On June 26, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported further details of the positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) (Press release, Telix Pharmaceuticals, JUN 26, 2023, View Source [SID1234632912]).

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New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.

TLX250-CDx PET/CT detected more lesions in liver and bone than diagnostic CT imaging alone. This reinforces the performance of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an excellent overall sensitivity and specificity of 86% and 87%, respectively, together with high intra-reader agreement.[1], [2]

The results were featured in an oral presentation delivered on Monday, 26 June 2023 (CDT) by Jeremie Calais, MD, Director of the Clinical Research Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at University of California, Los Angeles (UCLA), and a principal investigator in the Phase III ZIRCON study, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting in Chicago.

New data presented:

25 patients had ≥1 extrarenal lesions detected by whole body PET/CT (n=10), abdominal PET/CT (n=17), or both modalities (n=2)
Extrarenal lesions were mostly localised in bone, liver, lung, adrenal glands and lymph nodes
Jeremie Calais, MD commented, "It is a pleasure to be showcasing further results from Telix’s highly successful Phase III ZIRCON study at SNMMI, the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging worldwide. Data presented here in Chicago on extrarenal lesions demonstrates potential utility of TLX250-CDx for staging and monitoring high risk patients where there is a great deal of interest from the clinician community."

Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

On June 26, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical stage drug programs, reported that the company has published new findings in Oncotarget demonstrating drug candidate LP-284’s in vitro and in vivo antitumor potency for multiple non-Hodgkin’s lymphomas (NHL), including mantle cell lymphoma (MCL) and double-hit lymphoma (DHL) (Press release, Lantern Pharma, JUN 26, 2023, View Source [SID1234632908]). The journal article titled "LP-284 Targets Non-Hodgkin’s Lymphoma and DNA Damage Repair Deficiency" further supports LP-284’s development for NHL and advancement towards a first-in-human Phase 1 trial, which is anticipated for the second half of 2023.

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Non-Hodgkin’s lymphomas (NHL) remain one of the leading causes of cancer deaths globally and have an estimated 500,000 new cases globally, with NHL being the leading hematological malignancy in the US. Despite advances for NHL using combination and targeted therapies, nearly 20% to 40% of patients with certain subtypes still relapse after treatment. In aggressive subtypes of NHL, like MCL, nearly all patients relapse from standard-of-care (SOC) therapies.

"Given the efficacy of drug candidate LP-284 in preclinical studies and the mechanism of synthetic lethality where LP-284 seems to prefer blood cancers with deficiencies in the DNA repair pathways, we believe this drug candidate can be a powerful therapeutic option for a wide range of blood cancers with potential both as monotherapy in later stages of treatments and in earlier lines in combination with other agents," stated Panna Sharma, Lantern’s CEO and President. "We have developed this molecule from initial ideas to first-in-human clinical testing in a highly efficient and rapid manner by leveraging our AI platform, RADR. This is unheard of progress in oncology drug development and was achieved in less than 2.5 years and under $2 million USD, and we can readily scale the manufacturing of this molecule to meet global needs for NHL patients," continued Sharma.

"Our new findings in Oncotarget reveal that LP-284’s synthetically lethal mechanism of action is driven by the creation of double-strand DNA breaks and can be leveraged for multiple non-Hodgkin’s lymphomas that are DNA damage repair deficient," stated Kishor Bhatia, Ph.D., Lantern’s Chief Scientific Officer. "We have also demonstrated a critical preclinical finding that LP-284 has potent antitumor activity in MCL tumors that have grown resistant to standard-of-care agents. As nearly all patients with MCL relapse from standard-of-care treatment, they have an urgent and unmet need for potential new drug candidates, such as LP-284," continued Dr. Bhatia.

