On October 12, 2021 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer (NMIBC) (Press release, Protara Therapeutics, OCT 12, 2021, View Source [SID1234591095]). Protara expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021.

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"We are thrilled to have reached this important milestone and look forward to quickly initiating our Phase 1 study in patients with NMIBC," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "There is an urgent need for new treatments for NMIBC. We are seeing significant increases in recurrence and disease progression, as well as an escalating number of patients requiring cystectomies. Supported by the strength of the existing clinical data in NMIBC for OK-432, the originator therapy for TARA-002, we believe this treatment represents a promising new option for NMIBC patients."

The Phase 1 dose-finding, open-label trial will evaluate TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a maximum tolerated dose and recommended dose for a future Phase 2 clinical trial.

TARA-002 is manufactured from the same cell bank as OK-432, an approved therapy in Japan and Taiwan for multiple oncologic indications. In 2020, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432. The confirmatory, GMP-scale comparability data for TARA-002 in relation to OK-432 have been completed and were reviewed by FDA as part of the clearance of the IND.

About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of non-muscle invasive bladder cancer and lymphatic malformations (LMs) for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully demonstrated manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-6, IL-8, IL-12, interferon-gamma (IFN-γ)-, tumor necrosis factor-alpha (TNF-α), and vascular endothelial growth factor (VEGF) are secreted by immune cells to induce a strong local inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On October 12, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Acceleron Pharma Inc. (Nasdaq: XLRN) (Press release, Merck & Co, OCT 12, 2021, View Source [SID1234591094]). On Sept. 30, 2021, Merck announced that it had entered into a definitive agreement to acquire Acceleron.

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Upon the successful closing of the tender offer, stockholders of Acceleron will receive $180 in cash for each share of Acceleron common stock validly tendered and not validly withdrawn in the offer, without interest and less any required tax withholding. Following the purchase of shares in the tender offer, Acceleron will become a subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (the "SEC") a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Acceleron will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Acceleron board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at 5:00 p.m., Eastern Time, on Nov. 10, 2021, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Acceleron’s outstanding shares, receipt of applicable regulatory approvals, and other customary conditions. The transaction is expected to close in the fourth quarter of 2021.

On October 12, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported that it has scheduled a conference call for Tuesday, Nov. 2, 2021, at 8 a.m. (ET) its third quarter financial results for the period ending Oct. 1, 2021 (Press release, Leidos, OCT 12, 2021, View Source [SID1234591093]). The company plans to issue its quarterly earnings press release before the conference call on Nov. 2, 2021.

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The details for the earnings conference call follow:

Replay:

A telephone playback of the third quarter earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on Nov. 2, 2021, through 11:59 p.m. (ET) on Nov. 9, 2021. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415), and entering conference ID 13723845.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source

On October 12, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company developing novel immunotherapies for the treatment of solid tumors, reported its first patient was dosed in the company’s LUMINOS-103 bladder cancer sub-study (NCT04690699) (Press release, Istari Oncology, OCT 12, 2021, View Source [SID1234591092]). In this sub-study, the safety and response to the company’s novel intratumoral viral immunotherapy, PVSRIPO, is being assessed as a neoadjuvant therapy with or without PD-1 inhibitors in adult bladder cancer patients who are ineligible for chemotherapy. Positive results from this sub-study may lead to a future trial to determine if radical cystectomy (removal of the bladder) could be avoided.

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PVSRIPO is an investigational immunotherapy based on the live–attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has been shown to activate a patient’s innate and adaptive immune system to facilitate a systemic anti-tumor immune response. Because PVSRIPO utilizes CD155 (the poliovirus receptor) to enter both solid tumor cells and antigen–presenting cells (APCs) in the tumor microenvironment, it has the potential to treat a variety of cancers.

"PVSRIPO has shown impressive responses with monotherapy in patients participating in two phase 1clinical trials focused on glioblastoma and melanoma," said Matt Stober, president and CEO at Istari Oncology. "We look forward to further evaluating its therapeutic value as we aim to expand the potential treatment options for patients living with bladder cancer."

