On October 9, 2024 Alpha Fusion, Inc. (CEO: Sunao Fujioka, headquartered in Kita-ku, Osaka), reported that it has raised a total of ¥1.02 billion through a Series B funding round (Press release, Alpha Fusion, OCT 9, 2024, View Source [SID1234647119]). The round was led by SBI Investment Co., Ltd. and OSAKA University Venture Capital, with participation from several new investors. This funding will enable Alpha Fusion to accelerate its research and development efforts, enhance its supply chain, and deliver Japan’s cutting-edge cancer therapies to the global market as quickly as possible.

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Alpha Fusion Leading the World in Astatine-based Drug Discovery

Alpha Fusion is a pioneering startup dedicated to bringing "Targeted Alpha Therapy (TAT) using Astatine (At-211)" to cancer patients worldwide. As a leader in the clinical development of Astatine-based therapeutics, Alpha Fusion is advancing its pipeline and building a highly efficient supply chain using cyclotrons in collaboration with partners across the globe. TAT is highly anticipated to become a foundational drug discovery platform in oncology, offering the potential to create numerous novel treatments.

In the past year, several major pharmaceutical companies in Europe and the U.S. have acquired startups developing Actinium (Ac-225) -based radiopharmaceuticals, signaling a surge of interest in this field. Astatine (At-211) is garnering attention for its short half-life, which anticipates clinical safety, its halogen properties that allow it to be directly labeled into low-mid sized-molecule ligands, its ease of sourcing raw material, and the simplicity of its production using cyclotrons.

Business Progress and the Impact of Series B Funding

Since our Series A funding round in May 2023, Alpha Fusion has made significant strides, as detailed below:

1.1st Pipeline (Thyroid Cancer, Phase 1 ongoing): Progress in high-dose administration, approaching the determination of recommended dosages.

2. 2nd Pipeline (Prostate Cancer, Phase 1 ongoing): Successful completion of the world’s first administration of [211At]PSMA-5 to a patient in June.

3. Additional Pipelines: Multiple pipeline developments underway through both in-house R&D and collaborations.

July 2023: Initiated joint research with QST Chiba for tumor-specific targeting.
August 2023: Began joint research with QST Takasaki/Niigata University on novel Astatine-labeling platform technologies.
4. Supply Chain: Progress in manufacturing preparations for clinical trial drugs both domestically and internationally, shaping the future of our supply chain.

First half of 2024: Completion of Osaka University’s TAT Cyclotron building to enable efficient Astatine production.
First half of 2024: Set up GMP facilities for clinical trial drug production in Japan and advanced collaboration with overseas CDMOs.
5. Intellectual Property: Received patent approvals covering manufacturing methods, materials, and applications related to our pipeline.

6. Research Centers: Expanded domestic research operations, including a new center in Tsukuba (SakuLab-Tsukuba), in addition to Osaka University’s research hub.

7. Team Expansion: Strengthened the advisory board and enhanced functional capabilities critical to pharmaceutical development (e.g., supply chain, CMC, quality assurance, clinical development, regulatory affairs).

With this funding, we will accelerate our R&D efforts and prepare for company-sponsored clinical trials, enhance our supply chain for GMP-grade clinical trial drug production domestically and internationally, and further expand our team. We are committed to demonstrating the unique advantages of Astatine-based drug discovery with tangible business results and clinical evidence.

Investors in Series B Round (in no particular order):

New Investors:

SBI Investment Co., Ltd.
Mitsui Mining & Smelting Co., Ltd.
Kobe University Capital
Joyo Capital Partners
Existing Investors (Follow-on Investment):

OSAKA University Venture Capital
D3 LLC
JGC Corporation

On October 9, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), reported that Tom Equels, Chief Executive Officer of AIM, will participate in a fireside chat at the 2024 Healthcare Virtual Summit, presented by Maxim Group LLC on October 16, 2024 at 12:30 PM ET (Press release, AIM ImmunoTech, OCT 9, 2024, View Source [SID1234647102]).

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Maxim Senior Analysts will host a wide range of biotechnology, diagnostic, medical device, and healthcare information technology companies in a series of presentations and interactive discussions with CEOs and key management. Maxim also plans to host several topical industry panels that promise to be timely and engaging. To attend, just sign up to become an M-Vest member and stay tuned for more updates.

