On January 15, 2025 Be Biopharma, Inc. ("Be Bio" or "the Company"), a leader in B Cell Medicines (BCMs), reported the closing of its $92M Series C financing (Press release, Be Biopharma, JAN 15, 2025, View Source [SID1234649737]). The round includes participation from new investor Nextech with existing investors including ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb, and Takeda Ventures, among others. In conjunction with the financing, Melissa McCracken, Ph.D. of Nextech will join Be Bio’s Board of Directors.

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The proceeds from the Series C financing will be used to generate clinical proof-of-concept for BE-101 in the ongoing BeCoMe-9 Phase 1/2 clinical trial for people with hemophilia B and to advance BE-102 for the treatment of hypophosphatasia to the clinic. Both programs are built on Be Bio’s BCM product platform, creating durable, titratable, and redosable therapeutics that require no preconditioning and produce sustained and constant levels of therapeutic proteins.

"With this funding in hand, we are well-equipped to advance our two lead programs and solidify our position as a multi-program, clinical-stage company," said Joanne Smith-Farrell, Ph.D., Chief Executive Officer of Be Bio. "We are on track to demonstrate clinical proof-of-concept for BE-101 in Hemophilia B this year. Additionally, BE-102 is poised to enter the clinic next year, potentially demonstrating BCMs’ potential to become a new gold standard in enzyme replacement by providing hypophosphatasia patients with a transformative new option. I am grateful to our existing and new investors, who share our vision that BCMs can transform the treatment landscape for a wide range of diseases with potentially best-in-class medicines."

"We are excited to partner with Be Biopharma at this pivotal stage," stated Melissa McCracken, Ph.D., Partner at Nextech. "Be Bio has established itself as a leader in this field with their lead programs having best-in-class potential. We believe BCMs, as a class, could revolutionize treatment paradigms across indications . We look forward to supporting their groundbreaking work and witnessing the transformative impact on patient care."

On January 15, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported the pricing of its previously announced public offering of 4,857,780 shares of common stock at a public offering price of $0.30 per share (Press release, Azitra, JAN 15, 2025, View Source [SID1234649736]). The gross proceeds for the offering are expected to be approximately $1.5 million before deducting placement agent fees and other offering expenses. This offering is expected to close on January 16, 2025, subject to customary closing conditions. Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes.

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Maxim Group LLC is acting as sole placement agent in connection with the offering.

The public offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280648), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2024, as amended, and declared effective on July 8, 2024. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus, and when filed, the final prospectus supplement and accompanying prospectus, relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On January 15, 2025 Axcynsis Therapeutics Pte Ltd ("Axcynsis"), a privately held biopharmaceutical company specialized in delivering Antibody Drug Conjugates (ADCs) with breakthrough potential, reported the clearance of its Investigational New Drug application (IND) by the United States Food and Drug Administration (FDA) of AT03-65 for the treatment of patients with CLDN-6 positive solid tumors (Press release, Axcynsis Therapeutics, JAN 15, 2025, View Source [SID1234649735]). Axcynsis is planning to initiate a Phase 1 multicentre clinical trial in the United States in 1Q 2025.

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AT03-65 is a differentiated ADC that selectively binds to CLDN6 with strong affinity. It is enabled by AxcynDOT, a proprietary payload that incorporates a derivative of an approved oncology therapeutics with unique mechanism of action and broad anti-tumor activity, and coupled with a cleavable and hydrophilic proprietary linker. CLDN6 is overexpressed in many cancers including lung, ovarian, endometrial, uterine, testicular, and gastric cancers while exhibiting minimal expression in normal tissues. AT03-65 is designed to deliver targeted therapy to improve patient outcomes with advanced or metastatic CLDN6-positive cancers.

