On July 18, 2023 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that the first patient has been dosed in a Phase I study of the Company’s investigational targeted radiation therapy, TLX250, in combination with a Merck KGaA, Darmstadt, Germany (Merck) DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814) (Press release, Telix Pharmaceuticals, JUL 18, 2023, View Source [SID1234633297]). The study is being conducted in patients with solid tumours expressing carbonic-anhydrase IX (CAIX), a potential pan-cancer target.

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STARSTRUCK (ClinicalTrials.gov Identifier: NCT05868174) is a Phase Ib, open label, single-arm, multicentre dose escalation and dose expansion study to evaluate the safety profile, dosing and activity of TLX250 (177Lu-DOTA-girentuximab) in combination with the DNA damage response inhibitor (DDRi) peposertib, which is an inhibitor of DNA-PK. The target population is patients with CAIX-expressing solid tumours that are relapsed or refractory to standard therapies. Up to 80 patients will be assessed in this study in Australian sites.

The clinical hypothesis is that the combination of TLX250 and a DNA-PK inhibitor provides an enhancement in potency through their synergistic action on cancer cells. Targeted radiation effectively induces DNA damage in targeted cancer cells and the DNA-PK inhibitor may act to prevent the cell from repairing this damage, resulting in higher potency at lower doses. This hypothesis was confirmed in preclinical studies, conducted under a strategic research collaboration between Merck and Telix announced in 2019,[1] and provided evidence that the combined effect of Merck’s investigational DNA-PK inhibitor peposertib with Telix’s targeted radiation candidate has potential to significantly improve efficacy and reduce the required radiation dose for tumour reduction and remission, compared to targeted radiation alone.

Principal Investigator for the STARSTRUCK study, Professor Nat Lenzo, GenesisCare Group Clinical Director Theranostics said, "The treatment of advanced cancer can be extremely challenging. We are pleased to support the commencement of this study with Telix to help determine if there is a potential future clinical benefit regarding the combination of molecular targeted radiation and DNA-PK inhibitors."

Telix Chief Medical Officer, Dr. Colin Hayward stated, "Preclinical data has shown excellent combination response, which has potential to translate to additional response or more tolerable treatment regimens in patients. We would like to thank Prof. Lenzo and his clinical team at GenesisCare Murdoch, as well as the patients who will contribute to this important study."

Merck and Telix are continuing the initial scientific collaboration to further explore and optimise the combination of TLX250 or other next-generation targeted radiation therapy candidates with Merck’s DDRi compounds in preclinical studies.

About TLX250

TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets CAIX, a cell surface protein that is highly expressed in several human cancers, and is currently the subject of the STARLITE-1 (ClinicalTrials.gov Identifier: NCT05663710) and STARLITE-2 (NCT05239533) studies in combination with immunotherapy.[2] High CAIX tumour expression is generally correlated with poor prognosis.

Telix’s companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) was the subject of a successful global Phase III trial (ZIRCON trial, NCT03849118), which completed enrolment and reported positive top-line data during 2022.[3] Analyses of primary endpoints and key secondary endpoints of the ZIRCON trial were presented to the medical community for the first time at ASCO (Free ASCO Whitepaper) GU on 18 February 2023.[4] TLX250-CDx is currently being investigated in the Phase II STARBURST study (ClinicalTrials.gov Identifier: NCT05563272) exploring CAIX expression in patients with a diverse range of solid tumours for potential diagnostic and therapeutic applications.

On July 18, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its clinical trial application of 9MW2921 for advanced solid tumor was approved by the National Medical Products Administration (NMPA) (Press release, Mabwell Biotech, JUL 18, 2023, View Source [SID1234633296]). 9MW2921 is developed by Mabwell’s novel antibody-drug conjugate plateform IDDC.

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9MW2921 is a next generation antibody-drug conjugate (ADC) developed by Mabwell based on IDDC (Interchain-Disulfide Drug Conjugate) plateform for the treatment of solid tumors. It is an innovative antibody molecule linked to a novel payload (TOP1i) by a novel linker with fully autonomous intellectual property right. When 9MW2921 enters the body, it can specifically bind to antigens on the cell membrane surface, be internalized and transferred to the lysosome, release cytotoxic drug, and induce the apoptosis of tumor cells.

9MW2921 is pharmaceutical characterized as stable structure, homogeneous composition, high purity, and it is suitable for industrial scale-up. Compared with ADCs of the same class under development at home and abroad, 9MW2921 is significantly improved and optimized in endocytic activity, plasma stability, drug release characteristics, bystander killing effect, etc. In vivo pharmacodynamic studies demonstrated that 9MW2921 had a better tumor killing activity. In animal safety evaluation models including cynomolgus monkeys and rats, the on-target and off-target toxicities of 9MW2921 were effectively controlled, indicating that 9MW2921 has good safety profile and pharmacokinetic properties.

Belonging to the TACSTD family, Trop-2 is a cell surface glycoprotein encoded by the TACSTD gene. It is expressed in normal tissues at low levels, while overexpressed in multiple malignant tumors. Trop-2 expression correlates with tumor aggressiveness. Trop-2 overexpression promotes the growth, proliferation, and metastasis of tumor cells.

