On March 28, 2023 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company that employs a suite of innovative technologies to develop best-in-class radiopharmaceuticals for the monitoring and treatment of cancers, reported the licensing of a Granzyme B-targeted agent for PET imaging applications from Merck, known as MSD outside the United States and Canada (Press release, Ratio Therapeutics, MAR 28, 2023, View Source [SID1234629466]).

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Under the terms of the agreement, Merck will provide Ratio with several candidates and supporting preclinical and CMC data of its Granzyme B-targeted agent for PET imaging applications. Ratio will also be responsible for clinical development and will build a GMP production network for the PET imaging agent across North America, Western Europe, Japan, Australia, and beyond.

"We are thrilled to contribute our knowledge in nuclear medicine to advance the development of a novel imaging diagnostic in immunology and work alongside Merck, a global biopharmaceutical leader that has demonstrated a strong commitment to innovation and excellence for more than a century," said Dr. Jack Hoppin, Ratio’s Chairman and Chief Executive Officer. "The development of a Granzyme B-targeted agent for PET imaging has the potential to monitor responses to therapeutic interventions in clinical research."

Granzyme B is an enzyme released by activated immune cells, such as natural killer and cytotoxic T cells, with the primary function of killing tumor cells and normal cells infected with viruses. As such, Granzyme B holds potential to serve as a PET imaging biomarker to monitor immune cell activation in a variety of inflammatory diseases, autoimmune diseases, cancer and infection. The ability to visualize and quantify localized immune response empowers physicians to measure the early efficacy of therapies and modify treatment accordingly.

On March 28, 2023 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported the pricing of a public offering of 3,437,500 of its American Depositary Shares (the "ADSs") (or pre-funded warrants in lieu thereof), together with Series C warrants (the "Series C Warrants") to purchase up to 3,437,500 of its ADSs at a public offering price of $1.60 per ADS (or pre-funded warrant in lieu thereof) and associated Series C Warrant (Press release, TC Biopharm, MAR 28, 2023, View Source [SID1234629465]). The Series C Warrants will have an exercise price of $1.75 per ADS, are exercisable upon issuance and will expire five years following the date of issuance. Each ADS representing one ordinary share of the Company. The closing of the offering is expected to occur on or about March 30, 2023, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

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The gross proceeds to the Company from the offering are expected to be approximately $5.5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

A registration statement on Form F-1 (File No. 333-270808) relating to these securities has been filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on March 27, 2023. The offering will be made only by means of a prospectus, which is part of the effective registration statement. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The Company also has agreed that certain existing warrants to purchase up to an aggregate of 2,800,000 ADSs of the Company that were previously issued on November 30, 2022, at an exercise price of $5.00 per ADS and expiration dates of May 30, 2025 and May 30, 2028, will be amended effective upon the closing of the offering so that the amended warrants will have a reduced exercise price of $1.75 per ADS.

On March 28, 2023 Treatment of the first participant in a clinical trial of FLASH proton therapy for cancers in the bones of the chest has been completed at the Cincinnati Children’s/University of Cincinnati Medical Center Proton Therapy Center (Press release, Cincinnati Children’s Hospital Medical Center, MAR 28, 2023, View Source [SID1234629464]).

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FLASH is an investigational mode of radiation therapy delivery that can be administered to a patient in less than 1 second. Research in the laboratory suggests that FLASH may result in fewer side effects than standard forms of radiation delivery, and the clinical trial is testing the feasibility of FLASH to treat people with cancer.

The new study, called FAST-02, marks a significant achievement for the Proton Therapy Center in Cincinnati, which continues to lead the way in global research in the field of FLASH proton therapy.

FAST-02 follows a breakthrough last year in the world’s first clinical trial of FLASH proton therapy in people, the FAST-01 study (FeAsibility Study of FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases). That study focused on people with bone metastases in the extremities.

Now, Cincinnati Children’s researchers are collaborating with University of Cincinnati researchers to establish the efficacy of ultra-high dose rate proton therapy in treating painful bone metastases in the chest. The FAST-02 study is sponsored by Varian, a Siemens Healthineers company.

Ten adults whose metastatic cancer has spread to their chest bones will participate in the research clinical trial of FLASH proton therapy.

In pre-clinical testing, FLASH proton therapy has been shown to potentially reduce side effects of radiation treatment compared to conventional radiation. However, until recently, the technology to deliver FLASH radiation for cancer patients was not available.