On October 9, 2024 Arda Therapeutics, a pioneer in targeted cell depletion therapies for chronic diseases, reported the successful completion of a $43 million Series A financing round (Press release, Arda Therapeutics, OCT 9, 2024, View Source [SID1234647120]). The round was led by existing investor Andreessen Horowitz (a16z Bio + Health), with participation from Two Sigma Ventures, RV Invest, Eli Lilly and Company, GV, Biovision Ventures, Valhalla Ventures, Indicator Ventures, Alumni Ventures, LifeLink Ventures, Mana Ventures, Gaingels and ExitFund.

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For decades, the dominant approach in drug development has been to modulate individual proteins and signaling pathways to ameliorate disease. While this strategy has yielded some success, it often leads to limited efficacy and incremental gains, particularly for complex chronic diseases. Arda Therapeutics is pursuing a novel alternative by depleting the cells that drive disease rather than modulating the activity of the proteins they produce.

"Arda is at the forefront of a paradigm shift in treating chronic diseases," said Adam Freund, Ph.D., founder and CEO of Arda Therapeutics. "By focusing on the cells at the core of disease, we can develop therapies that are not only more effective, but also have the potential to fundamentally change patient outcomes. With drug approval rates declining and efficacy improvements stalling, Arda’s strategy to target cells—not pathways—offers a transformative shift in how chronic diseases are treated. With the support of our Series A investors, Arda is well positioned to progress our lead programs toward the clinic and expand our platform to tackle even more disease areas."

Arda’s sophisticated single-cell-based discovery engine identifies the specific pathogenic cells responsible for disease and their surface markers with unprecedented precision. This approach enables the development of targeted biologics that selectively eliminate harmful cells while preserving healthy tissue, leading to significantly greater efficacy and fewer side effects compared to conventional treatments. Arda’s platform has broad applicability across a wide range of diseases, including fibrotic conditions such as pulmonary fibrosis, as well as autoimmune and metabolic disorders.

"The field of oncology therapeutics has been focused on tumor cell clearance as a mechanism of action for decades. Many of our most potent cancer medicines – chemotherapy, CAR-T cells, antibody drug conjugates, T cell engagers, radiopharmaceuticals – fundamentally depend on our ability to identify pathogenic, or bad actor, cell populations and then target them precisely for killing," said Vineeta Agarwala, M.D., Ph.D., general partner at Andreessen Horowitz. "Arda is taking the ‘oncology toolbox’ outside of oncology. Applying the lessons learned from oncology, the Arda team is leveraging cutting-edge, single-cell biology and a deep understanding of the biology of diseases outside cancer to boldly extend the cell clearance paradigm to the treatment of chronic diseases."

Scott Turner, Ph.D., appointed to Chief Scientific Officer

In addition to the financing, Arda announced the appointment of Scott Turner, Ph.D., as chief scientific officer. Scott joins Arda after serving as chief scientific officer of Pliant Therapeutics, where he led the creation of the company’s fibrosis discovery platform and biomarker research, culminating in a successful Phase 2a study for Bexotegrast, an anti-fibrotic therapy. At Pliant, Scott promoted the use of single-cell data to dissect drug mechanisms of action and played a critical role in developing innovative fibrosis models and biomarker strategies that advanced several clinical programs. His leadership helped secure over $500 million in financing, including an IPO. Scott received a B.A. from UC Santa Cruz and a Ph.D. from UC Berkeley.

"I’m thrilled to be joining Arda at such an exciting time," said Dr. Turner. "The team has built an impressive platform for targeting pathogenic cells with precision, which holds tremendous potential for addressing the unmet needs in chronic disease. I look forward to working closely with the team to advance our lead programs toward the clinic and develop innovative therapies that can make a meaningful impact on patients’ lives."

"We are very excited to have Scott on the team," said Rèmi Laberge, Ph.D., co-founder and chief technology officer of Arda. "His deep expertise in fibrosis drug discovery will be instrumental as we drive our programs forward. I look forward to collaborating with him to push the capabilities of our cell depletion platform to the next level."

