On September 24, 2024 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on POSLUMA (flotufolastat F 18) injection (formerly known as 18F-rhPSMA-7.3) at the upcoming American Society for Therapeutic Radiology and Oncology (ASTRO) 2024 Annual Meeting, to be held in Washington, DC, from September 29 – October 2, 2024 (Press release, Blue Earth Diagnostics, SEP 24, 2024, View Source [SID1234646851]). POSLUMA is 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 or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

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"PET imaging with POSLUMA can reveal clinical information crucial to decision-making for men with prostate cancer, and we are excited to share new results with the radiation oncology community at ASTRO," said Marco Campione, Chief Executive Officer of Blue Earth Diagnostics. "Presentations by our collaborators include additional results from the completed Phase 3 SPOTLIGHT study, which evaluated POSLUMA in recurrent prostate cancer, and results from an investigator-initiated study of POSLUMA PET and MRI in recurrent disease. Blue Earth Diagnostics will also host an Industry-Expert Theater event, ‘Let’s Talk About POSLUMA (flotufolastat F 18)’."

Details of selected oral and poster presentations by Blue Earth Diagnostics and its collaborators are listed below.

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Sunday, September 29, 2024

Oral presentation

Title:

A Prospective Pilot Study Investigating 18F rhPSMA-7.3 PET/MRI to Detect Disease and Guide Radiotherapy Planning in Patients with Biochemically Recurrent Prostate Cancer Post-Prostatectomy

Presenter:

Devaki Shilpa Surasi, MD, MD Anderson Cancer Center, Houston, Texas

Session Type

Oral

Session Title:

QP 01 – GU 4: GU Quick Pitch

Session Time:

8:00 – 9:00 AM ET

Presentation Time:

8:50 – 9:00 AM ET

Location:

Room 207 B

Presentation No.:

1005

Tuesday, October 1, 2024

Poster presentation

Title:

18F-Flotufolastat Detection Rates in the Pelvis Region for Patients with Prostate Cancer Recurrence after Radical Prostatectomy and PSA Levels <1 ng/mL: Data from the Phase 3 SPOTLIGHT Study

Presenter:

Bridget F. Koontz,* MD, FASTRO, AdventHealth Cancer Institute, Orlando, FL, for the SPOTLIGHT Study Group (*Duke University Medical Center, Durham, NC – affiliation at time of study)

Session Title:

PQA 08 – PQA 08 Genitourinary Cancer, Patient Safety, and Nursing/Supportive Care Poster Q&A

Presentation Time:

2:30 – 3:45 PM ET

Location:

Hall C

Presentation No.:

3210

Blue Earth Diagnostics invites participants at the 2024 ASTRO Annual Meeting to attend the presentations above and visit the company at Exhibit Booth 1949. Blue Earth Diagnostics is hosting an Industry-Expert Theater event, "Let’s Talk About POSLUMA (flotufolastat F 18)," which will feature invited speakers Sean Collins, MD, PhD, Professor, Georgetown University Hospital and Elizabeth Hawk, MS, MD, PhD, DABNM, DABR, University of California San Diego, and be moderated by Todd Cohen, MD, Blue Earth Diagnostics, Inc. The event will be held on Sunday, September 29, 2024, from 12:00 PM to 1:00 PM ET, in Theater 1, Exhibit Hall, of the Walter E. Washington Convention Center. Blue Earth Diagnostics also has a Medical Affairs information booth at ASTRO, where attendees can learn about the Company’s clinical research. For full session details and scientific presentation listings, please see the ASTRO online program here.

Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA (flotufolastat F 18) injection is 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

Image interpretation errors can occur with POSLUMA PET. 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 POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
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 flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

On September 24, 2024 Amarex reported its work on behalf of Gibson Oncology has resulted in an Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for the drug LMP744 (Press release, Amarex Clinical Research, SEP 24, 2024, View Source [SID1234646850]).

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LMP744 treats gliomas, readily crossing the blood brain barrier (BBB) at 10 times the concentration required to kill cancer cells and sustains a high concentration for over 24 hours per dose.

"For decades glioblastoma brain cancer patients have not seen appreciable increases in overall survival rates with Temodar, the current standard of care treatment," said Mr. Randall Riggs, President & CEO of Gibson Oncology. "Our goal is to advance both LMP400 and LMP744 to market via the shortest and quickest path, thus benefiting cancer patients in need."

