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Cellectar Biosciences to Highlight 2025 Strategic Initiatives at Upcoming
Biotech Showcase during the JP Morgan Healthcare Conference

On January 12, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported plans to highlight the Company’s 2025 strategic initiatives at Biotech Showcase, taking place January 13-15, 2025 in San Francisco during the 43rd Annual JP Morgan Healthcare Conference (Press release, Cellectar Biosciences, JAN 12, 2025, View Source [SID1234649702]). James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 11:30 am Pacific Time.

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Iopofosine I 131 (iopofosine) is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The CLOVER-WaM study (NCT02952508) results demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR. These data were presented as a podium presentation during the 66th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic.

"We remain committed to bringing iopofosine to WM patients, who have limited treatment options for this incurable disease," said James Caruso, president and CEO of Cellectar. "We believe our ongoing communications with the U.S. Food and Drug Administration (FDA) indicate there is a path forward for a conditional U.S. market approval as part of the accelerated approval process. This aligns with our understanding of feedback provided by the European Medicines Agency for conditional EU market authorization, and we are harmonizing recommendations from both agencies for a global approval strategy."

The Company expects the confirmatory study to be a comparator, randomized controlled study with 40-60 patients per arm and full patient enrollment projected within 18 months of the first patient admitted to the study. The Company anticipates alignment with the FDA in the first half of 2025. With a current cash runway extending into the fourth quarter of 2025, the Company is assessing a variety of approaches to bring iopofosine to patients.

Mr. Caruso continued, "We believe iopofosine represents a compelling partnership opportunity for many reasons including the results observed from our clinical studies. The commercial work we conducted in WM provides strong evidence that iopofosine possesses a substantial market opportunity based upon patient outcomes, convenient fixed dosing, off-the-shelf global distribution, and orphan pricing. Cellectar’s goal to bring lifesaving radioconjugates, such as iopofosine, CLR 121225, and CLR 121125, to patients remains steadfast and we look forward to advancing our objectives throughout 2025."

Beyond iopofosine, the Company is focused on the development of its radioconjugate Phospholipid Drug ConjugateTM (PDC) programs, also known as phospholipid radioconjugates or PRCs. CLR 121225 is Cellectar’s lead alpha-emitting actinium-225 radioconjugate PRC. It has demonstrated activity and has been well tolerated in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer. It has also shown excellent biodistribution and uptake into tumors. In animal models of pancreatic adenocarcinoma, the single lowest dose tested provided tumor stasis, and the highest dose provided tumor volume reduction. The Company plans to file an Investigational New Drug (IND) application in the first quarter of 2025.

Cellectar’s lead Auger-emitting (iodine-125) PRC, CLR 121125, has demonstrated tolerability and activity in multiple animal models including triple negative breast cancer. Auger- emitters provide the greatest precision in targeted radiotherapy as the emissions only travel a few nanometers, therefore it is necessary for the isotope to be delivered intracellularly. The Company’s novel PDC platform uniquely provides the required targeted delivery. CLR121125 has received IND clearance and a Phase 1b/2a dose finding study in triple-negative breast cancer is planned.

The Company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125.

Biotech Showcase

A live webcast and a replay of Mr. Caruso’s presentation at Biotech Showcase will be available on the Company’s investor relations website.

Tune Therapeutics Completes Over $175M in Series B Financing to Advance Field-Leading Epigenome Editing Programs

On January 12, 2025 Tune Therapeutics (Tune) reported the completion of over $175M in financing led by New Enterprise Associates, Yosemite, Regeneron Ventures and Hevolution Foundation (Press release, Tune Therapeutics, JAN 12, 2025, View Source [SID1234649624]).

"It is deeply gratifying to have seen this platform and company evolve so far," said Tune Co-Founder Dr. Charles Gersbach, whose research at Duke University formed the basis for Tune’s TEMPO epi-editing platform. "Tune has already achieved a global landmark in the field, in the clinical application of epi-editing to a common and chronic disease. Thanks to the support of our investors, we anticipate the development of many more new epi-editing therapies in the years to come."

The funding will accelerate the development of the company’s existing pipeline, currently anchored by Tune-401 – its clinical-stage epigenetic silencing drug for chronic Hepatitis B (HBV). It will also support the development of additional gene, cell, and regenerative therapy programs already underway at Tune, and to progress its broader mission of bringing the power and versatility of epigenetic therapies to bear on common and chronic diseases.

