On December 18, 2023 Blue Water Biotech, Inc. (Nasdaq: BWV) ("BWB" or the "Company") reported the acquisition of Proteomedix AG, a private, commercial-stage diagnostics oncology company (the "Transaction"), and introduced a new name for the combined Company: Onconetix, Inc (Press release, Onconetix, DEC 18, 2023, View Source [SID1234641117]). The Transaction reflects a transformation of the business to one focused on the research, development and commercialization of proprietary science and technologies for therapeutics, diagnostics and services for the treatment of cancer.

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The acquisition of Proteomedix for all stock consideration provides its shareholders with an initial 19.9% ownership stake of Onconetix.

With the transaction Onconetix establishes a European headquarter with operations in Zurich, Switzerland. Two members of Proteomedix’ leadership team will become executives of Onconetix.

Onconetix’s commercial products are Entadfi, an FDA-approved, once-daily oral therapeutic for the treatment of benign prostatic hyperplasia (BPH), and Proclarix, a European CE IVD approval for prostate diagnostics and a lab developed test (LDT) currently in the U.S., originally developed by Proteomedix.

The new focus of Onconetix aligns the business with the market value drivers in oncology and extensive life sciences company-building expertise of its new leadership team under the direction of President and CEO, Dr. Neil J. Campbell.

"As physicians and patients face a myriad of medical challenges, particularly in the area of benign prostatic hyperplasia (BPH) and prostate cancer, Onconetix is committed to innovation and bringing global leadership to this area of need," said Dr. Campbell. "This pivotal move not only expands our global footprint, it enables us to harness the advanced technological platform and diagnostic expertise of Proteomedix. Furthermore, it is an important step in our overall transformation as a Company that strengthens our core mission of enhancing shareholder value and positions us at the emerging forefront of prostate cancer diagnostics," said Dr. Campbell.

Tungsten Advisors served as the exclusive financial advisor to Proteomedix AG.

About ENTADFI

ENTADFI is a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a more effective treatment option compared to other available therapies. We believe that ENTADFI will potentially improve the compliance issues in taking currently available therapies due to side effects associated with available therapies. Clinical trials have shown that ENTADFI is more effective in treating BPH symptoms, including urinary frequency, urgency, weak stream and difficulty initiating or maintaining urination, compared to finasteride monotherapy. Additionally, ENTADFI has demonstrated a favorable safety profile, with fewer adverse sexual side effects compared to finasteride. ENTADFI reduces potential for adverse sexual side effects, making it a preferred choice for men seeking relief from BPH symptoms without compromising their sexual health. ENTADFI has received FDA approval for the indication of initiating treatment of the signs and symptoms of BPH in men with an enlarged prostate for up to 26 weeks. More information about BPH and full ENTADFI prescribing information can be found on the product website at https://entadfipatient.com/ .

About Proclarix

Proclarix is CE-certified under IVDR in Europe and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix is available in Europe and expected to launch in the U.S. in 2024.

On December 18, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a boutique advisory firm has been engaged to identify strategic investment opportunities primarily to fund the advancement of the Company’s lead product candidate, PRP, to the completion of the Company’s planned Phase I, First-In-Human study in advanced cancer patients suffering from solid tumors (Press release, Propanc, DEC 18, 2023, View Source [SID1234638651]). Funds will also be utilized to advance the Company’s back up clinical candidate, Rec-PRP, a synthetic recombinant version of PRP, which will further enhance the potency and stability of the naturally derived proenzyme treatment. As part of the process, the opportunity to consider up-listing to a national US stock exchange will also be considered. The emerging boutique advisory firm currently has a $3B+ transaction history and access to a global network of investors the Company intends to fully utilize.

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PRP, a combination of two proenzymes trypsinogen and chymotrypsinogen, is a novel, targeted therapy for the treatment and prevention of metastatic cancer. Scientific evidence has shown potent effects against cancer stem cells, inducing these cells to differentiate (transform) into a less malignant, or dormant state, thus rendering them benign. Cancer stems cells represent the final frontier, as they are responsible for metastasis and invasion, causing the cancer to return and spread. They also eventually become resistant to standard treatment options like chemotherapy, where PRP has shown to be effective against chemoresistant pancreatic cancer cells, where patients suffer from a high mortality rate.

"PRP represents an exciting and novel method to control the threat of resistant tumors, which, if left untreated, can ultimately lead to patient death," said James Nathanielsz, Propanc’s Chief Executive Officer. "Importantly, PRP targets cancer stem cells, but leaves healthy stem cells alone. This means it is less toxic than standard treatments. We believe PRP could become a welcome addition to the treatment process for many aggressive cancer types, like pancreatic and ovarian cancers, where patient prognosis is often poor when left diagnosed. Therefore, we are offering an attractive investment opportunity to become involved in the development of a novel, first-in-class cancer therapy that as we progress further down the clinical development pathway, we believe has the potential to become a highly sought after strategic asset to the oncology portfolio of a global pharmaceutical, biotech, or mid-tier specialty company, serious about treating this killer disease."

