On April 18, 2023 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, reported that positive preclinical data regarding the Company’s next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL (Press release, Moleculin, APR 18, 2023, View Source [SID1234630237]). This research was sponsored by the Company.

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The poster titled, Exploration of Annamycin Organotropism to Target Primary and Metastatic Liver Cancers was presented by Rafal Zielinski, Ph.D., Department of Experimental Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center as part of the Experimental and Molecular Therapeutic Session "Novel Antitumor Agents, PI3K/AKT Inhibitors, Proteasome Inhibitors, and Topoisomerases". The poster outlined results from the analysis of the pharmacokinetics of two formulations of Annamycin, liposome formulated drug product (L-ANN) and free Annamycin (ANN), in the liver in comparison with doxorubicin (DOX) and to determine its tumoricidal potential in a hepatocellular carcinoma (HCC) model in situ and in experimental models of liver metastasis.

"Annamycin has continued to demonstrate in preclinical models promising results in hard-to-treat tumors. We are pleased with the findings from these preclinical models in HCC, the most common type of primary liver cancer that is responsible for more than 12,000 deaths per year in the US. The high antitumor activity seen preclinically with Annamycin is very encouraging and provides validation for expanded studies to assess activity in different tumor liver metastasis models as well as HCC models," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

Annamycin is the Company’s next-generation anthracycline that has been designed to be non-cardiotoxic (unlike currently prescribed anthracyclines) and has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin (a commonly prescribed anthracycline), as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines.

The levels of ANN and DOX in plasma and tissue homogenates were assessed using LC/MS. The antitumor efficacy of L-ANN was studied using HEPA 1-6 hepatocellular carcinoma models (subcutaneous, orthotopic, and experimental liver metastatic models) as well as CT26 colon cancer and MIA PaCa-2 pancreatic cancer liver metastasis models.

Data Highlights:

ANN exhibited significantly higher accumulation in the liver parenchyma when compared to DOX (6-fold higher AUC values).

Researchers observed clear inhibition of the subcutaneous tumor growth after systemic (IV) administration of L-ANN.

Increased liver uptake of the drug had a direct effect on activity of the drug in vivo. Remarkable activity of L-ANN was observed in orthotopic models. Significant inhibition of the tumor growth and extension of the survival of L-ANN treated mice vs. vehicle-receiving animals was observed in HEPA 1-6 models (median survival 29.5 vs 50 days (p<0.0001) and 28 vs 59 days (p<0.0001), respectively).

L-ANN treatment resulted in dramatic increase in survival (median survival >407 days) in the CT26 colon cancer experimental metastasis model. In a separate experiment, significant delay in tumor progression was also observed in pancreatic cancer (MIA PaCa-2) liver metastasis model.

Annamycin is currently being evaluated in ongoing clinical trials for the treatment of STS lung metastases and AML. For more information about the ongoing trials, please visit clinicaltrials.gov and reference identifiers NCT04887298 and NCT05319587, respectively. Unless specifically noted otherwise, references to "Annamycin" refer to the liposome formulated form of the drug.

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 April 18, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, reported promising clinical data from its Phase 1/2a first-in-human study of its DNA-based personalized cancer immunotherapy, EVX-02 in combination with the checkpoint inhibitor nivolumab (Press release, Evaxion Biotech, APR 18, 2023, View Source [SID1234630236]). Data were presented in the Late Breaking Research: Clinical Research 2 session at the 2023 AACR (Free AACR Whitepaper) (American Association for Cancer Research) meeting in Orlando, Florida.

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The study, in patients with resected melanoma, showed that:

· All 10 patients who received the full dosing schedule of 8 immunizations with EVX-02 were relapse-free at their last assessment
· Of these 10 patients, 9 completed the full study and were relapse-free at the 12-month end of study visit. One patient was prematurely terminated due to non-EVX-02 related adverse events (AEs), and was relapse-free at the last visit at 9 months
· The combination of EVX-02 and nivolumab was well tolerated and only mild EVX-02-associated AEs were observed
· Robust and long-lasting neoantigen-specific T-cell immune responses were confirmed in all EVX-02 completers
· The induced T-cell immune responses involved both CD4+ and CD8+ T cells

"We are extremely happy to share the positive clinical data from our Phase 1/2a EVX-02 study at AACR (Free AACR Whitepaper). We met both our primary endpoints on safety, tolerability and immunogenicity and our secondary endpoint on clinical efficacy. With all 10 patients who completed the EVX-02 treatment being relapse-free during the trial and with robust and treatment-specific immune responses, we see clear signs of a protective cancer vaccination effect", said Per Norlén, Chief Executive Officer of Evaxion. "The EVX-02 data affirm our ability to select the right neoantigens, matched to the cancer of each patient, and provide further validation of our AI platform PIONEERTM. They also support our plan to fast track our next-generation DNA-based personalized cancer immunotherapy, EVX-03, to the clinic in Q4."

