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Manhattan BioSolutions Named as an Awardee of Science in the City QuickFire Challenge

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"

Blue Water Biotech Acquires Proteomedix as Part of Transformation to Commercial Stage Oncology Company; Announces Name Change to Onconetix™

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.

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.

Anagenex and Nimbus Announce a Multi-Target Collaboration to Discover Small Molecule Therapeutics for Multiple Indications

On December 18, 2023 Anagenex and Nimbus Therapeutics (Nimbus) reported they have initiated a research collaboration (Press release, Nimbus Therapeutics, DEC 18, 2023, https://www.nimbustx.com/2023/12/18/anagenex-and-nimbus-announce-a-multi-target-collaboration-to-discover-small-molecule-therapeutics-for-multiple-indications/ [SID1234638779]). Anagenex, a pioneering drug discovery company pairing large-scale data generation with proprietary artificial intelligence (AI), will work closely with Nimbus to discover small molecule drugs for multiple challenging targets.

Through this multi-target collaboration, the companies will apply Anagenex’s AI driven parallel biochemistry platform to generate billions of experimentally measured datapoints for each of Nimbus’ nominated targets. Anagenex will then use the resulting data to train proprietary AI models that will generatively design 100 million new target-specific molecules to experimentally probe structure activity relationships at an unprecedented scale and speed ultimately identifying highly selective and potent drug candidates. Under the terms of the agreement, Anagenex will receive an upfront payment and will be eligible for option and R&D milestone payments from Nimbus on each of the programs under the collaboration.

"We are thrilled to be partnering with Nimbus, one of the original and most successful computationally aided drug discovery and development companies," said Nicolas Tilmans, CEO of Anagenex. "We’re very excited to join forces with them in attacking new targets beyond oncology a few hundred million compounds at a time."

"Anagenex’s platform is highly synergistic with Nimbus’ computational and structure-based drug discovery expertise," said Peter Tummino, Ph.D., Nimbus’ Chief Scientific Officer. "At Nimbus, we have prioritized important but difficult-to-drug targets across multiple therapy areas. This new collaboration with Anagenex perfectly complements our broader efforts across early discovery to advance new small molecule medicines against these targets with the goal of improving patients’ lives."

Kronos Bio announced an update on its pipeline

On December 18, 2023, Kronos Bio, Inc. (the "Company") reported an update on its pipeline (Press release, Kronos Bio, DEC 18, 2023, View Source [SID1234638681]). After a review of data from the phase 1b portion of its phase 1b/2 trial of lanraplenib, a SYK inhibitor, in combination with gilteritinib in FLT3-mutated relapsed/refractory acute myeloid leukemia, the Company has decided not to proceed to phase 2. This decision was based on a review of the data from 24 patients across the four dose cohorts (20 – 90 mg lanraplenib in combination with 120 mg gilteritinib). While there were blast reductions in some patients, no complete response (CR) or CR with partial hematologic recovery (CRh) was observed, with a number of patients discontinuing early in treatment. Patients in the study were older, more heavily pre-treated and frailer than the relapsed/refractory patients in earlier studies. Many patients experienced non-drug related infectious disease complications leading to discontinuation during the first two months of treatment without achieving the count recovery needed to achieve a CR or CRh. The Company believes there could be utility for lanraplenib in other indications and is open to further development of lanraplenib with a partner.

The Company also announced the designation a new development candidate, KB-9558, which targets the lysine acetyltransferase (KAT) domain of p300, a critical node of the IRF4 transcription regulatory network (TRN). IRF4 is a key driver in multiple myeloma. KB-9558 is the second molecule to emerge from the Company’s proprietary product engine, and is currently in IND-enabling studies, which are expected to be completed in the fourth quarter of 2024.

The Company’s first internally discovered molecule, KB-0742, an inhibitor of CDK9, has demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in pre-treated patients with transcriptionally addicted solid tumors. KB-0742 recently cleared the 80 mg dose in the dose escalation portion of the ongoing phase 1/2 trial. Patients currently in the two expansion cohorts will now be able to receive the 80 mg dose. The Company expects to provide data from the expansion phase of the trial in mid-2024.

HighField Biopharmaceuticals Doses First Patient in Phase 1 Trial of HFK1, a Unique Immunoliposome, for Treatment of HER2 low and HER2+ Cancers

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]).

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.