On February 1, 2023 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, will be reported its results for the fourth quarter 2022 on Thursday 16 February 2023. The briefing will take place at 10:00 am CET at (Press release, BerGenBio, FEB 1, 2023, View Source [SID1234626698]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo

where BerGenBio’s senior management team will provide an update on the Company
followed by a Q&A session. To attend in person please register by mail to
[email protected]

The presentation will webcast live and a link will be available at www.bergenbio.com in the Investors/Financial Reports section and a recording will be available shortly after the webcast has finished.

The fourth quarter financial report and presentation will be made available on the Company’s website in the Investors/Financial Reports section from 7:00am CET the same day.

On February 1, 2023 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will participate in two upcoming investor conferences (Press release, BeiGene, FEB 1, 2023, View Source [SID1234626697]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Guggenheim Oncology Conference 2023 on Wednesday, February 8, 2023 at 9:35 a.m. ET; and
The SVB Securities Global Biopharma Conference on Wednesday, February 15, 2023 at 1:40 p.m. ET.
Live webcasts of these events can be accessed from the investors section of BeiGene’s website at View Source and archived replays will be available for 90 days following the events.

On February 1, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported that the first patient has been dosed in the United States in its Phase 1/2 clinical trial evaluating AU-007 for the treatment of solid tumors (Press release, Aulos Bioscience, FEB 1, 2023, View Source [SID1234626696]). AU-007 is a human monoclonal antibody computationally designed by Biolojic Design to harness the power of interleukin-2 (IL-2) and eradicate solid tumors.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We’re pleased that our team has satisfied the FDA’s inquiries, enabling us to enroll and dose patients in the United States in our Phase 1/2 trial of AU-007," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "As the first computationally designed monoclonal antibody to enter a human clinical trial, AU-007 holds promise to become a potential new therapy for patients with advanced or metastatic solid tumor cancers. Based on early clinical data and strong preclinical data, it appears that AU-007 is safe and well tolerated to date. We thank the patients and clinical trial investigators who have chosen to participate in our study. We look forward to significantly expanding the number of trial sites in both the U.S. and Australia as well as presenting updated clinical data by year-end."

The Phase 1/2 clinical trial of AU-007 is a single, global protocol currently enrolling patients at four site locations in Australia and one site in Huntersville, North Carolina. The open label, first-in-human study is evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Phase 1 consists of three dose escalation arms evaluating AU-007 either as a monotherapy, in combination with a single loading dose of recombinant human IL-2 (aldesleukin), or with both AU-007 and aldesleukin administered once every two weeks. The aldesleukin will be administered subcutaneously, at much lower doses and much less frequently than the approved regimen of intravenously administered aldesleukin. The Phase 2 portion of the trial will evaluate a dosing regimen selected from dose escalation for expansion in specified tumor types to further define the safety and initial efficacy of AU-007.

"In low doses, IL-2 is an immune suppressant and at high levels, it is toxic. With AU-007, we are seeking to overcome these challenges through precision routing of IL-2 while producing an anti-cancer effect," said Jim Vasselli, M.D., Aulos Bioscience’s chief medical officer. "The unique profile we’ve seen so far with AU-007 gives it an advantage over all other IL-2 therapies currently in development. Through artificial intelligence, AU-007 has been designed to redirect IL-2 away from immunosuppressive Tregs and the vasculature and toward T effector and NK cells. By binding to IL-2 and not the IL-2 receptor, AU-007 has shown promising preclinical and initial clinical evidence that it can break the negative feedback loop to Tregs."

Early clinical data from the Phase 1/2 study were presented at the 37th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. The data showed an overall trend toward decreasing Tregs, which is consistent with data findings in preclinical studies – and completely unlike data reported from other IL-2 therapeutics, which demonstrate substantial increases in T regulatory cells (Tregs) due to the negative feedback loop induced by IL-2 produced endogenously by activated T cells. Additionally, initial pharmacokinetic data from the first three patients administered AU-007 as a monotherapy demonstrate characteristics similar to other IgG1 therapeutic human monoclonal antibodies.

To learn more about the clinical trial program, including study locations in the U.S. and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626).

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On February 1, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported preclinical data highlighting the Company’s next generation DaggerTM platform technology at the Emerging Cellular Therapies at the Forefront of Cancer Immunotherapy Keystone Symposia in Banff, Alberta, Canada (Press release, Allogene, FEB 1, 2023, View Source [SID1234626695]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Dagger technology, first unveiled at the Company’s R&D Showcase in November 2022, is designed to resist rejection of AlloCAR T cells by the host immune cells, enabling a prolonged window of persistence during which AlloCAR T cells can expand and actively target and destroy cancer cells. Dagger is a component of Allogene’s anti-CD70 product candidate ALLO-316, which is being evaluated in TRAVERSE, a Phase 1 study of patients with relapsed/refractory renal cell carcinoma (RCC).

"We are excited by the potential of this proprietary technology to enhance AlloCAR T cell function by preventing premature rejection of the cells while potentially reducing dependence on other lymphodepletion strategies," said Barbra Sasu, Ph.D., Chief Scientific Officer at Allogene. "The early clinical experience with ALLO-316 in advanced renal cell carcinoma suggests Dagger can meaningfully enhance AlloCAR T cell expansion and persistence. We are keen to apply this technology to other product candidates targeting both hematologic and solid tumors."

