212Pb-AR-RMX

iStock, Anton Vierietin Big Pharma can’t seem to get enough radiopharmaceutical biotechs. With Lilly, Sanofi and BMS chasing Novartis into the complex space, all eyes are on these specialty biotechs. Big Pharmas are snapping up radiopharmaceutical biotechs left and right, inspired by the market-leading position of Novartis, which has two therapies already approved. Behind these big ticket deals are a clutch of biotechs continuing to go at it alone. The use of targeted radioisotopes to treat cancer is not for the faint of heart. The specialized nature of this class of medicines means a Big Pharma can’t just buy the drug and cast off the rest of the company, as is often done when buying out a small company. Novartis has been the clear leader, with Pluvicto approved for prostate cancer and Lutathera for neuroendocrine tumors. The company developed Lutathera in-house and acquired Pluvicto through the acquisition of Endocyte in October 2018 in a deal valued at over $2 billion. The Swiss pharma has been hungry ever since to expand its pipeline in the space, with the acquisition of Mariana Oncology for $1 billion and a licensing deal expansion with PeptiDream, both this past spring. In 2023, Novartis’ peers started to take notice. Eli Lilly kicked off a string of deals in October 2023 with the $1.4 billion acquisition of Point BioPharma and followed that up with a partnership with Aktis Oncology that could also top $1 billion. Meanwhile, Bristol Myers Squibb dropped more than $4 billion in December 2023 for radiopharma-focused RayzeBio. And most recently, Sanofi is dipping its toe into the space, with a licensing deal worth $356 million upfront with RadioMedix. With so much cash being thrown around to buy into radiopharma, which biotechs are making waves on their own and may soon be wrapped up in the next Big Pharma deal? Here are five radiopharma companies you may be hearing about soon. Aktis Oncology Radiopharma-hungry Lilly inked a partnership with Aktis Oncology in May for $60 million, gaining access to the biotech’s targeted anticancer medicines. The deal could reach a whopping $1.1 billion in potential milestones and royalties later on. Aktis is using alpha-emitting particles for precision cancer targeting, while avoiding side effects. Lead programs target urothelial and other cancers. Late last month, Aktis also raked in a sizable $175 million oversubscribed Series B , underscoring the interest in the space. The round was led by RA Capital Management and co-led by RTW Investments and Janus Henderson Investors. Other participants included Bristol Myers Squibb, Lilly and MRL Ventures Fund, Merck’s venture fund, putting an exclamation point on the radiopharma frenzy. Aktis’ lead candidate is AKY-1189, a miniprotein alpha radioconjugate targeting Nectin-4 in development for solid tumors. The biotech has plenty of cash to go it alone for now, with CEO Matthew Roden reporting $300 million on hand. But with a trio of Big Pharmas making chase, Aktis is sure to be in the news again very soon. ARTBIO Launched in June last year, ARTBIO is creating a new class of radioligand therapies using the alpha-precursor isotope (Pb212) and tumor-specific targets. ARTBIO’s pipeline is still preclinical, but the most advanced is AB001, which targets prostate cancer. A December 2023 Series A , co-led by Third Rock Ventures and an undisclosed healthcare fund, brought in $90 million. Since then, the biotech has been signing deal after deal to shore up supply and manufacturing . Another deal from May will see ARTBIO work with fellow clinical-stage biotech FogPharma to develop so-called HEARTs , or Helicon-enabled 212Pb alpha radioligand therapies—a combination of both companies’ platforms. Nucleus RadioPharma This biotech is not developing therapies but instead offering integrated manufacturing and supply chain organization for radiopharmaceuticals. Nucleus’ platform has already attracted an investment from AstraZeneca, which pitched in to a Series A extension in June. Financial details were not disclosed, but the biotech raised $56 million in the original oversubscribed Series A one year ago, led by GE Health and Eclipse. The cash was expected to go towards multiple new manufacturing facilities around the U.S., including one near the Mayo Clinic, a contributor to the Series A round. Additional funds would help build technology for the development, manufacturing and distribution of radiopharmaceuticals. PeptiDream Novartis has returned to Japanese biotech PeptiDream time and time again to refill its stock of radiopharmaceuticals. In April, the two companies re-upped a partnership to total more than $2.7 billion in milestones. But the pair have been working together since 2010. And