Imugene Completes Strongly Supported $35M Placement & Launches $30M SPP

On August 18, 2023 Imugene Limited (ASX:IMU) (Company), a clinical stage immuno-oncology company, reported that it has received firm commitments from institutional and sophisticated investors for a $35 million placement (Placement Subscribers) of approximately 416.7m new fully paid ordinary shares (New Shares) in the Company at a price of $0.084 per share (Placement) (Press release, Imugene, AUG 18, 2023, View Source [SID1234634487]).

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The Placement received strong interest and support from specialist biotech institutional investors, as well as a number of the Company’s Directors and key management personnel who have committed approximately $840,000 (part of which shall be subject to shareholder approval at an extraordinary general meeting to be convened by the Company shortly).

The Placement is being followed by a share purchase plan (SPP), to raise approximately $30 million, for existing eligible shareholders (Eligible Shareholders) at the lower of $0.084 and a 2.5% discount to the 5-day VWAP up to and including the closing date of the SPP.

Under the Placement and SPP (together, the Offer), Placement Subscribers and Eligible Shareholders are anticipated to receive one free option for every New Share (New Options) subscribed for under the Offer (Options Offer). The New Options will have an exercise price of $0.118 per option with an expiration of 31 August 2026 and will be subject to shareholder approval. It is intended that the New Options will be quoted on the ASX. The funds raised from the Offer will be used:
 to make the upfront payment of US$8 million to Precision Biosciences Inc. (NASDAQ GS: DTIL) in accordance with the terms of the licence agreement entered into between the Company and Precisions Biosciences Inc. on 16 August 2023 (Licence Agreement);
 to meet the deferred consideration and milestone payment obligations under the Licence Agreement, including for the completion of the Phase 1b clinical trial for the licensed Azer-cel Allogeneic CD19 Car-T technology; and
 for associated manufacturing, clinical trial, regulatory and working capital costs relating to the Licence Agreement.

Further details in relation to the Licence Agreement can be found in the Company’s announcement dated 16 August 2023. In relation to the Offer, Imugene Founder and Executive Chairman Paul Hopper said: "I am delighted with the very strong support shown for the raise with institutional interest coming from Australia, Asia in particular, and the US. It was very important to the Board that our loyal individual shareholders be offered the opportunity to also participate via the SPP, and we are glad to say that their voice has been heard". Imugene Managing Director and CEO Leslie Chong said: "We appreciate the strong support and belief from new and existing investors in our Company’s vision. This raise places Imugene in an enviable position with regards to its balance sheet with the financial horsepower to execute across all our platforms. I thank all our investors for the confidence they have shown in our company." Bell Potter Securities Limited is acting as Lead Manager to the capital raising.

OFFER

About the Placement

Under the terms of the Placement, the Company has secured commitments of $35 million and proposes to issue a total of 416,666,667 New Shares to Placement Subscribers at a price of $0.084 per share, representing a discount of 10.64% to the last close on Tuesday, 15 August 2023 ($0.094), and a discount of 12.38% to the 20-day VWAP up to, and including, Tuesday, 15 August 2023 ($0.096). The Placement is being conducted under Imugene’s existing placement capacity pursuant to ASX Listing Rule 7.1, save for those commitments by certain Directors and will be subject to prior shareholder approval.

About the SPP

The Company will also offer a SPP to Eligible Shareholders at a price equal to the lower of:  $0.084 (being the same price as for the Placement); and  a 2.5% discount to the 5-day VWAP up to and including the closing date of the SPP. Under the SPP, Eligible Shareholders listed on the Imugene register at 7:00pm (Sydney time) on the record date of Thursday, 17 August 2023 with an address in Australia or New Zealand will be offered the opportunity to apply for up to $30,000 of fully paid ordinary New Shares in Imugene, without incurring brokerage fees or other transactions costs, irrespective of their holding size. The SPP is not underwritten.

Notwithstanding the target raise amount of $30 million, the Company reserves its right to increase or decrease the amount to be raised under the SPP. Any funds raised in excess of the target raise amount would also be used to fund the development of the CAR T drug Azer-Cel technology and associated costs relating to the Licence Agreement. The SPP shares will be issued pursuant to Exception 5 in ASX Listing Rule 7.2 and will not count towards Imugene’s placement capacity.

About the Options Offer

Under the Offer, Imugene intends to issue one free attaching New Option for every New Share subscribed for by Placement Subscribers and Eligible Shareholders under the SPP, for an aggregate of approximately 773.9m New Options to be issued. The New Options will have an exercise price of $0.118, and will expire on 31 August 2026. The offer for New Options will be set out in a prospectus (Prospectus) and the issuance of the New Options will be subject to shareholder approval at an extraordinary general meeting to be convened shortly.

Other information
The SPP (and Options Offer) will be made under a transaction specific Prospectus which is anticipated to be lodged with ASIC in accordance with the above timetable. Eligible Shareholders should carefully consider the Prospectus before deciding to apply under the SPP. Eligible Shareholders who wish to participate in the SPP will need to
complete the personalised application form (Application Form).

All dollar references are to the Australian dollar unless otherwise stated.

TFC Therapeutics Launches to Advance Novel Platform and Technologies in Cancer Biology

On August 17, 2023 TFC Therapeutics (TFC), a biotechnology company focused on developing novel biologics to target and eliminate key drivers of cancer recurrence and metastasis, reported a financing led by ARCH Venture Partners with participation from Breakout Ventures, Alexandria Real Estate Equities, and Alumni Ventures (Press release, TFC Therapeutics, AUG 17, 2023, View Source [SID1234634492]). In connection with the financing, Steven Gillis, Ph.D., Managing Director at ARCH, has been appointed as Chairman of the TFC Board of Directors.

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TFC has entered into an exclusive license agreement with Columbia University to develop a drug discovery platform that targets Tumor Macrophage Hybrid (TMH) cells. Under the terms of the agreement, TFC has the exclusive rights to develop and commercialize intellectual property developed at Columbia University by Azra Raza, Chan Soon-Shiong Professor of Medicine and Clinical Director of the Edward P. Evans Foundation Myelodysplastic Syndrome Center at Columbia University Vagelos College of Physicians and Surgeons, and Abdullah Ali, PhD, Assistant Professor of Medical Sciences (in Medicine) at Columbia University Vagelos College of Physicians and Surgeons.

TFC is focused on developing therapies to eliminate the most resilient cancers and stop disease recurrence. TFC’s emerging platform technologies are focused on the elimination of TMH cells, which are found in the bloodstream of patients with cancer. The presence of TMH cells in the circulation of cancer patients is associated with metastasis, resistance to traditional therapies, relapse, and poor outcomes. In animal models, these cells have been associated with metastasis and resistance to standard therapies.

"TFC is positioned to help patients fight cancer and overcome resistance to current therapies by developing biologics designed to target and eliminate a specific cell-type that may play a fundamental and causative role in metastasis and cancer recurrence," said Dr. Gillis. "Despite substantial R&D efforts and regulatory approvals of more anti-cancer therapies, new approaches to therapy are still sorely needed. I look forward to the results of ongoing work at TFC and hope that its efforts result in the development of a new and important means of therapy for cancer patients."

"At TFC, we remain committed to bringing forward a new approach to treatment of cancer metastasis and relapse that will benefit patients living with cancer," said Jennifer Power, Chief Executive Officer of TFC Therapeutics. "We believe that targeting a key driver of cancer, TMH cells, coupled with the financial support of our investor syndicate and the scientific acumen of our founders, gives TFC a significant advantage in building a valuable platform, pipeline and company."

TFC Leadership

The TFC team has deep experience in the development and commercialization of novel medicines. TFC’s Chief Executive Officer, Jennifer Power, is an experienced leader with over 20 years of experience in the development, commercialization, and delivery of medicines. Prior to joining TFC, Ms. Power was Deputy Director, Innovation Introduction at the Bill & Melinda Gates Foundation. Prior to that, she spent twelve years at Pfizer, Inc. where she served in multiple senior roles, leading strategic marketing and delivery of multi-billion-dollar drug portfolios. Ms. Power serves as an Advisory Board Member, Global Health JSC at Antiva Bioscience, Inc. Ms. Power received her MBA from Columbia University and her BA in Economics from Pomona College.

Guardant Health to Host Investor Day on September 7, 2023

On August 17, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported that the company will be hosting an Investor Day on September 7, 2023, in New York City, NY starting at 8:00 a.m. Eastern time / 5:00 a.m. Pacific Time (Press release, Guardant Health, AUG 17, 2023, View Source [SID1234634491]). The event will feature presentations by several members of the company’s leadership team.

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Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com. Due to limited capacity, in-person attendance is available by invitation only.

NextPoint Therapeutics Announces First Patient Dosed in Phase 1a/b Clinical Trial of NPX267, a Novel Therapeutic Targeting KIR3DL3 to Reactivate Exhausted T and NK Cells in HHLA2+ Solid Tumors

On August 17, 2023 NextPoint Therapeutics, a clinical-stage biotechnology company developing precision immuno-oncology therapeutics targeting the novel HHLA2 pathway, reported that the first patient has been dosed with NPX267 in a Phase 1 first-in-human clinical trial for the treatment of patients with solid tumors known to express HHLA2, a tumor antigen strongly upregulated in many human tumors independently of PD-L1 (Press release, NextPoint Therapeutics, AUG 17, 2023, View Source [SID1234634490]).