Next generation antibody-drug conjugate plateform IDDC

Mabwell has developed multiple ADC technology plateforms, and its anti-Nectin-4 ADC (R&D code: 9MW2821) is currently in the phase II clinical study.

IDDC is a next generation ADC site-specific conjugate technology plateform independently developed by Mabwell. It is composed of multiple systematized core patent technologies including site-specific conjugate process DARfinity, special designed linker IDconnect, novel payload Mtoxin, and conditional release structure LysOnly.

The next generation ADCs developed based on the above systematic patent technologies will carry better structural homogeneity, quality stability, pharmacodynamics and tolerability. Currently, the IDDC plateform has been validated in several products under development. It is expected multiple ADC products will enter clinical development in 2023 and 2024.

On July 18, 2023 Rakuten Medical, Inc. (Rakuten Medical), a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy-based on its proprietary Alluminox platform, reported that it will host a virtual R&D Day on the preliminary safety and efficacy findings from its open-label Phase 1b/2 study of Alluminox treatment using ASP-1929 in combination with anti-PD-1 therapy in recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Rakuten Medical, JUL 18, 2023, View Source [SID1234633295]). The webinar will take place on Thursday, August 10, 2023 at 8:30 AM PT / 11:30 AM ET.

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The event will feature Ann M. Gillenwater, Professor, Department of Head and Neck Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center who will discuss the promising results of the novel combination and the potential implications for the current treatment landscape. Rakuten Medical’s management team will provide other business updates including, but not limited to, a Japan commercial update and the Global Phase 3 Trial of ASP-1929 in India.

Rakuten Medical’s technology consists of drug and device components and which Rakuten Medical hopes will become a potential 5th pillar of cancer treatment. The Alluminox platform has been shown in pre-clinical trials to target specific tumors as well as immunosuppressive cells for destruction with minimal effects on surrounding normal tissue.

ASP-1929 targeting EGFR is approved in Japan and has been marketed as Akalux since January 2021 for unresectable locally advanced or recurrent head and neck cancer. ASP-1929 received Fast Track designation from the U.S. FDA in January 2018, and is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer but outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.

A live question and answer session will follow the formal presentation. Parties interested in participating in this event should click here to register and access the live webcast. Please note that practicing healthcare professionals and patients are not permitted to attend.

On July 18, 2023 Verismo Therapeutics, a clinical-stage CAR T company, Penn spinout, and pioneer of the novel KIR-CAR platform technology, reported that it has raised $17M in a second pre-Series A financing round (Press release, Verismo Therapeutics, JUL 18, 2023, View Source [SID1234633294]). The financing will support continued advancement of the clinical trial for SynKIR-110, a first-in-class KIR-CAR T cell immunotherapy candidate for solid tumors, and pre-clinical development of SynKIR-310, a KIR-CAR T cell immunotherapy therapeutic for blood cancers.

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The funding round was co-led by DongKoo Bio, HLB Innovation and HLB. The funding will be used to advance multiple programs targeting solid and liquid tumors. With this $17M investment Verismo will have secured a total of $50M in financing since launching in 2020.

About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acting as a novel costimulatory molecule for T cells, aids additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those refractory to traditional CAR T cell therapies. Furthermore, the KIR-CAR platform can be combined with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to provide the next-generation multimodal targeted immunotherapy for patients in need.

On July 18, 2023 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported the pricing of a global offering of ordinary shares, which may be represented by American Depository Shares ("ADSs") (Press release, argenx, JUL 18, 2023, View Source [SID1234633293]).

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The global offering is comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom. The Company anticipates total gross proceeds of approximately $1.1 billion (approximately €979.6 million) from the sale of 1,580,981 ADSs at a price of $490.00 per ADS and the sale of 663,918 ordinary shares at a price of €436.37 per ordinary share. Each of the ADSs represents the right to receive one ordinary share, nominal value of €0.10 per share. The U.S. offering and the European private placement are currently expected to close simultaneously on July 24, 2023, subject to customary closing conditions.

In addition, argenx has granted the underwriters of the offering a 30-day option to purchase up to 336,734 ordinary shares (which may be represented by ADSs) on the same terms and conditions.

argenx’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "ARGX" and argenx’s ordinary shares are currently listed on Euronext Brussels under the symbol "ARGX".

J.P. Morgan, Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities and TD Cowen are acting as joint bookrunning managers for the offering. Van Lanschot Kempen is acting as manager for the offering.

The securities are being offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the securities being offered in the United States was filed with the SEC on July 17, 2023. The final prospectus supplement relating to the securities being offered in the United States will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

When available, copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected], or by telephone at (866) 803- 9204; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, or by email at [email protected]; from Goldman Sachs & Co. LLC, 200 West Street, New York, NY 10282, Attn: Prospectus Department, by email at [email protected], or by telephone at 866-471-2526; from BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255- 0001, Attn: Prospectus Department, or by email at [email protected]; or from Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, by email at [email protected], or by telephone at (833) 297-2926.

A request for the admission to listing and trading of the ordinary shares (including the ordinary shares underlying the ADSs) on the regulated market of Euronext Brussels will be made.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.