Novartis is not PeptiDream’s only partner. The company also has deals with Roche’s Genentech , Lilly and Merck , totaling billions in potential milestones. So what is PeptiDream’s secret sauce? Its Peptide Discovery Platform System can find new drugs based on macrocyclic peptides, which can be screened against any biological target of interest very quickly, according to the company. PeptiDream boasts a 95% success rate. The technology was licensed from the University of Tokyo and optimized in-house. The company’s extensive pipeline is populated by other partnerships, including with Biohaven and RayzeBio, which was acquired by BMS for $4.1 billion in December 2023. Most but not all are in cancer, with PeptiDream’s single internal program, a myostatin inhibitor, focused on developing radioligands for obesity and other muscle disorders. RadioMedix Sanofi found the ideal partner to join the radiopharma race in RadioMedix last month, signing a deal that also included French radioligand developer Orano Med. Sanofi handed over €100 million ($110 million) upfront, with €220 million ($242.5 million) in sales milestones, plus royalties, to access a neuroendocrine tumor candidate. The deal focused on AlphaMedix, a targeted radioligand therapy that uses lead-212Pb to target cancer. RadioMedix and Orano Med are running a Phase II clinical trial for the candidate in patients with neuroendocrine tumors, with a readout expected this year. The company also has two other clinical programs and some earlier-stage assets in preclinical testing. In addition to therapeutics, RadioMedix develops radiopharmaceuticals for diagnosis and monitoring of cancer and has capabilities from development up to manufacturing.

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 20, 2024 /PRNewswire/ -- USA News Group – Cancer rates are rising globally, and the outlook is particularly concerning for men. A recent global study projects an 84% increase in cancer cases and a 93% rise in cancer deaths among men by 2050. According to Our World in Data, cancer has overtaken cardiovascular diseases as the leading cause of death in several wealthy nations. Despite warnings from the American Cancer Society, which found that 44% of cancer deaths in U.S. adults are linked to lifestyle factors, troubling trends continue. Another study revealed that even light drinking is associated with an increase in cancer deaths among older adults in Britain. Meanwhile, behind the scenes, biotech innovators are developing new targets for improved cancer therapies, driving the next wave of breakthroughs in oncology coming from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), G1 Therapeutics, Inc. (NASDAQ: GTHX), Arcellx, Inc. (NASDQ: ACLX), Sanofi (NASDAQ: SNY), and Halozyme Therapeutics, Inc. (NASDAQ: HALO) . Building upon seemingly strong results from its BRACELET-1 breast cancer study, O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) continues to make impressive strides toward a pivotal registration-enabling study for its flagship cancer therapy, pelareorep. The BRACELET-1 Phase 2 trial delivered highly encouraging data, reinforcing the potential for pelareorep-based therapies to bring meaningful benefits to patients with HR+/HER2- advanced or metastatic breast cancer. One of the most intriguing results is the median overall survival (OS) in the pelareorep arm, which has not yet been reached—indicating that more than half of the patients were still alive at the end of the study. For comparison, the median OS in the paclitaxel-only control group was 18.2 months. This translates into a two-year survival rate of 64% for patients receiving pelareorep + paclitaxel, nearly double the 33% rate observed in patients treated with paclitaxel alone. The progression-free survival (PFS) results were equally impressive, showing a median of 12.1 months for the combination therapy, compared to 6.4 months for paclitaxel monotherapy. "The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy." These results are more than just numbers—they underscore the potential of pelareorep to significantly extend survival times for breast cancer patients, offering renewed hope to those battling this aggressive form of cancer. The positive results from BRACELET-1 mirror those of the earlier IND-213 trial, which led to FDA Fast Track Designation for pelareorep back in 2017, further cementing its status as a therapy with game-changing potential. "Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer." With such compelling data in hand, Oncolytics is now preparing for the next major milestone: securing funding for a registration-enabling study. This critical step will bring pelareorep closer to becoming an approved treatment option for breast cancer