TYPE D MEETING OUTCOME WITH US FOOD AND DRUG ADMINISTRATION

On March 3, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported a regulatory update on its planned US clinical trial following its Type D meeting with the United States Food and Drug Administration (FDA) (Press release, Amplia Therapeutics, MAR 3, 2025, View Source [SID1234650784]).

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The Company has previously disclosed plans for a clinical trial in the US of its best-in-class FAK inhibitor narmafotinib, in combination with the chemotherapy regime FOLFIRINOX, in advanced pancreatic cancer patients. FOLFIRINOX, which is a mixture of four different drugs, is the preferred first-line treatment option for advanced pancreatic cancer in the US. The Company has previously reported1 that narmafotinib enhances the activity of FOLFIRINOX in preclinical models of pancreatic cancer.

A Type D meeting is an opportunity for a company to seek feedback from the FDA for specific questions regarding clinical development activities. The Company sought the FDA’s feedback regarding modifications to the clinical trial protocol previously submitted as part of the Investigational New Drug application cleared by the FDA in January 20242 . Specifically, the Company was seeking commentary regarding changes to the dose-escalation and dose-optimization phase of the study and concerning removal of a pharmacokinetic assessment of FOLFIRINOX in the trial. In the written response received by the Company, the FDA noted that the proposed changes ‘appear reasonable’ clearing the way for the Company to finalise the study protocol and initiate the final stages of trial planning prior to commencing the study.

Amplia CEO and MD Dr Chris Burns commented: "We are grateful for the thoughtful input from the FDA regarding the modifications to our clinical trial protocol. These changes will allow the Company to progress the trial in a more time-efficient and capital-efficient manner, and we are now in the final planning stages to start the trial in the coming months."

Dr Burns continued: "Positive data from this clinical study, combined with promising data from the current ACCENT trial – where narmafotinib is combined with gemcitabine and Abraxane – will position narmafotinib as the preferred drug to combine with the two main chemotherapy regimes used for the treatment of pancreatic cancer across the globe."

Entry into a Material Definitive Agreement.

On March 2, 2025, Akari Therapeutics, Plc (the "Company") reported to have entered into a securities purchase agreement (the "Purchase Agreement") with certain investors, including the Company’s Chairman, Dr. Hoyoung Huh, director, President and Chief Executive Officer, Dr. Samir R. Patel, and all other members of the Company’s board, pursuant to which the Company agreed to sell and issue in a private placement (the "Offering") an aggregate of 6,637,626 unregistered American Depository Shares ("ADSs"), each representing 2,000 of the Company’s ordinary shares (the "Shares"), or prefunded warrants in lieu thereof ("Pre-Funded Warrants"), and, in each case, Series A warrants to purchase ADS ("Series A Warrants") and Series B warrants to purchase ADS ("Series B Warrants", together with the Pre-Funded Warrants and Series A Warrants, the "Warrants," and together with the ADSs or Pre-Funded Warrants, the "Units")) (Filing, 8-K, Akari Therapeutics, MAR 2, 2025, View Source [SID1234650820]). The Units consist of (i) for investors committing less than $1.0 million in the Offering ("Tier 1 Investors") one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase one ADS and a Series B Warrant to purchase one ADS, (ii) for investors committing at least $1.0 million but less than $3.0 million in the Offering ("Tier 2 Investors") one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase 1.25 ADSs and a Series B Warrant to purchase one ADS, and (iii) for investors committing $3.0 million or more in the Offering ("Tier 3 Investors"), one ADS or Pre-Funded Warrant plus a Series A Warrant to purchase 1.5 ADSs and a Series B Warrant to purchase one ADS. The purchase price per Unit for investors purchasing ADSs is equal to $0.87 plus (a) $0.25 cents for Tier 1 Investors, (b) $0.28125 cents for Tier 2 Investors, or (c) $0.3125 for Tier 3 Investors (the "ADS Unit Purchase Price"). The purchase price per Pre-Funded Warrant and accompanying Series A Warrant and Series B Warrant is equal to $0.67 (which represents the ADS purchase price minus the $0.20 exercise price for such Pre-Funded Warrant) plus (a) $0.25 cents for Tier 1 Investors, (b) $0.28125 cents for Tier 2 Investors, or (c) $0.3125 for Tier 3 Investors (the "Pre-Funded Unit Purchase Price").

