On April 30, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported that a poster presentation titled "Final analysis of the randomized Phase 2 cohort of CM24 with nivolumab and chemotherapy in pancreatic cancer & potential serum biomarkers" is being presented during the session "Liquid Biopsy: Circulating Nucleic Acids 4 / Predictive Biomarkers 1" at the Annual Meeting of the American Association of Cancer Research (AACR 2025) on Wednesday, April 30, 2025 (Press release, Purple Biotech, APR 30, 2025, View Source;id=347386&p=2372871&I=1206939-c7Z3G6f3m8 [SID1234652394]).

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"These statistically significant biomarker results, with up to a 90% reduction in risk of death over the control group, are highly encouraging and we believe warrant a biomarker-driven Phase 2b study," stated Purple Biotech CEO Gil Efron. "The new, previously unpublished data presented at AACR (Free AACR Whitepaper) demonstrate significant overall survival (OS) and progression-free survival (PFS) benefit for patients meeting the criteria of either serum CEACAM1 or tumor CEACAM1 biomarkers. With these final data reported, we believe CM24 could potentially be positioned as a therapy targeting CEACAM1 in cancers with large unmet needs."

At AACR (Free AACR Whitepaper) 2025, Purple Biotech presented final data from its randomized, controlled, open-label, multicenter Phase 2 study (NCT04731467), which established proof of concept in a biomarker-enriched subgroup of 31 patients with advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) who were post-first line therapy, and compared treatment with CM24 + nivolumab + Nal-IRI/5FU/LV against treatment with Nal-IRI/5FU/LV alone.

The following is a summary of the findings.

The combination of CM24, nivolumab and Nal-IRI/5FU/LV chemotherapy was well tolerated and demonstrated quantitative improvement in all efficacy parameters, including OS, PFS, objective response rate (ORR), disease control rate (DCR) and CA19-9, in previously treated PDAC patients.

Without consideration of biomarkers, a consistent improvement in the treatment arm compared to the control arm was observed, as follows:

Prolongation of 2.4 months in OS HR=0.81 (p-0.575) and prolongation of 1.9 months in PFS HR=0.75 (p=0.463) vs. control arm
Higher ORR in experimental arm vs control arm (25% vs 6.7%)
Higher DCR in experimental arm vs control arm (62.5% vs 46.7%)
Consistent and continuous decrease in CA19-9 was observed in experimental arm vs control arm increase
Biomarker results included the following:

A statistically significant benefit to patients with defined pre-treatment ranges of serum CEACAM1 or tumor CEACAM1 expression (H score) compared to the control arm (representing a subgroup of 52% of patients):

Subgroup analyses of 16/31 patients meeting the criteria of CEACAM1+Tumor cell H score 115-275 or serum CEACAM1 levels 6K-15K pg/mL
78% reduction in risk of death (HR 0.22, 95% CI 0.07-0.7, p=0.006) and 95% reduction in the risk of progression or death (HR 0.05, 95% CI 0.01-0.44, p=0.0003)
Prolongation of 3.7 months in OS and 2.9 months in PFS
Statistically significant results in patients with defined pre-treatment serum CEACAM1 or myeloperoxidase (MPO) levels (representing a subgroup of 80% of patients):

Subgroup analyses for 24/30 patients meeting the criteria of MPO levels 200-600 ng/mL or serum CEACAM1 levels 6K-15K pg/mL
61% reduction in risk of death (HR = 0.39, 95% CI 0.16-0.98, p=0.039) and 72% reduction in the risk of progression or death (HR=0.28, 95% CI 0.11-0.73, p=0.006)
Prolongation of 2.4 months in OS and 2.2 months in median PFS
A statistically significant benefit for CM24-nivolumab treatment in patients with high CEACAM1+Tumor cell H score and low PD-L1 CPS (representing a subgroup of 38% of patients):

Subgroup analyses of 10/26 patients meeting the criteria of high CEACAM1+Tumor cell H score 115 and Low CPS 1 (
90% reduction in risk of death (HR = 0.1, 95% CI 0.01-0.89, p=0.013) and 81% reduction in the risk of progression or death (HR = 0.19, 95% CI 0.04-1.02, p=0.033)
Prolongation of 4 months in OS and 2 months in PFS
"The identification of CEACAM1 as a potential biomarker, both in serum and at the tumor, corresponds with the multi-faceted function of CEACAM1, as part of the neutrophil extracellular trap (NET) structure affecting NET-related tumor immune evasion, metastasis and other cancer-associated complications, such as thrombosis, at the level of the whole body, as well as modulation of the tumor microenvironment (TME)," stated Purple Biotech VP of Research and Development, Dr. Hadas Reuveni. "Targeting CEACAM1 by CM24 suggests a potential new approach that may address tumor-associated mechanisms affecting the patient at the levels of the tumor, the TME and the whole body. The biomarker data accumulated in this clinical study may help us to direct the treatment of patients who might have a higher chance to benefit from the treatment and could expand our understanding of CEACAM1 and NETs in cancer biology."

