On February 13, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the presentation of updated results from its ongoing Phase 1b/2 trial of batiraxcept in clear cell renal cell carcinoma (ccRCC) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place February 16-18, 2023 in San Francisco and virtually (Press release, Aravive, FEB 13, 2023, View Source [SID1234627113]). The poster presentation will highlight updated results from the Phase 1b portion of the trial in 26 patients with advanced or metastatic ccRCC who have progressed after 1 or 2 prior lines of immuno-oncology (IO)- and vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI)-based therapies.

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"We are pleased at the opportunity to present updated results from our Phase 1b trial of batiraxcept in ccRCC patients at this year’s ASCO (Free ASCO Whitepaper) GU meeting," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "Batiraxcept in combination with cabozantinib in ccRCC patients who have already received IO and VEGF-TKI treatment continues to yield highly encouraging results. Treatment is ongoing in the Phase 1b portion of the trial, and Phase 2 enrollment has been completed. We look forward to providing additional updates on this program throughout 2023."

"We continue to be encouraged by the safety and clinical activity observed in the Phase 1b trial of batiraxcept in patients with ccRCC," said Neil J. Shah, MBBS, Medical Oncologist, Memorial Sloan Kettering Cancer Center. "In addition to promising overall response rate and progression free survival data, baseline biomarker analysis may play a critical role in predicting response and will be further assessed throughout the Phase 2 and 3 trials. Importantly, the updated data continue to indicate the significant potential impact that dual AXL and VEGF inhibition by batiraxcept plus cabozantinib may have in patients who have failed prior VEGF-TKI treatments. Taken together, these findings remain promising and suggest that batiraxcept may serve as a much-needed treatment option for ccRCC patients on their second or later line of therapy."

Poster Presentation Details:

Title: A phase 1b/2 study of batiraxcept (AVB-S6-500) in combination with cabozantinib in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC)
Abstract Number: 666
Presenter: Neil Shah, MBBS
Session: Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers
Date/Time: Saturday, February 18, 2023; 7:00 AM – 8:00 AM; 12:30 PM – 2:00 PM PST
Location: Level 1 West Hall, Moscone West, San Francisco, CA and Virtual
As of January 17, 2023, safety, pharmacokinetics (PK), and pharmacodynamics (PD), and clinical activity of 15 mg/kg and 20 mg/kg batiraxcept in combination with 60 mg cabozantinib were evaluated in 26 patients with 2L+ ccRCC. Results highlighted in the poster include:

Batiraxcept in combination with 60 mg cabozantinib has a manageable safety profile in previously treated ccRCC; a similar safety profile was observed across the 15 mg/kg and 20 mg/kg dose cohorts.
No dose limiting toxicities were observed at either dose of batiraxcept.
A minimally efficacious concentration (MEC) of batiraxcept was determined to be > 12.2 mg/L, of which 19/26 patients achieved during Cycle 1, with no difference between 15 mg/kg and 20 mg/kg dose cohorts.
85% of patients (22/26) had a reduction in target lesions at the 8-week response assessment.
58% (15/26) of total population achieved a better response on batiraxcept plus cabozantinib than they did on prior therapy.
Best overall response of partial response was observed in 42% (11/26) of the overall population, 57% (8/14) of the prior VEGF-TKI-treated group and 55% (11/20) of the biomarker high (sAXL/GAS6) group.
9-month progression free survival (PFS) rate was 65% in the overall population, 69% in the biomarker high group (n=20) and 75% in the prior VEGF-TKI, biomarker high group (n=11).
Safety, PK/PD, and clinical activity results support a recommended Phase 2 dose of 15 mg/kg.
Batiraxcept was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced or metastatic ccRCC who have progressed after 1 or 2 prior lines of systemic therapy, including both IO-based and VEGF-TKI-based therapies (either in combination or sequentially). Fast Track Designation was based on data submitted to the agency from 26 patients treated with 15 mg/kg or 20 mg/kg batiraxcept plus 60 mg cabozantinib in the Phase 1b ccRCC study as of September 26, 2022. Results showed no dose limiting toxicities at either dose of batiraxcept. In addition, data demonstrated clinical activity of batiraxcept plus cabozantinib in patients with metastatic ccRCC, with an objective response rate (ORR) of 57% and median PFS of 11.4 months in this population (n=14/26).

