On March 26, 2024 The Swedish biotech company Neogap Therapeutics reported to have received SEK 5 million from Eurostars in a collaboration project with the French biotech company Okomera (Press release, Neogap Therapeutics, MAR 26, 2024, View Source,c3951209 [SID1234641451]). The funding aims to enhance the development of an analysis method for T-cell activity against the patient’s tumour.

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Neogap is developing pTTL, personalised Tumour Trained Lymphocytes, a tailored cell therapy that utilises modified proteins, known as neoantigens, to activate the immune system specifically against cancer cells. The therapy is currently being assessed in phase I/II clinical trials for the treatment of colorectal cancer.

As part of the Eurostars-funded project, Neogap collaborates with the French biotech company Okomera, which has developed an innovative method to analyse cell interactions. The method allows for the analysis of how T-cells kill tumour cells in what is known as a killing assay, requiring only a minimal quantity of the cell product. This analysis is set to deepen the understanding of the interactions between T-cells and tumour cells, potentially enabling predictions about the efficacy of Neogap’s cell therapy products. The goal is to develop a system that can easily and reliably measure the capability of Neogap’s T-cell product, pTTL, in eradicating cancer cells.

"We are very grateful for Eurostars’ backing, which not only recognises the scientific potential of our company but also reinforces our role as an innovator in analysis methods for next-generation cell therapies. The funding enables further research that is essential for advancing our cell therapy product to later clinical phases," says Samuel Svensson, CEO of Neogap Therapeutics.

"Through our collaboration with Neogap, we’re afforded the opportunity to integrate Okomera’s technology into developing analytical methods for their pioneering cancer therapies. We eagerly anticipate the advancements this partnership will bring to the field of precision medicine," says Sidarth Radjou, CEO of Okomera.

On March 26, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update (Press release, Mural Oncology, MAR 26, 2024, View Source [SID1234641450]).

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"We have made significant progress since becoming an independent company during the fourth quarter of 2023. We have amplified the company’s strong talent by bringing in world-class leaders in immuno-oncology. To date, nemvaleukin has generated promising data with durable responses both in monotherapy and in PD-1 combination across a range of solid tumor types. We expect our current cash reserves to fund our operations, including multiple clinical development programs, into 4Q 2025 and we are selectively exploring partnerships to further investigate the significant potential of both nemvaleukin and our preclinical programs," said Caroline Loew, Ph.D., Chief Executive Officer of Mural Oncology. "This year, we plan to continue to advance our late-stage clinical trials, including evaluating less frequent IV dosing for nemvaleukin. We also look forward to presenting pre-clinical data from our IL-18 and IL-12 programs at multiple oncology conferences and nominating candidates for each this year."

Recent Corporate Highlights and Upcoming Milestones

Mural Oncology spun out of Alkermes and became an independent, publicly traded immuno-oncology company in November 2023. Now led by an experienced and highly accomplished oncology-focused leadership team and board of directors, the company is leveraging its core competencies in immune cell modulation and protein engineering to develop a portfolio of investigational cytokine therapies designed to address areas of unmet need for patients with solid tumors.

Mural Oncology has completed evaluation of the less frequent IV (LFIV) dosing regimen of nemvaleukin in ARTISTRY-3, and determined the recommended phase 2 dose selection to be 30 µg/kg, to be evaluated in cohort 3 of ARTISTRY-6:

The new dosing regimen, a shift from five daily infusions (days 1-5) per three-week cycle to two infusions (on days 1 and 8) per three-week cycle, did not result in additional observed tolerability issues compared to previous studies of nemvaleukin. Notably, there were no dose-limiting toxicities at any dose tested and the desired pharmacodynamic effects were seen with twice per cycle dosing.
The company plans to evaluate the LFIV nemvaleukin dosing regimen in the open-label cohort 3 of ARTISTRY-6, the company’s ongoing phase 2 trial, to explore the safety and efficacy of this new dosing regimen in a homogeneous patient population.
The company looks forward to presenting data from ARTISTRY-3 at an upcoming medical conference.
Enrollment in ARTISTRY-6 and ARTISTRY-7 is ongoing:

Cohort 2 of ARTISTRY-6 is a potentially registrational, phase 2 trial evaluating nemvaleukin as a monotherapy in 90 mucosal melanoma patients. The company expects to report top-line data results from cohort 2 of ARTISTRY-6 in the first half of 2025.
Cohort 3 of ARTISTRY-6 is an open label extension of the trial that will evaluate the recommended phase 2 LFIV dosing regimen from ARTISTRY-3 as a monotherapy and in combination with pembrolizumab in approximately 50 patients with cutaneous melanoma. The company expects to report top-line data for monotherapy from cohort 3 of ARTISTRY-6 in the first half of 2025 and for the pembrolizumab combination in the second half of 2025.
ARTISTRY-7 is a potentially registrational, phase 3 trial evaluating nemvaleukin in combination with pembrolizumab compared to investigators’ choice chemotherapy in 448 patients with platinum-resistant ovarian cancer. Mural expects to report interim overall survival (OS) results based on approximately 75% of events in the first quarter of 2025 and final OS results in the second quarter of 2026.