Obtaining ODD for LMP744 for all gliomas underscores the promising and novel treatment of the drug to inhibit two cancer targets: TOPO 1 and downregulate cMyc overexpression through the drug’s potent binding of the G4 quadruplex of cMyc.

"This crucial designation could not come at a more critical time for the families who are fighting this disease," said Dr. Kush Dhody, President, Amarex. "Reaching this milestone sets the company up for future success and, most importantly, poises Gibson Oncology to continue its path to commercialization of this life-saving treatment."

Through a multi-year collaboration with cMyc expert, Dr. Danzhou Yang of Purdue University, Gibson Oncology discovered that LMP400, which received ODD earlier in the year, and LMP744 are potent nM inhibitors of both TOPO 1 and cMyc oncogene. Together, the teams determined that LMP744, a small molecule, selectively targets two well-known drivers of human cancers, cMyc oncogene and TOPO 1.

The discovery of this compound’s unique anti-cancer mechanism of action (MOA) allowed Gibson Oncology to better position LMP744 and LMP400 to cancer targets with high unmet medical needs.

Presently, LMP744 and LMP400 is positioned to enter a Phase 2 human clinical trial in recurrent gliomas in collaboration with the National Institutes of Health (NIH).

Gibson Oncology believes it is important to leverage the Orphan Drug Designation both drugs have received from the FDA for all gliomas, not just glioblastomas, which includes children with gliomas. Rapid regulatory advancement empowers LMP400 and LMP744 to the shortest and quickest path to market, thus benefiting cancer patients in need.

On September 24, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported its strategic plan for a Phase 2 study for its breast cancer vaccine (Press release, Anixa Biosciences, SEP 24, 2024, View Source [SID1234646849]). The Phase 1 trial is being conducted at Cleveland Clinic, funded by a grant from the U.S. Department of Defense.

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The proposed Phase 2 trial will evaluate the efficacy of the vaccine administered in the neoadjuvant (before surgery) setting, in combination with chemotherapy and Keytruda (pembrolizumab). The goal of neoadjuvant therapy is to reduce tumor burden and to prevent tumor recurrence with the intent to improve survival. This clinical trial approach allows Anixa to enroll a broader range of patients, encompassing multiple types of breast cancer. The therapeutic market for breast cancer is large due to the increase in prevalence of breast cancer and an increase in screening resulting in a demand for treatment. Compared with primary prevention, the development path for breast cancer treatment is expected to have a shorter path to approval. The therapeutic market covers all stages of breast cancer, from early to advanced and metastatic cases. In 2023, the market was valued at approximately $38.35 billion and is projected to reach $89.67 billion by 2030, growing at a compound annual growth rate (CAGR) of 12.9% (Maximize Market Research).

The key objectives of the trial include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy. A key component of this trial will be the evaluation of breast cancer tissue and the validation of the immunological mechanism of action of the vaccine.

The trial is expected to commence in 2025 and is projected to last approximately two to three years. Immunological responses to the vaccine will be made available as the trial advances, providing a faster and more cost-effective path toward potential approval and/or partnerships with pharmaceutical companies.

"We are excited to unveil our Phase 2 study plan, bringing us one step closer to a potentially transformative therapy for breast cancer patients," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "By targeting treatment rather than prevention, we can reach a broader patient population and potentially expedite the process of regulatory approval and partnerships. This trial marks a key milestone in advancing our mission to fight cancer through innovative therapies. While our Phase 2 trial focuses on the therapeutic market, with the data obtained in this trial, we expect to conduct additional, more informed studies for both recurrence prevention and primary prevention with partners in the future."

Initial Phase 1 data was presented at the San Antonio Breast Cancer Symposium in December 2023. The data showed no safety concerns, with protocol defined immune responses observed in a majority of patients. Additional data from the Phase 1 trial will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in early November 2024.

The Phase 1 trial is conducted in collaboration with Cleveland Clinic and is funded by a grant from the U.S. Department of Defense. Anixa is the exclusive worldwide licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic. The grant funding from the U.S. Department of Defense was provided to Cleveland Clinic.

On September 24, 2024 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to I ), reported that it has entered into a strategic collaboration with Alkyon Therapeutics, Inc. (AlkyonTx), a San Diego-based biotechnology company, to develop next-generation immunotherapy and other targeted therapy applications, using Nona’s Harbour Mice fully human antibody platform (Press release, Nona Biosciences, SEP 24, 2024, View Source [SID1234646848]).