On October 9, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that it has engaged Philippe Pultar, MD as his senior medical advisor to support Aprea with developing and advancing APR-1051, Aprea’s potential best in class WEE1 inhibitor (Press release, Aprea, OCT 9, 2024, View Source [SID1234647103]).

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Dr. Pultar is a seasoned pharmaceutical executive with extensive experience in oncology, including the development of a WEE1 inhibitor (azenosertib) from early to late-stage clinical development. Dr. Pultar has extensive experience in clinical development within both large and early-stage pharmaceutical companies. Engaging Dr. Pultar aligns with Aprea’s commitment to provide its WEE1 inhibitor program with all the necessary resources, including the best available professional talent and expertise, to succeed. Dr. Pultar was most recently employed at Zentalis Pharmaceuticals where he played a key role in the strategy and execution of the global clinical development of azenosertib, a WEE1 inhibitor.

Patient enrollment is currently ongoing in the Phase 1 ACESOT-1051 study, designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in advanced solid tumors harboring certain cancer-associated gene alterations. Aprea intends to provide an update on the progress of this clinical study by year end 2024. The WEE1 program is part of Aprea’s portfolio of DDR-targeted therapeutics aimed to deliver precision medicine solutions that ensure the right patients receive the most effective Aprea treatment, with the goals of improving outcomes and reducing treatment resistance.

"WEE1 inhibition is a promising therapeutic approach in oncology and my prior experience has given me a thorough understanding of biomarker driven clinical studies, the development and regulatory landscape as well as the likely attributes for a successful therapeutic," said Dr. Pultar. "Aprea has a great opportunity to be a leader in this space. I am quite impressed by the progress the team has made advancing APR-1051, which has a differentiated profile, and is supported by compelling pre-clinical data. I am very excited to be associated with this program and I believe APR-1051 has the potential to be best in class. I look forward to working with the talented scientists at Aprea with the goals of advancing its WEE1 program and bringing new treatments to patients battling difficulty-to-treat cancers."

"Dr. Pultar is a highly capable scientific leader with a track record of successfully leading programs through late-stage development and regulatory approval," said Oren Gilad, Ph.D., President and CEO of Aprea. "Given the recent initiation of our Phase 1 ACESOT-1051 clinical trial evaluating our promising WEE1 inhibitor, APR-1051, we are excited to bring on a high caliber advisor such as Dr. Pultar. Dr. Pultar’s prior experience in managing multiple clinical trials for a WEE1 inhibitor is particularly relevant and we hope to leverage his expertise as we advance our own program and maximize the therapeutic potential of APR-1051. His addition to the team is part of our broader strategy to bring in exceptional talent with the experience and skills to successfully advance our programs."

Dr. Nadeem Mirza will be stepping down as Chief Medical Officer effective as of October 9, 2024, to pursue other professional endeavors but will remain with the Company through a date not later than December 13, 2024, to ensure a smooth leadership transition.

About Philippe Pultar, MD

Dr. Pultar brings over 17 years of extensive experience in early and late-stage clinical development. From 2020 to 2023 he was Vice President, Clinical Development at Zentalis Pharmaceuticals where he was responsible for the strategy and execution of the global clinical development of azenosertib, working closely with co-development partners GSK, Pfizer, and Zentera for China. He initiated seven Phase 1 and Phase 2 trials with azenosertib as single agent and in combination with chemotherapy and targeted agents across multiple indications. Prior to Zentalis, he spent seven years at Novartis Oncology (2013 to 2020), including as Senior Clinical Development Medical Director. He was appointed Medical Lead in rare diseases and was assigned to New Drug Application (NDA) activities for Isturisa (osilodrostat). He led the writing and review of key EU and US NDA documents for Isturisa, resulting in its approval with broad indication in Cushing’s syndrome with limited post-approval commitments. He was also Medical Lead for Phase 2, 3 and 4 trials on Isturisa, Signifor (pasireotide) and Odomzo (sonidegib). Prior to Novartis he was employed in senior clinical development roles at Agennix AG (2011 to 2013) and ImClone Systems (2007 to 2011). Earlier in his career, he held positions at GPC Biotech, ALTANA Pharma, REDEON and MEDICERCLE.

