On June 2, 2022 A scientific team, led by the scientific founders of EtiraRx, reported that it has identified a small molecule, ERX-41, as a novel oral therapeutic agent that may have utility in treating multiple solid cancers, including triple negative breast cancer, glioblastoma, ovarian and pancreatic cancers (Press release, EtiraRx, JUN 2, 2022, View Source [SID1234616455]). EtiraRx, headquartered in Biolabs Pegasus Park, plans to initiate clinical trials as early as the first quarter of 2023.

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In the work, published in Nature Cancer, the researchers, led by Drs. Jung-Mo Ahn, Ganesh Raj and Ratna Vadlamudi, identified that ERX-41 dramatically enhances endoplasmic reticulum (ER) stress in cancer cells. Since aggressive cancer cells have higher basal levels of ER stress, the enhanced ER stress induced by ERX-41 is not compensated and causes cancer cell death. Normal cells have low basal of ER stress, can compensate for ERX-41 activity and do not undergo cell death after ERX-41 treatment. Using state-of-the-art molecular approaches, the team identified that the molecular target of ERX-41 is the protein encoded by the lysosomal acid lipase A (LIPA) gene and that pharmacologic inhibition of LIPA by ERX-41 enhances ER stress in cancer cells. The study set the foundation for clinical trials with patients with therapy-resistant cancers that are vulnerable to enhanced ER stress.

Said Dr. Raj, "These discoveries are exciting as they represent a novel approach to targeting the Achilles heel of many aggressive cancers- their vulnerability to enhanced ER stress. Our critical finding was that of a new therapeutic target (LIPA) and its undiscovered role in protein folding. By targeting LIPA with ERX-41, protein folding in the cancer cell was disrupted, causing ER stress and promoting cancer cell death. Our findings indicate the potential for an oral agent with a favorable therapeutic index to effectively treat patients with aggressive cancers, for whom options are limited."

EtiraRx is completing necessary preclinical studies and plans to initiate clinical trials with these compounds, which will take place the first quarter of 2023. Russell Hayward, CEO EtiraRx, said, "ERX-41 has the potential to be a first-in-class oral therapy that kills aggressive therapy-resistant cancers. We are committed to moving these drugs forward to clinical trials and make a difference in the lives of patients with lethal cancers."

On June 2, 2022 CEO Lisa S. Park and COO Michael J. Kim reported that have purchased additional shares in Prestige Biopharma and Prestige Biologics to stabilize stock prices of the two companies (Press release, Prestige BioPharma, JUN 2, 2022, View Source [SID1234616245]). Through Mason Partners, a joint investment company established by CEO Park and COO Kim, the two executive directors bought 137,420 shares of Prestige BioPharma’s stock. In addition, CEO Park and COO Kim bought 19,337 shares and 19,301 shares of Prestige Biologics’ stock respectively. Including the KRW 2 billion stock purchase previously announced on May 23, the two executive directors have purchased KRW 4 billion stock in total so far, and will consider further action to protect the market value of their companies.

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"We are confident with the value of our business and have been putting strenuous efforts towards the development and commercialization of our pipelines. The recent fall in stock price doesn’t reflect the potential value of our companies. We hope the in-house purchase would be a positive signal to the shareholders and help recover our market value. Prestige Biopharma and Prestige Biologics will continue to do the utmost to enhance future values," said Dr. Lisa S. Park, CEO of Prestige Biopharma.

Prestige BioPharma has requested European Medicines Agency (EMA) for re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin biosimilar HD201. The result is expected to be announced after 120 days. Prestige Biologics is strengthening its business as a global CDMO utilizing its state-of-the-art facilities and patented technologies.

On June 2, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the Company’s participation in the following upcoming investor and industry conferences to be held in June 2022 (Press release, Genprex, JUN 2, 2022, View Source [SID1234615486]).

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Event: LD Micro Invitational

Virtual Presentation Date: Available on-demand within the virtual platform for all delegates beginning June 8 at 4:00 p.m. PT

Presenter: Ryan Confer, Genprex’s Chief Financial Officer

A recording of this presentation will be available for replay on Genprex’s website for a period of time.

Event: BIO International Convention

On June 2, 2022 Aptose Biosciences, Inc. (NASDAQ: APTO, TSX: APS), reported that in the section of updated clinical findings with HM43239, the fifth bullet point should read "Eight total responses, including seven CRs and one PR, and favorable safety achieved at three separate dose levels (80 mg, 120 mg, 160 mg)" (Press release, Aptose Biosciences, JUN 2, 2022, View Source [SID1234615524]). The corrected release follows:

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Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today released highlights from a key opinion leader (KOL) and corporate update event held today, June 2, 2022. The event included an up-to-date review of clinical data for Aptose’s two investigational products under development for hematologic malignancies: HM43239, an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory B-cell malignancies, and in a separate Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

Guest KOLs included Brian Druker, M.D., of the Oregon Health & Science University, Naval G. Daver, M.D., of The University of Texas MD Anderson Cancer Center, and Brian Andrew Jonas, M.D., Ph.D., of the University of California, Davis, Comprehensive Cancer Center, who discussed the current treatment landscape and unmet medical need in treating patients with acute myeloid leukemia (AML), as well as their experiences with Aptose’s investigational therapies.

The webcast of the presentation, including the Q&A with the guest KOLs, is available on Aptose’s website here.

Aptose provided updated clinical findings with HM43239, a potent suppressor of FLT3, SYK, JAK 1/2 and mutant forms of cKIT kinases operative in AML:

Clinically validated in a highly diverse set of relapsed/refractory (R/R) AML patients
Fast Track Designation supported by multiple complete remissions (CRs) in FLT3-mutant refractory R/R AML, including those who failed prior therapy with other FLT3 inhibitors
New CRi at 160 mg dose in a R/R AML patient with wildtype FLT3 and other adverse mutations
Patient with CRi at 120 mg dose bridged to hematopoietic stem cell transplantation
Eight total responses, including seven CRs and one PR, and favorable safety achieved at three separate dose levels (80 mg, 120 mg, 160 mg)
One DLT of muscle weakness (not rhabdomyolysis) reported at 200 mg
Three separate doses (80 mg, 120 mg, 160 mg) selected for Expansion Clinical Trials
Single agent Expansion Clinical Trials in FLT3-mutated and FLT3-unmutated AML expected to begin in the second half of 2022
Combination (HM43239 with venetoclax) Expansion Clinical Trials in FLT3-mutated and FLT3-unmutated AML expected to begin in the first half of 2023
Aptose also reviewed clinical findings with the new G3 formulation of luxeptinib (Lux):

G3 formulation was designed to increase plasma exposure and lower pill burden
Patients already administered G3 formulation at 50 mg, 100 mg and 200 mg
G3 formulation is being tested in patients with R/R B-cell malignancies and R/R AML
G3 formulation encouraging with rapid absorption and exposures maintained over 3 days
Plan transition from G1 to G3 continuous dosing if PK modeling studies are supportive
"We’re pleased to announce a new complete remission (CRi) today with HM43239 in a relapsed AML patient with wildtype FLT3 and mutations in diverse genes (RAS, BCOR, U2AF1, SETBP1), expanding the genotypes and R/R AML patient population that may respond to this drug that has thus far been generally well tolerated," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We’ve identified three doses and target patient populations for our next stage of Expansion Clinical Trials with HM43239, as we move along a pathway toward registrational studies. For Lux, our new G3 formulation appears to be significantly better absorbed than the original formulation and we continue to believe in its potential as a unique dual lymphoid and myeloid kinome inhibitor."

On June 2, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that members of its senior management team will participate in a fireside chat at the Jefferies Healthcare Conference on Wednesday June 8, 2022 at 8:30 AM ET (Press release, Prothena, JUN 2, 2022, View Source [SID1234615523]).

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A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.