Final conclusions from the study:

The combination of CM24, nivolumab, and Nal-IRI/5FU/LV chemotherapy was well tolerated and
demonstrated quantitative improvement in all efficacy parameters, including OS, PFS, ORR and CA19-9, in previously treated PDAC patients.

Based on post-hoc analyses – serum CEACAM1 and MPO, a NET marker, are demonstrated as potential predictive biomarkers for CM24-based therapy, consistent with its mechanism of action (MoA) in targeting CEACAM1 to modulate immune evasion and NET activities.
Results imply that both serum and tumor CEACAM1 levels are potential predictive biomarkers for CM24 based therapy, suggesting multifaceted MoA and the crosstalk of the tumor with the TME and the whole body.
Improved outcome in patients with high tumor CEACAM1 expression and low PD-L1 CPS further support the mechanistic rationale of the CM24/nivolumab combination and highlight its potential in disease settings where immuno-oncology is less effective.
"The design of the randomized trial enabled us to evaluate the benefit of CM24 and nivolumab in combination with standard of care chemotherapy and to analyze potential biomarker data to better prepare for the next study." stated Purple Biotech Head of Clinical and Regulatory Affairs, Dr. Michael Schickler. "We currently expect the design of the next Phase 2b study to include an additional group testing CM24 alone in combination with standard of care with patients selected based on the identified biomarkers, potentially in indications such as gastric and/or biliary tract cancer, in addition to PDAC."

The poster will be available at the Publication section on Purple Biotech’s website following its presentation at the conference.

On April 30, 2025 Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)-powered drug discovery reported the financial results for its fourth quarter and fiscal year ending December 31, 2024 and provided a corporate update (Press release, Rakovina Therapeutics, APR 30, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-inc-announces-2024-financial-results-and-provides-corporate-update [SID1234652392]).

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2024 Highlights and Recent Developments

On April 29, 2025, we announced the intention to appoint Yevgeniy Meshcherekov and David Kideckel to the Company’s board of directors, subject to receiving approval from the TSX Venture Exchange. The Company also announces that Michael Liggett has retired from the Board. Subject to TSXV approval, Mr. Meshcherekov will replace Mr. Liggett as the chair of the audit committee of the Board
On April 28 & 29, 2025, we presented pre-clinical data related to the development of our kt-2000 and kt-5000 programs at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. These data demonstrate that select candidates derived from our AI collaborations may meet our target product profile for a PARP-1 selective lead candidate (kt-2000) and for an ATR-inhibitor (kt-5000).
On March 12, 2025, we announced that we had received the first synthesized batch of AI-generated ATR inhibitor compounds developed in collaboration with Variational AI.
On January 30, 2025, we announced the listing of common shares on the Frankfurt Stock Exchange (FSE) under the ticker symbol "7J0".
On January 13, 2025, we announced the successful achievement of a shortlist of AI-generated molecules targeting ATR (Ataxia Telangiectasia and Rad3-related protein) with specific designs for central nervous system (CNS) penetration.
On January 6, 2025, we announced the receipt of initial synthesized drug candidates: AI-generated PARP-inhibitor compounds for in vitro and in vivo validation in our laboratories.
On December 13, 2024, we announced the closing of an oversubscribed $3.0 million private placement offering (the "Private Placement"). The Private Placement consists of 50,000,000 units (the "Units") at a price of $0.06 per Unit. Each Unit consists of one common share of the Company (each, a "Common Share") and one Common Share purchase warrant (each, a "Warrant"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share of the Company for a period of 24 months from the date of issue at a price of $0.10 per Common Share. Rakovina retains the right to accelerate the Warrant exercise period if, upon written notice to the holder, the 20-day volume-weighted average price of its Common Shares exceeds $0.30.
On November 22, 2024, we delivered a poster presentation highlighting initial results of our Deep Docking and generative Artificial Intelligence (AI) PARP-inhibitor program at the Neuro-Oncology Annual Meeting in Houston, Texas.
On October 25, 2024, we presented our research on kt-3283, our lead small-molecule bifunctional inhibitor of PARP and HDAC enzymes at the 36th EORTC-NCI-AARC Symposium in Barcelona, Spain.
On October 23, 2024, we announced the receipt of initial results from the Company’s Deep Docking AI partnership following the evaluation of billions of molecular structures. This process resulted in a short-list of drug candidates that have been optimized to a specific target-product profile.
On September 17, 2024, we announced a research collaboration with Variational AI to employ the proprietary Enki AI platform to identify and develop novel small-molecule therapies against select DDR kinase targets for the treatment of cancer.
On July 26, 2024, we announced the final closing of an over-subscribed non-brokered private placement financing of units priced at $0.10 per unit with each unit consisting of one common share and one common share purchase warrant with an exercise price of $0.20 per warrant and a term of three years for gross proceeds to the Company of $2 million (the "2024 Private Placement"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.
On May 8, 2024, we announced the expansion of our collaborations with the University of British Columbia ("UBC") and our medicinal chemistry partner, Pharma Inventor Inc. to support the Company’s AI drug discovery initiatives.
On March 27, 2024, we announced a collaboration agreement with Dr. Artem Cherkasov granting Rakovina exclusive access to the proprietary Deep Docking AI Platform for DNA-damage response targets. We are using the Deep Docking platform to quickly analyze billions of molecular structures to evaluate their potential as targeted cancer drugs.
Summary Financial Results for the fourth quarter and year ended December 31, 2024

