On February 8, 2023 Prestige Biopharma, a Singapore-based biopharmaceutical company, reported the publication of ‘Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting’ in ‘BMC (BioMed Central) Cancer’ (Press release, Prestige BioPharma, FEB 8, 2023, View Source [SID1234626961]). HD201 (Tuznue) is the company’s Herceptin biosimilar. Based on the final analysis of phase 3 clinical trial, the company plans to expedite the preparation for BLA submission to US FDA (Food and Drug Administration).

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BMC cancer is a peer-reviewed open access medical journal that publishes original research on cancer and oncology. Following the previous analysis at a median follow-up of 31 months, this final analysis has compared long-term survival rates at a median follow-up of 37.7 months, confirming the comparable efficacy and safety of HD201 and trastuzumab. The publication of the final analysis was led by professor Xavier Pivot who took charge of the clinical trial of Roche’s Herceptin and Samsung Bioepis’ Herceptin biosimilar.

The global phase 3 clinical trial of HD201 was carried out from February 2018 to January 2022 in 12 countries for a total of 502 HER2 positive cancer patients who randomly received treatment with either HD201 or referent trastuzumab. According to the final analysis, which was performed after all patients completed the study at a median follow-up of 37.7 months, HD201 has shown excellence in long-term efficacy and safety. The 3-year event-free survival (EFS) rates were 85.6% and 84.9% in the HD201 and referent trastuzumab groups, respectively, and the 3-year overall survival (OS) rates were 95.6% and 96.0%, confirming comparability of HD201 and the referent trastuzumab.

Prestige Biopharma has previously supported the excellence of HD201 through several publications of studies and analysis. In July 2021, the company published a bridging study in ‘Pharmacology Research & Perspectives’ equivalent pharmacokinetic and safety profile to both US-Herceptin and EU- Herceptin. In March 2022, the company’s publication of phase 3 clinical trial analysis in ‘JAMA Oncology’ highlighted comparative efficacy and safety of HD201 and the referent trastuzumab in terms of the total pathological complete response rates.

Lisa S. Park, CEO of Prestige Biopharma, commented: "This final analysis, based on the data that we have been accumulated over the past three years, has once again proved the excellence of HD201, being published in a reputable journal in the field of oncology. Confident with high comparability with the original drug, efficient production through our affiliate company Prestige Biologics, and past experience in applying for marketing authorization to EMA, we will focus on getting the marketing authorization for HD201 in various regions including US, Europe, Canada, and Korea as soon as possible."

On February 8, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that it will present fourth quarter and full year 2022 financial results on Wednesday, February 15, 2023. Karyopharm’s management team will host a conference call and audio webcast at 8:00 a.m. ET on Wednesday, February 15, 2023, to discuss the financial results and other company updates (Press release, Karyopharm, FEB 8, 2023, View Source,-2023 [SID1234626959]).

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To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

On February 8, 2023 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in fireside chats at the following investor conferences in February (Press release, CRISPR Therapeutics, FEB 8, 2023, View Source [SID1234626958]).

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SVB Securities Global Biopharma Conference
Date: Wednesday, February 15, 2023
Time: 1:40 p.m. ET

Citi’s 2023 Virtual Oncology Leadership Summit
Date: Wednesday, February 22, 2023
Time: 1:00 p.m. ET

A live webcast of the fireside chats will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On February 8, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that its diagnostic 64Cu SAR-bisPSMA trial COBRA (NCT05249127)1 for patients with prostate cancer has reached its recruitment target (Press release, Clarity Pharmaceuticals, FEB 8, 2023, View Source [SID1234626957]).

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COBRA (Copper-64 SAR-bisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in 50 participants. The primary objectives of the trial are to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect the recurrence of prostate cancer.

Dr Neal Shore MD, FACS Lead Principal Investigator in the COBRA trial and CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre, commented, "We are very pleased to have reached our recruitment target for the COBRA trial. The data generated thus far on the SAR-bisPSMA product is very encouraging and shows high uptake of the agent by prostate cancer cells. The high uptake of product and the ability to image the patients at later timepoints adds both patient and clinic flexibility for locating and visualising even low volume tumours, a unique feature of this imaging technology. It is important for improving prostate cancer recurrence detection where the cancer burden may be quite low and thus identifying the specific location provides clinically important implications for the patients’ therapeutic selection. We look forward to analysing the COBRA trial data and advancing the clinical development of SAR-bisPSMA together with Clarity."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the progress in the development of the SAR-bisPSMA product across all of our trials, which continues to build a lot of excitement and was reflected by the pace of recruitment in the COBRA trial. In addition to potential clinical benefits due to higher uptake and the flexibility of imaging timepoints, 64Cu SAR-bisPSMA has a number of logistical and manufacturing advantages in comparison to other currently used PSMA agents. The ready-to-use product has been shipped to the trial sites in the US from a central manufacturing facility on-demand and on time, providing flexibility and reliability to the patients and their treating staff. This facilitates expanding the radiopharmaceutical field into the large oncology market, minimising logistical and image timing hindrances associated with the current generation of radio-diagnostics, and helping to focus on the needs of patients and their clinicians.

"COBRA is our second diagnostic trial of SAR-bisPSMA in prostate cancer. It reaches its recruitment target shortly after receiving positive top-line results in our PROPELLER trial. Running two trials with this product is in line with advice received from the US FDA to address the two relevant patient populations for registration of 64Cu SAR-bisPSMA: in pre-prostatectomy/pre-definitive treatment of patients with confirmed prostate cancer (PROPELLER trial); and in patients with suspected BCR of prostate cancer (COBRA trial).

"We look forward to analysing the data from the COBRA trial with a view to initiating a Phase III trial in this patient population."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of prostate cancer in the US and around 34,700 deaths from the disease3.

On February 8, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that C4T management will participate in a fireside chat and a panel discussion at two upcoming virtual conferences in February (Press release, C4 Therapeutics, FEB 8, 2023, View Source [SID1234626955]).

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Fireside Chat Details:

Event: SVB Securities Global Biopharma Conference
Date/Time: Wednesday, February 15 at 3:00 PM ET

Panel Discussion Details:

Event: 2023 Wells Fargo Targeted Protein Degradation Virtual Summit
Panel Title: Key Targets for Targeted Protein Degradation in Oncology and Potential Combo Strategies
Date/Time: Tuesday, February 21 at 12:00 PM ET

Live webcasts of the presentations will be available on the Investors section of the company’s website at www.c4therapeutics.com. Archived replays of the webcasts will be available for approximately 30 days following the presentations.