TGFBR2

FN Media Group Presents USA News Group News Commentary VANCOUVER, BC, Feb. 7, 2024 /PRNewswire/ -- USA News Group - One of the more worrying storylines of 2023 was the rising incidence of early-onset pancreatic cancer. As well, the deadly disease showed pancreatic cancer rates rising faster among women, causing increased alarm amongst doctors. Thankfully, 2023 also gave a lot of hope in terms of new treatments for the market that could reach US$36 billion by 2036, such as a potential mRNA vaccine, and other developments from biotech companies to lead into 2024, like O ncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Incyte Corporation (NASDAQ:INCY), Tango Therapeutics, Inc. (NASDAQ:TNGX), RayzeBio, Inc. (NASDAQ:RYZB) and its buyer Bristol-Myers Squibb Company (NYSE:BMY). After closing out 2022 with another fast track designation, O ncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and its flagship asset pelareorep continues to make strides in the battle against pancreatic cancer. This recognition came after pelareorep plus atezolizumab with gemcitabine and nab-paclitaxel achieved an impressive objective response rate (ORR) of 69%. The results were enough to garner the support of the Pancreatic Cancer Action Network (PanCAN), who selected pelareorep to receive the US$5 million Therapeutic Accelerator Award. "2023 was an outstanding year for Oncolytics and the development of pelareorep as a potential cancer therapy," said Dr. Matt Coffey, President and CEO of Oncolytics. "To date, we have studied pelareorep in more than 1,100 patients, and it has been shown to be well-tolerated with mild side effects. We believe our cash balance and strong data, supported by our active business development program, position us well for 2024." Most recently, Oncolytics added accomplished biopharmaceutical executive Pat Andrews to its Board of Directors. She comes with a track record of success in corporate strategy, first-in-class and first-for-the-company new product commercializations and business development, and a resume that includes 17 years with Pfizer leading a $900-million portfolio at the time, and later serving as CEO of Sumitomo Pharma Oncology (SMP), and as the Chief Commercial Officer for Incyte Corporation (NASDAQ:INCY), where she led the company through the launch of Jakafi, Incyte's first commercial product. "I am honored to join the Oncolytics board at this exciting time for the organization as it advances pelareorep toward registrational studies," said Ms. Andrews. "Promising recent results from the BRACELET-1 and GOBLET studies suggest that pelareorep has the potential to make an important contribution to cancer care, and I look forward to working with my fellow board members in addition to Dr. Coffey and the Executive Team to execute Oncolytics' clinical and corporate development plans." Andrews's previous employer Incyte Corporation (NASDAQ:INCY) also continues to be active in the pancreatic cancer space itself. Like Oncolytics Biotech, Incyte is also involved with PanCAN in bringing potentially pioneering treatment options to patients. Now, the market is watching out for the potential future approval of Incyte's INCA-33890 for pancreatic cancer, which is currently in Phase I. INCA-33890 is a novel PD-1x TGFbR2 bispecific antibody designed to conditionally antagonize TGF signaling in primary immune cells co-expressing PD-1. Through a licensing deal with Swedish pharmaceutical company Medivir, Tango Therapeutics, Inc. (NASDAQ:TNGX) received FDA clearance on its Investigational New Drug application for TNG348 back in September 2023. Now, in early 2024, Tango has dosed the first patient for the drug in a phase 1/2 clinical study. Tango licensed TNG348 from Medivir back in 2020. TNG348 is a novel USP1 inhibitor for the treatment of BRCA1/2-mutant and other homologous recombination deficiency (HRD)+ cancers. HRD+ cancers, including BRCA1/2 mutations, represent 5% of pancreatic cancers. "The preclinical data generated by Tango for TNG348 is promising and dosing the first patient in a clinical study is encouraging for patients with HRD+ cancers," said Jens Lindberg, CEO of Medivir. "The efforts undertaken by Tango to develop TNG348 into a clinical-staged drug are impressive and we will continue to follow the clinical development of TNG348 with great anticipation." Closing out 2023, Bristol-Myers Squibb Company (NYSE:BMY) struck a deal for roughly $4.1 billion to buy RayzeBio, Inc. (NASDAQ:RYZB), with the highlight of the deal being RYZ101, which is being tested in late-stage studies for a rare type of pancreatic cancer. It's a drug that uses radioactive particles to kill tumor cells. "[The RayzeBio acquisition] further strengthens our growth opportunities in the back half of the decade and beyond," said Chris Boerner, newly-appointed CEO of BMY. "Acquiring RayzeBio's differentiated actinium-based radiopharmaceutical platform will establish Bristol Myers Squibb's presence in one of the most promising and fastest-growing new modalities for