On December 18, 2023 HighField Biopharmaceuticals, a clinical stage immuno-oncology company using lipid-based therapeutics to treat cancer, reported the dosing of its first patient in its Phase 1 clinical trial of HFK1, a drug encapsulated immunoliposome containing doxorubicin for treatment of solid tumors (Press release, HighField Biopharmaceuticals, DEC 18, 2023, View Source [SID1234638669]).

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The multi-regional, open-label, clinical trial is enrolling patients who have advanced refractory solid tumors with HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers.

This trial is being conducted in the U.S., China and other countries. The first patient was dosed at Mary Crowley Cancer Research in Dallas, TX. A Phase 1a dose escalation portion of the study will enroll 24 patients followed by Phase 1b dose expansion trial with up to 60 patients. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HFK1. Preliminary results are expected in the fourth quarter.

"Our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors," said HighField CEO Yuhong Xu. "HFK1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."

Minal Barve, MD, is the Chief Medical Officer/Executive Medical Director and the principal investigator at Mary Crowley Cancer Research, a specialized clinical research center that offers access to new investigational therapies. "It is important to treat the full range of HER2 cancer expression levels. It opens the possibility of reaching more cancer cells within the patient, not just those with high HER2 expression levels. I hope that HFK1 will provide a treatment option for a broad range of tumor types that have HER2 expression, not just the strongly HER2 positive tumors," Dr. Barve said.

"At Mary Crowley Cancer Research, we are focused on rapidly advancing the discovery of potential new therapies that can positively impact the care of cancer patients in their lifetime," Dr. Barve added. "We are grateful for our partnership with HighField to provide even more patients with hope."

HighField’s immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, HighField’s immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types.

"A key differentiating factor of our immunoliposomes," observed HighField CBO Donald Wyatt, "is they not only are suitable for less toxic payloads than ADCs, but also are designed to have larger drug to antibody ratios that result in wider therapeutic windows, targeting more cancer cells with lower toxicity."

In the Phase 1a dose escalation portion of the clinical trial, patients will be enrolled into one of six dose groups to determine the highest tolerated dose. The Phase 1b study will assess HF158K1 in two types of solid tumors, and patients will be enrolled in one of two dose groups based on the Phase 1a findings. For more information visit NCT05861895 on clinicaltrials.gov.

On December 18, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast its presentation at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 (Press release, Regeneron, DEC 18, 2023, View Source [SID1234638652]). The presentation is scheduled for 2:15 p.m. Pacific Time (5:15 p.m. Eastern Time) and may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay and transcript of the webcast will be archived on the Company’s website for at least 30 days.

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On December 18, 2023 Manhattan BioSolutions, Inc. (Manhattan Bio or MABS), an emerging biotech company developing innovative precision biologics, reported its selection as an awardee of the Science in the City QuickFire Challenge launched by Johnson & Johnson Innovation LLC (Press release, Manhattan BioSolutions, DEC 18, 2023, View Source [SID1234649986]). As part of the award, Manhattan Bio will receive a one-year residency at JLABS @ NYC, including laboratory space, access to equipment, and connection to the global Johnson & Johnson Innovation network of experts.

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The QuickFire Challenges are designed to accelerate game-changing, early-stage innovations in the pharmaceutical and medical device sectors. With unique biologic platforms focusing on RNA degraders (RNADs) and antibody-drug conjugates (ADCs), Manhattan Bio is building a pipeline of medicines targeting selective vulnerabilities to treat cancers and other diseases. Manhattan Bio’s lead program, MABS-139, is a rationally designed RNA-degrading protein which exhibits broad anti-tumor efficacy in preclinical animal models and successfully completed Phase 1 dose-escalation study, yielding promising results. Additional programs being developed via internal R&D efforts and in collaboration with the National Cancer Institute and Binghamton University include ADCs utilizing proprietary tumor-cleavable linker-payload chemistries for targeted delivery of next-generation warheads to the tumor cells.

"We are very excited to be selected for QuickFire Challenge award," said Dr. Borys Shor, CEO of Manhattan Bio. "The network and resources available to us will be valuable as we continue to build out a broad pipeline of protein- and antibody-based therapeutics and accelerate progress toward the clinic. We greatly appreciate this recognition of our talented team’s dedication to advancing breakthrough innovations for patients"