On May 30, 2024 Syncromune Inc., a clinical-stage biopharmaceutical company focused on the development of SYNC-T, an in situ personalized therapy platform optimized for solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SYNC-T SV-102, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer (Press release, Syncromune, MAY 30, 2024, View Source [SID1234643872]).

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"Receiving clearance of our IND is a significant milestone for Syncromune and will allow us to rapidly advance the clinical development of SYNC-T SV-102," said Syncromune’s President and CEO, Eamonn Hobbs. "This clearance, following our recent presentation at AACR (Free AACR Whitepaper) of data demonstrating unprecedented response rates, underscores the potential of SYNC-T SV-102 to change the landscape of prostate cancer treatment."

"We are thrilled to obtain clearance to advance the SYNC-T SV-102 Therapy and the company is well-positioned to achieve key program milestones," added Charles Link, M.D., Syncromune’s Executive Chairman. "The prospects of this new combination multi-target approach and its broad potential applicability in the treatment of metastatic solid tumor cancers is incredibly exciting."

The SYNC-T platform is a novel and personalized in situ therapy that uses a unique combination approach of partial tumor oncolysis and a multi-target biologic drug comprised of four active pharmaceutical ingredients (APIs). First, oncolysis is performed via freezing to disrupt a portion of a target tumor which facilitates the release of cancer-specific signals and tumor antigens, activating the immune system and creating an in situ vaccine. Next, a fixed-dose combination multi-target biologic drug, SV-102, is directly infused into the tumor site. This is intended to further stimulate the immune system and block mechanisms that suppress the immune response. The combination approach is designed to promote T cell activation and proliferation, empowering the immune system to recognize and attack patient-specific cancer throughout the body.

In a Phase 1 trial conducted in metastatic castrate-resistant prostate cancer patients, SYNC-T SV-102 demonstrated an objective response rate (ORR) of 85% with five complete responses (CRs) and six partial responses (PRs) among the 13 evaluable subjects. Notably, 54% of the subjects demonstrated complete resolution of their bone metastases. The treatment was well tolerated, with a favorable side effect profile and no significant safety concerns.

For more information about Syncromune and its ongoing clinical trials, please visit www.syncromune.com.

On May 30, 2024 Step Pharma, the global leader in CTPS1 inhibition for targeted cancer treatment, reported it has received an issue notification from the United States Patent and Trademark Office (USPTO), indicating the grant of a new US patent, and that the International Nonproprietary Names (INN) expert committee has approved the name "dencatistat" for the Company’s lead compound STP938 (Press release, Step Pharma, MAY 30, 2024, View Source [SID1234643871]).

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The patent, US Patent No 11,987,573, covers one of the key compounds within the Company’s extensive portfolio of CTPS1 inhibitor assets. This patent issue strengthens Step Pharma’s intellectual property, which is safeguarded by a range of published and unpublished patent families. Previously, the Company announced that the European Patent Office (EPO) granted patent EP3870574, which covers the same key compounds.

In addition, Step Pharma announces that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) INN expert committee has approved "dencatistat" as the nonproprietary (generic) name for the Company’s lead compound STP938. Dencatistat (STP938) is a first-in-class oral cancer therapeutic specifically inhibiting CTPS1. This compound is currently in a Phase 1/2 clinical trial to evaluate its safety, tolerability, pharmacokinetics, and preliminary efficacy in adult patients with relapsed or refractory T cell and B cell lymphomas.

On May 30, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that John Celebi, President and Chief Executive Officer, will present at the Jefferies Global Healthcare Conference, being held in New York, NY, on Thursday, June 6, 2024 at 8:30 a.m. ET (Press release, Sensei Biotherapeutics, MAY 30, 2024, View Source [SID1234643870]).

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A webcast of Sensei’s presentation will be available in the Investors section of the Sensei website. A replay of the webcast will be on the website for approximately 90 days following the event. Registration for the webcast is available here.

On May 30, 2024 Sanofi reported the completion of its acquisition of Inhibrx, Inc. ("Inhibrx") (Press release, Sanofi, MAY 30, 2024, View Source [SID1234643869]). The acquisition adds SAR447537 (formerly INBRX-101) to Sanofi’s rare disease pipeline, underscoring the company’s commitment to pursuing differentiated and potential best-in-class medicines that build upon our existing strengths and capabilities.

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SAR447537 is a human recombinant protein that holds the promise of allowing alpha-1 antitrypsin deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent (monthly vs. weekly) dosing. AATD is an inherited rare disease characterized by low levels of AAT protein, predominantly affecting the lung with progressive deterioration of the tissue. SAR447537 may help to reduce inflammation and prevent further deterioration of lung function in affected individuals.

The former holders of shares of Inhibrx common stock voted to approve the acquisition at a special meeting of stockholders on May 24, 2024. Upon the closing of the acquisition, former shareholders of Inhibrx became entitled to receive $30.00 per share in cash, which represents a total equity value of approximately $1.7 billion (on a fully diluted basis), as well as one contingent value right per share to receive $5.00 upon the achievement of a regulatory milestone.

Sanofi completed its acquisition of Inhibrx through the merger of an indirect, wholly owned subsidiary of Sanofi with and into Inhibrx, with Inhibrx continuing as the surviving corporation and becoming an indirect, wholly owned subsidiary of Sanofi.

Prior to the closing of the acquisition, Inhibrx completed the spin-off of Inhibrx Biosciences, Inc. ("Inhibrx Biosciences"), distributing 92% of Inhibrx Biosciences’s shares to holders of shares of Inhibrx common stock as of May 17, 2024. Inhibrx Biosciences, which was a wholly owned subsidiary of Inhibrx prior to the distribution, acquired all of the assets of Inhibrx not related to SAR447537, which include INBRX-109 and INBRX-1061, as well as all Inhibrx employees, pursuant to an internal reorganization. Inhibrx continues to own the remaining 8% of Inhibrix Biosciences following the completion of the transactions. Inhibrx Biosciences began trading on the NASDAQ Global Market on May 30, 2024, under the ticker "INXB" and, beginning on May 31, 2024, will trade under the ticker "INBX".

As of May 30, 2024, Inhibrx common stock will cease to be traded on the NASDAQ Global Market and will be subsequently deregistered.

Lazard acted as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP acted as its legal counsel. Centerview Partners LLC acted as exclusive financial advisor to Inhibrx and Paul, Weiss, Rifkind, Wharton and Garrison LLP served as legal counsel.

On May 30, 2024 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and CEO, will present a company overview at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 9:30 am ET in New York, NY (Press release, Rigel, MAY 30, 2024, View Source [SID1234643868]).

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To access the live webcast or archived recording, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.