"This is a transformational event for Axcynsis and a significant milestone for our proprietary ADC platform using AxcynDOT," said Dr. Zou Bin, CEO of Axcynsis. "We are pleased that FDA has cleared AT03-65 which leverages our AxcynDOT technology for this first-in-human study. We are very excited with the potential of offering a transformative therapeutic option for patients with CLDN6-positive tumors as well as advancing our pipeline with differentiated and effective ADCs using AxcynDOT to improve the lives of cancer patients worldwide".

The upcoming Phase 1 multicentre clinical trial in the United States will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AT03-65 in patients with advanced CLDN6-positive solid tumors.

About AT03-65

AT03-65 is a recombinant anti-CLDN6 monoclonal antibody conjugated to AxcynDOT, a proprietary payload developed by Axcynsis with a differentiated mechanism of action and broad anti-cancer activities. AT03-65 is designed to target advanced, recurrent, or metastatic CLDN6+ solid tumors in patients who have progressed on or after standard systemic treatment or for whom no standard therapies are available.

The antibody of AT03-65 is rationally engineered for high affinity and specificity to CLDN6. Upon binding to CLDN6-expressing tumor cells, the ADC is internalized into lysosomes, where it releases its payload to inhibit tumor growth effectively. Preclinical studies demonstrate that AT03-65 not only directly kill CLDN6-positive tumor cells but also exhibits bystander killing effect, targeting neighboring CLDN6-negative tumor cells to enhance its anti-tumor efficacy. AT03-65 has demonstrated promising anti-tumor activities in multiple tumor mouse models and a favorable safety profile in non-human primates.

About AxcynDOT

This is a proprietary payload developed by Axcynsis. It is a derivative of trabectedin, an approved chemotherapy in the United States, Europe and selected Asian countries, with a unique mechanism of action that is differentiated from other DNA alkylating payloads. AxcynDOT is optimized with enhanced potency and improved safety profile compared to trabectedin.

On January 15, 2025 Imagenomix Corp., a leader in AI-driven precision medicine, reported a groundbreaking partnership with Alterome Therapeutics Inc., a pioneering oncology drug development company (Press release, Alterome Therapeutics, JAN 15, 2025, View Source [SID1234649734]). This collaboration will leverage Imagenomix’s cutting-edge artificial intelligence technologies to optimize clinical trial efficiency, improve patient stratification, and accelerate the development of Alterome’s targeted cancer therapies.

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The partnership represents a convergence of Imagenomix’s advanced AI expertise with Alterome’s innovative approach to precision oncology. Together, the companies aim to set a new standard for using AI to transform clinical trials and deliver life-saving treatments to patients faster.

Travis Wold, CEO of Imagenomix Corp., emphasized the transformative potential of the partnership:
"We are honored to collaborate with Alterome Therapeutics Inc., a trailblazer in precision oncology. At Imagenomix, we are committed to leveraging AI to advance medicine, and this partnership exemplifies the extraordinary impact of combining state-of-the-art technology with innovative therapeutic development."

Dr. Andrew Chi, Chief Medical Officer of Alterome Therapeutics Inc., shared his perspective on the collaboration:
"We are excited to integrate Imagenomix’s AI-powered analytics into our clinical trials., Together, we have an opportunity to redefine the way precision oncology clinical trials are conducted. By developing methods to rapidly identify critical patient selection biomarkers with unparalleled efficiency and scale we can potentially pave a new path to faster, more effective precision oncology trials. This approach could easily translate into routine patient care and ultimately improve patient outcomes."

Key Highlights of the Partnership:

Accelerated Drug Development: The Imagenomix Predict AI platform will streamline clinical trial timelines and improve cost-effectiveness.
Enhanced Precision: Advanced analytics aims to identify critical biomarkers with unprecedented speed, scale, and efficiency to ensure targeted patient selection for Alterome’s targeted therapy trials.
Industry Innovation: The partnership represents a paradigm shift in leveraging AI for oncology clinical trials, setting a new benchmark for the field.
This strategic collaboration underscores the shared commitment of Imagenomix Corp. and Alterome Therapeutics Inc. to harness the power of innovative technologies in delivering precision medicine breakthroughs.