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In addition, Dr. Huh, the Company’s Chairman, agreed to purchase $1 million of Units, with the purchase price thereof to be satisfied through his agreement to terminate a $1 million convertible note previously issued to him by the Company (the "Note Termination").

The gross proceeds from the Offering, including the $1 million Note Termination, and excluding the proceeds to be received upon exercise of the Pre-Funded Warrants, are expected to be approximately $7.1 million before deducting approximately $401,000 representing the fees and expenses of the placement agent payable by the Company. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.

The Series A and Series B Warrants will have an exercise price of $0.87 per ADS, which is equal to the Nasdaq official closing price of the Company’s ADSs on the Nasdaq Capital Market on February 28, 2025 and will be exercisable immediately following the date of issuance. The Series A Warrants and Series B Warrants will expire one year or five years, respectively, from the closing date of the Offering. The Pre-Funded Warrants will be exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full.

The Company paid Paulson Investment Company, LLC ("Paulson") (the "Placement Agent") (i) a cash fee equal to 7% (or 3.5% for any investor that is a director, insider or affiliate of the Company) of the aggregate purchase price for the Units sold in the Offering (and excluding the Units issued to Dr. Huh in respect to the Note Termination) and (ii) 3% of the total number of ADS issued in the Offering, including any of the ADSs issuable upon exercise of the Pre-Funded Warrants (and excluding the ADSs issued to Dr. Huh in respect to the Note Termination).

Pursuant to the Purchase Agreement, the Company has agreed to prepare and file a registration statement on Form S-3 with the Securities and Exchange Commission no later sixty days following the closing of the Offering to register the resale of the Shares (including ADSs issuable upon exercise of the Warrants) purchased pursuant to the Purchase Agreement. The Purchase Agreement also contains representations, warranties, indemnification and other provisions customary for transactions of this nature. The Offering is expected to close on March 5, 2025, subject to the satisfaction of customary closing conditions.

The securities to be issued to the purchasers under the Purchase Agreement were offered in reliance on an exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Rule 506 of Regulation D promulgated thereunder. The Company relied on this exemption from registration based in part on representations made by the purchasers, including that each purchaser is an "accredited investor", as defined in Rule 501(a) promulgated under the Securities Act.

The offer and sale of the securities pursuant to the Purchase Agreement have not been registered under the Securities Act or any state securities laws. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.

The foregoing summary of the terms of the Warrants and the Purchase Agreement is subject to, and qualified in its entirety by, the full text of such agreements, which are filed as Exhibits 4.1, 4.2, 4.3 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.

Cash-strapped Vincerx left mulling future after Oqory reverse merger falls apart

On March 2, 2025 Oqory reported its planned reverse merger with fellow antibody-drug conjugate company Vincerx Pharma has fallen apart at the last minute, leaving Vincerx to size up its remaining options in the final months before its cash runs dry (Press release, Oqory, MAR 2, 2025, View Source [SID1234650810]).

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The deal, which was expected to include a minimum fully diluted equity value of $13.66 million, would have seen 95% of the merged business owned by Oqory’s current equity holders while making use of Vincerx’s Nasdaq listing. When it announced the agreement in late December, Vincerx also initiated a C-suite clear-out that saw Ahmed Hamdy, M.D., stepping down as CEO and Chief Financial Officer Alexander Seelenberger leaving his role, alongside a wider "workforce reduction."

At the time, Vincerx’s Chief Operations Officer Raquel Izumi, Ph.D., who was moved into the acting CEO role, described being acquired by Oqory as "highlight[ing] Vincerx’s commitment to develop ADCs with improved safety profiles that allow patients to thrive on—rather than endure—their cancer therapies."

