On April 20, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported completion of the safety evaluation stage of the highest dose cohort of patients with acute myeloid leukemia (AML) who relapsed after or were refractory to available antileukemic therapies in its Phase 1 dose escalation clinical trial of GFH009 (Press release, Sellas Life Sciences, APR 20, 2023, View Source [SID1234630356]). No further dose escalations are planned in the AML group, while dose escalation continues in the lymphoma group with the addition of a 75 mg once-a-week dose cohort, which is planned to be the highest dose level for that group.

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"We are very encouraged by the strong efficacy signals and safety profile of our highly selective CDK9 inhibitor, GFH009, observed in this positive Phase 1 trial. We believe GFH009 could have the potential to address a major unmet medical need of patients with AML who relapse following treatment," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO of SELLAS. "We are highly motivated to expedite advancement of GFH009 with our upcoming Phase 2a trial, in order to potentially bring this novel treatment to AML patients who need it as quickly as possible."

"I am very much looking forward to participation in the Phase 2a clinical trial of GFH009," said M. Yair Levy, MD, the Director of Hematologic Malignancies research at Texas Oncology Baylor Charles A. Simmons Cancer Center in Dallas, TX. "Although venetoclax is a backbone of many AML treatments, some patients do not respond to treatment and many relapse after initial response. CDK9 inhibition in general, and GFH009 in particular with the AML data seen thus far, has a strong biological basis of synergy with the BCL2 inhibitor venetoclax and we hope that it may overcome leukemic cell resistance in the upcoming trial, given that it appears that MCL-1 upregulation plays a key role in developing venetoclax resistance and we have seen in the Phase 1 trial that GFH009 decreases MCL-1 levels."

The Company is finalizing the comprehensive data analysis to determine the recommended Phase 2 dose (RP2D) in AML, which will be announced following review by the U.S. Food and Drug Administration (FDA). SELLAS plans to commence a Phase 2a clinical trial during the second quarter of 2023 with GFH009 in combination with venetoclax and azacitidine (aza/ven) in patients with AML who relapsed after or are refractory to treatment with venetoclax based therapies. The trial will be a single arm open label dose ranging study with one dose level at the RP2D and one dose below RP2D. Primary endpoints will be complete response composite (CRc) rate and safety, and secondary endpoints will include duration of response (DOR), event free survival (EFS), overall survival (OS) and proportion of patients proceeding to transplant. The trial will include several sites in the United States, will initially enroll approximately 20 patients and, based on initial results, may be expanded into a registrational trial. Topline data from this study are expected in the fourth quarter of 2023.

Phase 1 results from the AML group :

In the Phase 1 trial, the AML group included dose levels of 9 mg, 15 mg, 22.5 mg, 30 mg, 40 mg, 45 mg and 60 mg. Dose levels of 9 mg to 40 mg were administered two times per week and dose levels of 30 mg, 45 mg and 60 mg were administered once a week.

Anti-tumor activity has been observed in both the AML and lymphoma groups in the Phase 1 trial at multiple dose levels, including a complete response, partial responses, stable disease, and decreases in tumor burden. GFH009 continued to be safe and well tolerated at all dose levels, with no dose limiting toxicities and no significant off target toxicities observed. Due to the encouraging safety profile, the maximum tolerated dose level has not been reached.

In the AML group, no further dose escalation is planned as all Phase 1 trial objectives in AML have been successfully met and results are summarized below:

Clinical efficacy was demonstrated with a complete response achieved at an intermediate dose level
Biological efficacy was observed with 50% or more decrease in leukemic cell blasts in bone marrow at multiple dose levels and 75% bone marrow blasts decrease at the highest studied dose level
Pharmacokinetics above IC90 in peripheral blood was maintained for 24 hours at target dose level
IC90 plus concentrations in peripheral blood were achieved after first infusion with once-a-week administration at the highest studied dose level
Pharmacodynamics representing consistent and dose related decrease in MCL1 and MYC biomarkers expression
Phase 2a trial in combination with aza/ven in patients with AML :

Disease relapse in patients with AML after initial response to aza/ven is a major unmet medical need with median overall survival of only 2.5 months. While the aza/ven regimen is a backbone of AML treatment, approximately one-third of patients do not respond to treatment and almost all patients who initially respond eventually relapse.

Based on the available Phase 1 data, the Phase 2a trial design will be submitted to the FDA by the end of the month. GFH009 will be studied in the Phase 2a trial in combination with aza/ven in patients relapsed after or refractory to venetoclax based therapies and will be based on the parameters discussed with the FDA. The study regimen is designed based on clinical data that showed efficacy in patients relapsing after aza/ven induced complete responses, preclinical in vivo data that demonstrated high levels of synergy of GFH009 and venetoclax in mouse models of AML, and in vitro biological synergies between BCL2 and MCL1 inhibition and AML cells dependence on MCL1 and BCL2. In addition, a significant proportion of patients with AML exhibit MYC dependence.

