On November 22, 2022 EXACT Therapeutics AS ("EXACT-Tx", Euronext Growth: EXTX), a Norwegian clinical stage precision health company utilising Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, and the Phoenix-based Translational Genomics Research Institute (TGen), part of City of Hope, reported the publication of a paper in the peer-reviewed Journal of Controlled Release titled "Effect of Acoustic Cluster Therapy combined with chemotherapy in a mouse model of pancreatic cancer" (Press release, Exact Therapeutics, NOV 22, 2022, View Source [SID1234624334]). This study was partly funded by a grant from Innovation Norway.

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The ACT technology is based on microclusters of microbubble-microdroplets and when sonicated, vaporisation of the microdroplets lead to the formation of larger ACT bubbles. The formation and subsequent oscillation of the ACT bubbles in the microvasculature produces mechanical bio-effects that enhance drug delivery and efficacy. TGen have evaluated the effectiveness of the technology in a preclinical pancreatic cancer model, and the results demonstrated that ACT significantly improved the therapeutic efficacy of two cornerstone treatment regimens in the management of pancreatic cancer. The best effect was seen when drug administration preceded the ACT treatment, but interestingly the anti-tumour effect was almost maintained when the drugs were administered after ACT-treatment was finalized. Similar observations have been made in previous work with ACT combined with chemotherapy. This suggests that the main effect of ACT is not on the drug itself, but rather affects the vasculature and tumour microenvironment to facilitate drug delivery and therapeutic response.

For the full article, please follow: https://www.sciencedirect.com/science/article/pii/S016836592200760X

"Our study demonstrates that ACT can significantly improve the effect of two standard of care chemotherapeutic regimens in a patient-derived pancreatic cancer model in mice. The ACT treatment resulted in a significant increase in tumour growth inhibition and a 7.2 times higher probability of having a complete remission of the tumour compared to the chemotherapeutics alone." said Dr. Haiyong Han, a Professor in TGen’s Molecular Medicine Division and the study’s senior author.

"Pancreatic cancer is known to be notoriously resistant to treatment, in part because of poor drug delivery." said Dr. Daniel Von Hoff, TGen’s Distinguished Professor and one of the national’s lead experts in pancreatic cancer. "The results from the study are some of the most encouraging ones we have seen in preclinical models for pancreatic cancer, and we look forward to being involved in the further development of this promising technology."

Dr Per Walday, CEO of EXACT-Tx, commented: "We are very pleased to announce the publication of these encouraging results from our collaboration with the prestigious Translational Genomics Research Institute in Phoenix, Arizona. These data are produced in a model with patient-derived material, which more closely resembles the tumour tissue characteristics of pancreatic cancer in man compared to cell-line based models. The results further underpin the established potential of ACT to enhance standard of care treatments for difficult to treat cancers and we look forward to progressing our clinical development program in this area."

On November 21, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported that company management will participate in a fireside chat and 1×1 investor meetings at the 5th Annual Evercore ISI HealthCONx Conference being held virtually November 29 – December 1, 2022 (Press release, Crinetics Pharmaceuticals, NOV 22, 2022, https://crinetics.com/crinetics-pharmaceuticals-to-participate-in-the-5th-annual-evercore-isi-healthconx-conference/ [SID1234624332]).

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Details of the Crinetics fireside chat are as follows:

Date & Time: November 30, 2022 at 1:00 PM (ET)
Moderator: Josh Schimmer, Research Analyst, Evercore ISI
Webcast Link: View Source
The presentation may be accessed from the Evercore ISI platform or from the Events & Presentations page in the Investors section on the Company’s website. A replay of the presentation will be accessible for 90 days.

In addition, if you are interested in arranging a virtual 1×1 meeting with members of the Crinetics management team, please contact your bank/conference representative.

On November 22, 2022 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, reported that Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics, will present a corporate overview at the upcoming 34th Annual Piper Sandler Healthcare Conference, in New York, NY on Thursday, December 1, 2022 at 10:10 a.m. ET (Press release, Bicara Therapeutics, NOV 22, 2022, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-at-34th-annual-piper-sandler-healthcare-conference [SID1234624330]).

