On September 24, 2024 BioCina Pty Ltd., a global end-to-end biologics Contract Development and Manufacturing Organization (CDMO), reported a new partnership with drug developer EnGeneIC Pty Ltd., for a project including technology transfer, process scale-up and GMP batch manufacture of EnGeneIC’s proprietary ‘EnGeneIC Dream Vector’ (EDV) nanocells (Press release, EnGeneIC, SEP 24, 2024, View Source [SID1234646845]).

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EnGeneIC’s mission is to transform cancer treatment through targeted cyto-immunotherapy by developing Antibody-Nanocell Drug Conjugates (ANDCs) using its EDV platform, which employs antibody-targeted, non-living ‘nanocells’ to deliver cytotoxic payloads directly into tumor cells. ANDCs enable the use of highly potent chemotherapeutic drugs encapsulated by nanocells, thereby reducing systemic toxicity, while also offering a new means for treating drug-resistant cancers and stimulating a potent anti-cancer immune response. This dual approach aims at safer, more targeted treatments with fewer side effects, for patients with nowhere else to turn. BioCina will deliver an end-to-end package of services in preparation for clinical and commercial manufacture of EDVs.

BioCina’s Chief Executive Officer, Mark W. Womack stated, "I’m so very proud for BioCina to be entrusted to advance EnGeneIC’s transformative therapeutic, which has the potential to make a profound impact on previously untreatable cancers."

EnGeneIC’s Co-Founder and CEO, Dr. Himanshu Brahmbhatt stated, "For several years, EnGeneIC has been searching for a contract cGMP manufacturer for its EDV cancer therapeutics. It has been a difficult road so we couldn’t be more pleased to be able to entrust our technology to the professional team at BioCina. Mark Womack and his colleagues are remarkable in that they are genuinely concerned about the plight of cancer patients. This gives great confidence to EnGeneIC that the partnership will succeed in getting cGMP quality EDV therapeutics to cancer patients in a timely manner."

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 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 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) ("BioVaxys" or the "Company") reported that it has closed the fourth tranche (the "Fourth Tranche") of its previously announced non-brokered private placement (the "Private Placement") with the issuance of 3,000,000 units (the "Units") of the Company at a price of $0.05 per Unit for aggregate gross proceeds of $150,000.00 (Press release, BioVaxys Technology, SEP 24, 2024, View Source [SID1234646846]). Each Unit consists of one common share in the capital of the Company (each, a "Share") and one whole Share purchase warrant (each, a "Warrant"), whereby each Warrant is convertible into one additional Share at an exercise price of $0.15 until September 23, 2026, being the date that is 24 months from the date of issue.

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The Company intends to use the proceeds of the Private Placement for general working capital purposes, including enabling the Company to fund and advance its business plans in regard to its successful recent acquisition of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., which was purchased from IMV USA ("IMV") on February 16, 2024.

No finder’s fees were paid in connection with the Fourth Tranche and all securities issued in connection therewith are subject to a statutory hold period under applicable Canadian securities laws expiring January 24, 2025, being the date that is four months and one day from the date of closing of the Fourth Tranche.

The securities described herein have not been, and will not be, registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), or any state securities laws, and may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities laws or pursuant to available exemptions therefrom. This news release does not constitute an offer to sell or a solicitation of an offer to buy of any securities in the United States.

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.