patients, offering a new lifeline in the fight against cancer. Set to be acquired by leading iron deficiency anemia treatment developer Pharmacosmos, commercial-stage oncology company G1 Therapeutics, Inc. (NASDAQ: GTHX) put out its Q2 2024 and operational highlights which included mention of its positive efficacy results from its Phase 2 trial of Trilaciclib in combination with a TROP2 ADC that were presented at the 2024 ASCO annual meeting, as well as final analysis of the Phase 3 PRESERVE 2 trial in 1L metastatic triple negative breast cancer (mTNBC) which showed continued evidence of myeloprotection, but didn't achieve its primary OS endpoint. "We are excited about what will be possible by the combined Pharmacosmos + G1 team as we meet the needs of more cancer patients," said Jack Bailey, CEO of G1 Therapeutics. "This transaction delivers a significant premium to our shareholders and better and broader access to COSELA for the cancer patients we seek to treat. In the meantime, as we move toward closing, our focus remains on accelerating and expanding the growth of the COSELA business in extensive stage small cell lung cancer; the double-digit quarter-over-quarter growth we experienced in vial volume and net revenue represents continued progress in that regard." Reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, Arcellx, Inc. (NASDQ: ACLX) recently put out its Q2 2024 financial results and business updates, which included mention of earning a $68 million milestone payment from Kite, a Gilead company, which Arcellx continues to have momentum with in advancements in anito-cel multiple myeloma. "We continue to make significant strides as we accelerate our business," said Rami Elghandour, Chairman and CEO of Arcellx. "We are thrilled about the momentum across our multiple myeloma program being developed in partnership with Kite. We believe anito-cel has the potential to be a best-in-class treatment option, and with the strength of our Kite partnership, we are well-positioned to change the treatment paradigm for multiple myeloma patients. We look forward to presenting data from the iMMagine-1 study by the end of this year. As iMMagine-1 continues to mature, we're also pleased with the progress in iMMagine-3, which was initiated by our partner Kite. More broadly, we believe that our novel synthetic binder, the D-Domain, which forms the basis of our technology platform and our lead program anito-cel, can be developed in oncology and non-oncology indications." Another joint oncology effort is coming from Sanofi (NASDAQ: SNY) through an exclusive licensing agreement with RadioMedix, and Orano Med to develop lead-212 (212Pb) radioligand therapies (RLTs) against cancer. The specifically focuses on the late-stage project, AlphaMedixTM (212Pb-DOTAMTATE), which currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedixTM is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles. "We are excited to develop a leading-edge project in the rapidly evolving field of radioligand therapies in rare cancers," said Dietmar Berger, Chief Medical Officer, Global Head of Development, of Sanofi. "Early results for 212Pb have demonstrated its differentiated biophysical and clinical profile, reinforcing its potential to be a transformative radioligand therapeutic for patients across multiple difficult-to-treat rare cancers. This agreement underscores our efforts to explore innovative collaborations that leverage novel technologies to address the needs of people living with cancer." Halozyme Therapeutics, Inc. (NASDAQ: HALO) is celebrating the FDA approval of Roche's Tecentriq Hybreza™ with its drug delivery technology ENHANZE® for multiple types of cancer. Tecentriq Hybreza™ offers a faster administration option, with a subcutaneous injection that takes about 7 minutes, compared to the 30-60 minutes required for the standard intravenous (IV) infusion of Tecentriq® (atezolizumab). This new treatment will be available in the U.S. for all approved adult uses of the IV version, including certain types of lung, liver, skin, and soft tissue cancers. "We are delighted that Tecentriq Hybreza has been approved in the U.S. for all approved adult indications of the IV treatment," said Dr. Helen Torley, president and CEO of Halozyme. "This approval represents another opportunity for our ENHANZE technology to provide patients and physicians with greater flexibility and a new option for how treatment is administered." The FDA's approval was based on pivotal data from Roche's Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. Article Source: USA NEWS GROUP [email protected] (604) 265-2873 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. 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