Dr. Pultar earned his medical thesis from Université de Médecine de Poitiers, France and practiced as a physician for several years. His foundational education includes Medical Studies and Residency at Université de Médecine de Poitiers, providing him with a solid academic background to complement his extensive practical experience in clinical development.

On October 9, 2024 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported four accepted abstracts at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024, in Barcelona, Spain (Press release, Arcus Biosciences, OCT 9, 2024, View Source [SID1234647121]). The data being presented include a growing body of evidence supporting the potential of casdatifan as a best-in-class HIF-2a inhibitor for the treatment of ccRCC.

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The oral presentation will highlight data from the approximately 30 patients in the 100mg daily monotherapy expansion cohort of ARC-20, a Phase 1/1b study evaluating casdatifan in late-line ccRCC. It will include data on safety and efficacy, including objective response rate and rate of primary progression, as well as other data to assess the depth and duration of responses. The presentation will also highlight data from the 50mg monotherapy expansion cohort of approximately 30 patients in the same setting.

"We are thrilled to be presenting the first clinical efficacy data from the ARC-20 study for our HIF-2a inhibitor, casdatifan, in an oral plenary session, as well as two additional posters that further highlight the differentiation of casdatifan in ccRCC and the therapeutic opportunities in other tumor types," said Terry Rosen, Ph.D., chief executive officer of Arcus. "These data support a potential best-in-class profile, and we are rapidly advancing a differentiated development program for casdatifan, including the planned initiation of our first Phase 3 study in the first half of 2025."

Arcus is pursuing a broad development program in both the first-line and post-anti-PD-1 settings with differentiated combinations to maximize the opportunity for casdatifan in ccRCC. In addition to the monotherapy cohorts of ARC-20, the study is also enrolling a cohort to evaluate casdatifan in combination with cabozantinib, a VEGFR tyrosine kinase inhibitor, which is intended to support the initiation of Arcus’s first Phase 3 study, PEAK-1, evaluating casdatifan in combination with cabozantinib versus cabozantinib monotherapy in patients with metastatic ccRCC who have previously received anti-PD-1 therapy. The primary endpoint will be progression-free survival with a key secondary endpoint of overall survival. Arcus also recently announced a clinical collaboration as part of its first-line strategy in advanced first-line ccRCC to evaluate casdatifan in combination with volrustomig, an investigational PD-1/CTLA-4 bispecific antibody.

Investors may dial in to the conference call at +1 (404) 975-4839 (local) or +1 (833) 470-1428 (toll-free), using Conference ID: 595409 on Thursday, October 24, 2024, at 5:00 AM PT / 8:00 AM ET. To access the live webcast and accompanying slide presentation, please visit the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

Four Accepted Abstracts Will Be Presented

Study

Title

Abstract Number

Session Type & Title

Session Date & Time

Casdatifan (HIF-2a Inhibitor)

ARC-20

Casdatifan in Patients (pts) with Previously Treated Clear Cell Renal Cell Cancer (ccRCC) and Other Solid Tumors; Preliminary Results From ARC-20: A Phase 1, Open-Label Dose Escalation and Expansion Study

4

Proffered Papers: Advancing patient care through novel clinical trials – Oral Plenary Session 3

10/24/2024, 10:54 AM – 11:06 AM CEST

AB521 (Casdatifan) Potently and Selectively Inhibits Hypoxia-Inducible Factor 2 Alpha (HIF-2α) Dependent Pro-Tumorigenic Activity

91

Molecular Targeted Agents

10/23/2024, 12:00 PM – 7:00 PM CEST

ARC-20

Clinical Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship for Casdatifan (AB521), a Small Molecule Inhibitor of HIF-2α, Confirms Best-in-class Potential in Treatment of Renal Cell Carcinoma

51

Molecular Targeted Agents

10/23/2024, 12:00 PM – 7:00 PM CEST

AB801 (AXL Inhibitor)

ARC-26

AB801, a Potent and Highly Selective Clinical Stage AXL Inhibitor, Sensitizes Tumors to Standard of Care Therapies

119

New Drugs

10/23/2024, 12:00 PM – 7:00 PM CEST