On February 5, 2025 Lantheus Holdings, Inc. (the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported piflufolastat F 18 data will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.

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Presentation details are as follows:

Date & Time: Thursday, February 13, 2025, 11:25 am – 12:45 pm PT and 5:45 PM-6:45 PM PT
Session Number: Poster Session A
Session Title: Prostate Cancer
Title: Early Detection of Recurrent Prostate Cancer Using 18F-DCFPyL PET/CT in Patients with Minimal PSA Levels
Presenter: Ida Sonni, University of California, Department of Radiation Oncology
Poster Number: J8

Date & Time: Thursday, February 13, 2025, 11:25 am – 12:45 pm PT and 5:45 PM-6:45 PM PT
Session Number: Poster Session A
Session Title: Prostate Cancer
Title: The Role of Conventional Imaging and Piflufolastat F18 in Newly-Diagnosed and Recurrent Prostate Cancer Patients: Preliminary Observations from the PYLARIFY Registry
Presenter: Neal Shore, Carolina Urologic Research Center
Poster Number: A19

About PYLARIFY (piflufolastat F 18) Injection
PYLARIFY (piflufolastat F 18) injection (also known as 18F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 400,000 scans across 48 states.

PYLARIFY (piflufolastat F 18) Injection

Indication

PYLARIFY (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Important Safety Information

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

(Press release, Lantheus, FEB 5, 2025, View Source [SID1234662961])

On February 5, 2025 NuFund Venture Group reported investment in Resolute Science, a preclinical-stage biotechnology company developing a pan-cancer platform targeting tumor-associated macrophages to deliver cytotoxic and radiotherapeutic payloads deep into solid tumors (Press release, Resolute Science, FEB 5, 2025, View Source [SID1234656391]). The funding will support IND-enabling studies for Resolute’s lead asset, RS-5, a MAC-TAC (Macrophage-Targeted Conjugate) carrying an MMAE payload showing profound single-agent anti-cancer efficacy.

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SAN DIEGO, Feb. 5, 2025 /PRNewswire-PRWeb/ — NuFund, a leading venture group, is thrilled to announce its investment in Resolute Science, Inc., a preclinical-stage biotechnology company developing a novel class of pan-cancer therapeutics for the treatment of aggressive and hard-to-treat solid tumors.

Resolute Science is advancing a pipeline of first-in-class synthetic drug conjugates to deliver targeted cytotoxic and radiotherapeutics deep into tumors. The modular design of its MAC-TAC (Macrophage Targeted Conjugate) platform enables the rapid development of drug candidates carrying a variety of payloads. Resolute’s approach has the potential to overcome the resistance mechanisms associated with cancer-cell targeting therapeutics, delivering more effective and well-tolerated treatments to patients who have run out of options.

Solid tumors have two main cell populations: cancer cells and tumor-associated macrophages (TAMs). TAMs are stable, abundant, non-dividing, and often comprise 30% to 50% of a solid tumor’s mass. By targeting TAMs to receive, process, and distribute payloads throughout the tumor, Resolute aims to improve drug penetration into tumors, reduce off-target toxicity, and deliver greater and more durable anti-cancer efficacy compared to existing treatment options.

"Resolute has developed a potentially breakthrough approach for cancer therapy by targeting a receptor expressed by tumor-associated macrophages to deliver payloads into tumors," explains John Montana, NuFund member and Deal Lead. "Early preclinical data is impressive, and NuFund is proud to help support the company’s drive through the IND-enabling stage and ultimately position them for clinical studies in cancer patients."

As part of the investment, NuFund’s John Montana will join Resolute Science as a board observer. Additionally, James Mackay, a NuFund member and existing Senior Business Advisor to Resolute, will join Resolute’s Board of Directors. While Mackay’s board appointment is independent of this transaction, his deep industry expertise and continued involvement with Resolute further strengthen the company’s leadership as it advances its programs toward the clinic.