At December 31, 2024, the Company had positive working capital of approximately $321,442.

For the three- and twelve-months ending December 31, 2024, the Company reported a net loss of $1,483,988 and $4,072,618, respectively. Research and development operating expenses were $744,533 and $2,341,600 for the three and twelve months ended December 31, 2024, respectively. General and administrative expenses were $650,268 and $1,446,451 for the three- and twelve-months ending December 31, 2024, respectively. Total cash operating expenses related to research and development and general and administrative expenses for the three and twelve months ended December 31, 2024, were $3,165,554 and $1,243,517 respectively.

Selected Financial Information As at December 31, 2024 $
Cash & cash equivalents 1,312,743
Working capital 321,442
Intangible assets 3,977,473
Total Assets 6,240,920
Total liabilities 1,942,005
Deficit (14,997,929)
Total equity 4,298,915
Statements of net loss and comprehensive loss data: For the three months ended December 31, 2024 $ For the year ended December 31, 2024 $
Research & Development 744,533 2,341,600
General and administrative 650,268 1,446,451
Net loss and comprehensive loss (1,483,988) (2,612,925)
Basic and diluted income (loss) per share (0.01) (0.05)
Operating cash burn 1,243,517 3,165,554
Weighted average shares outstanding 100,089,471 82,549,477
Rakovina Therapeutics’ financial statements as filed with SEDAR can be accessed from the Company’s website at: View Source

On April 30, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will present at the Citizens Life Sciences Conference taking place in New York City on Wednesday, May 7, 2025 beginning at 3:30 p.m. Eastern Time (Press release, Quince Therapeutics, APR 30, 2025, View Source [SID1234652391]).

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A live webcast of the presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On April 30, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported the presentation of full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer (Press release, Nanobiotix, APR 30, 2025, View Source [SID1234652390]). The study, conducted by The University of Texas MD Anderson Cancer Center, will be presented by principal investigator Dr. Eugene Koay on Sunday, May 4th at 11:00 AM EDT / 5:00 PM CEST during the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025).

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PRESENTATION #E25-2265: NANORAY Pancreas: A Phase 1 Study of NBTXR3 (JNJ-1900) Activated by Radiotherapy for Locally Advanced or Borderline Resectable Pancreatic Cancer (LAPC or BRPC)
Koay EJ, Liu S, Guerrero P, Stokes E, Katz MHG, Ikoma N, Snyder RA, Tzeng CD, Overman MJ, Pant S, Wolff RA, Javle M, Holliday EB, Ludmir EB, Das P, Noticewala S, Koong AC, Tamm EP, Bhutani M

Nanobiotix ConferenceCall

Nanobiotix will host a conference call and webcast featuring Nanobiotix chief executive officer and chairman of the executive board, Laurent Levy, to discuss the data on Monday May 5th, 2025, at 8:00 AM EDT / 2:00 PM CEST.

Details for the call are as follows:

Webcast link: click here

Audio-only dial-in link: click here

Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to [email protected].

About JNJ-1900 (NBTXR3)

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On April 30, 2025 Mabqi reported that Sylvain Yon, CEO, will be attending BioEquity Europe 2025, Europe’s leading international event connecting biopharma leaders and financial dealmakers with emerging biotech innovators (Press release, Mabqi, APR 30, 2025, View Source [SID1234652389]).

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The event will take place from May 12 to 14, 2025, at the Bruges Meeting & Convention Center (BMCC) in Belgium, followed by two days of virtual partnering on May 20 and 21, 2025.

During this key industry meeting, Mabqi will showcase the latest preclinical results of lead candidate MQI-201 and growing portfolio of first-in-class and best-in-class proprietary functional antibodies, including pH-sensitive antibodies and antibody-drug conjugates (ADCs) with strong therapeutic potential in oncology.

"BioEquity Europe offers a unique platform to highlight our innovation, engage with potential partners, and enhance Mabqi’s visibility within the global biotech and investor community."