) for drug development programs. Under the terms of the agreement, Leo Price, PhD, OcellO’s Chief Executive Officer and Chief Scientific Officer, will join CrownBio as Senior Vice President, In Vitro, to lead the Company’s in vitro business in the US and Europe.

"I am delighted to join CrownBio and help grow the company’s in vitro portfolio," said Dr. Price. "We will continue our shared heritage of innovation and dedication to customer service to serve complex needs in early-stage cancer drug development. Our combined expertise is particularly suited for disease-relevant large-scale screening, allowing our customers to evaluate multiple drug combinations in a rapid, scientifically rigorous, and cost-effective way."

Clovis Oncology Announces First Quarter 2021 Operating Results

On May 5, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended March 31, 2021, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the rest of the year (Press release, Clovis Oncology, MAY 5, 2021, View Source [SID1234579215]).

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"The second quarter of 2021 marks an important moment in our commitment to targeted radionuclide therapies, as the FDA clearance of our INDs for FAP-2286 enables us to initiate the Phase 1 portion of the LuMIERE study this quarter as planned. We are increasingly enthusiastic about FAP-2286 and its potential to treat patients with solid tumors, and about targeted radiotherapeutics as a class," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "While continuing headwinds from COVID-19 impacted Rubraca sales this quarter, we believe this effect will lessen over the course of this year. Importantly, since each approved PARP inhibitor faced some impact from COVID-19 in the US market in Q1 2021 compared to Q4 2020, we believe we maintained market share in the US. Finally, we are not far from top-line ATHENA monotherapy data as a front-line maintenance treatment for women with advanced ovarian cancer, expected in the second half of this year, which will be the most important indication for Rubraca."

First Quarter 2021 Financial Results

Clovis reported global net product revenues for Rubraca of $38.1 million for Q1 2021, which included US product revenues of $31.7 million and ex-US product revenues of $6.4 million, respectively. This represents an 11% decrease year-over-year, compared to Q1 2020 net product revenues of $42.6 million, which included US net product revenues of $39.3 million and ex-US net product revenues of $3.3 million. The decrease was primarily due to fewer diagnoses and fewer patient starts, substantially due to the ongoing COVID-19 pandemic. In addition, first quarter 2020 was the Company’s strongest quarter of US Rubraca sales to date, and the COVID-19 pandemic had limited, if any, effect on Q1 2020 net revenues.

Research and development expenses totaled $52.8 million for Q1 2021, down 23% compared to $68.2 million for the comparable period in 2020, due primarily to lower spending on Rubraca clinical trials. As previously discussed, the Company expects research and development expenses to be lower in the full year 2021 compared to 2020.

Selling, general and administrative expenses totaled $29.9 million for Q1 2021, down 30% compared to $42.6 million for the comparable period in 2020, due to the COVID-19 situation globally and overall cost reduction efforts. Clovis continues to expect selling, general and administrative expenses to decrease in the full year 2021 compared to 2020.

Clovis reported a net loss for Q1 2021 of $66.3 million, or ($0.64) per share, compared to a net loss for Q1 2020 of $99.3 million, or ($1.39) per share. Net loss for Q1 2021 included share-based compensation expense of $4.0 million, compared to $13.0 million for the comparable period of 2020.

Clovis had $190.9 million in cash and cash equivalents as of March 31, 2021, which together with the ATHENA clinical trial financing, is expected to fund the Company’s operating plan into early 2023 based on current revenue and expense forecasts.

As of March 31, 2021, the Company had drawn $113.6 million under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial financing and had up to $61.4 million available to draw under the agreement to fund the expenses of the ATHENA trial.

Net cash used in operating activities was $61.9 million for Q1 2021, down from $82.5 million reported in Q1 2020. Cash burn in Q1 2021 was $48.1 million, down 28% from $66.9 million in Q1 2020. We expect this trend of lower cash burn to continue in 2021.

Clovis Oncology Pipeline Highlights

Anticipated Rubraca Pipeline Events in 2021

Top-line data from the ATHENA Phase 3 study in first-line maintenance treatment ovarian cancer setting evaluating Rubraca monotherapy versus placebo are expected in the second-half of 2021, contingent upon the occurrence of the protocol-specified progression-free survival (PFS) events. Data from the combination arm of Rubraca plus Opdivo (nivolumab) versus Rubraca monotherapy are expected a year or more later.

LODESTAR, the Company’s Phase 2 trial of Rubraca in patients with solid tumors with deleterious mutations in homologous recombination repair (HRR) genes is currently enrolling. This study may be registration-enabling, with a potential regulatory filing in 1H 2022.

LuMIERE Phase 1/2 Study of FAP-2286 Expected to Begin 1H 2021

FAP-2286 is Clovis Oncology’s peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) and is the lead candidate in the Company’s PTRT development program. With FDA clearance of each of the treatment and imaging IND applications for FAP-2286, Clovis expects to open for enrollment the Phase 1/2 LuMIERE clinical study this quarter. The Phase 1 portion of the LuMIERE study will evaluate the safety of the FAP-targeting investigational therapeutic agent and identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

Interim LIO-1 Data of Lucitanib and Opdivo in Combination Expected in 2021

Clovis Oncology’s Phase 1b/2 LIO-1 study is evaluating the combination of lucitanib and Opdivo in gynecologic cancers, and the Phase 2 portion is enrolling patients into four expansion cohorts: non-clear cell ovarian; non-clear cell endometrial; cervical; and clear-cell ovarian and endometrial cancers. Interim data from the non-clear-cell ovarian cancer expansion cohort have been accepted as a poster presentation at ASCO (Free ASCO Whitepaper) in early June, and while evidence of clinical activity has been observed, Clovis does not believe that the efficacy data support further development in non-clear-cell ovarian cancer. Enrollment continues in the three other expansion cohorts, and the Company continues to plan to submit an abstract to a medical meeting later this year describing the interim endometrial cohort data.

Conference Call Details

Clovis will hold a conference call to discuss Q1 2021 results this morning, May 5, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants (877) 698-7048, International participants (647) 689-5448, conference ID: 3219208.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. 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 approved in the US 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. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. 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. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

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 an unlicensed medical product outside the US and Europe.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. FAP is highly expressed on cancer-associated fibroblasts (CAFs) in many epithelial cancers, including more than 90% of breast, lung, colorectal, and pancreatic carcinomas.i Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

About Lucitanib

Lucitanib is an investigational angiogenesis inhibitor which inhibits vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy. Clovis holds global rights for lucitanib excluding China.

Lucitanib is an unlicensed medical product.