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Molecure announces first patient dosed in Phase I trial with novel, first-in-class dual arginase inhibitor OATD-02 for the treatment of cancer

On March 8, 2023 Molecure S.A. ("Molecure": WSE: MOC) a clinical stage biotechnology company that uses its world leading medicinal chemistry and biology capabilities to discover and develop first in class small molecule drug candidates that directly modulate unexplored protein and RNA targets to treat multiple incurable diseases, reported that the first patient has been dosed in a Phase I trial evaluating OATD-02 as a monotherapy in cancer patients with advanced solid tumors (Press release, Molecure, MAR 8, 2023, View Source [SID1234640062]).

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The Phase I trial is an open-label, multi-center, first in human, dose escalation study to evaluate safety, tolerability, anti-cancer activity and to establish the maximum tolerated dose of OATD-02. The study is being conducted at three sites in Poland and will enroll a maximum of 40 patients with selected advanced and/or metastatic solid tumors including colorectal cancer, ovarian cancer, pancreatic cancer or renal cell carcinoma.

Marcin Szumowski, Chief Executive Officer of Molecure, said, "We are very excited to start this first in human clinical trial with OATD-02, the second candidate from Molecure’s proprietary pipeline to enter clinical development. This is another important milestone for the company and underpins our commitment to deliver novel medicines that can provide significant benefit to people suffering from advanced and/or metastatic solid tumors. We believe OATD-02 has shown a very promising pre-clinical profile, and we look forward to seeing the initial data from this first in human study in the latter part of 2023."

Dr Samson Fung, Chief Medical Officer added: "OATD-02 is the first and only dual acting arginase inhibitor in development globally to treat solid tumors. This novel drug candidate has been designed to improve treatment outcomes, including in more advanced disease, helping to restore the patient’s antitumor immune response by overcoming the immunosuppressive tumor environment. The important data emerging from this trial will help to guide future clinical development for OATD-02, which we hope will bring treatment benefits to patients with a broad range of tumors."

10-Q – Quarterly report [Sections 13 or 15(d)]

Puma Biotechnology has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

Supernus to Participate in Two Upcoming Investor Conferences

On March 8, 2023 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Supernus Pharmaceuticals management team will participate in the following March investor conferences (Press release, Supernus, MAR 8, 2023, View Source [SID1234628377]).

Barclays Global Healthcare Conference
Date: Wednesday, March 15, 2023
Place: Loews Miami Beach Hotel, Miami, Fla.

Jefferies Biotech on the Bay Summit
Date: Thursday, March 16, 2023
Place: The 1 Hotel South Beach, Miami, Fla.

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

invoX Pharma Completes Acquisition of F-star Therapeutics, Inc.

On March 8, 2023 invoX Pharma Limited ("invoX"), a U.K.-based wholly-owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK) with an advancing pipeline of innovative products, reported that it has successfully completed the acquisition of F-star Therapeutics, Inc. ("F-star") (NASDAQ:FSTX), a clinical-stage biopharmaceutical company pioneering bispecific antibodies in immunotherapy, for an aggregate cash consideration of approximately $161 million (or $7.12 per share) (Press release, InvoX Pharma, MAR 8, 2023, View Source [SID1234628367]).

F-star is currently executing Phase 2 trials in Europe and the U.S. in patients with PD-1 acquired resistant head and neck cancer, and in checkpoint inhibitor-naïve patients with non-small cell lung cancer (NSCLC) and diffuse large B-cell lymphoma (DLBCL). The Company also has further earlier clinical studies underway with patients in both geographies.

All required regulatory approvals for closing of the transaction have been obtained, including clearance from the regulatory agency in charge of enforcing the U.K.’s National Security and Investment Act and the Committee on Foreign Investment in the United States ("CFIUS").

Ben Toogood, Chief Executive Officer of invoX, commented:

"The closing of the transaction today significantly strengthens invoX’s pharmaceutical business, accelerating the build of a pipeline with a core focus on oncology and respiratory therapeutics. Most importantly, it provides the capital to ensure patients enrolled in F-star’s clinical studies will continue to have access to potentially life-saving therapies.

‘We are pleased to have reached agreement with regulators in the U.S. following substantial and thorough discussion. This clearance is a clear signal that governments recognize the importance of collaboration among trusted parties to advance patient-centered innovations in biotechnology.

‘We believe this will lay a solid foundation and understanding for our steps into the future and leaves us well positioned to continue to grow worldwide through further investment opportunities. We are also excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform."

Additional information

invoX reported the completion of the cash tender offer by its direct wholly owned subsidiary Fennec Acquisition Incorporated ("Purchaser") to purchase all of the issued and outstanding shares (each a "Share" and collectively, "Shares") of common stock of F-star for a price of $7.12 per Share net to the holder in cash, without interest, subject to any withholding of taxes required by applicable law. The tender offer expired at 5:00 p.m., Eastern Time, on March 8, 2023.

