On October 16, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported that it will present at the 16th Annual Protein & Antibody Engineering Summit (PEGS) to be held from November 5-7, 2024 in Barcelona as well as at the Cell 2024 conference by Oxford Global from November 6-8, 2024 in London (Press release, MediGene, OCT 16, 2024, View Source [SID1234647234]). In addition, two posters will be presented at the 39th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from November 6-10, 2024, in Houston, TX, USA.

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Oral presentation

PEGS 2024
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Location: Montjuic Palau de Congressos- Fira Barcelona, Spain
Date and time: Thursday, November 7, 2024, 8:25 am local time
Presenter: Kanuj Mishra, PhD, Team Lead & Lab Head, Innovation
Session: Next-Generation Immunotherapies
Title: Seamless Integration of a Universal Epitope into Recombinant TCRs for Tagging and Tracking of TCR-T Cells Expressing 3S TCRs

The presentation will highlight the Company’s latest technology, UniTope & TraCR, an innovative combination of universal TCR tagging and tracking. This advanced system is engineered to greatly improve the precision and efficiency of T cell receptor identification and monitoring, providing benefits for immunotherapy research and clinical applications.

Cell 2024 by Oxford Global
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Panel Discussion
Location: Novotel London West, London, UK
Date/time: Wednesday, November 6, 2024, 3 p.m. local time
Presenter: Kirsty Crame, MD, Vice President, Clinical Strategy and Development
Session: Exploring Autologous Vs. Allogenic Therapies

Keynote Address
Location: Novotel London West, London, UK
Date/time: Thursday, November 7, 2024, 9.30 a.m. local time
Presenter: Kirsty Crame, MD, Vice President, Clinical Strategy and Development
Session: CGT Development
Title: Making The Ordinary Extraordinary: MDG1015 A Clinic Ready 3rd Generation TCR-T Therapy

Oral presentation
Location: Novotel London West, London, UK
Date/time: Friday, November 8, 2024, 2.20 p.m. local time
Presenter: Prof. Dolores Schendel, CSO
Session: iPSCs and stem cell therapy development
Title: TCR-T Platform for Solid Tumors

SITC 2024
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Location: George R. Brown Convention Center in Houston, TX
Date and time: November 6-10, 2024 in Houston, TX

Details on the poster presentation are as follows:
Abstract and Title: " UniTope & TraCR – A universal tagging and tracking system for TCR-T cells directly integrated in recombinant TCR."
Authors: Kanuj Mishra, Justyna Ogonek, Dolores Schendel, Barbara Loesch
Abstract number: 20
Date/time: Saturday, November 9, 2024, George R. Brown Convention Center – Level 1 -Exhibit Halls AB, poster reception from 7:10-8.30 p.m.
Presenter: Barbara Loesch, PhD, Head of Technology and Innovation Department
Session: Biomarkers, Immune Monitoring and Novel Technologies

Abstract and Title: "The IFN-γ Biosensor – A universal tool for IFN-γ detection in cellular co-culture assays."
Authors: Barbara Loesch, Kanuj Mishra, Justyna Ogonek, Dolores Schendel
Abstract number: 21
Date/time: Friday, November 8, 2024, George R. Brown Convention Center – Level 1 -Exhibit Halls AB, poster reception from 5:30-7 p.m.
Presenter: Barbara Loesch, PhD, Head of Technology and Innovation Department
Session: Biomarkers, Immune Monitoring and Novel Technologies

On October 16, 2024 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the European Commission has adopted the European Medicines Agency (EMA) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma (Press release, Theriva Biologics, OCT 16, 2024, View Source [SID1234647233]). The United States Food and Drug Administration (FDA) has previously granted orphan drug designation and rare pediatric disease designation to VCN-01 for the treatment of retinoblastoma.

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"We are very pleased with the European Commission’s grant of orphan medicinal product designation to VCN-01, emphasizing the urgent need for new treatment options for retinoblastoma," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We have previously reported encouraging results from an investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma, and we are working closely with leading physicians and regulatory agencies worldwide to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in children with this challenging disease."

The EMA recommends orphan designation for products intended to treat, prevent or diagnose a disease that is life-threatening or chronically debilitating and either the prevalence of the condition in the European Union (EU) does not exceed 5 in 10,000 or it is unlikely that marketing of the product would generate sufficient returns to justify the investment needed for its development. Additionally, there should be no authorizable method of diagnosis, prevention or treatment of the condition, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Orphan designation is designed to provide drug developers with various benefits to support the development of novel therapies, including 10-years of market exclusivity once they receive marketing authorization in the EU, protocol assistance, administrative and procedural assistance, and reduced fees for regulatory activities.

