Gastro-Enteropancreatic Neuroendocrine Tumor

FN Media Group Presents USA News Group News Commentary VANCOUVER, BC, March 14, 2024 /PRNewswire/ -- USA News Group - Known as one of the most deadly forms of cancer, pancreatic cancer still has the highest mortality rate of all major cancers today. However, researchers and the biotech sector are working diligently to improve the chances of those who receive this dire diagnosis. Recently, in late 2023, researchers at the Mayo Clinic made a discovery that advances knowledge of how pancreatic cancer spreads and identified a new potential therapeutic target along the way. With the American Cancer Society projecting a record year for new cancer cases in 2024, and Europe facing a pancreatic cancer emergency, it's important to focus on the advances being made in the biotech sector that are giving hope to patients and their families. Among the developers making gains include O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Novartis AG (NYSE: NVS), ImmunityBio, Inc. (NASDAQ: IBRX), Aclaris Therapeutics, Inc. (NASDAQ: ACRS), and Nuvation Bio Inc. (NYSE: NUVB). There is a point of optimism to build upon, as the Pancreatic Cancer Action Network (PanCAN) has stated the five-year survival rate for pancreatic cancer has increased to 13%. Among the therapy developers that have garnered accolades and support from PanCAN is O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), which late last year took home a US$5 million Therapeutic Accelerator Award based on the promising results being delivered by its flagship asset, pelareorep. Since winning the award, Oncolytics has moved to make an amendment to its ongoing GOBLET gastrointestinal cancer study to include a new (fifth) cohort. This new cohort will evaluate the immunotherapy asset pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) both with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). "We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients," said Dr. Matt Coffey, President and CEO of Oncolytics. "Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program. Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel. This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year." Oncolytics is conducting the GOBLET trial to investigate the effectiveness of pelareorep in enhancing the treatment of pancreatic cancer, a disease known for its poor 5-year survival rate. This is largely due to the cancer's ability to hide from the immune system and create an environment that suppresses immune response. In late 2022, the FDA granted pelareorep a fast track designation, acknowledging its potential to stimulate both the innate and adaptive immune systems and alter the tumor microenvironment. This makes pelareorep a promising candidate for combination therapy. "This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients." After discontinuing development of its monoclonal antibody NIS793 for the treatment of patients with pancreatic cancer, Novartis AG (NYSE: NVS) has opened 2024 with positive data from its Lutathera asset. In a mid-January release, Novartis announced that Lutathera significantly reduced the risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors. "These positive results for Lutathera are practice-changing and offer new first-line treatment data for patients who have a significant unmet need," said Dr. Simron Singh, Associate Professor of Medicine at the University of Toronto and co-founder of the Susan Leslie Clinic for Neuroendocrine Tumours at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, Ontario, Canada. "This study confirms the clinical benefit of first-line radioligand therapy for newly diagnosed patients living with these types of advanced GEP-NETs. These findings should instill confidence among physicians in using Lutathera as a first-line treatment for patients with this life-threatening type of cancer." Back in early 2022, ImmunityBio, Inc. (NASDAQ: IBRX) showed promising results for its Nant Pancreatic Cancer Vaccine. Now, in February 2024, ImmunityBio has announced full accrual of its first two phases of a cancer vaccine trial in participants with Lynch Syndrome and the initiation of a randomized control phase of the trial. Lynch Syndrome is one of the most common hereditary cancer syndromes, occurring in 1 in every 300 Americans. People with Lynch Syndrome can not only develop colorectal cancer 20 years prior to the average age of diagnosis for that form of cancer but are also at an increased risk of developing many other types of cancers, including pancreatic. "We are encouraged by how rapidly this study has been able to enroll participants," said Asad Umar, D.V.M., Ph.D., a senior advisor to the Director for Translational Research in NCI's Division of Cancer Prevention (DCP) and a scientific lead for the trial. "It is a strong indication of an unmet need and