On February 13, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE) (the "Company"), a biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported a one-for-twenty reverse stock split of the Company’s common stock, par value $0.001, which became effective at 5:00 pm Eastern Time on February 10, 2023 (Press release, Aprea, FEB 13, 2023, View Source [SID1234627112]). The Company’s common stock will trade on the Nasdaq Global Select Market on a split-adjusted basis beginning on February 13, 2023, under the Company’s existing trading symbol "APRE".

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The Company is implementing the reverse stock split as planned to increase the per share price of its common stock to regain compliance with the listing requirements of the Nasdaq Global Select Market. The reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 53,631,405 to approximately 2,681,570. There will be no change to the number of authorized shares or the par value per share. The new CUSIP number following the reverse stock split will be 03836J201.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage ownership interest in the Company, except to the extent that the reverse stock split results in any of the Company’s stockholders owning a fractional share. No fractional shares will be issued in connection with the reverse stock split. Following the completion of the reverse stock split, the Company’s exchange agent will aggregate all fractional shares that otherwise would have been issued as a result of the Reverse Stock Split and those shares will be sold into the market. Stockholders who would otherwise hold a fractional share of common stock will receive a cash payment from the proceeds of that sale in lieu of such fractional share.

As of the effective date of the reverse stock split, the number of shares of common stock available for issuance under the Company’s equity incentive plans and issuable upon the exercise of stock options and restricted stock units outstanding immediately prior to the reverse stock split will be proportionately affected by the reverse stock split. The exercise prices of the Company’s outstanding options will be adjusted in accordance with their respective terms.

Computershare Trust Co., N.A. ("Computershare") is acting as the exchange agent for the reverse stock split and will provide notice and instructions to stockholders of record regarding the reverse stock split. Computershare will be issuing, automatically and without the need for stockholder action, all of the post-split shares in paperless, "book-entry" form, and Computershare will hold the shares in an account set up for each respective stockholder. Stockholders who currently hold certificates will need to exchange their certificates to receive their "book-entry" accounts at Computershare. Those stockholders holding common stock in "street name" will receive instructions from their brokers.

On February 13, 2023 AnPac Bio-Medical Science Co., Ltd. (the "Company") (NASDAQ: ANPC), a company with operations in the United States and China reported that on February 13, 2023, the Company, through its subsidiary Foodbase Group Inc., entered into a definitive equity purchase agreement to acquire a group of affiliated companies, SLV Windfall Group LLC, Windfall SLV Development LLC and SLV Windfall Management, LLC, which are engaged in developing, marketing and selling real estate in Savannah Lakes Village, a planned community located in McCormick County, South Carolina (Press release, Anpac Bio, FEB 13, 2023, View Source [SID1234627111]). SLV Windfall Group LLC currently owns a few dozen buildable lots, approximately 500 acres of undeveloped land for future development projects, and has secured the exclusive right to purchase on favorable terms from the local land authorities over 2,000 buildable lot. Savannah Lakes Village is a well-developed community which has been in existence for more than 30 years. The Company plans to file the necessary applications to qualify the land development at Savannah Lakes Village as a U.S. EB-5 immigration investment project.

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Pursuant to the equity purchase agreement, the Company agreed to purchase 100% of the issued and outstanding equity interests of the affiliated companies for an aggregate consideration of $28,000,000, payable in the form of cash in four installment payments pursuant to a payment schedule based on milestone events. The initial closing of the transaction is expected to take place in the second quarter of 2023.

