On January 17, 2023 – Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, reported two new collaborations with McSAF and Cristal Therapeutics to expand its bioconjugates offering (Press release, Cristal Therapeutics, JAN 17, 2023, View Source [SID1234626286]).

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The collaborations will enable the integration of two novel conjugation platforms, McSAF Inside and CliCr, into the Lonza Bioconjugation Toolbox. The Lonza Bioconjugation Toolbox comprises a range of tailored solutions for the technology selection, development and manufacturing of bioconjugates to advance the development of novel bioconjugate-based therapies.

Cristal Therapeutic CliCr technology is a novel class of versatile and highly reactive bioorthogonal reagents that supports the straightforward and highly-efficient generation of a large range of bioconjugates. The CliCr technology relies on metal-free click chemistry and provides improved yields and broad applicability compatible with biochemically-relevant reaction conditions.

McSAF Inside Technology allows for the fast and efficient generation of homogeneous and stable antibodydrug conjugates (ADCs) from native antibodies. The technology relies on a set of unique reagents for the sitespecific conjugation of a linker-payload to previously reduced interchain cysteines of a native antibody. Compared to conventional methods, McSAF Inside produces ADCs of high purity and stability and can support novel bioconjugates, based on antibody fragments or other therapeutic proteins that contain an accessible disulfide bond.

Through the new agreements, Cristal Therapeutics and McSAF will gain access to Lonza’s integrated bioconjugates offering and will be able to leverage Lonza’s expertise in developing and manufacturing bioconjugates. At the same time, the collaborations build additional capabilities into Lonza’s service portfolio, furthering the development of an end-to-end bioconjugates offering that can support customers in overcoming a range of development and manufacturing challenges.

Iwan Bertholjotti, Senior Director Commercial Development, Bioconjugates, Lonza, commented: "CliCr and McSAF Inside are great additions to the Lonza Bioconjugation Toolbox, allowing us to extend our portfolio of technologies for drug developers involved in developing novel bioconjugates/ADCs. These collaborations are creating a unique industry network to facilitate the development of novel bioconjugates with potential to treat life-threatening diseases.

" Marie-Claude Viaud-Massuard, Co-Founder and Chief Scientific Officer, McSAF said: "The robustness, scalability and broad compatibility of McSAF’s technology enabled a successful transfer to the Lonza team. Choosing McSAF’s technology provides a high degree of flexibility, allowing the combination of multiple proteins and linker-payloads in order to optimize and select the best candidate. In addition, customers will mitigate the risk associated with CMC stages through Lonza’s expertise and their understanding of McSAF know-how."

Werner Cautreels, CEO, Cristal Therapeutics added: "CliCr is a powerful metal-free click chemistry technology for the life science industry which offers shorter reaction times and greater yields and hence attractive CoG than comparative reagents on the market. Our collaboration with Lonza will help to extend the impact of this innovative technology for use in straightforward bioconjugation in a plethora of important applications in therapeutic or diagnostic products. "

On January 17, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat at the B. Riley Securities’ 3rd Annual Oncology Conference, taking place on Wednesday, January 18, 2023, at 11:00 a.m. EST (Press release, Checkpoint Therapeutics, JAN 17, 2023, View Source [SID1234626285]).

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For more information and to register for the conference, please click here. A replay of the fireside chat will also be available on the registration link after the meeting.

On january 17, 2023 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biotechnology company using its gene editing platform to deliver life-saving cell and gene therapies, reported that Cibus Global LLC, a Delaware limited liability company ("Cibus"), and Calyxt, Inc. (NASDAQ: CLXT) ("Calyxt"), reported that Calyxt and Calypso Merger Subsidiary, LLC, a Delaware limited liability company and wholly-owned subsidiary of Calyxt, entered into an Agreement and Plan of Merger with Cibus and certain other parties named therein (the "Merger Agreement"), pursuant to which, subject to the terms and conditions thereof, Calyxt and Cibus will merge in an all-stock transaction (Press release, Cellectis, JAN 17, 2023, View Source [SID1234626284]).

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The transaction combines two companies in agriculture-based gene editing, with facilities for trait development and next-generation plant breeding.

Cellectis currently holds a 49.1 % equity interest in Calyxt. Following the closing of the merger, Cellectis is expected to own approximately 2.5% of the equity interests of the combined company. In connection with the Merger Agreement, Cellectis executed a voting agreement with Cibus to vote in favor of and approve all the transactions contemplated by the Merger Agreement, subject to the terms and conditions thereof.

The closing of the transaction is subject to the approval of Calyxt’s stockholders, the approval of Cibus’ members, the receipt of required regulatory approvals (to the extent applicable) and satisfaction of other customary closing conditions. In connection with the transaction, Calyxt will file a registration statement on Form S-4 with the U.S. Securities and Exchange Commission, registering the issuance of the shares of common stock to be issued as merger consideration. The closing of the transaction is currently expected to occur in the second quarter of 2023.