LUMINOS-103 is a phase 1/2, multi-center, open-label, single-arm basket trial evaluating the administration of PVSRIPO with or without PD-1/L1 inhibitors across multiple tumor types, including muscle-invasive bladder cancer, and head and neck cancer (a sub-study that opened for enrollment in August 2021). The phase 2 LUMINOS-103 bladder cancer sub-study will be conducted at approximately 10 research sites across the U.S. It will evaluate both a neoadjuvant approach in patients with resectable disease, and separately in a cohort of patients with metastatic disease.

An analysis of each cohort comprising the LUMINOS-103 bladder cancer sub-study is planned once 25 to 30 patients per cohort have been enrolled and treated for at least two months. Study endpoints include objective response rate (by RECIST criteria), durability of response, progression and recurrence–free survival, and overall survival.

"Bladder cancer patients, particularly those who cannot receive cisplatin-based chemotherapy or who have advanced disease, are urgently in need of viable treatment options that limit systemic toxicity and improve patient outcomes," said Dr. Neal Shore, MD FACS, U.S. chief medical officer of surgery and urology at GenisisCare US and principal investigator responsible for dosing the first patient in Istari Oncology’s LUMINOS-103 bladder cancer sub-study. "We are excited to be initiating the LUMINOS-103 sub-study at the Carolina Urologic Research Center, and we are hopeful that the promising data achieved in previous clinical studies investigating PVSRIPO in patients with glioblastoma and melanoma will translate to positive outcomes for those in the bladder cancer community."

According to the Bladder Cancer Advocacy Network (BCAN), a national advocacy organization devoted to advancing bladder cancer research and supporting those impacted by the disease, bladder cancer most often begins in the urothelial cells that line the inside of the bladder with most tumors developing on the inner layer of the bladder. Bladder cancer becomes more difficult to treat as it grows through the layers of the bladder and into the muscle wall. Though less frequently, bladder cancer can also occur in the kidneys and ureters. The American Cancer Society estimates 84,000 new cases of bladder cancer in the U.S. in 2021.

For more information about Istari Oncology and its ongoing clinical trials, visit www.istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO targets cells using the poliovirus receptor CD155, which is widely expressed on both the malignant cells of most solid tumors and key antigen presenting cells within the tumor microenvironment. PVSRIPO targets tumors using three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of poliovirus vaccine-specific T cells. PVSRIPO has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

On October 12, 2021 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported a new strategic collaboration with Labcorp, a leading global life sciences company, to develop and commercialize new RNA-based gene signatures as diagnostics for people with cancer (Press release, GeneCentric Therapeutics, OCT 12, 2021, View Source [SID1234591091]).

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This latest collaboration builds on the organizations’ existing relationship. It involves ribonucleic acid (RNA)-based diagnostics and companion diagnostics development, combining GeneCentric’s extensive pipeline of predictive response gene signatures with Labcorp’s decades-long leadership in bringing new tests to market.

RNA-based gene signatures will be co-developed alongside Labcorp Drug Development, while subsequent tests will be deployed to major academic and community cancer centers through Labcorp Diagnostics. RNA-based gene signatures and associated diagnostic development will be accomplished through retrospective analysis of Labcorp’s de-identified clinical and genomic data and through GeneCentric’s pharmaceutical and biotechnology partnerships. Under the agreement, GeneCentric stands to earn development milestones in addition to commercialization terms. Additionally, Labcorp has made an upfront investment in the company.

"Labcorp has been a great partner as GeneCentric pioneered RNA-based gene signature technology and diagnostics to where they are today," said Michael Milburn, Ph.D., GeneCentric president and CEO. "They have an established track record of innovation in the precision medicine space with their extensive menu of companion and complementary diagnostic tests, as well as a shared vision for the promise of RNA signatures as the next generation of cancer diagnostics. This expanded collaboration will be instrumental in helping us commercialize our novel, RNA-based diagnostics."

RNA-based gene signatures provide deeper insights of the tumor and immune micro-environment when compared to traditional DNA testing. They can be used to identify a broader patient population that may benefit from targeted or immunotherapy.

"Our latest strategic collaboration with GeneCentric will draw upon their industry-leading RNA-based signatures and help facilitate the creation of better tools for oncology diagnostics, drug development and patient care," said Steven Anderson, Ph.D., senior vice president and chief scientific officer at Labcorp Drug Development. "The new diagnostics developed through this arrangement will further our goal of enabling physicians to improve outcomes by tailoring treatment options based on precision medicine."