Catamaran Bio Announces Lead CAR-NK Cell Therapy Programs and Upcoming Data Presentation at ASH 2021

On November 4, 2021 Catamaran Bio, Inc., a biotechnology company developing off-the-shelf CAR-NK cell therapies to treat cancer, reported that it has designated CAT-179, a HER2-targeted CAR-NK cell therapy, and CAT-248, a CD70-targeted CAR-NK cell therapy, as its first preclinical development programs (Press release, Catamaran Bio, NOV 4, 2021, View Source [SID1234594524]). The company also announced that data supporting the CAT-248 program will be presented during a poster session at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held virtually and in person in Atlanta from December 11-14, 2021.

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At ASH (Free ASH Whitepaper), Catamaran will present data demonstrating the successful deployment of its proprietary TAILWIND platform to generate a CAR-NK cell therapy which demonstrates high levels of cytotoxicity against various tumor cell lines. Catamaran’s TAILWIND platform provides an integrated CAR-NK solution that includes technology to overcome the immunosuppressive tumor microenvironment, CAR architectures optimized for NK cells, and non-viral transposon engineering for efficient manufacturing of CAR-NK cell therapies. The ASH (Free ASH Whitepaper) presentation will focus on preclinical data supporting CAT‑248, Catamaran’s allogeneic CAR-NK cell therapy directed against CD70, a tumor antigen that is highly expressed on certain types of cancers, including renal cell carcinoma, pancreatic cancer, and acute myeloid leukemia. This work is a collaboration between Catamaran and the lab of Dr. Branden Moriarity, scientific co-founder of Catamaran and Associate Professor in the Department of Pediatrics, Division of Hematology/Oncology at the University of Minnesota Medical School.

"The unveiling of our initial two development programs demonstrates Catamaran’s rapid progress toward delivering off-the-shelf CAR‑NK cell therapies capable of reaching solid tumors," said Alvin Shih, MD, Chief Executive Officer of Catamaran Bio. "The new preclinical data we will be presenting at ASH (Free ASH Whitepaper) demonstrate the viability and potential of our TAILWIND platform to enable a leading-edge solution for skillfully designing and efficiently manufacturing CAR-NK cell therapies for the treatment of cancer. We are excited to continue advancing our lead programs toward the clinic, as we seek to extend the transformative potential of cell therapy to patients with solid tumors."

The details of Catamaran’s presentation at ASH (Free ASH Whitepaper) 2021 are as follows:

Title: Engineering CD70-Directed CAR-NK Cells for the Treatment of Hematological and Solid Malignancies
Poster session: Abstract 1691, Session 703, Cellular Immunotherapies: Basic and Translational
Date and time: Saturday, December 11, 2021, from 5:30 – 7:30 p.m. ET
Location: Hall B5 at Georgia World Congress Center and via virtual meeting registration
Presenters: Eugene Choi (Principal Scientist, Catamaran Bio) and Celeste Richardson (SVP Research, Catamaran Bio)

Wugen Announces Data Presentation at the 63rd Annual Society of Hematology (ASH) Annual Meeting

On November 4, 2021 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present preclinical data on the characterization of WU-CART-007 at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held virtually and in-person in Atlanta, Georgia from December 11-14, 2021 (Press release, Wugen, NOV 4, 2021, View Source [SID1234594542]). The results demonstrate preclinical safety and anti-tumor activity of WU-CART-007. Wugen is preparing to begin enrollment for a Phase 1/2 clinical trial for relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL) (NCT#04984356).

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The details of Wugen’s presentation at ASH (Free ASH Whitepaper) are as follows:

Title: Characterization of WU-CART-007, an Allogeneic CD7-Targeted CAR-T Cell Therapy for T-Cell Malignancies
Abstract Number: 2772
Poster session: Session 703. Cellular Immunotherapies: Basic and Translational
Date and time: Sunday, December 12, 2021, 6:00 – 8:00 p.m. ET
Location: Hall B5 (Georgia World Congress Center)
Authors: Tom Leedom, Alexander S. Hamil, Ph.D., Somayeh Pouyanfard, Jennifer Govero, Ph.D., Rachel Langland, B.Sc., Anna Ballard, Ph.D., Liz Schwarzkopf, Andrew Martens, Andrew Espenschied, Pooja Vinay, M.S., Michael James, Nitin Mahajan, Ph.D., David H. Spencer, M.D., Kenneth M. Chrobak, Ph.D., Matthew L Cooper, Ph.D., and Ayman Kabakibi, Ph.D.

CytomX Therapeutics Announces Third Quarter 2021 Financial Results and Provides Business Update

On November 4, 2021 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated therapeutics, reported third quarter 2021 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 4, 2021, View Source [SID1234594601]).

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"With intense focus on execution, the CytomX team made significant progress with clinical site initiation and patient enrollment during the past quarter. As a result, we remain on track to announce initial data by year end from our ongoing Phase 2 expansion study evaluating CX-2029 in defined cancer types," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "We also remain on track for initial data from the praluzatamab ravtansine Phase 2 breast cancer clinical program in 2022. In addition, we are expanding the reach of our versatile platform with anticipated fourth quarter IND filing for our first conditionally activated T-cell bispecific antibody, CX-904, and with the presentation at SITC (Free SITC Whitepaper) 2021 of our emerging drug discovery work in the field of conditional cytokines," added Dr. McCarthy.