"We are incredibly proud to see Tune progress successfully into the clinic," said Reed Jobs, Founder and Investor at Yosemite. "The Yosemite team has been an enthusiastic backer of Tune from the beginning, as we feel that few technologies have the biological power of epigenetic medicine to transform disease outcomes for the better. The range of potential applications and indications is vast and will only continue to expand."

"To date, modern medicine and pharmacology has done much to extend our lifespans, but far less for our active healthspans," explains William Greene, Chief Investment Officer at Hevolution Foundation. "Chronic diseases of ageing are accelerating in incidence, prevalence, and severity, and current approaches are simply inadequate. It is our belief that epigenetic editing may prove to be the transformative modality we need to enable a new era of regenerative medicine."

Since its founding in 2021, Tune has made impressive strides in the development and application of its novel and potentially transformative epigenome editing platform. At the 2023 ASGCT (Free ASGCT Whitepaper) conference, Tune announced a global first in the field: the durable repression of a therapeutically relevant gene (PCSK9) in non-human primates using genetic tuning. This gene repression was accompanied by an enduring reduction of LDL cholesterol levels that is still ongoing almost 2 years after a single, transient delivery of the epi-silencing construct. Later that year, the company unveiled Tune-401, a first-in-class epigenetic silencer for chronic Hepatitis B, a condition that impacts over 250 million people, and is the leading cause of liver cancer worldwide.

In November of 2024, Tune announced it was moving to the clinical stage, having received approval to begin clinical trials in New Zealand, and subsequently in Hong Kong – supported by world-renowned hepatologists and Principal Investigators Dr. Ed Gane and Dr. Man-Fung Yuen, respectively. With its lead program now in the clinic, Tune is leveraging this momentum to enhance its platform capabilities and develop its other gene and cell therapy programs.

"With this renewed support, we are well-positioned to advance our HBV clinical program, to invest in our platform, and to expand our pipeline," said Akira Matsuno, Co-Founder, President and CFO of Tune Therapeutics. "We are grateful to all our investors for their deep confidence in our team and approach, backed by compelling data that continues to underscore the transformational potential of epi-editing as a therapeutic modality."

Castle Biosciences Announces Preliminary Unaudited Fourth Quarter and Full-Year 2024 Results

On January 12, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported certain unaudited preliminary performance results for the fourth quarter and year ended Dec. 31, 2024 (Press release, Castle Biosciences, JAN 12, 2025, View Source [SID1234649623]).

"Our strong fourth quarter performance underscores continued momentum built throughout 2024, reflecting the strength of our growth initiatives and the dedication of our team," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "As a result, we expect to meet or exceed the top end of our full-year 2024 revenue guidance of $320-330 million. This achievement reflects our commitment to delivering value to our stockholders while advancing our mission of improving health through innovative tests that guide patient care."

Preliminary, Unaudited Fourth Quarter Ended Dec. 31, 2024, Highlights

Delivered 24,071 total test reports in the fourth quarter of 2024, compared to 20,284 in the same period of 2023, an increase of 19%:
DecisionDx-Melanoma test reports delivered in the quarter were 8,672, compared to 8,591 in the fourth quarter of 2023, an increase of 1%.
DecisionDx-SCC test reports delivered in the quarter were 4,299, compared to 3,530 in the fourth quarter of 2023, an increase of 22%.
MyPath Melanoma test reports delivered in the quarter were 879, compared to 1,018 in the fourth quarter of 2023, a decrease of 14%.
TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 6,672 compared to 3,441 in the fourth quarter of 2023, an increase of 94%.
IDgenetix test reports delivered in the quarter were 3,125 compared to 3,299 in the fourth quarter of 2023, a decrease of 5%. In late 2024, the Company made modifications to its promotional investments for IDgenetix, shifting resources to inside sales and non-personal promotion.
DecisionDx-UM test reports delivered in the quarter were 424, compared to 405 in the fourth quarter of 2023, an increase of 5%.
Preliminary, Unaudited Year Ended Dec. 31, 2024, Highlights