"Our dedicated team of researchers, clinicians, and staff are committed to advancing the field of cancer treatment and finding new ways to improve patient outcomes," said John Breneman, MD, medical director of the Cincinnati Children’s/UC Medical Center Proton Therapy Center, who is principal site investigator for the FAST-02 clinical trial.

The Proton Therapy Center in Cincinnati is a state-of-the-art facility that features cutting-edge technology and equipment, allowing researchers to develop and test new treatments for a wide range of malignancies.

"This trial of an ultra-high dose rate of proton therapy is just one of our efforts to develop new and innovative cancer treatments," said John Perentesis, MD, who is research director of the Proton Therapy Center and director of oncology and cancer programs at Cincinnati Children’s. "Our goal is to establish a foundation for future potential trials in brain tumors, sarcomas, lymphomas, lung cancer, and other malignancies, and we are excited about the impact this research might have on cancer care."

Anthony Mascia, PhD, who is chief physicist at the Proton Therapy Center in Cincinnati, said: "The promise of FLASH is to be able to deliver treatment at ultra-high dose rates with potentially fewer side effects. We currently are doing research studies into its efficacy, which, if confirmed, could transform radiation oncology."

The $126 million Cincinnati Children’s/UC Medical Center Proton Therapy Center incorporates a $24 million, one-of-a-kind research facility, which includes integrated laboratories and a fully operational proton treatment room dedicated exclusively for research. In addition, children and adults from around the world receive treatment for more than 30 types of cancer in the two clinical proton therapy rooms.

The Proton Therapy Center on the Liberty Campus of Cincinnati Children’s is one of only a few facilities in the world that can deliver FLASH proton therapy in a clinical setting. With this latest clinical trial, the medical center continues to push the boundaries of cancer treatment – and to offer hope to patients and families affected by this devastating disease.

On March 28, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), reported its full-year 2022 financial results and provided updates on key events and achievements since the start of 2022 (Press release, Antengene, MAR 28, 2023, View Source [SID1234629463]).

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1. Sales Revenue Reached 5.6 Times Year-Over-Year while the Adjusted Loss Narrowed by 10.3%

– XPOVIO (selinexor), Antengene’s first commercialized product and the world’s first oral XPO1 inhibitor leveraging a novel mechanism of action, generated a total of RMB160 million in revenue in 2022, a sum amounted to 5.6 times of 2021 (the product was commercially launched in Mainland of China on May 13, 2022).

– As a result of the strong revenue growth, the adjusted loss for 2022 was narrowed by 10.3%.

2. First/Best-in-Class Potential Clinical Programs as Value Drivers for Future Growth of Antengene

– Antengene has built a pipeline of 9 oncology programs at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. Some of these assets, such as ATG-031 (anti-CD24 antibody), have first-in-class potentials; while others, such as ATG-008 (mTORC1/2 inhibitor), ATG-037 (CD73 inhibitor), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-008 (ATR inhibitor), ATG-022 (Claudin 18.2 antibody-drug conjugate), and ATG-017 (ERK1/2 inhibitor), have best-in-class potentials. These assets are currently being evaluated in a total of 16 clinical trials around the world.

– Clinical achievements in 2022 and early 2023 include obtaining 7 IND approvals and an Orphan Drug Designation, as well as the dosing of the first patient in 5 studies.

– Released results from 16 preclinical and clinical studies at 7 renowned international congresses and medical journals including the AACR (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper), SITC (Free SITC Whitepaper), CSCO, EHA (Free EHA Whitepaper), ASH (Free ASH Whitepaper) and BMC Medicine.

3. Fast-Growing Pan-APAC Commercialization of XPOVIO

– The commercialization network for XPOVIO in China now covers 600 hospitals and over 120 direct-to-patient (DTP) pharmacies in over 30 provinces and autonomous regions, and municipalities. XPOVIO attained 34 urban-customized commercial health insurance listings (Huiminbao).

– 6 XPOVIO regimens received a total of 27 inclusions or upgraded recommendations by 7 major clinical guidelines and evidence-based studies. In addition, XPOVIO was also included into 2 Guiding Principles for Clinical Applications and expert consensuses.

