On May 15, 2024 Amplia Therapeutics reported the successful completion of its $4.27 million fully underwritten, non-renounceable entitlement offer which was well supported by existing eligible shareholders and new institutional and sophisticated investors (Entitlement Offer) (Press release, Amplia Therapeutics, MAY 15, 2024, View Source [SID1234643366]).

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Under the Entitlement Offer eligible shareholders were entitled to apply for two (2) fully paid ordinary shares (New Shares) for every five (5) shares held on Friday 19 April 2024 (Record Date) at the offer price of $0.055. The Entitlement Offer will issue 77,602,838 New Shares raising a total of $4.27 million (before costs).

In total, Amplia received valid applications from eligible shareholders for 36,049,966 New Shares ($1.983 million). The resultant shortfall of 41,552,872 New Shares ($2.285 million) (Shortfall) was placed by the Lead Manager and Underwriter, Taylor Collison Limited (Lead Manager), to new and existing institutional and sophisticated investors.

Amplia’s CEO and Managing Director Dr Chris Burns commented "Amplia’s Board and Management are extremely grateful for the ongoing support of our shareholders and advisors and we welcome new shareholders to the Company. Our successful Entitlement Offer permits the Company to continue to actively progress development of our best-in-class FAK inhibitor narmafotinib, with specific focus on delivering critical interim data in our ongoing Phase 2 ACCENT trial in pancreatic cancer."

Director Participation
As previously announced, US based Company Director, Dr Robert Peach, committed to sub-underwrite A$150,000 in the Entitlement Offer and was proportionally allocated A$105,000 in the Shortfall. In addition, Managing Director and CEO, Chris Burns, and Company Director, Jane Bell, cumulatively took up $78,000 of their rights under the Entitlement Offer.

Use of funds
The proceeds from the Entitlement Offer will be used to fund the ongoing Phase 2 ACCENT trial in pancreatic cancer to an Interim Analysis (expected in Q3 2024), as well as undertake production of additional narmafotinib capsules and support a pilot Investigator Initiated trial in ovarian cancer currently in planning.

ACCENT Trial Update
The Company is pleased to announce that the ongoing Phase 2a ACCENT trial in advanced pancreatic cancer patients is progressing to plan. In this stage of the trial, newly diagnosed advanced (metastatic) pancreatic cancer patients receive orally-dosed narmafotinib (at the optimal 400 mg dose identified from the Phase 1b trial) combined with the standard-of-care chemotherapy gemcitabine and Abraxane. At present, nineteen (19) patients of a total of 26 are enrolled in trial sites in Australia and South Korea. An interim analysis will be conducted to determine whether six (6) or more patients on the trial record a partial response, and if so, a further 24 patients will be enrolled, bringing the patient cohort to 50 patients in total. The Company previously disclosed that six (6) patients out of fourteen (14) recorded a partial response in the Phase 1b stage of the trial. Dr Burns commented: "The excellent recruitment progress and support from clinicians seen to date in the ACCENT trial is extremely encouraging and we expect it to allow us to report Interim Data in Q3 this year."

About the ACCENT Trial
The protocol for the ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The trial is a single-arm open label study conducted in two stages. The first stage (Phase 1b) determined an optimal dose of narmafotinib (AMP945) by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of narmafotinib when dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer.

This second stage (Phase 2a) of the trial currently underway will assess efficacy of narmafotinib in combination with gemcitabine and Abraxane, along with continued assessment of safety and tolerability. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS).

More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.

The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On May 15, 2024 MediGene, an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported the company’s proprietary T cell receptor (TCR) discovery process to obtain optimal affinity 3S (sensitive, specific and safe) TCRs at the 21th Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) Annual Meeting in Mainz from May 15 – 17, 2024 (Press release, MediGene, MAY 15, 2024, View Source [SID1234643365]). Data presented also shows the clear benefit of adding the PD1-41BB costimulatory switch protein (CSP) to further armor and enhance these 3S TCR-T cells, which enables them to overcome the immunosuppressive tumor microenvironment.

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The poster with the title "Selection of superior KRAS G12V mutation-specific T cell receptors with unique characteristics for 3rd generation armored and enhanced T cell therapy" will be available on Wednesday, May 15, 2024, following the presentation on Medigene’s website: View Source

"The discovery process of unique TCR sequences is the first key step to generate TCR-T cells with optimal safety, efficacy and durability," said Dr. Selwyn Ho, Chief Executive Officer at Medigene. "Employing a high-throughput process as part of our End-To-End (E2E) Platform enabled us to discover unique TCR sequences with distinct features with respect to specificity, sensitivity and safety (3S). These potential best-in-class 3S TCRs hold promise for utilization across diverse modalities, here focusing on T cell receptor engineered T cell (TCR-T) therapies, but also for use in T cell engagers and TCR natural killer cell therapies. "

He continued: "Our TCRs can undergo further enhancement through integration of various technologies within our E2E Platform such as with our exclusive PD1-41BB CSP, which significantly enhances TCR-T cell functionality, persistence and proliferation and offers the promise of highly effective and durable TCR-T therapies in patients."