The Company expects to meet or exceed top end of full-year 2024 revenue guidance of $320-330 million.
Delivered 96,071 total test reports in 2024, compared to 70,429 in the same period of 2023, an increase of 36%:
DecisionDx-Melanoma test reports delivered in 2024 were 36,008, compared to 33,330 in 2023, an increase of 8%.
DecisionDx-SCC test reports delivered in 2024 were 16,348, compared to 11,442 in 2023, an increase of 43%.
MyPath Melanoma test reports delivered in 2024 were 3,909, compared to 3,962 in 2023, a decrease of 1%.
TissueCypher Barrett’s Esophagus test reports delivered in 2024 were 20,956 compared to 9,100 in 2023, an increase of 130%.
IDgenetix test reports delivered in 2024 were 17,151, compared to 10,921 in 2023, an increase of 57%.
DecisionDx-UM test reports delivered in 2024 were 1,699, compared to 1,674 in 2023, an increase of 1%.
Cash, Cash Equivalents and Marketable Investment Securities

Year-end 2024 cash and cash equivalents are expected to be approximately $120 million. Additionally, the Company estimates that it held approximately $173 million in marketable investment securities as of year-end 2024.

Recent Publication Highlight

Findings from the prospective, multicenter DECIDE study demonstrating the significant impact of the DecisionDx-Melanoma test on sentinel lymph node biopsy (SLNB) decision-making for patients with melanoma were recently published in the World Journal of Surgical Oncology. The data showed that integrating DecisionDx-Melanoma test results into the treatment decision-making process resulted in 18.5% fewer SLNBs performed compared to a matched patient cohort for whom the test was not used to guide SLNB decisions (p<0.001). Additionally, no patient with a DecisionDx-Melanoma-predicted risk of SLN positivity of less than 5% who decided to have an SLNB procedure had a positive node.

Recent Reimbursement Update

On January 9, 2025, Medicare Administrative Contractor, Novitas, finalized a local coverage determination that includes language signifying non-coverage by Medicare for our DecisionDx-SCC test.

IDEAYA Biosciences Announces Participation at the 43rd Annual J.P. Morgan Healthcare Conference and 2025 Corporate Guidance

On January 12, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation at the 43rd Annual J.P. Morgan Healthcare Conference and provided 2025 corporate guidance and program updates (Press release, Ideaya Biosciences, JAN 12, 2025, View Source [SID1234649622]).

43rd Annual J.P. Morgan Healthcare Conference
Monday, January 13th, 2025, at 5:15 PM PT (8:15 PM ET)

Presentation by Yujiro S. Hata, Chief Executive Officer, IDEAYA Biosciences, followed by analyst-hosted Q&A with Anupam Rama, Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan
2025 Corporate Guidance to be Presented at the 43rd Annual J.P. Morgan Healthcare Conference:

Corporate financial guidance
$1.2 billion of cash, cash equivalents and marketable securities as of September 30, 2024, is anticipated to fund operations into at least 2028
Darovasertib, a potential first-in-class Phase 2/3 PKC inhibitor program targeting Metastatic Uveal Melanoma (MUM) and Uveal Melanoma (UM)
Median progression free survival readout for potential Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in first-line (1L) patients with HLA-A2-negative MUM targeted by year-end 2025, pending enrollment status and data maturity. Enrollment has exceeded over 200 patients as of January 6, 2025
Phase 2 1L MUM median overall survival readout for the darovasertib and crizotinib combination in approximately 38 1L MUM patients targeted in 2025
Targeting Phase 2 neoadjuvant UM clinical data update for darovasertib in over 75 patients and a regulatory update in 2025
Initiation of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is planned for the first half of 2025
IDE397, a potential first-in-class Phase 2 MAT2A Inhibitor program targeting MTAP-deletion solid tumors
Clinical program update(s) for Phase 1/2 study of IDE397 in combination with Trodelvy in MTAP-deletion urothelial cancer (UC) in 2025
Target to enable wholly owned IDE397 + IDE892 (IDEAYA PRMT5) clinical combination in the second half of 2025 to target MTAP-deletion non-small cell lung cancer (NSCLC)
IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i ADC targeting Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors (NETs)
Clinical program update(s) targeted in 2025
Updated IDE849 clinical program slides have been provided in the JPM 2025 corporate presentation, including preclinical product profile, CT-scan tumor size waterfall plot by RECIST 1.1, and SCLC patient case study
IDE275 (GSK959), a potential first-in-class Phase 1 Werner Helicase program targeting MSI-high solid tumors
Targeting presentation at a medical conference with GSK, highlighting IDE275’s differentiated potential best-in-class profile, in the first half of 2025
IDE161, a potential first-in-class Phase 1 PARG inhibitor program targeting solid tumors
Targeting Phase 1 expansion of IDE161 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in MSI-high and MSS endometrial cancer in 2025
Targeting clinical combination(s) of IDE161 with Topo-ADCs in 2025
IDE705 (GSK101), a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor targeting homologous recombination deficiency (HRD) solid tumors
Targeting Phase 2 expansion in HRD solid tumors, enabling a potential $10 million milestone payment from GSK
3 IND-filings targeted in 2025, representing IDEAYA’s 7th, 8th, and 9th potential clinical stage precision medicine oncology program targeting solid tumors
IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-year 2025. Combination potential with IDE397
IDE034, a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC, in the second half of 2025. Combination potential with IDE161
IDE251, a potential first-in-class KAT6/7 dual inhibitor development candidate, in the second half of 2025. Combination potential with multiple programs in IDEAYA’s pipeline
IDEAYA’s updated JPM 2025 corporate presentation reflecting its 2025 corporate guidance is available on its website under the Investor Relations section: View Source

