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Aptose to Hold Interim Clinical Update Webcast on Saturday, June 10, 2023

On May 31, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported that the company management team will provide a clinical update on Saturday, June 10, 2023, at 12:00 PM EST / 6:00 PM CEST, in conjunction with EHA (Free EHA Whitepaper) 2023 International Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Frankfurt, Germany (Press release, Aptose Biosciences, MAY 31, 2023, View Source [SID1234632297]). The webcast event will include an interim review of Aptose’s lead compound tuspetinib, a myeloid kinase inhibitor, currently being tested as a monotherapy and in combination with venetoclax in the phase 1/2 APTIVATE trial.

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Tuspetinib, administered as a once-daily oral tablet, is a precision targeted kinase inhibitor designed to suppress a select handful of kinases known to drive proliferation of acute myeloid leukemia (AML) while maintaining a favorable safety profile. Aptose management will highlight additional insights from the completed Phase 1/2 dose escalation clinical trial of tuspetinib and review early trends from the ongoing APTIVATE trial.

Aptose Clinical Update Webcast Details

Date & Time: Saturday, June 10, 2023, 12:00 PM ET

Participant Webcast Link: Link

Participant Dial-in:

Toll Free Investors Dial: 1-877-407-9039

Toll/International Investors Dial: 1-201-689-8470

Conference ID: 13739137

The slides will be available on Aptose’s website here and the webcast of the presentation will be archived shortly after the conclusion of the event.

In addition, an abstract on tuspetinib was recently published in EHA (Free EHA Whitepaper)’s open access library here:

Abstract: PB1766

Title: IN VITRO ACQUIRED RESISTANCE TO THE ORAL MYELOID KINASE INHIBITOR TUSPETINIB CREATES SYNTHETIC LETHAL VULNERABILITY TO VENETOCLAX

Session Title: Acute myeloid leukemia – Biology & Translational Research

Tuspetinib (TUS) is a once daily, oral agent that potently inhibits JAK1/2, SYK, RSK1/2, wildtype and mutant forms of FLT3, and mutant forms of KIT kinases, thereby simultaneously suppressing multiple oncogenic signaling pathways that mediate resistance to various drugs. TUS as a single agent has generated complete remissions in relapsed/refractory (R/R) acute myeloid leukemia (AML) patients with diverse mutations and demonstrated favorable safety in a Phase 1 trial (NCT03850574). TUS is now in a Phase 1/2 expansion trial (APTIVATE) for R/R AML patients with high unmet need as a monotherapy and as a doublet in combination with venetoclax. The clinical activity against diverse mutational subpopulations led us to investigate alterations in AML cells that may give rise to TUS resistance, and to understand the sensitivity of resistant isolates to venetoclax and other agents used to treat AML.

Resistance to TUS in MOLM-14 cells required prolonged high-level drug exposure, but ultimately yielded a stable phenotype. Strikingly, acquired TUS resistance generated a synthetic lethal vulnerability in which the cells were unusually hypersensitive to venetoclax. This suggests that concurrent administration of TUS and venetoclax may be advantageous clinically as TUS and venetoclax could act in concert to discourage the emergence of drug resistance during treatment.

For full published abstract, please visit: View Source

Phio Pharmaceuticals Announces $4 Million Concurrent Registered Direct Offering and Private Placement Priced At-the-Market Under Nasdaq Rules

On May 31, 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 that it has entered into definitive agreements for the issuance and sale of an aggregate of 233,646 of its shares of common stock at a purchase price of $4.28 per share in a registered direct offering (Press release, Phio Pharmaceuticals, MAY 31, 2023, View Source [SID1234632296]). In a concurrent private placement, Phio has also agreed to issue and sell an aggregate of 700,935 of its shares of common stock (or common stock equivalents), at the same purchase price of $4.28 per share (or common stock equivalent) as in the registered direct offering. In addition, the Company has agreed to issue in the offerings 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. The offerings are expected to close on or about June 2, 2023, subject to the satisfaction of customary closing conditions.

Logo – View Source

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

Each series of warrants will have an exercise price $4.03 per share and become exercisable immediately upon issuance. 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.

The gross proceeds to the Company from the concurrent offerings are expected to be approximately $4 million, before deducting the placement agent’s fees and other offering expenses payable by Phio. Phio currently intends to use the net proceeds from the offerings for the development of its immuno-oncology programs, working capital and general corporate purposes.