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Nona Biosciences’ proprietary Harbour Mice platform has extensive potential for generating both conventional and novel heavy chain only (HCAb) antibodies that are fully human, affinity matured with excellent solubility and developability, enhancing the efficacy and precision of advanced therapies. The technology is clinically validated, globally patent protected, and worldwide endorsed and recognized.

"We are excited to partner with Alkyon Therapeutics and support their efforts to harness the power of big data in drug discovery," said Dr. Jingsong Wang, Chairman of Nona Biosciences. "This agreement underscores our dedication to leveraging our world-leading antibody discovery technologies in diverse applications to accelerate oncology drug development and enhance translatability to the clinic."

"At Alkyon, we are eager to work with Nona Biosciences, utilizing their Harbour Mice platform to advance our immunotherapy research," said Dr. Benjamin Titz, Co-Founder of Alkyon Therapeutics, Inc. "By leveraging its proprietary platform to generate deep insights into the tumor microenvironment—particularly the extracellular matrix (ECM) and stroma—Alkyon uncovers novel therapeutic targets with enhanced translational potential, accelerating the development of breakthrough treatments for solid cancers."

On September 24, 2024 Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for the treatment of prostate cancer and other cancers, reported that the first patient has been dosed with CONV01-α in the Phase II CONVERGE-01 trial evaluating CONV01-α, Ac-225 rosopatamab tetraxetan, for the treatment of patients with prostate-specific membrane antigen (PSMA) PET-positive metastatic castration resistant prostate cancer (mCRPC) (Press release, Convergent Therapeutics, SEP 24, 2024, View Source [SID1234646847]).

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Previously conducted academic studies of CONV01-α have shown encouraging therapeutic results in patients with prostate cancer. According to Neil Bander, MD, Convergent’s Co-founder and CSO, "In patients treated at Weill Cornell Medicine, CONV01-α demonstrated a prostate-specific antigen decline of 50% (PSA50) in 67% of patients and a PSA decline of 90% (PSA90) in 27% of patients." These results have prompted initiation of the CONVERGE-01 trial under Convergent’s own Investigational New Drug License (IND). "We look forward to evaluating the full potential of CONV01-α and advancing the Phase II trial in the months ahead."

The CONVERGE-01 trial is a Phase II, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, the first 5 participants will receive In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants will then be enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 will enroll Lu-177-PSMA-radioligand therapy-naïve participants and Part 3 will enroll participants who received prior Lu-177-PSMA-radioligand therapy. All patients will receive Ac-225 rosopatamab tetraxetan in a single fractionated two-week cycle. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06549465.

Chief Medical Officer Appointment

Convergent announced that Richard Messmann, MD, MHS, MSc, has joined the company as Chief Medical Officer. Dr. Messmann is a medical oncologist and biochemist with over 25 years of experience in oncology drug development, including responsibility for the global clinical development and successful regulatory submission of Pluvicto and Locametz for the treatment of men with PSMA-expressing, mCRPC. Dr. Messmann has held leadership positions at Endocyte, Advanced Accelerator Applications (a subsidiary of Novartis), Fusion Pharmaceuticals, Amgen, Eli Lilly & Co., and others.

Immediately prior to joining Convergent Therapeutics, Dr. Messmann was the Senior Vice President and clinical lead for Fusion’s development of the actinium radiotherapeutic FPI-2265. While at Amgen, he was the executive medical director and global program lead for the development of xaluritamig (AMG 509) in prostate cancer.

"We are excited to welcome Dr. Messmann to the Convergent team as we expand our clinical program for CONV01-α," said Convergent’s Co-founder and CEO, Philip Kantoff, MD. "His deep knowledge and experience in oncology drug development, specifically leading the late-stage development of radiopharmaceuticals, is an important addition to our team as we look forward to progressing this asset forward."

Series A Extension Funding

Convergent announced a $40 million Series A extension by Novo Holdings, a holding and investment company wholly owned by the Novo Nordisk Foundation. This additional funding increases the total Series A raise to $130 million to support the development of Convergent’s radiopharmaceutical pipeline, including CONV01-α. Jim Trenkle, PhD, Partner in the Venture Investments group at Novo Holdings, joins the Convergent Board of Directors.

About CONV01-α
CONV01-α, Convergent’s alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeting prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called 225Ac, which releases alpha particles which kill cancer cells through DNA double strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers.