BioVaxys to Present at the Emerging Growth Conference on October 30th, 2024

On October 28, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat a range of cancers, infectious diseases, and immune modulated disorders reported that Chief Executive Officer James Passin has been invited to present live at the Emerging Growth Conference on October 30th, 2024 at 9:40 AM EST (Press release, BioVaxys Technology, OCT 28, 2024, View Source [SID1234647458]). This live interactive online event will give existing shareholders and the investment community the opportunity to interact with the Company’s CEO in real time.

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Please submit your questions in advance to [email protected] or ask your questions during the event.

If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on EmergingGrowth.com and on the Emerging Growth YouTube Channel, View Source We will release a link to that after the event.

Immutep to Present New Phase IIb Data in PD-L1 Negative (CPS <1) Head and Neck Cancer at ESMO Immuno-Oncology 2024

On October 28, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it will present new data from Cohort B of the TACTI-003 Phase IIb trial in first line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1) at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2024 taking place 11-13 December in Geneva, Switzerland (Press release, Immutep, OCT 28, 2024, View Source [SID1234647441]).

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Presentation details:

Title: TACTI-003 Cohort B: Eftilagimod Alpha (Soluble LAG-3) and Pembrolizumab in FirstLine Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma with CPS <1

Presenter: Martin Forster, M.D., Ph.D., University College London (UCL) Cancer Institute and UCL Hospital NHS Foundation, London, UK

Presentation Number: 152P
Date and Time: Thursday, 12 December 2024 at 12:30 – 13:30PM CET

Abstracts will be made available on the ESMO (Free ESMO Whitepaper) I-O website on 5 December 2024 at 00:05 CET. The poster containing new data, not in the abstract, will be available on the Posters & Publications section of Immutep’s website after its presentation on 12 December 2024.

IDEAYA Biosciences Announces IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Phase 1 Study in MSI-High Solid Tumors

On October 28, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE275 (GSK959), a potential first-in-class and best-in-class Werner Helicase (WRN) inhibitor (Press release, Ideaya Biosciences, OCT 28, 2024, View Source [SID1234647459]). IDE275 (GSK959) has demonstrated robust and selective synthetic lethality preclinically in the high microsatellite instability (MSI-High) biomarker setting, and the Phase 1 clinical trial will enroll patients having tumors characterized by MSI-High.

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"IDE275 represents IDEAYA’s fifth potential first-in-class clinical program in our precision medicine oncology pipeline and has a potentially differentiated best-in-class profile that we are targeting to present at a future medical conference with GSK. The robust preclinical efficacy observed by IDE275 selectively in the MSH-High biomarker setting, including monotherapy regressions, provides a double-digit % prevalence target patient population across several major solid tumor types, including endometrial, colorectal and gastric cancer," added Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE275 (GSK959) is a potential first-in-class small molecule inhibitor of Werner Helicase that was discovered by IDEAYA in collaboration with GSK. In preclinical studies, IDE275 has demonstrated robust and selective synthetic lethality in the MSI-High biomarker setting, including single-agent tumor regressions in-vivo in MSI-High CDX and PDX models derived from colorectal, endometrial and gastric cancers. Initiation of the Phase 1 trial for IDE275 is projected in the fourth quarter of 2024. GSK is the sponsor of the IND application and plans to develop IDE275 (GSK959) as both a monotherapy agent and in combination with a PD-1 inhibitor in a Phase 1 clinical trial for patients having MSI-High tumors. The percent prevalence of MSI-High in solid tumors, including endometrial, colorectal, and gastric cancers, has been reported at approximately 31%, 20%, and 19%, respectively (JCO Precision Oncology, September 2017).

GSK is responsible for 80% of global research and development costs for IDE275 (GSK959) and IDEAYA is responsible for 20% of such costs. IDEAYA is eligible to receive a $7 million milestone payment upon acceptance of the IND by the U.S. Food and Drug Administration (FDA), and a potential additional $10 million milestone payment upon initiation of Phase 1 clinical dose expansion. IDEAYA may potentially also receive up to $465 million in further later-stage development and regulatory milestones. Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of IDE275 (GSK959) – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.

MAIA Biotechnology Announces $2.44 Million Private Placement

On October 28, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,079,784 shares of common stock at a purchase price of $2.259 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, OCT 28, 2024, View Source [SID1234647460]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.51 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be approximately $2.44 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund manufacturing of THIO to be used in the Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC) and as working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a 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.

Parabilis Medicines™ – Formerly FogPharma – Announces New Company Name and Unveils AI- and Physics-Based Discovery Platform

On October 28, 2024 Parabilis Medicines (formerly FogPharma), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer, reported a corporate name change (Press release, Parabilis Medicines, OCT 28, 2024, View Source [SID1234649752]). The company’s new name, Parabilis (pronounced puh-RAH-buh-liss), draws on Greek and Latin etymologies to mean both ‘beyond what’s possible’ and ‘obtainable,’ reflecting the company’s drive to expand what is therapeutically possible for the treatment of serious diseases, and its commitment to ensuring its medicines reach and benefit patients globally.

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Parabilis also unveiled its expanded Helicon platform, which seamlessly integrates highly innovative AI and experimental technologies to discover, optimize, and deliver Helicon peptide therapeutics for not-yet-drugged targets, in addition to cutting-edge data science techniques the company is employing to optimize trial design and guide future clinical strategies.

"The name Parabilis captures the tremendous aspirations of a group of passionate innovators who are grounded in pragmatism. We are combining breakthrough science, industry-leading artificial intelligence (AI) capabilities, and a relentless drive to create real medicines that change what is possible in treating disease," said Mathai Mammen, M.D., Ph.D., Chairman and CEO of Parabilis Medicines. "That clarity of ambition is reflected in the way we approach our work, integrating data science and new product planning throughout the drug discovery and development lifecycle to ensure we’re single-mindedly pursuing only those medicines that anticipate and address profound unmet needs. Our new company name embodies this spirit: break boundaries, crush dogma, operate with the highest ambitions, and focus relentlessly on the patient at all times."

Parabilis’s investigational lead candidate, FOG-001, is the only clinical-stage inhibitor of the interaction of β-catenin with TCF, a known driver of colorectal cancer (CRC) with a significant role in multiple additional cancers. This target has been a towering challenge in the pharmaceutical industry, known for decades to be a key node, yet intractable. Now 16 months into its development, FOG-001 continues to enroll mostly CRC patients in its Phase 1 precision guided program. The company is also advancing its discovery portfolio with applications in protein degraders and radioligand therapies for the treatment of cancer, with four late discovery programs and integration of AI and advanced data science into every aspect of the discovery and development process.

In early 2024, the company raised a $145 million Series E financing to support the ongoing clinical development of FOG-001 and accelerate its broader Helicon peptide portfolio and platform.