A live audio webcast of the presentation and Q&A session will be available under the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of the webcast will be accessible for 30 days following the live event.

Telix to Acquire Next-Generation Therapeutic Assets and Innovative Biologics Technology Platform

On January 12, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) reported it has entered into an asset purchase agreement with antibody engineering company ImaginAb, Inc. (ImaginAb) to acquire a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities (Press release, Telix Pharmaceuticals, JAN 12, 2025, View Source [SID1234649621]).

This transaction adds a pipeline of early-stage drug candidates against high-value targets including DLL3[1] and integrin αvβ6[2], as well as several other novel targets in discovery stage. These next generation drug candidates fit synergistically with Telix’s therapeutics pipeline, enabling expansion to future therapy areas with unmet clinical need. The acquired intellectual property utilizes small engineered antibody formats that enable highly specific cancer targeting, combined with fast tumor uptake and blood clearance. This technology has the potential to be highly effective for imaging and treating tumors with a broad range of radioisotopes, with alpha emitters of particular interest.

The transaction also includes a state-of-the-art research facility in California, staffed by a talented team of discovery, protein engineering and radiopharmaceutical development experts. Together, these assets will provide Telix with further in-house capabilities in antibody engineering and preclinical development, as well as a novel biologics platform to create the next generation of Telix precision medicine and therapeutic products, beyond the current clinical-stage pipeline.

Richard Valeix, Chief Executive Officer, Therapeutics, Telix, said, "The combination of a proprietary drug discovery platform, pipeline of promising theranostic assets and a talented team of subject matter experts will enhance Telix’s research and innovation capability now and into the future. This acquisition will enable Telix to explore new disease areas with state-of-the-art radiotherapeutic technology."

Dr. Anna M. Wu, Co-Founder and Board Member, ImaginAb, added, "As the radiopharmaceutical sector gains momentum there is a significant need for targeting agents to be more selective, deliver less off-target radiation, and better match the pharmacology and radiobiology of a given radionuclide. The team’s deep expertise in antibody engineering and the resulting development of a valuable, proprietary platform technology has led to clinical proof-of-concept. Telix is the right partner to unlock the future therapeutic potential of this platform."

Transaction details

Telix will acquire these assets through an asset purchase agreement with a concurrent technology license agreement to be signed at closing. The purchase price for the transaction is US$45 million (AU$73 million)[3], comprised of US$10 million in cash and US$31 million in equity at closing, and a deferred payment of up to US$4 million in equity at the conclusion of a 15-month indemnity period.

Upon achievement of specific key development and commercial milestones, Telix will pay up to a total of US$185 million (AU$299 million), a portion of which may be paid in cash or equity at Telix’s election[4]. Royalties are also payable on net sales in the low single digits on a limited number of platform and early-stage products after the first four products have been developed, as well as single-digit sublicense fees, as applicable.

Telix will issue ordinary shares to ImaginAb within its Listing Rule 7.1 placement capacity as consideration for the acquisition. Upfront equity consideration will be subject to voluntary escrow (lock-up/leak-out) restrictions with equal tranches being released from escrow 60, 90 and 120 days after closing. Completion of the transaction is subject to customary conditions, including regulatory approvals and other third-party consents. Telix cannot guarantee this transaction will close in any specific timeframe or on the terms summarized here, if at all.