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On November 22, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) a global biotechnology company, reported that the results of the final progression free survival (PFS) analysis of the ALPINE trial will be presented at a late-breaking oral presentation session at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in New Orleans (Press release, BeiGene, NOV 22, 2022, View Source [SID1234624329]). ALPINE is a global Phase 3 trial comparing BRUKINSA (zanubrutinib) with IMBRUVICA (ibrutinib) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). The results will be presented at 10:15 am CST during the late-breaking abstract session on Tuesday, December 13, 2022 in the Ernest N. Morial Convention Center, Hall E.

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In this final PFS analysis, BRUKINSA achieved superior PFS compared with ibrutinib, as assessed by both Independent Review Committee (IRC) and investigator (HR: 0.65 [95% CI, 0.49-0.86] p =.0024, for both investigator and IRC). The PFS results favored zanubrutinib consistently across major pre-defined subgroups including IGHV status and patients with del(17p)/TP53, regardless of IRC or investigator assessment.

"BRUKINSA is the only BTK inhibitor to demonstrate superior efficacy over ibrutinib in any treatment setting; The ALPINE trial results demonstrate superiority for both PFS and ORR versus ibrutinib in relapsed or refractory CLL/SLL," said Mehrdad Mobasher, M.D., M.P.H. Chief Medical Officer, Hematology at BeiGene. "With nearly 30 months of follow up in this trial, we have seen a very consistent safety and tolerability profile for BRUKINSA and look forward to sharing detailed results from this analysis at ASH (Free ASH Whitepaper)."

CLL is one of the most common types of leukemia, accounting for about one-quarter of new cases of leukemiai The condition is characterized by consecutive relapses, with response to therapy ultimately determining clinical benefit, including survival.

At this pre-defined response analysis with a median follow up of 29.6 months, BRUKINSA was generally well-tolerated with a safety profile consistent with previous reports. Overall discontinuation rates were lower with BRUKINSA (26.3%) compared to ibrutinib (41.2%), as well as discontinuations due to adverse events (16.2 vs 22.8%) or progressive disease (7.3 vs 12.9%).

Cardiac safety measures at this analysis favored BRUKINSA compared with ibrutinib: the rate of atrial fibrillation/flutter in the BRUKINSA arm remained low (5.2%) compared with ibrutinib (13.3%) and there were zero grade 5 adverse events due to cardiac disorders with BRUKINSA versus six in the ibrutinib arm.

Investor Events

Sunday, December 11, 2022 – BeiGene will host an ancillary event in New Orleans at 8:00 pm CST for investors and analysts attending ASH (Free ASH Whitepaper). BeiGene senior management will review highlights of the presented data, and special guests will join them for a Q&A panel.
Tuesday, December 13, 2022 – BeiGene will host a webcast following the ALPINE late-breaker presentation at 2:00 pm CST. BeiGene senior management along with invited medical experts will review the presented data and join for a Q&A panel.
Tuesday, December 13, 2022 – BeiGene will host a webcast in Chinese at 6:00 pm CST / December 14, 2022 8:00 am China time to capture Company presentations at ASH (Free ASH Whitepaper). BeiGene senior management will review highlights of the presented data.
These events can be accessed live from the investors section of BeiGene’s website at View Source, View Source or View Source Archived replays will be posted for 90 days following the events.

About BRUKINSA

BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,700 subjects in 35 trials in more than 30 countries and regions. To date, BRUKINSA is approved in 60 markets, including the United States, China, the European Union Great Britain, Canada, Australia, South Korea, Switzerland, and additional international markets.

On November 22, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the results of its special meeting of stockholders (the "Special Meeting"), held as a virtual meeting on November 22, 2022 (Press release, Athenex, NOV 22, 2022, View Source [SID1234624328]).

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Athenex shareholders have approved all three proposals put before them today at the Special Meeting, including: (1) to effect an increase in the total number of authorized shares of common stock of the Company, (2) to authorize a reverse stock split of the Company’s common stock, which is intended to increase the per share price of the common stock and enable the Company to regain compliance with the Nasdaq continued listing requirements, and (3) to increase the number of shares available for issuance under the Company’s 2017 Omnibus Incentive Plan.

Further details on the voting results for each of the proposals put before the shareholders at the Special Meeting can be found in the Current Report on Form 8-K that Athenex intends to file with the Securities and Exchange Commission later today.