On April 20, 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 353,983 shares of common stock, at a purchase price of $5.65 per share, priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, APR 20, 2023, View Source [SID1234630354]). In a concurrent private placement, Phio also issued to the investors unregistered Series A warrants to purchase up to an aggregate of 353,983 shares of common stock and unregistered Series B warrants to purchase up to an aggregate of 353,983 shares of common stock.

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

Each series of warrants has an exercise price of $5.40 per share and are 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 offering are approximately $2.0 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 (but excluding the unregistered warrants issued in the concurrent private placement and the shares of common stock underlying such unregistered warrants) 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 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 unregistered warrants 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 such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, 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.

In connection with the offering, the Company amended certain existing warrants to purchase up to an aggregate of 191,619 shares of the Company’s common stock that were previously issued in April 2018 through January 2021 at exercise prices ranging from $26.52 to $2,079.00, such that each of the amended warrants have an exercise price of $5.40 per share, at an additional offering price of $0.125 per amended warrant.

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.

On April 20, 2023 Kineta, Inc. (Nasdaq: KA) (the "Company" or "Kineta"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that it has entered into a definitive agreement for the purchase and sale of 1,425,179 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at a purchase price of $4.21 per share of common stock (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Kineta, APR 20, 2023, View Source;utm_medium=rss&utm_campaign=kineta-inc-announces-6-million-registered-direct-offering-priced-at-the-market-under-nasdaq-rules [SID1234630353]). In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 1,425,179 shares of common stock with an exercise price of $4.08 per share which will be immediately exercisable for a period of five years following issuance. The closing of the offering is expected to occur on or about April 24, 2023, subject to the satisfaction of customary closing conditions.

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

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $6 million. The Company intends to use the net proceeds from this offering for working capital purposes.

The shares of common stock, pre-funded warrants and shares of common stock underlying the pre-funded warrants (but not the warrants or the shares of common stock underlying the warrants) described above are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-269340), previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on January 30, 2023. The offering of the shares of common stock and pre-funded warrants is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement, when available, may be obtained on the SEC’s website at View Source and 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 warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold 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.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

On April 20, 2023 ISA reported that it will be participating and presenting in person, at the following scientific and business conferences in May and June of 2023 (Press release, ISA Pharmaceuticals, APR 20, 2023, View Source [SID1234630352]).

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ISA’s versatile synthetic long peptide (SLP) immunotherapy platform is yielding multiple, highly promising clinical stage immunotherapeutics for the treatment of different cancer types and infectious diseases. It has demonstrated to be best-in-class technology to strongly and specifically activate the human immune system. SLP immunotherapeutics have been tested in multiple human clinical proof-of-concept and phase 2 trials, both as monotherapies and in combination with checkpoint inhibitors or standard-of-care chemotherapy.

LSX World Congress

Date: 3-4 May 2023, London, UK

Attending: Gerben Moolhuizen

CIMT 2023

Date: 3-5 May 2023, Mainz, Germany

Poster presentation to be announced

Attending: Esmé van der Gracht

Bio€quity Europe

Date: 14-16 May 2023, Dublin, Ireland

Company Presentation by: Gerben Moolhuizen

Attending: Gerben Moolhuizen, Anton Mat

ASCO Annual Meeting

Date: 2-6 June 2023, Boston, US

Poster presentation to be announced

Attending: Gerben Moolhuizen, Cornelis (Kees) Melief, Leon Hooftman

BIO International Convention

Date: 5-8 June, Boston, US

Attending: Anton Mat

EASL Congress

Date: 21-24 June 2023, Vienna, Austria

Attending: Anton Mat

If you would like to meet with the ISA Pharmaceuticals team at any of the above events, please contact us at [email protected]. For more information.

On April 20, 2023 Geron Corporation (Nasdaq: GERN) reported that it has granted non-statutory stock options to purchase an aggregate of 1,684,220 shares of Geron common stock as inducements to newly hired employees in connection with commencement of employment with the Company (Press release, Geron, APR 20, 2023, View Source [SID1234630350]).

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The stock options were granted on April 19, 2023 at an exercise price of $2.49 per share, which is equal to the closing price of Geron common stock on the date of grant. Stock options representing an aggregate of 1,586,000 shares have a 10-year term and vest over four years, with 12.5% of the shares underlying the options vesting on the six-month anniversary of commencement of employment for the respective employees and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Stock options representing an aggregate of 98,220 shares have a 10-year term and vest in full upon achievement of certain regulatory milestones, subject to continued employment with Geron through the applicable vesting dates. All of the stock options were granted as material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the stock option agreements covering the grants and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.