Key Publication Highlights:

LP-284’s mechanism of action, synthetic lethality, was demonstrated to be caused by LP-284’s induction of DNA double-strand breaks. Cells treated with LP-284 had significantly increased double-strand DNA breaks when compared to control-treated cells.
Nanomolar potency was demonstrated for LP-284 in 15 NHL cell lines, with the lowest IC-50s observed for the 6 MCL and 7 DHL/Triple Hit Lymphoma cell lines, which had average IC-50s of 342 nM and 613 nM respectively.
LP-284 treatment of 2 mg/kg and 4 mg/kg inhibited tumor growth of mice implanted with MCL xenografts by 63% and 113% respectively. LP-284’s tumor growth inhibition was greater than 2X that of the MCL SOC agents bortezomib or ibrutinib.
In mouse MCL xenograft tumors that had grown resistant to either bortezomib or ibrutinib, subsequent LP-284 treatment at 4 mg/kg led to near-complete tumor regression, whereas control-treated tumors continued to grow uncontrollably.
LP-284’s antitumor potency can be enhanced when combined with the FDA-approved agent spironolactone. Treatment of multiple myeloma cells with LP-284 + spironolactone led to a 2.4 fold decrease in IC-50 when compared to LP-284 treatment alone.
Combined, these new in vitro and in vivo results for LP-284 strongly support its anti-tumor activity for NHLs, including advanced MCL tumors that have grown resistant to SOC agents. Based on the potential of LP-284 for MCL, Lantern was granted an FDA Orphan Drug Designation for LP-284 in MCL.

The full journal article can be found on Lantern’s website or at the Oncotarget website. Oncotarget is primarily an oncology-focused, peer-reviewed, open-access journal which aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science.

On June 26, 2023 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the publication of preclinical data from their pan-cancer, fibroblast activation protein-α (FAP)-targeted program, PNT2004, at the 2023 Annual Meeting of the Society of Nuclear Medicine & Molecular Imaging (SNMMI), taking place June 24-27, 2023, in Chicago, IL (Press release, Point Biopharma, JUN 26, 2023, View Source [SID1234632907]).

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PNT6555, the lead candidate in the PNT2004 program, led to complete and durable tumor regression and improved survival in HEK-mFAP tumor-bearing mice when chelated to any one of the three radioisotopes studied: lutetium-177 (177Lu), actinium-225 (225Ac), and terbium-161 (161Tb). Additionally, 177Lu-PNT6555 in combination with anti-PD-1 checkpoint blockade was assessed in the aggressive, immunocompetent CT26-mFAP mouse model and demonstrated a significant survival benefit compared to either treatment alone.

"By continuing to develop expertise in more isotopes, POINT is better positioned to create optimized next-generation radioligands, which match a ligand’s properties with the most appropriate isotope," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "The expertise to discover and develop new radioligands and advance them into clinical trials has been built into POINT. We look to fill our toolbox of isotopes as full as we can, evaluate them in discovery and development, and aim to bring forward candidates we believe could generate compelling patient benefit."

Presentation details are as follows:

Title: Preclinical application of novel isotopes and combination therapy with the FAP-targeted ligand PNT6555

Abstract ID: 180

Session Name: Imaging and Therapy in Preclinical Oncology Models – Session 2

Session Date: Monday, June 26th

Session Time: 10:00 AM – 11:15 AM CT

Presentation Time: 10:45 AM – 10:55 AM CT

Following the presentation of these data the poster will be made available on POINT’s Investor Relations website, View Source

On June 26, 2023 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, and AdvanCell, a company developing an innovative pipeline of targeted alpha therapies with a platform technology to produce 212Pb radiopharmaceuticals, reported a collaboration on the development of a global 212Pb radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of 212Pb-labeled radioligands by each company (Press release, Point Biopharma, JUN 26, 2023, View Source [SID1234632906]).

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212Pb is differentiated as both an alpha and beta-emitting isotope with a simple decay chain that has demonstrated promising clinical results1 in compassionate use and phase 1 settings. 212Pb is produced via a generator using thorium (228Th, 1.9 year half-life) or radium (224Ra, 3.6 day half-life) sources. 228Th is available in significant quantities and has a half-life that supports 212Pb generators with ~1 year shelf-lives stationed at a selected number of regional locations globally. The short half-life of 212Pb (10.6 hours) has the benefit of delivering >99% of the tumor cell–killing radiation in only 72 hours, which reduces the time that the ligand needs to be retained in the tumor, a common limitation for targeted radioligand therapies. The short half-life may also promote the earlier maintenance of functional immune cells infiltrating the tumor relative to longer-lived isotopes. In contrast, only ~20% of the decays from 225Ac occur in 72 hours, so prolonged tumor retention is required to achieve the same payload delivery.