– In 2022, XPOVIO obtained NDA approvals in 3 markets including Australia, Singapore, and Taiwan, China. In addition, Antengene secured the first APAC reimbursement listing for XPOVIO by the Pharmaceutical Benefits Scheme (PBS) in Australia. NDAs for XPOVIO were submitted in 3 other countries and regions including Macau, China, Thailand, and Malaysia.

– In 2023, Antengene expects XPOVIO to be approved in Hong Kong, China and Macau, China and plans to submit an NDA for XPOVIO in Indonesia. Moreover, the company also plans to submit a supplementary New Drug Application (sNDA) for XPOVIO for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) in Mainland of China.

4. High Profile Clinical Trial Collaborations in 2022

– Entered into a clinical collaboration with BeiGene on a Phase I/II study evaluating XPOVIO in combination with tislelizumab in patients with T and NK-cell lymphoma.

– Entered into a clinical collaboration with MSD on the Phase I STAMINA-001 trial designed to evaluate ATG-037 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors.

5. A Strong Cash and Bank Balance to Provide Runway Beyond 2025

– As of December 31st, 2022, the company has a cash and bank balance of about RMB1.8 billion. This strong cash and bank balance, together with the strong near-term revenue growth potential of XPOVIO and careful spending, enables the continuous growth, development, and operation of Antengene beyond 2025.

"In 2022, we made notable strides on multiple fronts of our business. The revenue from our lead product, XPOVIO, reached RMB160 million in 2022, a sum amounted to 5.6 times year-over-year. Meanwhile, we delivered crucial milestones in drug discovery and development, with a number of our potential BIC/FIC programs already entered clinical studies in Australia, Mainland of China, and the U.S. We expect these clinical programs to begin yielding results sometime during 2023 and 2024," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "This impressive performance is a testament to the highly effective global collaboration by our commercial teams and the company’s strong capabilities in drug discovery and development. Moreover, we expect our cash and bank balances totalling about RMB1.8 billion to support Antengene’s planned operations and revenue growth beyond 2025. Moving forward, we will continuously strive to become a leading multinational biopharmaceutical company with a portfolio of commercialized products, committed to improving the quality of life for cancer patients and creating value for our shareholders and partners."

On March 28, 2023 Mount Sinai Medical Center (MSMC) reported the results of a clinical trial led by Brian Slomovitz, MD, Professor of Obstetrics/Gynecology and Division Director at Mount Sinai Medical Center in Miami Beach, Florida (Press release, Mount Sinai Hospital, MAR 28, 2023, View Source [SID1234629462]). The investigator-initiated phase II trial, sponsored by the GOG Foundation, investigated the combination of ribociclib and letrozole in patients with recurrent low-grade serous ovarian cancer (LGSOC) (GOG-3026) presenting positive results that will change the standard of care for this cancer moving forward. As the Principal Investigator for this trial, Dr. Slomovitz presented the results at The Society of Gynecologic Oncology’s 2023 Annual Meeting on Women’s Cancer in Tampa, Florida.

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Ribociclib and letrozole combination is active in patients with advanced or recurrent LGSOC: Phase II trial results:

ORR, PFS, DOR compare favorably to most active agents previously investigated.
In this trial, the reported response rate was 23%, the progression-free survival 19.1 months, and the duration of response of 19.1 months. Sixty-four percent of evaluable patients experienced a reduction in target tumor size.

"These results are promising. Women with this disease have limited treatment options. The progression-free survival and duration of response are both 6 months greater than what we have observed with the current standard treatments," stated Dr. Slomovitz. LGSOC is a rare subtype of ovarian cancer, which typically occurs in younger women and may arise from a non-invasive precursor disease (serous borderline tumor). Approximately 80% of women with LGSOC suffer disease recurrence following primary therapy. Traditional treatment options, including chemotherapy, hormonal therapy, and biologic targeted therapies, have limited clinical efficacy and short durations of response. In particular, response rates to chemotherapy range from 0-15%. Treatment options for women with recurrent disease remains an unmet need.

Dr. Slomovitz added, "Our next steps are to compare this regimen of ribociclib and letrozole vs the best current therapies in a head-to-head study. Hopefully this work can lead to an FDA approval for this combination."

Mount Sinai Medical Center is excited about this promising advancement for gynecologic cancer patients dealing with rare tumors. This is yet another opportunity to help transform the standard of care in gynecologic oncology.