Mr. Haohan Xu, the Co-CEO of the Company commented, "We believe this acquisition will expand the scope of our operations meaningfully and bring significant value to our shareholders. We are in the process of acquiring some business-to-business e-commerce food businesses. The acquisition of the SLV project will potentially give the Company an opportunity to use the 500 acres of undeveloped land to build low costs smart food warehouse and distribution centers. We also plan to build and sell residential properties with great profit potential, thanks to the favorable terms granted by the local land authorities and use the profits generated from the sale of these residential properties to fund the construction of the smart food warehouse and distribution centers."

About SLV Windfall Group LLC

SLV Windfall Group LLC, a Delaware limited liability company headquartered in South Carolina, currently owns a few dozens of buildable lots, approximately 500 acres of undeveloped land for future development projects, and has secured the exclusive right to purchase on favorable terms from the local land authorities over 2,000 buildable lot, located in the Savannah Lakes Village of McCormick County in South Carolina. The Savannah Lakes Village is a lakefront community spread over 4,300 acres and wrapped around a massive 71,000-acre waterside and forest. The community has been well developed for more than 30 years, with 90 miles of finished roads and all types of public infrastructure, including water supply, sewers, cable and high-speed internet. The fully constructed infrastructure and utilities are currently estimated to have a value of $350 million.

On February 13, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported the following topline results from its MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, FEB 13, 2023, View Source [SID1234627110]). The final MB-105 results align with the overall safety profile of Annamycin and observations made in previously completed and ongoing clinical studies evaluating Annamycin. Additionally in the last cohort where all subjects were at least 60 years of age, Annamycin demonstrated an overall response rate (ORR) of 80%.

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"We are very pleased with these topline results, both in terms of safety and the initial data suggesting efficacy," said Moleculin Chairman and CEO Walter Klemp, "especially since these patients were relapsed or refractory." Mr. Klemp continued, "Given the recently published research showing that Annamycin in combination with Cytarabine substantially outperformed Annamycin as a single agent in an aggressive AML mouse model, these topline results are encouraging as we continue to develop Annamycin in combination with Cytarabine for the treatment of AML. Having previously announced the start of our open label MB-106 trial of Annamycin in combination with Cytarabine for the treatment of AML Phase 1/2 trial in Poland and Italy, we are optimistic about Annamycin’s potential for the treatment of AML, as we continue to gather the data that ultimately will be necessary to support approval."

"We also are encouraged by the absence of cardiotoxicity with Annamycin to date," Mr. Klemp added. "This is particularly relevant in light of a recently published retrospective study showing that the incidence of heart failure more than doubles for cancer patients treated with anthracyclines compared to cancer patients not receiving anthracyclines.1 Annamycin was designed to be non-cardiotoxic, and we believe the initial safety data, if replicated along with efficacy data as our development work continues, suggest an opportunity for Annamycin to become a preferred anthracycline treatment for AML and other indications."

Topline results in MB-105, an open label, single arm clinical trial conducted in Europe showed one CRi (complete response with incomplete recovery of peripheral blood count) and three PRs (Partial Response) for an 80% overall response rate (ORR) in the last cohort. In this cohort, the age range at time of treatment of the 5 subjects was 62-73. The subject who achieved the CRi was 65 years of age at time of treatment.

For purposes of this clinical trial, a CR means that the subject’s bone marrow blasts reduced to 5% or less (with CRi meaning a CR where there was incomplete recovery of white blood cell and/or platelet counts), and a PR means the subject’s bone marrow blasts reduced by 50% and resulted in a blast count of 25% or less. 20 subjects were enrolled in the trial with the age range of 24-76 years with a median age of 64.5. The median number of prior therapies for all subjects was 4 (range 1-18). Of the 20 subjects enrolled, 17 received the full 3 consecutive days of dosing per protocol. PRs (3) and CRi (1) were noted in 4 (80%) of the 5 subjects dosed according to protocol in the last cohort (240 mg/m2).

