On February 24, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 3:10 p.m. ET in Boston, MA (Press release, Nuvation Bio, FEB 24, 2025, View Source [SID1234650493]).

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A live webcast of the presentation will be available on the Nuvation Bio website at View Source An archived recording will be available for 90 days following the event.

On February 24, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the full year ended December 31, 2024, and provided a business update (Press release, Azitra, FEB 24, 2025, View Source [SID1234650461]).

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FY 2024 and Recent Business Highlights

Initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients; Initial safety data from first set of Netherton syndrome patients expected in the first half of 2025 with topline data from the Phase 1b trial by year-end 2025
Received clearance from the U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for adults with moderate to severe EGFRi-associated dermal toxicity
FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
Announced closing of $10.0 million and $5.0 million public offerings
Strengthened intellectual property (IP) portfolio with newly granted and allowed patents
"This is a very exciting time in the growth and evolution of Azitra as we seek to drive shareholder value through development of first-in-class drugs to treat dermatological diseases," said Francisco Salva, CEO of Azitra. "Azitra is currently advancing a therapeutic pipeline with multiple programs developed from our proprietary platform of engineered proteins delivered using topical live biotherapeutic products. Our initial focus is the development of genetically engineered strains of Staphylococcus epidermidis (S. epidermidis) to enable the delivery of critical missing natural proteins and disease-modifying proteins through the stratum corneum of the skin. This advantage could allow Azitra to address several dermatological conditions that are significantly underserved by current standards of care."

Salva continued, "Our lead product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. In August 2024, we initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients to assess multiple safety, tolerability, and efficacy endpoints. Initial safety data from this trial is expected in the first half of 2025 with topline results by year-end 2025."

Salva continued, "In addition to ATR-12, Azitra has made significant progress with our next most advanced product, ATR-04. ATR-04 is a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFR inhibitor ("EGFRi") associated rash, which impacts approximately 150,000 patients in the United States annually, representing a market opportunity in excess of $1 billion. Our next milestone in the development of ATR-04 is the first patient dosed in a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity, which we expect to occur in the first half of 2025."

Salva concluded, "We look forward to capitalizing on multiple value-building milestones during 2025, including clinical data from our ATR-12 program. These events are expected to provide key inflection points for the company and investors throughout the year as we continue to position Azitra as a leading and innovative company developing transformative drugs for underserved patients with life-altering dermatological diseases."

Pipeline and Upcoming Milestones
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome with Multiple Milestones Expected

In August 2024, initiated a Phase 1b clinical trial investigating ATR-12 in adult Netherton syndrome patients. Trial is designed to assess multiple safety, tolerability, and efficacy endpoints, providing a springboard for several potential value creating events during the year
Initial safety data from first set of Netherton syndrome patients in the first half of 2025
Topline data from the Phase 1b trial by year-end 2025
Azitra presented compelling preclinical data for ATR-12 in Netherton syndrome at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting. Among the findings presented at the conference, ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Additionally, ATR-12 produced higher amounts of LEKTI subunit compared to topical application of LEKTI protein alone after 24 hours and resulted in deeper skin penetration of LEKTI.

ATR-04 – Addressing an Unmet Need in a Multi-billion Dollar Market Opportunity

In August, Azitra received clearance from the U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi-associated dermal toxicity
In September, the FDA granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash
Also in 2024, Azitra presented preclinical data at the Society of Investigative Dermatology (SID) and the European Academy of Dermatology and Venereology (EADV) annual meetings showing ATR-04 inhibits IL-36g and S. aureus, both of which are key drivers of the disease
Plan to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial in patients undergoing EGFR inhibitors with dermal toxicity in first half of 2025
Financial Results for the Year Ended December 31, 2024
Service Revenue – Related Party: The Company generated $0.8 thousand of service revenue during the year ended December 31, 2024, compared to $0.7 million for fiscal year 2023.
Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2024, were $4.7 million compared to $3.6 million for fiscal year 2023.
General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2024, were $6.3 million compared to $4.5 million for fiscal year 2023.
Net Loss was $9.0 million for the year ended December 31, 2024, compared to $11.3 million for fiscal year 2023.
Cash and cash equivalents: As of December 31, 2024, the Company had cash and cash equivalents of $4.6 million, which does not include gross proceeds of approximately $2.2 million from follow-on offerings in January and February, 2025.

On February 24, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the publication of circulating tumor DNA (ctDNA) results for its lead immunotherapy candidate, Versamune HPV, in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, PDS Biotechnology, FEB 24, 2025, View Source [SID1234650478]).

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The trial demonstrated that Versamune HPV was associated with greater and earlier clearance of HPV16-positive cancer cells from the bloodstream in patients with locally advanced cervical cancer. Notably, the elimination of HPV16-positive ctDNA correlated with extended patient survival without cancer recurrence, reinforcing its potential to improve long-term outcomes. The data underscore the potential of Versamune HPV in HPV16-positive cancers as the Company prepares to initiate a Phase 3 clinical trial for Versamune HPV in HPV16-positive head and neck squamous cell carcinoma (HNSCC) in the first quarter of this year.

"These findings highlight the transformative potential of Versamune HPV in broadly treating various HPV16-associated cancers. Combining Versamune HPV with chemoradiation (CRT) was linked to rapid HPV16 ctDNA decline," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe that such results showing a strong correlation between a biomarker such as ctDNA and survival may allow us to initiate discussions with the U.S. Food and Drug Administration regarding the potential for an accelerated regulatory pathway such as Breakthrough Therapy designation in cervical cancer. We also think this finding that links the reduction of ctDNA level with improved survival may apply to other HPV16-positive cancers like HNSCC. This endpoint is currently included within our VERSATILE-003 Phase 3 clinical trial."