the treatment of patients with solid tumors – delivering radioactive payloads to cancer cells in a targeted manner," added Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Drug Development of Bristol Myers Squibb. "In addition, RayzeBio's platform has the potential to be a significant IND engine, generating several therapeutic candidates in the future by leveraging our global drug development capabilities and infrastructure." Article Source: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. USA News Group is Source of all content listed above. FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with USA News Group or any company mentioned herein. The commentary, views and opinions expressed in this release by USA News Group are solely those of USA News Group and are not shared by and do not reflect in any manner the views or opinions of FNM. FNM is not liable for any investment decisions by its readers or subscribers. FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM was not compensated by any public company mentioned herein to disseminate this press release. This release contains "forward-loking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements. Media Contact Information: FN Media Group, LLC Media Contact e-mail: [email protected] U.S. Phone: +1(954)345-0611 SOURCE USA News Group

ROCKVILLE, Md. and SHANGHAI, Dec. 7, 2023 /PRNewswire/ -- AbelZeta Pharma Inc. (the Company, or AbelZeta), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative cell therapies for cancer, inflammatory and immunological diseases, today announced an agreement with AstraZeneca to co-develop C-CAR031, an autologous, armored GPC3-targeting chimeric antigen receptor T Cells (CAR-T) therapy, in hepatocellular carcinoma (HCC). C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform, and is manufactured by AbelZeta in China. Continue Reading HCC is one of the most common cancers and major causes of cancer deaths in China1, with 466 thousand new cases each year, accounting for about 50% of the total global new cases. Approximately 45% of deaths worldwide from HCC occur in greater China.2 "We are pleased to collaborate with AstraZeneca in pursuing this novel CAR-T treatment for solid tumors." Post this Under the terms of the agreement, AbelZeta will receive an upfront payment from AstraZeneca for the co-development and commercialization of C-CAR031 in China. AbelZeta is also eligible to receive milestone payments and royalties for the global development of AZD5851, which is being solely developed, manufactured and commercialized by AstraZeneca outside of China. At AACR 2023, the Company presented preliminary safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) data from an investigator-initiated trial (IIT) in China showing promising anti-tumor activity and robust PK/PD profiles for C-CAR031 in patients with advanced HCC. "We are pleased to collaborate with AstraZeneca in pursuing this novel CAR-T treatment for solid tumors," said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta. "The treatment of advanced HCC has always been a great challenge, and I believe this CAR-T therapy has the potential to redefine therapeutic paradigms in HCC and other GPC3-expressing solid tumors." Mark Cobbold, Vice President, Head Cell Therapy, Oncology R&D, AstraZeneca said: "This agreement with AbelZeta accelerates the investigation of our innovative armoring CAR-T platform in solid tumors and advances our ambition to bring novel cell therapies to more people living with hard-to-treat cancers." About HCC Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.3,4 Several types of primary liver cancer occur in adults, HCC being the most common form. About 75% of all primary liver cancers in adults are HCC.3 Liver cancers are categorized based on the originating cell type. Hepatocellular carcinoma begins in the liver as either a single tumor or several small nodules and at this local stage can be treated by locally targeted or surgical methods. However, most patients are diagnosed at advanced-stage, or their disease progresses to advanced-stage HCC when the prognosis is poor, with a 5-year survival rate of only 7% and a median survival of ~20 months.5 Chinese Clinical Oncology Vol 2, No 4 (December 16, 2013) Frontiers in Public Health doi: 10.3389/fpubh.2022.801981 ASCO. Liver Cancer: View All Pages. Available at: . Accessed November 2023. WHO. Liver Cancer Fact Sheet. Available at: . Accessed November 2023. NEJM Evid 2022;1(8) DOI: 10.1056/EVIDoa2100070 and N Engl J Med 2020; 382:1894-1905 DOI: 10.1056/NEJMoa1915745 About AbelZeta Pharma, Inc. AbelZeta Pharma is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. The Company is focusing on developing innovative and proprietary cell-based therapeutic products, and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. The Company advances research and development in its own research and GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. Phone: +1 (240) 552 5870 Email: [email protected] SOURCE AbelZeta Pharma, Inc.

