On January 27, 2022 Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), reported that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy (Press release, Dizal Pharma, JAN 27, 2022, View Source [SID1234607464]).

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"Lung cancer patients with exon20 insertion mutations need better treatment. Sunvozertinib was specifically designed with high selectivity for inhibiting mutated EGFR, which causes cancers. Available clinical evidence shows that Sunvozertinib has the potential to provide the patients with a new and much improved targeted therapy," said Dr. Xiaolin Zhang, Chief Executive Officer at Dizal. "We are very pleased with FDA’s decision. Now Sunvozertinib has received Breakthrough Therapy Designation from both US FDA and China CDE, which validates Sunvozertinib’s differentiated profile. At Dizal, we are committed to discover and develop innovative medicines for the benefit of cancer patients globally."

Breakthrough Therapy designation is a process designed by US FDA, China CDE, and other regulatory agencies to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)[1].

About DZD9008 (Sunvozertinib)

DZD9008 is a rationally designed selective, irreversible, novel EGFR inhibitor. In global Phase 1/2 studies, it has demonstrated promising antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. Its confirmed ORR is 45.5% at 200 mg and 41.9% at 300 mg (data cut-off by July 30, 2021). It also shows efficacy among patients with brain metastasis or previously treated by Amivantamab. It was well tolerated with a manageable AE profile.

Dizal is conducting Phase 2 pivotal clinical trials in China, U.S., EU, Japan, Australia, South Korea and other countries and regions.

On January 27, 2022 OS Therapies, a research and clinical-stage biopharmaceutical company reported that the Data Safety & Monitoring Committee (DSMC) approved open enrollment for AOST-2121: an open label Phase IIb Trial of OST-HER2 (Listeria monocytogenes) in Recurred, Resected Osteosarcoma (OS) (Press release, OS Therapies, JAN 27, 2022, View Source [SID1234607463]). OS is a deadly and debilitating cancer of the bone that usually occurs in adolescence and young adults (AYA).

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OS Therapies’ OST-HER2 is a Lm vector-based off-the-shelf Immunotherapy intended to prevent metastasis, delay recurrence, and increase overall survival. The FDA had requested a safety roll-out staggering the first three patients by three weeks – safety data from these patients has given the safety committee the ability to open the trial nationally to the remaining patients.

"The Osteosarcoma Community has been anxiously awaiting the clinical trial of this very promising technology ever since it was provisionally approved for dogs by the USDA – we just want to try it on our kids," said Miriam Cohen, Chair of the Osteosarcoma Collaborative (www.oscollaborative.org), an OS patient advocacy organization that has supported the trial.

Eleven of the twenty clinical trial sites currently open include:
Seattle Children’s Hospital
Connecticut Children’s Hospital
UPMC Children’s Hospital of Pittsburgh
Kaiser Permanente Downey Medical Center
St. Jude’s Children’s Research Hospital
Johns Hopkins Baltimore
UT Southwestern Children’s Medical Center
Hackensack University Medical Center
Children’s Hospital of Orange County
Rady Children’s Hospital
Children’s Hospital of Philadelphia (CHoP)

About Osteosarcoma
Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescent and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with initially metastatic or recurrence after chemotherapy, there is a significantly poorer prognosis.

On January 27, 2022 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported to offer for the second time two lung cancer research award programs to support early-stage lung cancer researchers from underrepresented populations in the biomedical research workforce (Press release, LUNGevity Foundation, JAN 27, 2022, View Source [SID1234607462]). These awards, to be granted in 2022, are in addition to LUNGevity’s 2022 Career Development Awards.

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The 2022 LUNGevity Health Equity and Inclusiveness Research Fellow Award program supports fellows interested in translational lung cancer research who belong to underrepresented minorities in STEM, as per the National Science Foundation. Applicants must hold a doctoral degree, be within the first or second year of their fellowship, and plan to pursue a lung cancer research career. This is a mentored award, which may be for a maximum of $100,000 over two years ($50,000 per year).

The 2022 LUNGevity Health Equity and Inclusiveness Junior Investigator Award program supports physician-scientists interested in conducting lung cancer clinical research. Applicants must hold a doctoral degree, be within the first five years of their first faculty appointment, and have completed a training fellowship. This is a mentored award, which may be for a maximum of $200,000 over two years ($100,000 per year).

"Healthcare inequity is a long-standing problem for underserved communities," explained Robert A. Winn, MD, director of Virginia Commonwealth University Massey Cancer Center and LUNGevity board member. "Lack of ethnic and racial minority clinicians and researchers exacerbates the issue. Programs like the LUNGevity HEI Awards that increase access to clinicians who understand the unique needs of underserved communities are a means to bridging the inequity gap."