BostonGene to Showcase Multi-Modal AI-Powered Platform at the 22nd Annual Meeting of the Japanese Society of Medical Oncology

On March 2, 2025 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported its participation in the 22nd Annual Meeting of the Japanese Society of Medical Oncology (JSMO2025) from March 6–8, 2025, in Kobe, Japan (Press release, BostonGene, MAR 2, 2025, View Source [SID1234650791]). This premier conference is dedicated to advancing precision oncology and fostering collaboration among global oncology experts.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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BostonGene will present research demonstrating how its AI-powered multiomics platform transforms cancer biology understanding and enhances treatment selection by integrating multi-scale, multi-modal data analysis.

During the event, Nathan Fowler, MD, Chief Medical Officer at BostonGene, will deliver a keynote presentation titled "Cutting Edge of Genomic Medicine and Novel Therapy in Hematologic Malignancies." Dr Fowler will highlight how BostonGene, in collaboration with renowned clinical partners, leverages multiomics techniques to identify biomarker predictors of treatment success, driving the next evolution of drug development.

Thursday, March 6 | 8:30 AM – 10:00 AM JST
Symposium 3 – Room 4
Oral presentations

Multiomic clustering of cutaneous melanoma patients to reveal survival trends based on tumor immune evasion features:

The presentation highlights BostonGene’s innovative approach of combining genomic and transcriptomic data to identify tumor immune microenvironment patterns linked to survival in patients with cutaneous melanoma.

Saturday, March 8 | 8:30 AM – 9:30 AM JST
Unraveling sarcomatoid features in clear cell renal cell carcinoma with RNA-seq:

This presentation will showcase the value of predictive modeling in developing targeted therapy to treat clear cell renal carcinoma, emphasizing BostonGene’s Tumor PortraitTM test in identifying unique and targetable clinical characteristics in cancer.

Saturday, March 8 | 8:30 AM – 9:30 AM JST
Poster presentations

Effective immune-based treatment of extraskeletal myxoid chondrosarcoma guided by next-generation gene profiling:

The presentation demonstrates cases of advanced disease with limited treatment options where BostonGene’s comprehensive genomic profiling guided targeted therapy selection.

Thursday, March 6 | 1:05 PM – 1:50 PM JST
Leveraging mappability and analysis of allele frequencies to mitigate false positive germline variant calling:

This study describes BostonGene’s advanced bioinformatic approaches to improve the reliability of germline variant detection in next-generation sequencing analysis.

Friday, March 7 | 2:05 PM – 2:50 PM JST
Evaluating the clinical utility of RNA- and DNA-based comprehensive genomic profiling in patients with advanced cancers:

This large prospective research study describes the diagnostic and clinical utility of BostonGene’s comprehensive genomic profiling in patients with advanced malignancies.

Friday, March 7 | 2:05 PM – 2:50 PM JST
Machine learning (ML)-enabled automation for high-throughput data processing in flow cytometry:

This study highlights BostonGene’s novel machine learning-based cell classification algorithm to significantly reduce turnaround time for analyzing cell populations.

Saturday, March 8 | 1:05 PM – 1:50 PM JST
For more information or to schedule a meeting with BostonGene during the event, please contact Zlata Polyakova at [email protected].

CARsgen’s Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA

On March 2, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to satricabtagene autoleucel ("satri-cel", CT041) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction cancer (G/GEJ) in patients who have failed at least two prior lines of therapy (Press release, Carsgen Therapeutics, MAR 2, 2025, View Source [SID1234650789]).

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The company plans to submit a New Drug Application (NDA) for satri-cel to the NMPA in the first half of 2025.

"We are fully committed to advancing the preparation work for the NDA submission of satri-cel. We are delighted that satri-cel has received Breakthrough Therapy Designation, which is expected to expedite its approval process and bring this therapy to patients as soon as possible," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.

About Satri-cel

Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced gastric/gastroesophageal junction cancer in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of GC/GEJ.