-Based on preliminary data from ongoing clinical trials, focusing on next-generation CAR T product candidates, CTX112™ targeting CD19 and CTX131™ targeting CD70- -Expanding trials of CTX112 into autoimmune disease, with planned initiation in the first half of 2024, in addition to the ongoing clinical trial in B-cell malignancies- -Expanding trials of CTX131 into hematologic malignancies, including T- and B-cell malignancies, in addition to the ongoing clinical trial in solid tumors- -Next-generation candidates manufactured at internal GMP facility exhibit increased manufacturing robustness and scalability- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today provided an update on its immuno-oncology pipeline of CRISPR/Cas9 gene-edited allogeneic chimeric antigen receptor (CAR) T cell product candidates. The Company’s first-generation allogeneic CAR T candidates, CTX110 and CTX130, provided important proof of concept that allogeneic CAR T cells can produce durable remissions following a standard lymphodepletion regimen. Preliminary data from ongoing clinical trials of its next-generation candidates, CTX112 targeting CD19 and CTX131 targeting CD70, suggest that these candidates may improve upon that clinical profile. Emerging pharmacology data, including pharmacokinetics, indicate that the novel potency gene edits in CTX112 and CTX131 lead to significantly higher CAR T cell expansion and functional persistence in patients compared to the first-generation candidates. In addition, the next-generation candidates exhibit increased manufacturing robustness, with a higher and more consistent number of CAR T cells produced per batch. Based on these considerations, the Company is focusing on the development of CTX112 and CTX131 and will be transitioning patients treated with CTX110 and CTX130 to long-term follow-up where applicable. “Our next-generation allogeneic CAR T candidates reflect our mission of innovating continuously to bring potentially transformative medicines to patients as quickly as possible,” said Samarth Kulkarni, Ph.D., Chief Executive Officer and Chairman of the Board of CRISPR Therapeutics. “We are excited about our next-generation CAR T platform, and focusing our efforts on these candidates will allow us to advance these potentially best-in-class CAR T therapies more efficiently and rapidly.” “We are very encouraged by the progress and early clinical data from our next-generation candidates. While we saw benefits from consolidation dosing with CTX110, we believe CTX112 could result in even better outcomes for patients,” said PK Morrow, M.D., Chief Medical Officer of CRISPR Therapeutics. “We thank the patients, families, and investigators who have participated in our clinical trials of CTX110 and CTX130 and look forward to applying learnings from these programs to expedite the development of CTX112 and CTX131.” In December 2022, the Company presented data from Part A of the Phase 1/2 clinical trial of CTX110 that showed the potential for CTX110 to produce durable complete remissions in heavily pre-treated patients following a standard lymphodepletion regimen. In new data updated today, Part B of the trial demonstrated an increased 6-month complete response (CR) rate following the inclusion of consolidation dosing, as shown in the table below. The safety profile of CTX110 in Part B remained consistent with the positively differentiated safety profile observed in Part A. CTX112 and CTX131 have the potential to improve upon the efficacy observed with CTX110 and CTX130. These next-generation candidates each incorporate two novel gene edits—knock-out of Regnase-1 and transforming growth factor-beta receptor type 2 (TGFBR2)—that have the potential to enhance CAR T potency and reduce CAR T exhaustion. Editing Regnase-1 removes an intrinsic “brake” on T cell function while editing TGFBR2 removes a key extrinsic “brake” on T cell anti-tumor activity. CRISPR Therapeutics identified this combination of edits through systematic screening of dozens of new and previously described genes. In preclinical studies, these edits synergistically improved potency approximately 10-fold compared to the first-generation candidates. Clinical trials are ongoing for CTX112 in B-cell malignancies and for CTX131 in solid tumors. The Company is producing CTX112 and CTX131 for clinical trials at its internal GMP manufacturing facility. Furthermore, CRISPR Therapeutics announced plans to initiate new clinical trials of CTX112 and CTX131 in additional indications. The Company plans to expand the evaluation of CTX112 beyond oncology into autoimmune diseases. Early clinical studies have shown that CD19-directed autologous CAR T therapy can produce long-lasting remissions in multiple autoimmune indications. CTX112 has the potential to provide similar results with several advantages, including greater scalability, lower cost of goods, and no patient apheresis. The Company plans to initiate a clinical trial in systemic lupus erythematosus (SLE) in the first half of 2024, with the potential to expand into additional autoimmune indications in the future. CTX110 is a wholly-owned, healthy donor-derived gene-edited allogeneic CAR T investigational therapy targeting cluster of differentiation 19, or CD19, and CTX112 is a next-generation, wholly-owned, allogeneic CAR T product candidate targeting CD19, which incorporates additional edits designed to enhance CAR T potency and reduce CAR T exhaustion. CTX112 is being investigated in an ongoing clinical trial designed to assess safety and efficacy of the product candidate in adult patients with relapsed or refractory CD19-positive B-cell malignancies who have received at least two prior lines of therapy. CTX130 is a wholly-owned, healthy donor-derived gene-edited allogeneic CAR T investigational therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies, and CTX131 is a next-generation, wholly-owned, allogeneic CAR T product candidate targeting CD70, which incorporates additional edits designed to enhance CAR T potency and reduce CAR T exhaustion. CTX131 is being investigated in a clinical trial designed to assess the safety and efficacy of the product candidate in adult patients with relapsed or refractory solid tumors. CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and cardiometabolic diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom. For more information, please visit www.crisprtx.com. CRISPR THERAPEUTICS® standard character mark and design logo, CTX110®, CTX112™, CTX130™, and CTX131™ are trademarks and registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners. The content above comes from the network. if any infringement, please contact us to modify.