of the willingness of participants to help science make new discoveries in the area of cancer prevention." Moving on from a disastrous year in 2023, Aclaris Therapeutics, Inc. (NASDAQ: ACRS) is resurrecting its asset zunsemetinib as a potential cancer treatment. As per the company's last corporate update of 2023, Aclaris now plans to explore zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. "Throughout our history, Aclaris has remained focused on developing novel drugs where there is a lack of satisfactory treatment options," said Dr. Neal Walker, Co-Founder, Chairman, and Interim CEO of Aclaris in a January 2024 strategic business review. "We are well capitalized and we have recently taken the hard but necessary steps to streamline our operations to reduce costs and preserve capital in order to put Aclaris in an optimal position for the future." In early January 2024, the FDA cleared the investigational new drug (IND) application of Nuvation Bio Inc. (NYSE: NUVB) to evaluate its first clinical candidate from its novel drug-drug conjugate (DDC) platform, NUV-1511. "This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents," said David Hung, M.D., Founder, President, and CEO of Nuvation Bio. "We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the Phase 1/2 study." The initial part of the Phase 1/2 study will assess safety and tolerability and investigate the potential effectiveness in patients with advanced solid tumors. It will focus on patients with pancreatic cancer, HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), and platinum-resistant ovarian cancer (PROC). Nuvation is already undergoing dosing in the Phase 1 monotherapy study of NUV-868 in solid tumors in patients with pancreatic cancer, ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC), triple-negative breast cancer and other solid tumors. "We remain focused on strong clinical execution of our NUV-868 program for advanced solid tumors," said Hung in his company's Q3 2023 business update. Article Source: Article Source: USA News Group [email protected] DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. 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Pictured: A collage of biopharma M&A/ Nicole Bean for BioSpace After a slow 2022 and early part of 2023, the pace of mergers and acquisitions in the pharmaceutical and biotech sectors has accelerated since the middle of last year, highlighted by Pfizer’s $43 billion takeover of Seagen. Since the calendar turned to 2024, we have seen some blockbusters, including Novo Nordisk's $16.5 billion purchase agreement for Catalent and the closing of Bristol Myers Squibb's $4.8 billion acquisition of Mirati Therapeutics. With interest in takeover activity rebounding, BioSpace is pleased to introduce our mergers and acquisitions tracker, which will be updated regularly. Follow along as we keep you up to date on which companies are getting together and which are being absorbed. March March 5 Status: Pending; anticipated closing late Q2 Deal value: Undisclosed Akari Therapeutics and Peak Bio announced an all-stock “merger of equals,” though the combined company will carry the Akari name and continue to be traded on the Nasdaq Capital Market under the AKTX ticker symbol. The new partners plan to focus on business development and licensing across therapeutic areas, including cancer, autoimmune conditions and inflammatory diseases. March 4 Status: Completed Deal value: Undisclosed Eilean Therapeutics said it has purchased privately held startup Ness Therapeutics in an all-equity deal. San Diego–based Ness is developing PTPN2 inhibitors for immuno-oncology. Eilean has been testing small molecule inhibitors that target escape mutations in hematologic and solid tumors. March 4 Status: Pending Deal value: Up to $82 million plus royalties Melbourne, Australia-based Telix Pharmaceuticals will acquire privately held radioisotope production technology company ARTMS, of Burnaby, British Columbia. Telix said that, among other things, ARTMS will be able to support production of Zircaix (TLX250-CDx), its investigational PET imaging agent for identifying clear cell renal cell carcinoma. The deal calls for Telix to pay $42.5 million in stock upfront, $15 million in cash at closing and as much as $24.5 million in contingencies, as well as future royalties. March 1 Status: Pending Deal value: Undisclosed Precisio Biotix Therapeutics announced the purchase of CC Bio, maker of the Zeus bioinformatics platform for antibacterial lysis analysis. Precisio said the Zeus platform is “highly complementary” to its LysiThru lysin screening and engineering system. March 1 Status: Pending Deal value: Up to $31 million Kinnate Biopharma has agreed to sell exarafenib, its investigational pan-RAF inhibitor, to France’s Pierre Fabre Laboratories. Kinnate is in the process of being acquired by Xoma. February