In earlier cohorts receiving lower doses, 2 subjects (1 at 120 mg/m2 and 1 at 180 mg/m2) although qualified to receive a second cycle (they exhibited a 50% decrease in marrow blasts and marrow blasts < 25%), did not meet what the protocol defined as a PR at that time. Per protocol at that time to achieve a PR, these subjects were required to have normalization of blood counts/hematologic values in addition to bone marrow blast reduction to qualify as a PR which did not occur. The final version of the protocol required just a >50% reduction in marrow blasts to qualify as a PR. Despite these subjects qualifying to receive a second cycle of treatment, the two subjects were recorded as having a best overall response of "treatment failure" as they did not mean the definition of PR as defined by the protocol at that time.

All subjects have been included in the evaluation for cardiotoxicity by an independent expert, with none noted. The most frequently reported adverse events (occurring in >10 % of subjects) were hematologic in nature, being neutropenia, thrombocytopenia and anemia.

The clinical study report for MB-105 has been finalized, internally published and reviewed and the Company expects to share detailed data in a paper and/or publication in the near future.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases and the treatment of relapsed or refractory AML.

Study Design

The Company evaluated Annamycin in both the U.S. (MB-104) and Europe (MB-105) in open label, single arm clinical trials to assess the safety and efficacy of Annamycin for the treatment of adults with relapsed or refractory acute myeloid leukemia. Enrollment occurred in cohorts of at least 3 subjects in a conventional 3+3 escalating dose design, starting at a dose level of 120 mg/m2/day administered for 3 days. Dose escalation took place on the basis of safety assessments in sequential cohorts of at least 3 subjects each. The initial cohort received 120 mg/m2/day for 3 days. For Cohorts 1, 2, 3, 4, and 5 dose escalation occurred in 30-mg/m2/day increments until subjects are enrolled at a 240-mg/m2/day dose. The primary outcome of the study was evaluation of safety and identification of the maximum tolerated dose (MTD) and the recommend phase 2 dose (RP2D) for Annamycin. As announced in February 2022, upon safely reaching the RP2D of 240 mg/m2 in the MB-105 trial, the Company concluded recruitment for the trial. Based on the safety and dosage data from the two successfully concluded single agent Annamycin AML Phase 1 trials, MB-104 and MB-105, Moleculin is conducting its ongoing Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are refractory to or relapsed after induction therapy (MB-106).

About Annamycin

Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple early-stage human clinical trials, including ongoing trials for the treatment of acute myeloid leukemia (AML) and STS lung metastases. For that reason, although additional data will be necessary, the Company believes Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently approved anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes the drug may have the potential to treat additional indications.

On February 13, 2023 BioNova Pharmaceuticals Limited (BioNova), a company dedicated to the discovery, development and commercialization of innovative medicines for the treatment of diseases with unmet medical needs, reported that the first patient has been dosed in the phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin’s Lymphoma (NHL) (Press release, Sutro Biopharma, FEB 13, 2023, View Source [SID1234627109]).

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BN301 is a novel target, site-specific antibody drug conjugate (ADC) comprised of a human aglycosylated anti-CD74 IgG1 antibody and 2 non-cleavable maytansinoid drug-linkers. BN301/STRO-001 was granted Orphan Drug Designation by the US FDA for multiplemyeloma in October 2018. Through a licensing agreement with Sutro Biopharma, Inc. (Sutro, NASDAQ: STRO) in October 2021, BioNova gained the option to obtain exclusive rights to develop and commercialize BN301 in Greater China territory, includingmainland China, Hong Kong, Macau and Taiwan.

The multi-center Phase 1/2 clinical trial of BN301 is to evaluate BN301 in patients with B-cell NHL who have previously failed standard therapy or who are intolerant to standard therapy. This study is comprised of a Phase 1 dose escalation part and a Phase 2dose expansion part.

"We are very pleased with the Sutro collaboration and very excited about this important milestone for BN301 global development." said Ye Hua, M.D., Founder and CEO of BioNova, "Patients with relapsed/refractory NHL have limited treatment options and their prognosis are usually poor. We are hopeful that this novel target ADC could provide those patients with a potential new treatment option. Together with Sutro colleagues, our development team is working diligently and efficiently to advance BN301 clinical development program in China."