A total of 66 patients with locally advanced cervical cancer were enrolled, with 49 receiving CRT and 17 receiving a combination of CRT and Versamune HPV. Patient blood was collected at baseline, weeks 1, 3, and 5 of CRT, and 3 to 4 months after CRT to measure HPV ctDNA. MRI was performed at baseline and before brachytherapy to determine tumor shrinkage.

Median follow-up was 23 months. At 3-4 months follow-up, 5/5 (100%) HPV16-positive patients receiving CRT + Versamune HPV had no detectable HPV16-positive ctDNA, whereas 3/6 (50%) of patients receiving only CRT had no detectable ctDNA.

HPV ctDNA clearance at 3-4 months correlated with better 2-year recurrence free survival (RFS) (92.9% vs. 30%, log-rank; P = 0.0067). The strongest predictor of RFS was HPV ctDNA clearance at 3-4 months follow-up, achieving a concordance index score of 0.83.

The 36-month overall survival (OS) and progression free survival rates were earlier reported to be 100% for the 8 patients in the trial who received 5 doses of Versamune HPV + CRT and an 84.4% 36-month OS rate for 17 patients who received at least 2 doses of Versamune HPV + CRT.

On February 24, 2025 Vicero, Inc., a preclinical-stage biopharmaceutical company developing next-generation VINCOBODIES for immune-mediated diseases, reported compelling safety and efficacy data for VCR-036, its novel dual-targeting immunotherapy candidate (Press release, Vicero Bio, FEB 24, 2025, View Source [SID1234650494]). The findings, which demonstrate the potential of this pentavalent PD-1/CTLA-4 antibody to treat solid tumors, have been selected for late-breaker presentation at the inaugural American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-oncology (AACR IO) Conference.

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"These results highlight the potential of our bispecific PD-1/CTLA-4 program to redefine combination immunotherapy," said Vikram Kansra, PhD, Founder and Chief Executive Officer of Vicero. "Our VINCOBODY platform enables the development of multi-specific therapies designed to deliver the efficacy of dual checkpoint blockade while mitigating the toxicity challenges associated with traditional monoclonal antibodies. The promising data for VCR-036 reinforce our commitment to expanding the therapeutic window for patients with solid tumors and advancing the next generation of immuno-oncology treatments."

Key findings from the preclinical studies include:

Superior safety profile with 100% survival rate compared to 50% survival with standard combination therapy
Complete tumor regression achieved with 5 mg/kg dosing, with sustained remission after tumor rechallenge
Favorable pharmacokinetics supporting potential dosing of ~1 mg flat subcutaneous dose every 6 weeks in humans
Significantly reduced immune-related adverse events compared to combination pembrolizumab/ipilimumab therapy
"The demonstrated efficacy and safety profile of VCR-036, combined with its convenient six-week subcutaneous dosing schedule, uniquely positions this therapy to potentially address a significant unmet need in the large checkpoint inhibitor market," said Alison Finger, Chief Operating Officer of Vicero. "These attributes could offer meaningful advantages for patients and reduce the treatment burden while creating substantial value in the immunotherapy landscape. We look forward to advancing this program to the clinic."

Poster Presentation Details

Title: VCR-036 VINCOBODY: A novel, highly potent, pentavalent, toxicity-sparing PD 1/CTLA-4 VHH neutralizer with robust pre-clinical safety and efficacy
Date & Time: Tuesday, February 25, 1:45–4:45 pm
Session: Poster Session B (Poster number #LB-B009)
Presenter: Vikram Kansra, PhD, Founder and Chief Executive Officer of Vicero, Inc.

The poster will be available on www.vicerobio.com following the conference.

About VINCOBODIES
VINCOBODIES are an advancement in antibody engineering, leveraging single monomeric variable domains to offer key advantages over traditional antibody therapies. These next-generation molecules are designed to selectively target cytokines, enhancing the body’s natural immune response while achieving superior tissue penetration. With exceptional stability—remaining functional at temperatures up to 90ºC across diverse pH conditions—VINCOBODIES also streamline manufacturing and enable high-yield, high-concentration production. Most notably, their unique structural properties allow them to engage multiple targets with high affinity and avidity using a single scaffold, potentially unlocking new therapeutic possibilities.

On February 24, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, reported that Northwestern University/Northwestern Memorial Hospital is starting recruitment for the CLD-101 clinical trial of its immunotherapy product (Press release, Calidi Biotherapeutics, FEB 24, 2025, View Source [SID1234653215]).

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Calidi Biotherapeutics has completed the shipment of the first batch of CLD-101, which comprises allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7. This batch will support a new clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer.

This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, represents a major step forward in cancer therapy. Building on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology, the upcoming Phase 1B/2 trial introduces multiple doses of CLD-101 regime in newly diagnosed patients, aiming to enhance therapeutic efficacy and improve patient outcomes.

"I am extremely excited about the commencement of recruitment for the multiple dose CLD-101 trial in newly diagnosed HGG patients. This increases the probability of success due to the improved treatment regimen initiated as early as possible in this devastating disease," said Dr. Lesniak, chairman of the Department of Neurological Surgery at Northwestern University’s Feinberg School of Medicine. The trial has been granted funding by the NIH/NCI SPORE to support this pioneering study.

Both Dr. Lesniak and Dr. Stupp bring a wealth of experience in treating brain tumors. Dr. Stupp is globally recognized for developing the FDA-approved Stupp Protocol, a treatment that transformed Glioblastoma care.

"We are proud to have assembled a world-class team of surgeons and neuro-oncologists to lead this trial," said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. "Should the results of this trial demonstrate treatment outcomes consistent with the previous study, now in a larger patient group and with multiple doses of CLD-101, the implications could be transformative for the treatment of brain tumors. Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer."