On October 4, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing therapies that target families of oncogenic mutations in patients with genetically defined cancers, reported forthcoming presentations during the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, October 11-15, 2023 (Press release, Black Diamond Therapeutics, OCT 4, 2023, View Source [SID1234635636]). The three poster presentations include initial dose escalation data from the Company’s Phase 1 clinical trial of BDTX-1535 in non-small cell lung cancer (NSCLC), the study design of this ongoing Phase 1 clinical trial, and preclinical data for BDTX-4933.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details for the presentations are as follows:

Title: Phase 1 Study of BDTX-1535, an Oral 4th Generation EGFR Inhibitor, in Patients with NSCLC and
GBM: Preliminary Dose Escalation Results
Speaker: Helena Yu, M.D., Associate Attending Physician, Memorial Sloan Kettering Cancer Center
Time: Poster Session C, Saturday, October 14, 12:30 pm-4:00 pm
Location/Poster #: Level 2, Exhibit Hall D, #C022

Title: A Phase 1 Study to Assess BDTX-1535, an Oral 4th Generation EGFR Inhibitor, in Patients with NSCLC and GBM
Speaker: Helena Yu, M.D., Associate Attending Physician, Memorial Sloan Kettering Cancer Center
Time: Poster Session C, Saturday, October 14, 12:30 pm-4:00 pm
Location/Poster #: Level 2, Exhibit Hall D, #C036

Title: Preclinical Efficacy of BDTX-4933, a Brain-penetrant, Orthosteric RAF Inhibitor, Targeting Oncogenic RAF Conformation Shared by Groups of BRAF and Upstream Driver Mutations
Speaker: Elizabeth Buck, Ph.D., Chief Scientific Officer, Black Diamond Therapeutics
Time: Poster Session A, Thursday, October 12, 12:30 pm-4:00 pm
Location/Poster #: Level 2, Exhibit Hall D, #A090

About BDTX-1535
BDTX-1535 is a brain-penetrant and potent MasterKey inhibitor of oncogenic mutations of epidermal growth factor receptor (EGFR) in non-small cell lung cancer (NSCLC), including families of intrinsic driver mutations and acquired resistance C797S mutation that result post-treatment with osimertinib. While current treatments for NSCLC target singular mutations, BDTX-1535 has the potential to address approximately 50 different mutations across a diverse group of patients in multiple lines of therapy. BDTX-1535 also has the potential to treat patients with glioblastoma multiforme (GBM) expressing EGFR alterations. The ongoing BDTX-1535 Phase 1 clinical trial is currently in dose expansion for NSCLC and dose escalation for GBM.

On October 4, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the compensation committee of BioCryst’s board of directors granted 23 newly-hired employees stock options to purchase an aggregate of 128,800 shares, and restricted stock units (RSUs) covering an aggregate of 88,650 shares, of BioCryst common stock (Press release, BioCryst Pharmaceuticals, OCT 4, 2023, View Source [SID1234635635]). The options and RSUs were granted as of September 29, 2023, as inducements material to each employee entering into employment with BioCryst. The options and RSUs were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The options have an exercise price of $7.08 per share, which is equal to the closing price of BioCryst common stock on the grant date. The options and RSUs vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee’s continued service with the company. Each stock option has a 10-year term. The options and RSUs are subject to the terms and conditions of BioCryst’s Inducement Equity Incentive Plan and a stock option agreement or restricted stock unit agreement, as applicable, covering the grant.

On October 4, 2023 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, reported the presentation of encouraging pharmacodynamic data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers (Press release, Aulos Bioscience, OCT 4, 2023, View Source [SID1234635634]). The new data will be featured at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 11-15, 2023, in Boston, Massachusetts.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The Phase 1 dose escalation data for our lead candidate, AU-007, builds upon the favorable safety profile data shared during ASCO (Free ASCO Whitepaper) earlier this year," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "We’re extremely encouraged by these latest data. In assessing the biological activity of AU-007 alone or with low dose, subcutaneous aldesleukin in patients with advanced solid tumor cancers, data show a reduction in the circulating cell counts of patients’ regulatory T cells, which suppress the immune system, as well as eosinophils, which at high cell counts can be associated with toxicity in the lungs. At the same time, the data demonstrate an overall trend in increasing natural killer cells and effector T cells that can kill tumor cells. These insights underscore that AU-007, the first human monoclonal antibody designed using artificial intelligence to be tested in a clinical trial, has a unique mechanism of action that enables it to bind to IL-2, rather than IL-2 receptors, with exquisite precision. Our new data confirm that by binding only to the portion of IL-2 that binds to CD25, AU-007 accurately redirects IL-2 away from high-affinity IL-2 receptors on immunosuppressive regulatory T cells and eosinophils to medium-affinity receptors on natural killer cells and effector T cells. No other IL-2 therapy in development exhibits these capabilities. We look forward to presenting further details at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference."

Details of the poster presentation are as follows:

Poster Number and Title: C033: Preliminary pharmacodynamic evaluation of AU-007 in phase 1 dose escalation trial in patients with advanced solid tumors

Abstract: 35393

Session: Poster Session C

Session Date and Time: Saturday, October 14, 2023, 12:30-4:00 p.m. EDT

The poster will be presented in Level 2, Exhibit Hall D at the John B. Hynes Veterans Memorial Convention Center (Hynes Convention Center).

About AU-007

AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the AU-007 Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On October 3, 2023 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported that it has commenced an underwritten public offering of its common stock and pre-funded warrants (Press release, ALX Oncology, OCT 4, 2023, View Source [SID1234635633]). All shares of common stock and pre-funded warrants in this offering will be sold by ALX Oncology. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. ALX Oncology intends to use the net proceeds from the offering to fund ongoing development of evorpacept, including clinical trials targeting market expansion, and for working capital and general corporate purposes. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public offering, including shares of common stock underlying the pre-funded warrants.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Piper Sandler and Cantor are acting as the joint book-running managers for the proposed offering.

The securities described above are being offered by ALX Oncology pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On October 4, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported the National Institutes of Health (NIH) awarded Actinium a Small Business Technology Transfer grant extension to support its clinical collaboration with Memorial Sloan Kettering Cancer Center (MSK) to study Iomab-ACT, Actinium’s CD45-targeting radiotherapeutic, for targeted conditioning to achieve lymphodepletion therapy along with the reduction of cytokine release syndrome and neurotoxicity prior to administration of a CD19-targeted CAR-T cell therapy developed at MSK (Press release, Actinium Pharmaceuticals, OCT 4, 2023, View Source [SID1234635632]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Iomab-ACT has the potential to significantly improve the patient journey and increase patient access to revolutionary therapies like cellular and gene therapies by eliminating or reducing the need for non-targeted chemotherapy," said Sandesh Seth, Chairman and Chief Executive Officer. "We are grateful to have been awarded the extension of this NIH grant, which will fund the advancement of this important clinical collaboration."

Iomab-ACT is a next-generation, CD45-targeted conditioning agent intended to enable either lymphodepletion or reduced intensity conditioning prior to CAR-T and gene therapies with multi-indication potential. Iomab-ACT has the potential to reduce toxicities and improve patient outcomes when paired with MSK’s CD19 CAR-T cell therapy in difficult to treat relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and diffuse large B cell lymphoma (DLBCL). This grant will advance the ongoing study of Iomab-ACT for patients with relapsed or refractory B-ALL or DLBCL.