"We constantly strive to use the right isotope for the job, and variations in ligand and tumor characteristics require different isotope properties," said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "Adding 212Pb to our toolbox increases the optionality for new programs with the goal of developing new therapeutic options with improved clinical outcomes. Importantly, AdvanCell’s proprietary 212Pb generator technology based on 228Th sources is next-generation technology that we believe can scale to commercial quantities. Having a greater range of isotope choices, combined with supply chain visibility and control over access, will facilitate not only robust clinical development programs but also make eventual supply for commercialization more predictable as we look to expand our pipeline to bring next-generation radioligands to more patients."

"AdvanCell is delighted to collaborate with POINT Biopharma, whose excellence and track record in manufacturing and clinical development we have admired and respected for some time," said Andrew Adamovich, Chief Executive Officer of AdvanCell. "AdvanCell was founded on the belief that targeted alpha therapies will change the course of cancer treatment. These treatments have demonstrated incredible efficacy but have been hampered by manufacturing and supply issues. AdvanCell’s technology, in combination with POINT’s demonstrated manufacturing expertise and our joint commitment to developing life-saving therapies, will deliver on the promise of targeted alpha therapy and positively impact the lives of many. As AdvanCell progresses ADVC001, our lead clinical program for the treatment of metastatic prostate cancer, this collaboration will accelerate clinical development and ensure the scaled supply of these important medicines."

On June 26, 2023 Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, reported that it has completed the second closing of its previously announced securities purchase agreement, resulting in $34 million of new capital before placement agent and transaction fees (Press release, Orchard Theraputics, JUN 26, 2023, View Source [SID1234632905]).

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In March 2023, the company completed the first closing of an innovative financing arrangement, led by RA Capital Management with participation from other leading healthcare investors that resulted in $34 million of new capital before placement agent and transaction fees. Per the terms of the agreement, the company could bring in an aggregate of up to $188 million (inclusive of the $68 million raised at the first and second closings) at increasing valuations following the achievement of certain U.S. regulatory milestones for OTL-200 for MLD. The conditions of the second closing included shareholder approval and the company’s intention to initiate a biologics license application (BLA) submission following receipt of minutes from a productive pre-BLA meeting with the U.S. Food and Drug Administration for OTL-200, both of which have been achieved. The second closing comprises the sale of units at a purchase price of $8.00 per unit for aggregate proceeds of $34 million, including the issuance of 4.25 million American Depository Shares (ADSs) as well as warrants.

"The initiation of our BLA submission marks a significant de-risking event for Orchard and our OTL-200 program ahead of a potential U.S. approval in MLD," said Frank Thomas, president and chief operating officer of Orchard Therapeutics. "This next wave of funding from the second closing is expected to provide important capital to support preparations for our anticipated first U.S. launch and advance our next-in-line neurometabolic programs derived from our HSC gene therapy platform. We want to thank each of the participating investors for supporting this unique and innovative structure and partnering with us to develop a standout company in the field of gene therapy."

Guggenheim Securities, LLC acted as the sole placement agent for the private placement.

Orchard intends to use the net proceeds from the offering to support its growing commercial capabilities for Libmeldy, prepare for a potential U.S. approval for OTL-200 and advance its HSC gene therapy portfolio. The company expects that its existing cash, cash equivalents and investments, inclusive of the proceeds from the second closing, will fund its anticipated operating, debt service and capital expenditure requirements into mid-2025, with the potential for additional runway extension pending the exercise of the warrants issued as part of the financing.

The securities were sold in a private placement and have not been registered under the Securities Act of 1933, as amended (Securities Act), and may not be offered or sold in the U.S. absent registration or an applicable exemption from registration requirements. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission (SEC), for purposes of registering the resale of the ordinary shares issued or issuable in connection with the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.