The shares of common stock (or common stock equivalents) 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) are being 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. The offering of the shares of common stock (or common stock equivalents) to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be 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 offer and sale of the securities in the private placement and the unregistered warrants described above are being made 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, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement, the unregistered warrants and underlying shares of common stock 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 commercially reasonable 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.

Triumvira Immunologics Highlights Positive Phase 1 Clinical Data on TAC01-HER2 in Solid Tumors at ASCO 2023 Annual Meeting

On May 31, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that positive data from its Phase I/II trial investigating the safety and efficacy of autologous TAC01-HER2 in refractory solid tumors (TACTIC-2/NCT04727151), will be presented at the 2023 American Society Of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 2-6 in Chicago (Press release, Triumvira Immunologics, MAY 31, 2023, View Source [SID1234632294]). Benjamin L. Schlechter, MD, from Harvard Medical School, and a Senior Physician in Gastrointestinal Oncology at Dana-Farber Cancer Institute, will highlight updated clinical data demonstrating the potential of TAC01-HER2 as a targeted therapy for patients who are refractory to existing HER2-targeted therapies.

"We are encouraged by the promising results from the TACTIC-2 trial, which demonstrate the safety and compelling clinical activity of autologous TAC01-HER2 in refractory solid tumors," said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "These findings suggest that TAC technology has the potential to transform the treatment landscape for patients with HER2-positive gastric and esophageal cancers, offering a novel approach that harnesses the natural biology of T cells. We look forward to further exploring the therapeutic benefits of TAC01-HER2 in the phase 2 component of the trial and advancing its development towards improving patient outcomes in this population that has been deprived of significant therapeutic progress over the last 40 years."

"The interim results from the Phase I TACTIC-02 study are very promising, demonstrating a favorable safety profile for TAC01-HER2 treatment and early signals of clinical activity," stated Dr. Benjamin Schlechter, Principal Investigator of the study. "The observed disease control rate of 83% at 3 months and impressive partial responses in advanced gastric and GEJ cancer patients highlight the therapeutic potential of TAC01-HER2. These findings warrant further investigation and hold promise for addressing the therapeutic needs of patients with HER2-positive gastric and esophageal cancers."

Key Findings

Interim results from the Phase I TACTIC-02 study suggest a highly favorable safety profile for TAC-01 HER2 treatment with the potential of being an outpatient procedure.
One DLT (dose limiting toxicities) of Grade 3 pneumonitis and one Grade 3 CRS were observed at the highest dose level, both resolved with standard of care measures, without the need for ICU admission. No neurotoxicities reported to date across all cohorts.
TAC01-HER2 demonstrated early signals of clinical activity, highlighting two partial responses (in a stage IVb gastric cancer patient and a stage IV GEJ patient, at DL 2 and 4, respectively) and a disease control rate of 67% across DL2-4.
In gastric/GEJ/esophageal cancer patients, the DCR is 83%, while the ORR is 33% across DL 2-4.
Presentation Details:

Title: A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC01-HER2 in Relapsed or Refractory Solid Tumors (TACTIC-2)
Authors: Benjamin L. Schlechter, MD, Senior Physician, Instructor in Medicine, Harvard Medical School and Attending Physician, Medical Oncology, Dana-Farber Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Poster Session Display Date and Time: 6/3/2023, 8:00 AM-11:00 AM
Poster Discussion Session Date and Time: 6/3/2023, 3:00 PM-4:30 PM
Abstract Number: 2519

Abstract titles are currently available on the ASCO (Free ASCO Whitepaper) website. A copy of the presentations will be available after the closure of the meeting, under the Presentations & Publications tab of the News & Resources section of the Company’s website.

Tempest to Present at the Jefferies Global Healthcare Conference

On May 31, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will present at the Jefferies Global Healthcare Conference on Wednesday, June 7, 2023 at 2:00 p.m. ET (Press release, Tempest Therapeutics, MAY 31, 2023, View Source [SID1234632292]).

To access the live or archived recording of the company presentation, please visit the investor section of the Tempest website at View Source

Sutro Biopharma to Participate in the Jefferies Healthcare Conference

On May 31, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that Bill Newell, Chief Executive Officer, will participate in a fireside chat at the Jefferies Healthcare Conference on Wednesday, June 7, 2023, at 4:30 p.m. ET/1:30 p.m. PT in New York City (Press release, Sutro Biopharma, MAY 31, 2023, View Source [SID1234632291]).

A webcast of the fireside chat will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. An archived replay will be available for at least 30 days after the event.