On January 17, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Thursday, February 2, 2023, at 8:00 a.m. CST to review second quarter 2023 financial results (Press release, Bio-Techne, JAN 17, 2023, https://investors.bio-techne.com/news/detail/347/bio-techne-to-host-conference-call-on-february-2-2023-to-announce-second-quarter-2023-financial-results [SID1234626283]).

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Access to the discussion may be obtained as follows:

Time:

8:00 a.m. CST

Date:

February 2, 2023

Dial-in:

1-877-407-9208 or 1-201-493-6784 (for international callers)

Conference ID:

13735661

Webcast:

https://viavidwebcastscom/startherejsp?ei=1594125&tp_key=12f30d96f5

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13735661.

The replay will be available from 11:00 a.m. CST on Thursday, February 2, 2023, until 11:00 p.m. CST on Thursday, March 2, 2023.

On January 17, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company,reported that it will share clinical data and patient-reported outcomes for its PD-1 inhibitor, tislelizumab, at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, notably, an oral presentation for interim results of the global pivotal phase 3 trial RATIONALE 305 of tislelizumab in combination with chemotherapy in first-line gastric or gastroesophageal junction (G/GEJ) cancer (Press release, BeiGene, JAN 17, 2023, View Source [SID1234626282]). At the interim analysis, RATIONALE 305 trial met one of the primary endpoints of overall survival (OS) in patients with G/GEJ whose tumors express PD-L1.

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"With more than one million gastric cancer cases and approximately 770,000 deaths in 2020, we have a meaningful opportunity to advance care for these patients. We are pleased to report a significant survival benefit for tislelizumab and chemotherapy at this interim analysis of the RATIONALE 305 trial," Mark Lanasa, M.D., Chief Medical Officer, Solid Tumors at BeiGene. "We look forward to sharing additional results as the study continues, including results for the intent-to-treat population."

Analyses from additional studies of tislelizumab as monotherapy and in combination will be presented at the conference.

Tislelizumab presentations 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium

Abstract 286 Phase 3 Study of Tislelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as First-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Jan 19, 2023 Oral Presentation (4:15pm, PST)
Abstract 340 Randomized, global, phase 3 study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic esophageal squamous cell carcinoma (RATIONALE-306): non-Asia subgroup

Jan 19, 2023 Poster Session A (12:00pm and 4:45pm, PST)
Abstract 495 Tislelizumab versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: Impact on health-related quality of life in RATIONALE-301 population

Jan 20, 2023 Rapid Abstract Session (7:00am – 7:45am, PST)
About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to Fcγ receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Tislelizumab is the first investigational medicine from BeiGene’s immuno-oncology biologics program and is being evaluated in solid tumor and hematologic malignancies, as monotherapy and in combination.

The global tislelizumab clinical development program includes more than 11,500 subjects enrolled to-date in 21 registration-enabling trials, from more than 30 countries and regions.

Biologics License Applications (BLA) for tislelizumab are under review with U.S. and European Union (E.U.) regulators; for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the U.S.; for non-small cell lung cancer and unresectable recurrent locally advanced or metastatic ESCC in the E.U.

Tislelizumab is approved by the China NMPA as a treatment for nine indications and additional three supplemental BLAs under review at CDE. Tislelizumab is not approved for use outside of China.

About the Clinical Trials

RATIONALE 301 (NCT03412773) is a global, Phase 3, randomized, open-label study of tislelizumab compared with sorafenib as a first-line treatment in adult patients with unresectable hepatocellular cancer (HCC), G/GEJ adenocarcinoma. The primary endpoint of the study is non-inferiority of Overall Survival between the two treatment groups. The key secondary endpoint is Overall Response Rate, as assessed by Blinded Independent Review Committee (BIRC) per RECIST v1.1. Other secondary endpoints include other efficacy assessments such as Progression Free Survival, Duration of Response, and Time to Progression per BIRC, as well as measures of health-related quality of life, and safety and tolerability.

RATIONALE 305 (NCT03777657) is a randomized, double-blind, placebo-controlled global Phase 3 trial comparing the efficacy and safety of tislelizumab combined with chemotherapy and placebo combined with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint of the trial is OS. Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety. A total of 997 patients from 13 countries and regions globally, including close to 50 percent from outside of China, were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy.

RATIONALE 306 (NCT03783442) is a randomized, placebo-controlled, double-blind, global Phase 3 study to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a first-line treatment in patients with advanced or metastatic ESCC. The primary endpoint of the trial is overall survival (OS). Secondary endpoints include progression free survival, overall response rate, and duration of response per RECIST v1.1, as well as health-related quality of life measures and safety.

The trial enrolled 649 patients at research centers across Asia-Pacific, Europe, and North America. Patients were randomized 1:1 to receive either tislelizumab plus chemotherapy or placebo plus chemotherapy.