"We are grateful for NuFund’s support as we work to translate our therapeutics into the clinic, said Dr. Faith H. Barnett, Founder and CEO of Resolute Science. "NuFund’s financial backing and confidence in Resolute will help us bring new therapies to cancer patients, particularly those with limited or no treatment options. I’m also excited to welcome James to our board. He has been an incredible asset to our company"

This investment will support Resolute Science in advancing its lead asset, RS-5, a MAC-TAC carrying an MMAE payload, through IND-enabling studies and submission. RS-5 has demonstrated potent single-agent anti-cancer efficacy in 16 preclinical studies across multiple tumor models while being well tolerated.

On February 5, 2025 Boston Scientific reported its financial annual report of the year 2024 (Presentation, Boston Scientific, FEB 5, 2025, View Source [SID1234652112]).

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On February 5, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the closing of its previously announced best-efforts public offering of 762,500 common shares at a public offering price of $4.00 per share (Press release, BriaCell Therapeutics, FEB 5, 2025, View Source [SID1234650080]). The Company received gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, of $3.05 million. The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as sole placement agent for the offering.

The securities were offered and sold pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering was made by means of a prospectus supplement and prospectus which have been filed with the SEC and are available on the SEC’s website at www.sec.gov . You should read the applicable prospectus supplement and prospectus for more complete information about the Company and the offering. You may obtain these documents free of charge by visiting the SEC website at www.sec.gov . Alternatively, you may obtain copies by contacting ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 5, 2025 Armaceutica reported US patent granted titled: Bifunctional Compositions for the Treatment of Cancer (Press release, Armaceutica, FEB 5, 2025, View Source [SID1234650068]). This drug, which is often used to treat malaria, is being repurposed by Armaceutica, Inc. to treat various types of cancer.

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Renato Aguilera, Ph.D. and Biology Professor and cancer researcher at the University of Texas at El Paso, published data demonstrating that the drug (pyronaridine, or PND) kills various types of cancer cells.3

Pyronaridine was shown to preferentially kill certain types of leukemia, lymphoma, melanoma, multiple myeloma, lung, ovarian, and breast cancer cells while limiting off-target toxicities in normal, healthy cells.3 That is, pyronaridine had reduced effects on non-cancerous cells with a favorable selective cytotoxicity index (SCI), as compared with cancerous cells.3

Dr. Aguilera’s studies revealed that pyronaridine inhibits the activity of a critical enzyme (topoisomerase II) required for DNA replication and cancer cell division.4

Studies on mice with metastatic human breast cancer showed the group that received pyronaridine had smaller tumor volumes (P<0.0001) and increased longevity than control mice.4 A study on dogs with cancer showed pyronaridine reduced tumor volumes and increased longevity.1 In one case a lymphoma tumor shrunk by 70%.1 A pilot study on terminally-ill humans with late-stage cancers of the breast, lung and liver; pyronaridine appears to have increased longevity.1

The company’s CEO, Ernest Armstrong, said: "Pyronaridine represents a disruptive breakthrough relative to other cancer therapies. Pyronaridine has been proven safe and effective for malaria in at least four phase 3 studies and is an approved drug in parts of Asia and Africa." 2

Patent offices in Australia, Canada, EU, Israel, Japan, Malaysia, Mexico, Philippines, Russia, Thailand and the UK have granted patents corresponding to U S Patent No.: 12,201,626.

If you or a loved one has ever been treated with chemotherapy, you’ll understand how devastating the side effects can be.

Dr. Aguilera stated: "If the drug were available in the US and approved as an anti-cancer treatment, I would take it in an instant, if I came down with cancer."

Armaceutica, Inc. is a US-based pharmaceutical company focused on low-toxicity cancer treatments. Armaceutica is seeking a partner to develop pyronaridine into an approved drug for cancer, a process that will take several years.

References: 1US Patent No.: 12,201,626, Jan. 21, 2025. 2Croft et al., Malaria Journal 2012, 11:270. 3 Villanueva PJ, et al., PLOS One, 5 Nov 2018, 13(11):e0206467. 4 Villanueva PJ, et al., Clinical Cancer Drugs 2021, 8:50-56.