Mural Oncology will present preclinical IL-18 and IL-12 data for the first time at the upcoming AACR (Free AACR Whitepaper) conference.

The company intends to nominate development candidates for these engineered IL-18 and IL-12 therapies later this year.
Financial Results for the Quarter Ended December 31, 2023

Cash Position: As of December 31, 2023, cash and cash equivalents were $270.9 million.

R&D Expenses: Research and development expenses were $42.2 million for the fourth quarter of 2023 and were primarily due to employee-related expenses and expenses related to ARTISTRY-7. These expenses included $5.6 million of non-cash, share-based compensation expenses.

G&A Expenses: General and administrative expenses were $16.3 million for the fourth quarter of 2023, including $9.7 million in non-cash, share-based compensation expenses.

Net Loss: Net loss was $59.5 million for the fourth quarter of 2023. This included $15.2 million non-cash, share-based compensation, of which approximately $11.7 million was driven by one-time charges related to the separation from Alkermes and conversion of employee equity during the fourth quarter of 2023.
Financial Guidance

The company’s cash resources are expected to fund its operations into the fourth quarter 2025.
After the spin out from Alkermes on November 15, 2023, the company incurred certain non-cash, share-based compensation, most of which was one-time in nature, and this is reflected in today’s reported results. Furthermore, the company’s 2023 financial results reflect carve-out financials until the date of the spin out. The company anticipates reporting lower operating expenses in the quarters going forward.
About Nemvaleukin
Nemvaleukin is a novel, engineered cytokine designed to leverage antitumor effects of the IL-2 pathway while mitigating its hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials.

On March 26, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the successful completion of its purchase of AL102 and related drug candidate AL101 from Ayala Pharmaceuticals, Inc (Press release, Immunome, MAR 26, 2024, View Source [SID1234641448]).

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"AL102 is a high-quality asset that complements our existing pipeline of targeted cancer therapies," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe that AL102 can establish a new standard of care for the treatment of desmoid tumors. In parallel, we are excited to advance our preclinical programs towards Phase 1 trials."

AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy. AL102 is a potential once-daily oral treatment for desmoid tumors. Data from clinical trials have shown AL102 may be more effective in treating desmoid tumors than OGSIVEO (nirogacestat), which recently became the first treatment approved for desmoid tumors by the U.S. Food and Drug Administration in November 2023.

On March 26, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds to the Company of approximately $15.0 million, before deducting placement agent fees and offering expenses (Press release, iBioPharma, MAR 26, 2024, View Source [SID1234641447]).

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The fully subscribed PIPE financing included participation from ADAR1 Capital Management, Lynx1 Capital Management, Ikarian Capital and other institutional and accredited investors. The Company intends to use the net proceeds from the offering for general corporate purposes, including research and development and working capital. The Company also expects the net proceeds will extend its cash runway to fund its operating plan through fiscal year 2025.

"We appreciate the support of this outstanding group of healthcare specialist investors that shares the vision of leveraging our cutting-edge AI/Machine learning platform to deliver best-in-class drugs," said iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D.

Pursuant to the terms of the securities purchase agreement, the Company is selling an aggregate of 5,287,278 shares of common stock (or pre-funded warrant in lieu thereof) and common warrants to purchase up to 5,287,278 shares of common stock at a purchase price of $2.85 per share (or pre-funded warrant in lieu thereof), subject to certain beneficial ownership limitations set by each holder. The warrants issued in the offering are exercisable six (6) months upon issuance at an exercise price of $2.64 per share and will expire five years from the date of issuance.

Chardan acted as the sole placement agent for the PIPE financing.

The unregistered shares of common stock, pre-funded warrants and warrants sold in the PIPE financing described above were offered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the warrants and the shares of common stock underlying the pre-funded warrants and warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the terms of the securities purchase agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered shares of common stock and the shares issuable upon exercise of the unregistered pre-funded warrants and warrants.

This press release shall 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 26, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported that Thane Wettig, Chief Executive Officer, will participate in a corporate presentation at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, from 3:00-3:40 PM Eastern Time (Press release, FibroGen, MAR 26, 2024, View Source [SID1234641446]). Company management will also participate in virtual one-on-one meetings with investors during the conference.

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The live audio webcast of the event will be available to investors and other interested parties on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for 30 days.