On September 24, 2024 Araris Biotech AG ("Araris"), a Swiss oncology biotech company developing next-generation antibody drug conjugates (ADCs), reported it has entered into an Agreement with Innate Pharma ("Innate") (Press release, Araris Biotech, SEP 24, 2024, View Source [SID1234651284]). Under the agreement, Innate will assign its portfolio of patents related to its ADC transglutaminase conjugation technology to Araris.

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"We are excited to acquire Innate’s portfolio of transglutaminase related patents, as this transaction further positions Araris as a leader in the development of ADCs using transglutaminase conjugation technology," said Dragan Grabulovski, Ph.D., CEO and co-founder of Araris. "We look forward to continuing to develop next-generation sitespecific ADCs and believe this acquisition not only expands our intellectual property portfolio, but also strengthens our competitive edge."

The newly acquired patents encompass a broad range of intellectual property that cover use of bacterial transglutaminase in conjugating various linker-payloads to antibodies.

On September 24, 2024 Generate:Biomedicines ("Generate") reported a multi-target collaboration with Novartis (NYSE: NVS) to discover and develop protein therapeutics across multiple disease areas (Press release, Generate Biomedicines, SEP 24, 2024, https://generatebiomedicines.com/media-center/generatebiomedicines-announces-multi-target-collaboration-with-novartis [SID1234650142]). The collaboration leverages Generate’s proprietary generative AI platform, ​"The Generate Platform," to create potentially first- and best-in-class molecules through AI-based optimization and de novo generation.

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The collaboration will combine The Generate Platform, which integrates machine learning with high-throughput experimental validation, with Novartis expertise and capabilities in target biology, biologics development, and clinical development to create novel therapeutics and to accelerate the pace of drug discovery and development.

"We are delighted to collaborate with Generate to explore the promise of generative AI in enhancing and accelerating the discovery of next-generation biologics," said Fiona Marshall, President of Biomedical Research at Novartis. ​"This collaboration offers an opportunity to leverage the unique strengths of our respective companies, from target biology and biologics discovery to machine learning/​AI and clinical development, in order to bring forward new medicines with transformative potential for patients."

"Partnering with a world-leading drug discovery and development organization like Novartis allows us to broaden the use of our cutting-edge generative biology platform to tackle even more areas of unmet medical need," said Mike Nally, Chief Executive Officer of Generate:Biomedicines. ​"We look forward to working closely with the team at Novartis to continue to demonstrate the transformative potential of programming biology to create better medicines for patients, faster."

Under the terms of the collaboration agreement, Generate will receive a total upfront payment of $65 million in cash from Novartis, which includes $15 million for the purchase of equity in Generate. Generate is also eligible to receive more than $1 billion in performance-based milestone payments, in addition to tiered royalties up to low double-digits. The number of targets and therapeutic areas are not being disclosed.

On September 24, 2024 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing breakthrough therapies via local administration for metastatic and primary cancers to bone and other organs, reported publication of clinical data in the peer-reviewed Journal of the American Academy of Orthopaedic Surgeons (JAAOS) on ZetaFuse (Zeta-ZF-002)for the treatment of multi-level DDD in a Stage 4 lung cancer patient (Press release, Zetagen Therapeutics, SEP 24, 2024, View Source [SID1234647538]).

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"We are seeing promising consistency between our pre-clinical and clinical data with our ‘Zeta’ oncology platform," said Joe C. Loy, Chief Executive Officer of Zetagen. "This new data published in JAAOS further validates that our drugs in development with our proprietary formulations are producing the desired outcomes."

JAAOS Report Overview

The report, entitled Treating Multi-level Cervical Degenerative Disc Disease (DDD) in a Stage IV Lung Cancer Patient with Significant Comorbidities Using a Breakthrough Therapy focused on a 64-year-old, Stage 4, non-small cell lung cancer (NSCLC) patient with cervical DDD at three levels of the spine. The patient has several comorbidities which includes obesity and long-term smoking.

Due to a recent work-related accident which resulted in degenerative changes in the neck, the patient was referred for surgical consultation. Under an FDA Expanded Access protocol, (Compassionate Use) ZetaFuse (Zeta-ZF-002) was administered to promote bone formation in the patient’s three-level ACDF procedure. Despite the compromised health, ongoing chemotherapy treatments and poor bone physiology of the patient, case study results exceeded expectations, confirming radiographic fusion at all three cervical levels by eight months.

"Knowing the patient had been treated previously for his lung cancer with cytotoxic therapy and immunotherapy, which are known to negatively impact bone healing and, in spite of extensive exposure to these agents over the last three (3) years, our patient showed an excellent bone healing response to the novel, drug eluting biomaterial of the ZetaFuse," said Pedro Sanz-Altamira, MD, PhD, hematologist and oncology specialist at Dana Farber Cancer Institute who has been treating the case study patient for several years.