About Retinoblastoma

Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 – 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In Europe, retinoblastoma has an estimated incidence rate of 1 per 13,844 live births (14.1 per million children under the age of 5) with approximately 300 children diagnosed per year (Stacey et al. 2021). Preserving life and preventing the loss of an eye, blindness and other serious effects of treatment that reduce the patient’s life span or the quality of life, remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 140 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

On October 16, 2024 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that the Company will be providing a corporate update at the upcoming investor conferences on the dates below (Press release, Soligenix, OCT 16, 2024, View Source [SID1234647231]).

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2024 Maxim Healthcare Virtual Summit, held October 17, 2024. For more information, please refer to the conference website https://m-vest.com/events/healthcare-10152024.

ThinkEquity Conference, held October 30, 2024. For more information, please refer to the conference website View Source

Spartan Capital Investor Conference 2024, held November 4, 2024. For more information, please refer to the conference website View Source
Key members of Soligenix management will hold one-on-one meetings throughout the conferences. If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected].

On October 16, 2024 Skyhawk Therapeutics, Inc., a clinical-stage biotechnology company developing novel small molecule therapies designed to modulate critical RNA targets, reported the company will deliver a poster presentation highlighting preclinical data on SKY-1214 at the 36th European Organization for Research and Treatment of Cancer (EORTC)-National Cancer Institute (NCI)-American Association for Cancer Research (AACR) (Free AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium ("EORTC-NCI-AACR") to be held from October 23-25, 2024 in Barcelona, Spain (Press release, Skyhawk Therapeutics, OCT 16, 2024, View Source [SID1234647230]).

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SKY-1214 is an oral RNA splicing modulator developed through the company’s novel RNA-splicing platform and being developed for difficult to treat multiple myeloma (MM) and non-Hodgkin’s lymphoma (NHL). SKY-1214 targets FANCL/FANCI, critical components of the Fanconi anemia DNA damage repair pathway, which MM and NHL cells use to maintain their genome integrity.

Details of the data presentation are as follows:

Title: "Preclinical characterization of SKY-1214, a small molecule splicing

modulator of Fanconi Anemia pathway members for the treatment of

multiple myeloma and non-Hodgkin’s lymphoma"

Session Type: New Drugs

Poster Number: #PB104

Date: Wednesday, 23 October 2024

Location: Exhibition Hall

Presenter: Simone Rauch, PhD, Skyhawk Therapeutics

On October 16, 2024 Kintara Therapeutics, Inc. ("Kintara") (NASDAQ: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported a correction to the press release previously issued by Kintara on October 16, 2024. Kintara announced today that its Board of Directors (the "Board") has approved a reverse stock split of Kintara’s common stock at a ratio of 1-for-35 (Press release, Kintara Therapeutics, OCT 16, 2024, View Source [SID1234647229]). Kintara’s common stock is expected to begin trading on a post-reverse stock split basis on the Nasdaq Capital Market on October 18, 2024, under the new name TuHURA Biosciences, Inc. and under the new symbol "HURA" following the anticipated closing of the merger (the "Merger") with TuHURA Biosciences, Inc. ("TuHURA"), with a new CUSIP number 898920 103. This press release corrects the previous announcement which contained a scrivener’s error stating Kintara’s common stock was expected to begin trading on a post-reverse stock split basis on October 17, 2024; as correctly stated above, Kintara’s common stock is expected to begin trading on a post-reverse stock split basis on October 18, 2024.

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The reverse stock split was approved by Kintara’s stockholders at Kintara’s special meeting of stockholders held on October 4, 2024, to be effected in the Board’s discretion of not less than 1-for-20 and not more than 1-for-40. The final reverse stock split ratio of 1-for-35 was approved by the Board on October 4, 2024.

As a result of the reverse stock split, every thirty-five pre-split shares of Kintara’s common stock outstanding will become one share of common stock. The reverse stock split is expected to reduce the number of shares of Kintara’s outstanding common stock from approximately 55.6 million shares to approximately 1.6 million shares. The par value of Kintara’s common stock will remain unchanged at $0.001 per share after the reverse stock split. The reverse stock split will not change the authorized number of shares of Kintara’s common stock. The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in Kintara’s equity, except to the extent that the reverse stock split results in some stockholders owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Instead, in lieu of any fractional shares to which a stockholder of record would otherwise be entitled as a result of the reverse stock split, Kintara will issue to such stockholder such additional fraction of a share as is necessary to increase such resulting fractional share to a full share of common stock. The reverse stock split will also apply to common stock issuable upon the exercise of Kintara’s outstanding warrants and stock options, with a proportionate adjustment to the exercise prices thereof, and under Kintara’s equity incentive plans.

Following the closing of the Merger, the combined company’s total outstanding common stock is expected to be approximately 42.0 million shares.

Equinity Trust Company, LLC is acting as the exchange agent and transfer agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.