Projects funded in 2022 are expected to have a direct impact on the early detection of lung cancer or the outcomes of lung cancer or to provide a clear conceptual or experimental foundation for the future development of methods of early detection and/or individualized treatment, including through targeted therapy and immunotherapy.

The RFAs for these awards are available on the LUNGevity website at LUNGevity.org/apply-for-award and the ProposalCentral website at proposalcentral.com.

"LUNGevity is proud to fund these awards to establish more diverse voices in the lung cancer workforce," stated LUNGevity CEO Andrea Ferris.

Letters of intent for both awards must be submitted by February 23, 2022.

On January 27, 2022 Peregrine Market Access, a leading life science commercialization partner, reported that it has been selected by Nonagen Bioscience to become its contract commercialization organization for Oncuria, a breakthrough bladder cancer diagnostic test that is being developed to aid in detection, therapy choice, and disease monitoring (Press release, Nonagen Bioscience, JAN 27, 2022, View Source [SID1234607461]). Under a multiyear, multimillion dollar agreement, Peregrine Market Access will lead the United States launch of Oncuria.

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"After an extensive search for the right commercialization partner, we are confident that Peregrine Market Access is the optimal choice to help us succeed in bringing Oncuria to market," explains Nonagen Bioscience CEO Charles Joel Rosser, MD, MBA. "John Guarino and his world-class team not only have the experience and expertise to help us navigate the complexities of launching a novel device in the United States, but they also share our passion to improve the lives of people living with chronic, life-threatening conditions."

Nonagen Bioscience’s Oncuria is a cutting-edge multiplex immunoassay that measures 10 protein biomarkers associated with bladder cancer using easy-to-collect urine samples. Oncuria is currently being investigated to aid in the diagnosis of bladder cancer and to monitor people with early-stage bladder cancer for cancer recurrence. Additionally, the ability of the Oncuria assay and a proprietary algorithm that uses the 10-biomarker molecular signature is being investigated to predict whether patients with intermediate- to high-risk, early-stage bladder cancer will respond to bacillus Calmette-Guérin (BCG), a first-line treatment for bladder cancer, or whether they should proceed with other treatment options. Oncuria received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in September 2021 for predicting the response to BCG therapy. That designation acknowledges the utility and potential clinical benefit of Oncuria and allows for expedited review with the FDA.

"We are excited to become an extension of the team at Nonagen Bioscience to advance a game-changing immunoassay in the fight against bladder cancer," says John Guarino, president and founder of Peregrine Market Access. "This partnership with Nonagen Bioscience will enable Peregrine to showcase the breadth and depth of our capabilities and, most importantly, to contribute to the noble work of saving people’s lives through timely intervention."

Nonagen Bioscience aims to give physicians and patients an effective diagnostic tool to improve clinical outcomes and reduce healthcare costs. The statistics surrounding bladder cancer demonstrate the unmet needs that exist: Each year, there are an estimated 84,000 new cases of bladder cancer diagnosed and more than 700,000 people living with bladder cancer in the United States.1 It is the fourth most common form of cancer in American men.2 Up to 77% of early-stage bladder tumors treated with current approaches (tumor resection and/or intravesical BCG or chemotherapy) will recur.3 More than half of patients who receive BCG as the first-line treatment for bladder cancer will fail to respond, and in 20% of patients the disease grows and extends during or after BCG treatment.4,5

On January 27, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $1.0 billion aggregate principal amount of 6.125% senior secured notes due 2027 (the "Notes") (Press release, Bausch Health, JAN 27, 2022, View Source [SID1234607460]). The Notes will be sold to investors at a price of 100% of the principal amount thereof.

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As previously announced, the Company is also seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur upon completion of the initial public offering ("IPO") of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing").

The proceeds from the offering of the Notes, along with the expected proceeds from the New Term B Loans, the Bausch + Lomb IPO and the repayment of an intercompany note owed to us by Bausch + Lomb (which repayment is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the Company’s previously announced conditional redemption in full of its outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund the Company’s previously announced conditional partial redemption of its outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025 and, collectively with the 6.125% Senior Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Credit Agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Credit Agreement and existing senior secured notes.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

The redemption of the 6.125% Notes due 2025 is conditioned upon the completion of the Credit Agreement Refinancing (the "6.125% Notes Condition"). The Company intends to discharge the indenture governing the 6.125% Notes due 2025 concurrently with satisfying such 6.125% Notes Condition. The partial redemption of the 9.000% Notes due 2025 is conditioned upon the receipt of aggregate gross proceeds from the Bausch + Lomb IPO, the Bausch + Lomb Debt Financing, the Credit Agreement Refinancing and the offering of the Notes of at least $7.0 billion (the "9.000% Notes Condition" and, together with the 6.125% Notes Condition, the "Conditions"). This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.