After expiration of the tender offer on March 8, 2023, invoX completed the acquisition of F-star through a merger under Section 251(h) of the General Corporation Law of the State of Delaware (the "DGCL"). Each Share issued and outstanding immediately prior to the effective time of the merger (other than Shares (i) held in the treasury of F-star or owned by invoX, Purchaser or F-star, or any direct or indirect wholly owned subsidiary thereof, immediately prior to the effective time of the merger or (ii) held by a holder who is entitled to demand and has properly demanded appraisal of such Shares in accordance with Section 262 of the DGCL) was converted into the right to receive $7.12 per Share, payable net to the holder in cash, without interest, subject to any withholding of taxes required by applicable law. As a consequence of the merger, the Shares are no longer listed on NASDAQ and will no longer be registered under the Exchange Act.

Advisors
Morgan Stanley & Co. LLC acted as financial advisor to F-star. Shearman & Sterling LLP and Milbank LLP served as legal counsel to invoX and Sino Biopharm, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. and Mills & Reeve LLP, UK served as legal counsel to F-star.

RenovoRx Phase III Open Label TIGeR-PaC Interim Analysis Shows Promising Data That Support Continued Clinical Investigation of RenovoGemTM as a Treatment Option for Locally Advanced Pancreatic Cancer

On March 8, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, reported promising interim data in the Phase III open label TIGeR-PaC clinical trial (Press release, Renovorx, MAR 8, 2023, View Source [SID1234628366]). The study is investigating the Company’s first product candidate, RenovoGem, as a potential treatment option in locally advanced pancreatic cancer ("LAPC").

The interim analysis suggests a 6-month potential improvement in median overall survival with RenovoGem, pending ongoing clinical investigation. TIGeR-PaC is a randomized multi-center Phase III open label clinical trial designed to investigate the Company’s first product candidate, RenovoGem, which utilizes RenovoRx’s proprietary therapy platform, RenovoTAMP, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat LAPC following stereotactic body radiation therapy ("SBRT"). The study compares treatment with RenovoTAMP versus standard of care systemic intravenous ("IV") administration of gemcitabine and nab-paclitaxel, which has a seven-week survival benefit and $1 billion addressable market.

This first-of-two interim analyses indicates that the TIGeR-PaC study is on track to demonstrate increased lifespan for patients being treated with RenovoGem for LAPC. Final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: this first analysis with 30% of the specified events (deaths) reported and the second analysis when 60% of the events have been reported (expected in 2024).

In this interim analysis, the control and treatment arms demonstrated divergence in median overall survival for patients. The study is designed to randomize 114 patients (57 in each arm) with all patients receiving upfront induction chemotherapy and SBRT. The TIGeR-PaC Data Monitoring Committee ("DMC") met and determined the interim data is promising and warrants continuation of this pivotal trial. As of the date of the analysis, 45 patients from U.S. sites had been randomized in this trial and the survival status of all subjects was used for the analysis.

23 patients were randomized to intra-arterial gemcitabine (RenovoGem investigational treatment) arm and 22 to continuation of IV gemcitabine and nab-paclitaxel (control or standard of care) arm. There were an equal number of primary events, 13 in each arm.
The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the intra-arterial RenovoGem arm. (NOTE: Both arms’ median overall survival calculations do not include 4 to 5-months of life since diagnosis during the induction chemotherapy and radiation phase of the trial).
Observed a positive trend in median overall survival by 24-weeks (6-months); in this interim analysis, the statistical significance was not reached to stop the study early (p=0.051).
"We are pleased with the promising readout of our study’s first interim analysis, and we extend our sincere and continued strong appreciation to all the patients, investigators, and team members involved in reaching this important milestone," said Shaun Bagai, CEO of RenovoRx. "Based on these data, we will continue our ongoing clinical trial to collect more data to support our new drug application. Our team intends to engage further with the FDA to facilitate an expeditious path forward for our treatment platform."

Bagai added, "Our mission is to transform the current standard of care for patients diagnosed with difficult-to-treat cancers, such as LAPC. The trend has been to layer additional drugs to the current standard of care that can double, triple, or quadruple, drug regimen for these patients. Our vision is to greatly improve existing treatment drugs by focusing on their targeted delivery to tumors, and, ultimately, improve quality of life and survival."

TIGeR-PaC Principal Investigator, Michael J. Pishvaian, M.D., Ph.D. at Johns Hopkins Medicine, said, "Results from the interim analysis echo those of the Phase I/II and observational studies. The data suggests that RenovoGem has the potential to enhance patient survival. This is important because treatment of locally advanced pancreatic cancer is often limited to systemic, high dose IV chemotherapy treatment, which often comes with debilitating side effects to patients."

Dr. Pishvaian added, "Importantly, these results provide hope for a potentially improved, compelling new treatment option for this important patient population. If study data continues to trend positive, the RenovoGem platform holds promise for expanding to other indications, including other cancers and/or more advanced stages of cancer."

Full data from the first interim analysis of the TIGeR-PaC study will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 17, 2023, in Orlando, Florida.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

About Locally Advanced Pancreatic Cancer (LAPC)

According to American Cancer Society’s Cancer Facts & Figures 2023, pancreatic cancer has a 5-year combined overall survival rate of 12% (Stages I-IV) and is on track to be the second leading cause of cancer-related deaths before 2030. LAPC is diagnosed when the disease has not spread far beyond pancreas, however, has advanced to the point where it cannot be surgically removed. LAPC is typically associated with patients in stage 3 of the disease as determined by the TNM (tumor, nodes and metastasis) grading system.