The Dagger platform arms AlloCAR T cells with a CD70-targeting receptor designed to recognize and deplete CD70 positive host cells while also masking the CD70 molecule expressed on the AlloCAR T cells themselves, preventing fratricide. CD70 is expressed on activated T cells and NK cells, and by selectively depleting alloreactive host cells, Dagger can potentially prevent the immune rejection of AlloCAR T cells. The results from these pre-clinical studies show that:

A CD70 Dagger construct was optimized to selectively eliminate alloreactive T cells, enabling enhanced AlloCAR T cell survival in several in vitro models of rejection
Allogeneic CAR T cells expressing dual CD19 CAR and CD70 Dagger receptors demonstrated the ability to simultaneously kill CD19-positive tumor cells and resist rejection and fratricide
CD19 AlloCAR T cells armed with a CD70 Dagger were endowed with dual specificity and prevented CD19 antigen loss dependent escape by tumor cells in vitro and in vivo
The Company has pursued an integrated strategy within Research and Development aimed at matching technology with insights obtained from the clinic to improve patient outcomes. In addition to ALLO-316, the Company plans to deploy Dagger technology to enhance the persistence and activity of next generation AlloCAR T products.

About ALLO-316
ALLO-316, an AlloCAR T investigational product targets CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In March 2022, The U.S. Food and Drug Administration granted Fast Track Designation (FTD) based on the potential of ALLO-316 to address the unmet need for patients with difficult to treat RCC who have failed standard RCC therapies.

On February 1, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that the company will present results from a novel same-section, spatial multiomic study at the Advances in Genome Biology and Technology (AGBT) Annual Meeting being held in Hollywood, Florida from February 6-9, 2023 (Press release, Akoya Biosciences, FEB 1, 2023, View Source [SID1234626694]). Leveraging the high-speed imaging platform, PhenoCycler-Fusion, company scientists to showcase how imaging both RNA and protein biomarkers simultaneously, in a single tissue section, can give a more complete picture of tumor biology.

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Protein and RNA biomarkers play complementary roles in defining cell phenotypes and cell states, respectively, in a tissue sample. Proteins are the key effectors of cell function and detecting cell surface protein markers can serve as a ground truth for cell identity. RNA markers such as cytokines and chemokines can provide an insight into signaling pathways that result in changes in cell states, arising from interactions within the tumor microenvironment. Measuring both analytes within the same tissue can give researchers an accurate picture of tumor progression and response to therapy.

First unveiled at the AGBT Annual Meeting in 2022, the company’s RNA chemistry was combined with the company’s industry-leading proteomics offering in a novel multiomic study featuring 46 samples, 23 tissue types and simultaneous detection of RNA and protein biomarkers from each section. The ability to scale the chemistry across multiple samples and a diversity of tissue types is a key requirement for discovering robust biomarker signatures.

The study was conducted on the PhenoCycler-Fusion System which enables rapid imaging of whole slides at single-cell resolution. In addition to the speed of imaging, the system has a proprietary file compression algorithm that can reduce file sizes from terabytes to gigabytes. This powerful combination makes it easier for researchers to scale up their studies with higher weekly throughput, while reducing data storage costs.

This new dataset will be presented at Akoya’s opening in-suite talk. Details below. To register, click here.

In Suite Talk: True Spatial Multiomics: One section, Two analytes

Date: Tuesday, February 7, 10:30 – 11:00 am ET

Speakers: Niro Ramachandran, Ph.D., Chief Business Officer, Akoya Biosciences and Julia Kennedy-Darling, Ph.D., VP Innovation, Akoya Biosciences

Venue: Exhibit Suite #313, Third Floor, Diplomat Hotel

"We are excited to highlight the breakthrough capabilities of our spatial transcriptomics chemistry and how a multiomic view of each sample can uncover a new dimension in tissue biology," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "We are looking forward to sharing these datasets with the genomics community at AGBT."

Additional talks and poster presentations featuring collaborators and customers are listed by date and time below:

Poster and Flash Talk: High-speed multiomic spatial phenotyping of immunotherapy responses in head and neck cancer
Presenter: Oliver Braubach, Ph.D., Akoya Biosciences
Date and Time: Tuesday, February 7, 1:30 – 3:30 PM
Poster Number: 129
Dr. Braubach will also be presenting a Flash Talk on this poster in the Grand Ballroom on Tuesday, February 7th at 11:25 AM – 11:49 AM

Poster and Flash Talk: A multiomic spatial phenotypic atlas of triple-negative breast cancer in women of African ancestry
Presenter: Jasmine Plummer, Ph.D. Director, St. Jude Center for Spatial Omics, St. Jude Children’s Research Hospital
Date and Time: Tuesday, February 7, 1:30 – 3:30 PM
Poster Number: 137
Dr. Plummer will also be presenting a Flash Talk on this poster in the Grand Ballroom on Tuesday, February 7th at 11:25 AM – 11:49 AM

Presentation: Mechanisms of metaplastic progression to adenocarcinoma revealed by high-speed multiomic spatial phenotyping of FFPE human samples
Presenter: John Hickey, Ph.D., Stanford University
Date and Time: Tuesday, February 7, 7:50 – 8:10 PM
Concurrent Session: Cancer, Grand Ballroom

Presentation: High-speed multiomic spatial phenotyping of FFPE human cohorts to dissect mechanisms of environmental-conditioned metastasis
Presenter: Julia Kennedy-Darling, Ph.D., Akoya Biosciences; presenting on behalf of Garry Nolan, Ph.D., Stanford University
Date and Time: Tuesday, February 7, 8:30 – 8:50 PM
Concurrent Session: Cancer, Grand Ballroom

Poster: Rapid whole-slide spatial analysis of FFPE tissues with true multiomic panels enables the discovery of key cellular niches
Author: Julia Kennedy-Darling, Ph.D., Akoya Biosciences
Date and Time: Wednesday, February 8, 4:45 – 6:10 PM
Poster Number: 532