Third Quarter Business Highlights and Recent Developments

Clinical site activation and patient enrollment for the ongoing Phase 2 study of CytomX’s wholly owned conditional antibody-drug conjugate (ADC), praluzatamab ravtansine (CX-2009), made substantial progress, including opening additional sites in U.S., Europe, and Asia, as well as partnering with patient advocacy groups to encourage enrollment from underrepresented populations. Praluzatamab ravtansine is currently being evaluated in a Phase 2 study as monotherapy in patients with human epidermal growth factor receptor 2-non-amplified breast cancer and, in combination with pacmilimab (CX-072), in patients with triple-negative breast cancer. Initial data from this study is on track for 2022.
Patient enrollment into the expansion cohorts continued for the Phase 2 study of CX-2029, evaluating the CD71-directed conditionally activated ADC co-developed by CytomX and AbbVie in four cancer indications: squamous non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal and gastro-esophageal junction cancers, and diffuse large B-cell lymphoma. Initial data from this study is on track for the fourth quarter of 2021.
BMS-986249, a Probody version of ipilimumab, continued to be studied by Bristol Myers Squibb, CytomX’s collaboration partner, in combination with nivolumab, the anti-PD-1 antibody, across four different advanced malignancies: melanoma, hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer. Bristol Myers Squibb is also evaluating BMS-986288, a Probody version of non-fucosylated ipilimumab, as monotherapy or in combination with nivolumab, in a Phase 1 study.
CytomX expects to submit an investigational new drug application for CX-904 to the U.S. Food and Drug Administration in late 2021. CX-904 is a conditionally activated T-cell-engaging bispecific antibody candidate against the epidermal growth factor receptor on tumor cells and CD3 on T cells and is partnered with Amgen.
A CytomX abstract highlighting company progress in the field of conditionally active cytokines has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting (SITC 2021), which will be held from November 12-14, 2021 at the Walter E. Washington Convention Center, Washington, DC. This presentation will detail the preclinical characterization and improved therapeutic index of a masked interferon alpha-2b (IFN-a2b) leveraging CytomX proprietary conditional activation technologies.
CytomX published a preclinical study in Cancer Immunology Research showing that systemic administration of conditionally activated anti-programmed cell death ligand 1 (anti-PD-L1) and anti-programmed cell death protein 1 (anti-PD-1) antibodies to tumor-bearing mice elicited antitumor activity similar to that of traditional PD-1/PD-L1-targeted antibodies, but with reduced systemic immune-mediated toxicity. These data provide further preclinical rationale to support the ongoing development of pacmilimab (CX-072), currently in a Phase 2 study in combination with praluzatamab ravtansine in patients with TNBC. The preclinical article can be accessed at View Source
CytomX appointed Alan Ashworth, Ph.D., FRS, a world-renowned expert in cancer research and a global leader in cancer therapy development, to its board of directors.
Third Quarter 2021 Financial Results
Cash, cash equivalents, and investments totaled $336 million as of September 30, 2021, compared to $316 million as of December 31, 2020.

Revenue was $18 million for the three months ended September 30, 2021, relatively flat when compared to the corresponding period in 2020.

Research and development expenses increased $5 million during the three months ended September 30, 2021 to $29 million compared to the corresponding period in 2020. The increase was driven mainly by personnel, clinical trial, and consulting and contract service expenses primarily related to praluzatamab ravtansine and CX-2029.

General and administrative expenses increased $2.5 million during the three months ended September 30, 2021 to $11 million compared to the corresponding period in 2020. The increase was attributable to personnel related and recruiting expenses as well as professional services.

Conference Call & Webcast
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 3886792. A live webcast of the call can be accessed at the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until November 11, 2021.

BioLife Solutions to Report Third Quarter 2021 Financial Results and Provide Business Update on November 11, 2021

On November 4, 2021 BioLife Solutions, Inc. (NASDAQ: BLFS), a leading supplier of class-defining bioproduction tools and services for the cell and gene therapies ("CGT") and broader biopharma markets, reported the Company’s third quarter 2021 financial results will be released after market close on Thursday, November 11th (Press release, BioLife Science, NOV 4, 2021, View Source [SID1234594634]). The Company will host a conference call and live webcast at 4:30pm ET (1:30pm PT) that day. Management will provide an overview of the Company’s financial results and a general business update.

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To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source Alternatively, you may access the live conference call by dialing 1 (844) 825-0512 or international callers at 1 (315) 625-6880 with the following Conference ID: 7075159. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.

Orion Receives Funding to Advance its Lead GPCR-Targeted Therapeutic

On November 4, 2021 Orion Biotechnology Canada Ltd., a clinical stage company unlocking the therapeutic potential of G Protein-Coupled Receptors (GPCRs) with a novel drug modality, proven discovery platform and best-in-class molecules, reported that it is receiving advisory services and conditional funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) (Press release, Orion Biotechnology, NOV 4, 2021, View Source [SID1234595541]). The funding will support the development of Orion’s lead compound, OB-002, a GPCR analog of CCL5 with best-in-class potency and broad applicability across a range of serious diseases including cancer and neuroinflammation. Working in collaboration with NRC’s Human Health Therapeutics Research Centre, the objectives of the project will be to further expand the translational research of OB-002, including an assessment of the molecules’ ability to cross the blood brain barrier (BBB).

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"We are very pleased to receive advisory services and this funding from NRC IRAP," said Mark Groper, President and CEO of Orion Biotechnology. "Their support will help accelerate development of OB-002 as a potentially important therapy for the treatment of serious illnesses".

"GPCRs are implicated in a wide range of human physiological processes and we are interested in expanding our knowledge of OB-002’s pharmacological profile and mechanism of action," commented Ian McGowan, Orion’s Chief Medical Officer. "This project, supported by NRC IRAP and our collaborators, will prove important as we continue to progress OB-002 into the clinic"