The presented data highlighted the specificity and sensitivity of TCR-T cells co-expressing the PD1-41BB CSP alongside one of three distinct 3S TCRs targeting the mKRAS G12V neoantigen. These TCR-T cells displayed markedly increased secretion of interferon gamma (IFNγ) observed upon TCR-T cell stimulation with mKRAS G12V-positive tumor cells, contrasting with the absence of IFN γ secretion upon stimulation with any tumor or healthy cell expressing naturally occurring wild-type KRAS protein.

All three 3S TCRs also demonstrated high sensitivity to the mKRAS G12V neoantigen, as demonstrated by their activation in response to extremely low levels of mKRAS-G12V peptide. Concurrent expression of the PD1-41BB CSP significantly augmented TCR-T cell functionality, enabling sustained cytotoxicity targeting 3D tumor spheroids across multiple rounds of tumor exposure. This underscores the potent anti-cancer efficacy of the TCR-T cells.

From a safety perspective, all three 3S TCRs combined with the PD1-41BB CSP demonstrated favorable safety profiles, with no IFNγ secretion or cytotoxicity when exposed to healthy cells from major tissues or organs, affirming their selective cytotoxicity towards cancer cells while sparing healthy tissue from toxicity.

On May 15, 2024 OmniAb, Inc. (Nasdaq: OABI) reported its participation in the 20th Annual PEGS Boston – The Essential Protein & Antibody Engineering Summit underway at the Omni Hotel (Press release, OmniAb, MAY 15, 2024, View Source [SID1234643364]). Earlier today the Company presented an overview of xPloration, a high-throughput single B-cell screening platform that leverages machine learning and Artificial Intelligence (AI), in a presentation titled "Deep Screening in Harmony with Artificial Intelligence for Bispecific Antibody Discovery."

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"xPloration enables large-scale data collection of massive, diverse antibody repertoires generated utilizing the Biological Intelligence built into our proprietary engineered animals, and facilitates efficient evaluation of AI selections from these repertoires," said Bob Chen, Ph.D., Senior Director, Discovery Systems. "The synergy between xPloration, OmniFlic, OmniClic, and OmniDeep enables new bispecific antibody discovery workflows for our partners. We are delighted that our innovative technology stack continues to make important impacts on partner R&D pipelines, and assists in delivering novel, highly effective therapeutic solutions to patients."

Today’s presentation included a case study demonstrating the ability to rapidly discover antibody panels from the Company’s OmniFlic and OmniClic platforms against a promising target called NKp46. These antibodies may be used by partners in a natural killer cell engager bispecific antibody. With xPloration, OmniAb’s scientific team screened tens of millions of cells and recovered thousands of unique antibody sequences. The team applied OmniDeep to help understand natural immune repertoires and to guide antibody selection and characterization, resulting in a large panel of high-affinity, potentially developable antibodies.

Dr. Chen’s presentation is available on the Scientific Publications section of OmniAb’s website.

For more information about OmniAb’s proprietary technologies, please visit www.omniab.com or contact our business development team at [email protected].

On May 15, 2024 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, reported that Seth Lederman, M.D., Chief Executive Officer, will participate virtually in a fireside chat at A.G.P.’s Healthcare Company Showcase on Tuesday, May 21, 2024, at 9:00 a.m. ET (Press release, TONIX Pharmaceuticals, MAY 15, 2024, View Source [SID1234643363]).

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A live webcast of the presentation can be found here. A replay of the presentation will also be available under the IR Events tab of the Tonix website at www.tonixpharma.com following the event.

On May 15, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported progress on its Phase 1b clinical study for their lead compound PH-762 (Press release, Phio Pharmaceuticals, MAY 15, 2024, https://phiopharma.com/phio-pharmaceuticals-announces-completion-of-dosing-in-first-patient-cohort-in-ph-762-phase-1b-dose-escalation-study/ [SID1234643362]). Dosing of the first cohort of patients was completed and screening for the next dose cohort is on-going.

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Phio’s Phase 1b study (NCT 06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This study will assess the tumor response, and determine the recommended dose for further study of PH-762.

"This is exciting news for Phio and our lead compound PH-762 with the dosing of the 1st cohort completed, we look forward to advancing the study to bring an innovative treatment option to patients with skin carcinomas," said Robert Bitterman, CEO of Phio Pharmaceuticals.