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The Phase 1a/1b open-label, multi-center study (NCT05958199) consists of a dose escalation and an expansion stage to evaluate the tolerability, pharmacokinetics, immunogenicity and biomarker strategy of NPX267 in patients with metastatic solid tumors including epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) and other indications.

Killer cell immunoglobulin-like receptor 3DL3 (KIR3DL3) is expressed on effector T cells and natural killer (NK) cells in the tumor microenvironment and is an inhibitory receptor for the tumor antigen HHLA2, expressed on a range of solid tumors. Binding of KIR3DL3 to HHLA2 is believed to allow tumors to cloak themselves and hide from immune cells.

"Many cancers hijack the HHLA2 pathway to evade the immune system, whose signaling mechanisms were independently co-discovered by NextPoint’s scientific co-founders, Dr. XingXing Zang and Dr. Gordon Freeman," said Detlev Biniszkiewicz, PhD, Chief Executive Officer of NextPoint Therapeutics. "Because HHLA2 is expressed independently of PD-L1 and is often highly expressed in PD-L1-negative cancers, targeting the HHLA2-KIR3DL3 interaction is a promising new approach for patients with cancer."

"We are excited to launch the clinical evaluation of NPX267, our lead therapeutic program targeting the HHLA2 pathway," said Leena Gandhi, MD, PhD, Chief Medical Officer of NextPoint Therapeutics. "This study will provide important data on the therapeutic activity of NPX267 as well as the mechanism of HHLA2-mediated immunosuppression via KIR3DL3 and inform our clinical strategy for developing precision immunotherapeutic treatments for patients."

About NPX267

NPX267 is a first-in-class monoclonal antibody targeting KIR3DL3, the inhibitory receptor for the HHLA2 pathway (B7-H7), and is designed to prevent immune escape in solid tumors. By blocking the binding of KIR3DL3 on exhausted T and NK cells to HHLA2 expressed on tumor cells, NPX267 may be able to reactivate tumor antigen-primed immune cells in HHLA2-expressing solid tumors. Preventing KIR3DL3-mediated immune suppression may enhance anti-tumor immune responses for patients with HHLA2-positive cancers – a tumor antigen expressed independently of PD-L1. To learn more, visit www.clinicaltrials.gov (NCT05958199).

QiLu Pharmaceutical’s Iruplinalkib Phase III INSPIRE Study Researched Primary Endpoint and was Selected for 2023 WCLC Oral Presentation

On August 17, 2023 QiLu Pharmaceutical’s reported that iruplinalkib’s phase III clinical trial (INSPIRE) results were chosen for oral presentation at the 2023 World Conference on Lung Cancer (WCLC) (Press release, Qilu Pharmaceutical, AUG 17, 2023, View Source [SID1234634489]).

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The iruplinalkib INSPIRE study is a randomized, open, multi-center phase III clinical trial, designed to evaluate the efficacy and safety of Iruplinalkib (oral 180 mg, once daily; 60 mg once daily for the 7-day lead-in phase) versus crizotinib (oral 250 mg, twice daily) in patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have not previously received ALK TKI treatment. The primary endpoint is progression-free survival (PFS), as assessed by an Independent Review Committee (IRC). The leading investigator of the study is Professor Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences. The study was carried out across 40 hospitals in China.

Between September 4, 2019, and December 2, 2020, a total of 292 patients were enrolled and randomized to treatment (iruplinalkib group 143; crizotinib group 149). The published results were based on an interim analysis of the study, reviewed by the Independent Data Monitoring Committee (IDMC) (data cut-off date: November 13, 2022). The median follow-up time for the iruplinalkib and crizotinib groups was 23.98 months and 24.54 months, respectively. The results showed that the primary endpoint PFS (per RECIST v1.1 by IRC) met the pre-defined criteria, and the PFS in iruplinalkib group was significantly improved compared to the crizotinib group, with median PFS of 27.70 months and 14.62 months, respectively (hazard ratio, 0.344 [98.02% confidence interval 0.226-0.523]). In terms of secondary endpoints such as duration of response (DoR) and control of intracranial disease, the results in iruplinalkib group were also superior to those from the crizotinib group. In this study, the safety of Iruplinalkib was consistent with the safety profile of previous studies. Iruplinalkib showed a good safety profile and no increased safety risk compared to crizotinib.

On June 28, 2023, the China National Medical Products Administration approved iruplinalkib tablets for market launch, for the treatment of patients with locally advanced or metastatic ALK-positive NSCLC who have progressed or are intolerant to crizotinib. Currently, the new drug application for iruplinalkib as a first-line treatment for ALK-positive, advanced NSCLC patients has been submitted and accepted by China CDE. Iruplinalkib may be a new treatment option for patients.