On June 2, 2023 Sanofi reported that it will present new data at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6, including an oral presentation where results will be shared for the first time of a first-in-human study of an investigational trifunctional anti-CD123 natural killer (NK) cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia (Press release, Sanofi, JUN 2, 2023, View Source [SID1234632396]).

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Peter Adamson
Global Development Head, Oncology
"The presentation of data at ASCO (Free ASCO Whitepaper) from our initial clinical trial of SAR443579, a novel NK cell engager, supports the potential of this investigational approach for patients with hematologic malignancies. At Sanofi, we are continuing to build our early oncology pipeline, which leverages leading-edge R&D platforms, to drive a range of investigational approaches for patients with difficult-to-treat cancers."

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SAR443579 for the treatment of hematological malignancies. Fast Track Designation is an FDA process designed to facilitate the development, and expedite the review of, medicines to treat serious conditions and fill unmet medical need. The FDA created this process to help deliver important new drugs to patients earlier, and it covers a broad range of serious illnesses.

Olivier Nataf
Global Head, Oncology
"Having recently joined Sanofi as Global Head, Oncology, I am looking forward to coming together with the global oncology community at ASCO (Free ASCO Whitepaper) to discuss the future of cancer treatment and latest oncology research. This year, we are focused on highlighting our pipeline and exploring new opportunities that allow us to continue helping those living with cancer. Cancer is complex and we understand that innovation does not happen in isolation, so exploring strategic partnerships and collaborations that align science and technology with evolving medical needs is essential to our journey."

Sanofi’s oncology pipeline has doubled since 2019, and we are exploring the advancement of potentially transformative therapies and focusing research on areas of high unmet needs for those living with various types of cancer.

Other Sanofi data to be presented at ASCO (Free ASCO Whitepaper) include studies in several priority areas of focus, such as relapsed multiple myeloma, advanced solid tumors and non-small cell lung cancer.

Early data for SAR443579, an investigational trifunctional anti-CD123 NK cell engager*

Abstract #7005: A first-in-human study of CD123 NK Cell Engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia or high risk-myelodysplasia

Updated results of the Phase 3 IKEMA study of Sarclisa (isatuximab) in relapsed multiple myeloma

Abstract #8029: Long-term outcomes with isatuximab-carfilzomib-dexamethasone (Isa-Kd) in relapsed multiple myeloma patients with 1q21+ status: updated results from the Phase 3 IKEMA study

Early safety results of investigational tusamitamab ravtansine in advanced solid tumors*

Abstract #e15003: Phase 1/2 study of tusamitamab ravtansine in patients with advanced solid tumors: pooled safety analysis of corneal adverse events

Analysis of extended adjuvant endocrine therapy in HR+/HER2- breast cancer

Abstract #e12509: Side effects and impacts of extended adjuvant endocrine therapy: A qualitative study among women with HR+/HER2- breast cancer

Click here to view these abstracts located in the ASCO (Free ASCO Whitepaper) Meeting Library.

*These assets are currently under investigation and their safety and efficacy has not been fully evaluated by any health authority.

On June 2, 2023 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that Angèle Maki, Ph.D., Senior Vice President, Business Development of ReCode Therapeutics, will present a company overview at 8:30 a.m. ET on Friday, June 9, 2023 at the Jefferies Healthcare Conference being held in New York, NY (Press release, ReCode Therapeutics, JUN 2, 2023, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-present-at-jefferies-healthcare-conference [SID1234632395]).

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On June 2, 2023 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the company will present a company overview at the following conferences (Press release, PTC Therapeutics, JUN 2, 2023, View Source [SID1234632394]):

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Jefferies Healthcare Conference
Wednesday, June 7 at 12:30 p.m. EDT

Goldman Sachs 44th Annual Global Healthcare Conference
Wednesday, June 14 at 1:40 p.m. EDT/10:40 a.m. PDT

The presentations will be webcast live on the Events and Presentations page under the Investor section of PTC Therapeutics’ website at View Source and will be archived for 30 days following the presentations. It is recommended that users connect to PTC’s website several minutes prior to the start of the webcast to ensure a timely connection.

On June 2, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported preliminary data from a Phase 2 clinical trial of the company’s lead therapeutic candidate, PT-112, in patients with recurrent thymic epithelial tumors (TETs), specifically thymoma and thymic carcinoma (Press release, Promontory Therapeutics, JUN 2, 2023, View Source [SID1234632393]). The trial is being conducted under formal collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health (see NCT05104736). The data were published online in an abstract for the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Based on preliminary data to date, PT-112 appears to be safe and tolerable, and clinically active in patients with recurrent TETs. The initial translational evidence of PT-112 immune activation is encouraging and supportive of further investigation," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD. "We are excited to provide a potential treatment option for patients with relapsed TETs, and are thrilled to continue our collaboration with the NCI."

The Phase 2 clinical trial with the NCI is designed to assess the safety, tolerability, and clinical activity of PT-112 in patients with thymoma and thymic carcinoma, and to explore PT-112’s ability to promote immune activation and immune cell infiltration in response to treatment, via the extensive immuno-profiling capabilities of the NCI.

Promontory is providing NCI with PT-112 drug supply and support for correlative research, and NCI is overseeing enrollment and treatment of the clinical trial’s intended 53 patients.

For more information about Promontory’s clinical trials, visit www.PromontoryTx.com.

About PT-112
PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress and the Phase 2a dose confirmation cohort in non-small cell lung cancer (NSCLC) patients was reported at ESMO (Free ESMO Whitepaper) I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal CRADA with the NCI.

On June 2, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported the closing of its previously announced registered direct offering of 233,646 shares of common stock, at a purchase price of $4.28 per share (Press release, Phio Pharmaceuticals, JUN 2, 2023, View Source [SID1234632392]). In a concurrent private placement, Phio also issued 700,935 shares of common stock (or common stock equivalents in lieu thereof), at a purchase price of $4.28 per share. In addition, the Company issued in the registered direct offering and in the concurrent private placement unregistered Series A warrants to purchase up to an aggregate of 934,581 shares of common stock and unregistered Series B warrants to purchase up to an aggregate of 934,581 shares of common stock. The registered direct offering and the private placement were priced at-the-market under Nasdaq rules.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the concurrent offerings.

Each series of warrants has an exercise price of $4.03 per share and is exercisable immediately. The Series A warrants have a term of five and one-half years from the date of issuance and the Series B warrants have a term of eighteen months from the date of issuance.

Gross proceeds to the Company from the concurrent offerings are approximately $4.0 million, before deducting the placement agent’s fees and other offering expenses payable by Phio. Phio intends to use the net proceeds from the offering for the development of its immuno-oncology programs, working capital and general corporate purposes.

The shares of common stock offered in the registered direct offering (but excluding the securities offered in the private placement and the shares of common stock underlying the unregistered warrants issued in the registered direct offering) were offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-256100), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on May 13, 2021 and declared effective by the SEC on May 21, 2021. A final prospectus supplement and an accompanying base prospectus relating to the shares of common stock offered in the registered direct offering were filed with the SEC and are available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The securities in the concurrent private placement described above were offered in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying the unregistered warrants in the concurrent private placement, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the concurrent private placement and the shares of common stock underlying the unregistered warrants in the concurrent private placement may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

Phio has agreed to file an initial registration statement with the SEC covering the resale of the securities to be issued in the private placement no later than 10 days following May 31, 2023 and to use its best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 70 days after May 31, 2023 in the event of a "full review" by the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.