"Spine surgeons have no approved resources to treat cancer patients which have such orthopedic fusion needs, and we are pleased that this patient has seen outcomes which surpassed expectations in such a short period of time," said Nikhil Thakur, MD, Chief Medical Officer of Zetagen and Orthopaedic spine surgeon in Boston, MA.

View the JAAOS publication via open access here.

A New Approach to Treating Metastatic Cancer

Zetagen is dedicated to developing breakthrough therapies via local administration for metastatic and primary cancers to bone and other organs which may provide increased survival rates. The Company’s proprietary "Zeta" oncology platform is based on a novel, opioid growth factor receptor (OGFR) antagonist pathway which targets the management of the p21 transcript.

ZetaFuse (Zeta-ZF-002), the focus of the JAAOS publication, shares the same mechanism of action as Zetagen’s lead oncology drug candidate, ZetaMet (Zeta-BC-003), and were awarded separate Breakthrough Designations by the U.S. Food and Drug Administration (FDA) based upon their clinical indication. ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, developed via a proprietary control release carrier developed to resolve metastatic breast cancer bone lesions, inhibiting pain while regenerating bone, with the potential to increase survival rates.

Peer-reviewed 2-year follow up data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of lytic lesions, significant reduction in pain, prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i]

This patient had two groups of spinal lesions, a total of seven spinal lesions in all, one-group had two advanced lesions (T7 & L1) treated initially with fractionated radiation and when the cancer and pain returned, treated via an outpatient procedure with ZetaMet (Zeta-BC-003). Sixty (60) days later a second group of five new lesions appeared on the patient’s sacrum. She decided to forego fractionated radiation, the FDA approved a second procedure with ZetaMet (Zeta-BC-003), patient experienced significant reduction in pain (4x), and nine (9) months later independent radiologist reports showed no active tumor, no skeletal related events (SREs- fractures) in either lesion group, and the patient experienced complete resolution with the second lesion group with an increased survival rate of 36 months. View this publication via open access here.

"I am delighted to see these results being shared with our peers in scientific community," said Bryan Margulies, PhD, Chief Scientific Officer of Zetagen. "These observations build off of the extensive preclinical data we have generated over several years and we look forward to further advancing our ongoing human clinical trials as we continue to develop the ‘Zeta’ platform for patients living with metastatic and primary cancers."

[i] Pain Management. Volume 13, Issue 10, October 2023, Pages 569-577 View Source

On September 24, 2024 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotech developing RNA interference (RNAi) therapies for KRAS-driven cancers, reported significant new findings from its Phase 2 trial of LODER in patients with non-resectable locally advanced pancreatic cancer (LAPC) which bear the KRAS G12D or G12V mutation (approximately 70% of pancreatic cancer patients) (Press release, Silexion Therapeutics, SEP 24, 2024, View Source [SID1234646852]). Overall the updated analysis reveals a 56% objective response rate (ORR) in patients treated with LODER, with the ORR increasing to 67% in patients whose previously non-resectable tumors became resectable. This marks a significant step forward in potentially improving surgical outcomes for LAPC patients.

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Silexion had previously reported that patients treated with LODER in combination with standard-of-care (SoC) chemotherapy experienced a 9.3-month improvement in overall survival (OS) compared to chemotherapy alone. The new data now underscores LODERs additional potential to increase the resectability of tumors, opening up more surgical options for patients with otherwise inoperable pancreatic cancer.

Silexion is also progressing with the development of its next generation product, SIL-204, which builds upon the efficacy of the LODER. SIL-204 is designed to target a broader range of KRAS mutations, covering pan- G12x and G13D, as well as the previously reported findings of properties which should make it more effective clinically such as improved stability and enhanced ability to get to the site of action for silencing the KRAS oncogene. These improved properties demonstrated in preclinical models position SIL-204 as a promising option for the treatment of difficult-to-treat cancers such as locally advanced pancreatic cancer. Silexion continues to proceed with the development of this optimized candidate.

"We are very encouraged by these new findings, which demonstrate LODER’s ability to significantly improve tumor resectability in patients with non-resectable pancreatic cancer, and the improved profile of SIL-204" said Ilan Hadar, Chairman and CEO of Silexion. "As we advance our broader pipeline to address KRAS-driven cancers, this data further validates our oncogene silencing approach."

About the Phase 2 Trial of LODER

The open-label Phase 2 trial enrolled 48 patients in the mITT population with non-resectable locally advanced pancreatic cancer (LAPC) and borderline resectable pancreatic cancer (BRPC) across the U.S. and Israel. The trial was conducted in two parts:

Cohort 1 (n=29): Patients were randomized 1:1 to receive either LODER with SoC chemotherapy or SoC chemotherapy alone. The primary endpoint was overall survival (OS), with 16 patients confirmed to harbor the KRAS G12D/V mutation.
Cohort 2 (n=19): This cohort enrolled patients with non-resectable tumors, LAPC or BRPC, with the key endpoints focused on ORR and safety. Seven patients in this cohort were confirmed to have KRAS G12D/V mutations.
Objective Response Rate for 23 patients confirmed with KRAS G12D/V (Cohorts 1+2)

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.