Feb. 29 Status: Completed Deal value: Undisclosed JAMP Pharma Group purchased a shuttered drug manufacturing facility in Lévis, Quebec, that belonged to Pharmalab, a company that went out of business in August 2023. Quebec-based JAMP announced plans to rehire a “significant portion” of the 250 former Pharmalab workers at the site to serve the Canadian market. Feb. 28 Status: Pending; anticipated closing early Q2 Deal value: $130 million CoreRx agreed to purchase fellow Florida firm Societal CDMO for $1.10 per share in cash. Societal said the combined company seeks to establish itself as “a preferred CDMO partner in the small molecule space” when the deal closes. Feb. 28 Status: Pending Deal value: Undisclosed Gingko Bioworks announced a trio of acquisitions: Patch Biosciences, Proof Diagnostics and the artificial intelligence and software infrastructure of Reverie Labs. Terms of the sale agreements were not disclosed, but Ginkgo said its board approved stock grants of about $3.5 million to four Reverie employees and nearly $4.3 million to eight Patch Bio employees. Feb. 26 Status: Pending; anticipated closing Q2 Deal value: $135 million NGM Biopharmaceuticals agreed to a buyout by affiliates of venture capital firm The Column Group for $1.55 per share. NGM Bio recently presented data on trials of a dual ILT2/ILT4 antagonist antibody and another compound to treat compensated cirrhosis. Feb. 26 Status: Completed Deal value: $4.1 billion Bristol Myers Squibb closed its previously announced $62.50-per-share takeover of radiopharmaceutical developer RayzeBio. The target company’s portfolio includes RYZ101, an SSTR2-targeting radiotherapeutic that is currently in late-stage testing for gastroenteropancreatic neuroendocrine tumors and is also being trialed for small cell lung cancer. Feb. 22 Status: Pending Deal value: Up to $117.5 million plus royalties Rigel Pharmaceuticals is purchasing the U.S. rights to FDA-approved non-small cell lung cancer drug Gavreto (pralsetinib) from Blueprint Medicines for $15 million. Rigel could be on the hook for an additional $97.5 million in commercial milestone payments and $5 million in regulatory milestone compensation, as well as future tiered royalties. Blueprint regained the global rights to Gavreto from Roche in early 2023. Feb. 22 Status: Completed Deal value: Up to $1.2 billion AstraZeneca closed its acquisition of Chinese cell therapy company Gracell Biotechnologies, giving the British pharma giant ownership of the investigational cell therapy GC012F, a dual-targeting autologous CAR-T therapy, as well as Gracell’s FasTCAR platform for CAR-T development. The deal, announced Dec. 23, is valued at $2 per share. Unspecified regulatory milestone payments could bring the total value to $1.2 billion. Feb. 21 Status: Completed Deal value: $1 million plus contingencies BioVaxys Technology completed the purchase of the discovery, preclinical and clinical assets of bankrupt Canadian immuno-oncology developer Immunovaccine Technologies (IMV). BioVaxys made $750,000 in upfront payments and issued $250,000 in stock to IMV creditors. The company also agreed to make unspecified milestone payments, share licensing revenues and offer royalty payments to the creditors. IMV initiated U.S. bankruptcy proceedings in May 2023, Pharmaceutical Technology reported. Feb. 20 Status: Completed Deal value: $28.2 million Syncona closed its acquisition of Freeline Therapeutics for $6.50 per share in cash, in a deal that had been announced in November. Freeline had been in early-stage trials of FLT201, an adeno-associated virus (AAV) candidate gene therapy for Gaucher disease. Feb. 16 Status: Pending Deal value: $120 million Biotech royalty aggregator Xoma announced an agreement to take over precision oncology firm Kinnate Biopharma for an estimated $120 million in cash. Kinnate's pipeline includes a brain-penetrant MEK inhibitor, a highly selective c-MET inhibitor and exarafenib, a pan-RAF inhibitor in early-stage trials. Feb. 14 Status: Completed Deal value: $180 million Concentra Biosciences completed its acquisition of Theseus Pharmaceuticals, first disclosed Dec. 22. The $4.05-per-share price was at the top end of a previously announced range to purchase Theseus, a clinical-stage company developing pan-variant tyrosine kinase inhibitors and other targeted therapies. Feb. 12 Status: Pending; anticipated closing Q1 Deal value: $4.3 billion Gilead Sciences announced plans to acquire CymaBay Therapeutics for $32.50 per share in cash. The news broke the same day CymaBay announced that the FDA accepted the New Drug Application for its lead candidate seladelpar for the management of primary biliary cholangitis. Feb. 7 Status: Pending Deal value: Up to $123.1 million Telix Pharmaceuticals agreed to purchase QSAM Biosciences in an all-stock transaction. Contingent value rights could be worth as