On January 15, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported key clinical, regulatory and corporate milestones achieved over 2024 and outlined its expected upcoming milestones (Press release, AIM ImmunoTech, JAN 15, 2025, View Source [SID1234649733]).

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"It is clear that 2024 was a foundational year for AIM on the clinical, regulatory and corporate fronts. Without a doubt, our team continued to drive our strategy forward and deliver results. We believe this progress has positioned AIM for an exciting 2025 and the opportunity to drive value for our stockholders," stated Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Looking ahead, we believe we are poised for an exciting 2025 with a number of key milestones expected over the next 18 months across important clinical trials addressing major unmet medical needs. Certain of these trials are being funded in part by major oncology interests such as the National Cancer Institute, AstraZeneca and Merck, which we believe emphasizes their great potential to change lives for the better. Our team is committed to the seamless execution of our clinical development programs and, if successful, we believe each holds the potential to drive significant value in the near and long term."

2024 Clinical Achievement Highlights

Metastatic Pancreatic Ductal Adenocarcinoma Program

Commenced enrollment and dosing in DURIPANC Phase 1b/2 study combining Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of late-stage pancreatic cancer;
Announced that the first dose level was generally well-tolerated in the DURIPANC Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer; and
Reported positive preliminary data from Phase 1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer.
Phase 2 Locally Advanced Pancreatic Adenocarcinoma Program

Received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study ("AMP-270") of Ampligen as a therapy for locally advanced pancreatic cancer; and
Announced the publication of new positive data analysis from a long-term Early Access Program studying Ampligen for the treatment of advanced pancreatic ductal adenocarcinoma.
The Company sought FDA guidance on expansion of inclusion criteria and treatment arms, and then subsequently amended the study protocol. The study is recruiting patients. These adjustments are also expected to result in substantial reductions in clinical costs.
Phase 2 Recurrent Ovarian Cancer Program

Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurrent ovarian cancer.
Phase 2 Post-COVID Conditions Program

Reported positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue ("AMP-518"); and
Reported an analysis of the AMP-518 clinical trial, based upon statistically significant data, which supports the Company’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID-19 condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.
Grants of Intellectual Property in 2024
Further, the Company was also granted two important patents covering Ampligen for the treatment of:

Endometriosis, a painful chronic condition that affects nearly 10% of women of reproductive age, or approximately 6.5 million women in the United States. This patent was granted in the United States.
The Post-COVID Condition of Fatigue. This method and compositions patent was granted in the Netherlands.
Additionally, AIM successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen. The Company announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma.

Expected Upcoming, Value-Driving Milestones

Metastatic Pancreatic Ductal Adenocarcinoma
Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center

Q1 2025: Complete Phase 1b
Early Q2 2025: Launch of Phase 2
Q2/Q3 2026: Last patient enrolled in Phase 2
Locally Advanced Pancreas Cancer (LAPC)
Phase 2 Ampligen Combined with Standard of Care (SOC) versus SOC Alone Following First-Line Therapy in Subjects with LAPC (NCT05494697); AIM funded

Q1 2025: Buffet Cancer Center expected to enroll first subject
H1 2025: first subject dosed
Refractory Melanoma
Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute

H1 2025: First patient dosed
Stage 4 Triple Negative Breast Cancer
Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute

Q2 2026: Expected completion of enrollment
Advanced Recurrent Ovarian Cancer
Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck

H1 2025: Expected last patient dosed and completion of study
Advanced Recurrent Ovarian Cancer
Phase 2 Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (NCT02432378); Grant funded by the National Cancer Institute

H1 2025: First patient dosed
Post COVID Chronic Fatigue Conditions / Long Covid
Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen in Patients with Post-COVID Conditions (NCT05592418); AIM funded

Q1 2025: Final approved study results to be published on clinicaltrials.gov