much as $90 million on top of the base price. Telix highlighted QSAM’s lead asset, an investigational radiopharmaceutical treatment for primary and metastatic bone cancer called CycloSam (Samarium-153-DOTMP). QSAM had signed a term sheet for the planned acquisition in November that included a $2 million pre-closing collaboration fee from Australia-based Telix to continue its development work. Feb. 7 Status: Pending Deal value: Up to $880 million Jazz Pharmaceuticals signed a definitive agreement to purchase the proprietary Kirsten rat sarcoma virus (KRAS) inhibitor program of Redx Pharma for $10 million upfront and as much as $870 million in development, regulatory and commercial milestone payments, as well as potential royalties. The next milestone is FDA Investigational New Drug clearance, the companies said. Feb. 6 Status: Pending Deal value: Up to $87.5 million Immunome said it would acquire the AL102 investigational small molecule gamma secretase inhibitor and a related drug candidate from Ayala Pharmaceuticals for $50 million in cash and stock, with contingencies for an additional $37.5 million in milestone payments. Ayala subsequently announced that it had completed enrollment in a Phase III study to evaluate AL102 in desmoid tumors. Feb. 5 Status: Pending; anticipated closing in first half of 2024 Deal value: $2.9 billion Novartis reached an agreement with MorphoSys to acquire the German biotech for more than $73 per share in cash. At the center of the merger is pelabresib, an investigational small molecule inhibitor of the BET protein which suppresses the expression of abnormal genes involved in cancer development. The companies expect the acquisition to close in the first half of the year. Feb. 5 Status: Pending; anticipated closing late 2024 Deal value: $16.5 billion Novo Nordisk made a splash with a $16.5 billion offer—the largest new M&A announcement in the biotech sector so far this year—to take over troubled CDMO Catalent. Novo Holdings, the investment arm of the Novo Nordisk Foundation, will purchase all outstanding Catalent shares for $63.50 each and flip three manufacturing plants to Novo Nordisk for $11 million as the latter seeks to ramp up production of its blockbuster diabetes drug Ozempic and weight-loss medication Wegovy. Neil Versel is the business editor at BioSpace. You can reach him at neil.versel@biospace.com. Follow him on LinkedIn or X.

Through the RayzeBio acquisition, BMS will gain access to an RPT manufacturing facility. Credit: JHVEPhoto / Shutterstock.com. Bristol Myers Squibb (BMS) has announced the conclusion of its acquisition of RayzeBio, a clinical-stage radiopharmaceutical company, for $4.1bn. RayzeBio is now a wholly owned BMS subsidiary. The companies signed an agreement for the acquisition in December 2023 in which BMS would acquire all outstanding shares of RayzeBio. The acquisition introduces a radiopharmaceutical therapeutics (RPTs) pipeline to BMS, including the lead programme, RYZ101 (²²⁵Ac-DOTATATE). This therapy is designed to target somatostatin receptor (SSTR)2, which is overexpressed in gastroenteropancreatic neuroendocrine tumours (GEP-NETs) and extensive stage small cell lung cancer (ES-SCLC). A Phase III clinical trial is currently enrolling subjects to assess RYZ101 in individuals with SSTR-positive GEP-NETs who have previously received treatment with lutetium-177-based somatostatin therapies. See Also: CC-98633 by Bristol-Myers Squibb for Refractory Multiple Myeloma: Likelihood of Approval CC-98633 by Bristol-Myers Squibb for Relapsed Multiple Myeloma: Likelihood of Approval Interim data from the Phase Ib portion of the ACTION-1 clinical trial for RYZ101 have shown encouraging tolerability and efficacy. A Phase Ib trial is also progressing to assess RYZ101 as a first-line treatment for ES-SCLC in combination with standard-of-care therapy. The acquisition also includes an RPT manufacturing facility which will commence operations in the first half of 2024. BMS CEO Chris Boerner stated: “We are excited to complete this transaction, which adds RPTs, one of the fastest-growing new modalities for treating patients with solid tumours. “By strengthening and further diversifying our oncology pipeline beyond I-O, we will unlock exciting opportunities that support BMS’s growth in the back half of the decade and beyond. RayzeBio is a pioneer in the application of this novel modality, and we look forward to working with their talented team to accelerate their preclinical and clinical programmes for the benefit of patients around the world.” The latest deal comes after BMS entered a $674m collaboration with US deep tech company VantAI. The partnership will focus on using VantAI’s generative AI platform to design and develop molecular glues – a small molecule that induces or stabilises interactions between two proteins that would not normally go together.