About the Phase 1/2a Study with EVX-02

The open-label, single-arm, multi-center Phase 1/2a study (NCT04455503) was designed to evaluate the combination of EVX-02 plus nivolumab in patients who had undergone complete surgical resection of late stage melanoma and were at high risk for recurrence. The primary objectives of the 12-month study were to assess the safety, tolerability and immunogenicity of EVX-02 plus nivolumab. In addition, the study was intended to evaluate relapse free survival. Evaxion reported initial, interim safety and immunogenicity data from the first 8 patients in the study in November 2022.

On April 18, 2023 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial stage biopharmaceutical company developing and commercializing innovative vaccines, will report first quarter 2023 financial results on Tuesday, May 2, 2023, after the U.S. financial markets close (Press release, Dynavax Technologies, APR 18, 2023, View Source [SID1234630235]).

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Dynavax will host a conference call and live audio webcast on Tuesday, May 2, 2023, at 4:30 p.m. ET/1:30 p.m. PT.

The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

On April 18, 2023 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that a comparative biochemical analysis identified rivoceranib, its lead investigational drug, as the most selective vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor when compared with other tyrosine kinase inhibitors (TKIs) with known activity against VEGFR-2 (Press release, Elevar Therapeutics, APR 18, 2023, View Source [SID1234630233]).

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The results of the analysis were shared today in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando.

"Though VEGFR-2 is a known target for anti-cancer therapy, clinical use of VEGFR-2 inhibitors has been challenged by limited efficacy and various side effects, potentially due to low selectivity," said Seong Jang, Elevar’s chief operating officer and the poster’s lead author. "Rivoceranib’s noteworthy selectivity for VEGFR-2 as compared to other TKIs in this biochemical analysis marks a valuable demonstration of its potential as an anti-cancer therapy, as with increased selectivity comes the possibility of more effective VEGFR-2 dosing and diminished toxicity toward unintended targets, both of which are vitally important to the patients who are confronted with disease."

Elevar is developing rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a treatment option for hepatocellular carcinoma (HCC), the most common type of liver cancer; as a monotherapy treatment option for adenoid cystic carcinoma (ACC); and as mono and combination therapies in other tumor cell types.

For the biochemical analysis, the activity of rivoceranib and 10 U.S. Food and Drug Administration (FDA)-approved TKIs with known activity against VEGFR-2 were compared against a panel of 270 kinases.

Noteworthy results:

Rivoceranib retains greater overall activity of non-targeted kinases compared with reference inhibitors.
Substantial differences in overall residual kinase activity were observed across the panel of 270 kinases among the 11 inhibitors. Among all inhibitors profiled, rivoceranib demonstrated the greatest residual kinase activity across the panel of kinases.
Rivoceranib is the most selective inhibitor of VEGFR-2 kinase activity among the tested inhibitors.
Rivoceranib demonstrated >95% inhibition of VEGFR-2, with 54.7% to 99.5% inhibition of only five kinases (i.e., FLT1, FLT4, Ret, PDGFR, and Lyn) detected at both rivoceranib concentrations.
Compared with rivoceranib, all reference inhibitors tested demonstrated activity against a broader array of kinases.
Key conclusions:

Rivoceranib was identified as the most selective inhibitor of VEGFR-2 in the analysis of the inhibitory profiles of rivoceranib and 10 reference inhibitors against a panel of 270 known kinases.
Differences in selectivity among compounds with a similar range of VEGFR-2 kinase inhibition potency are clinically relevant, as toxicities associated with available VEGFR-2 inhibitors are thought to be due in part to their inhibitory effects against kinases outside of the VEGFR family.
With the increased selectivity seen with rivoceranib, more effective targeting of VEGFR-2 may be achieved due to an ability to deliver higher therapeutic doses with fewer off-target toxicities compared to other TKIs.
This increased ability to reach higher drug concentrations could potentially result in greater anti-tumor efficacy as well as a capacity to achieve adequate concentrations of the drug at sites with limited drug penetration, such as brain metastases.
Rivoceranib, as the most selective inhibitor of VEGFR-2, represents an attractive option for improved VEGFR-2 targeting in cancer.
In June 2022, Elevar announced at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting that in its Phase 2 clinical trial (Study RM-202) of rivoceranib monotherapy in patients with progressive recurrent or metastatic ACC, rivoceranib demonstrated clinical effectiveness, as indicated by substantially reduced tumor progression during the six months after rivoceranib treatment compared to the tumor progression during the six months prior to rivoceranib treatment. There are no currently approved therapies for ACC and the trial was the largest to date in ACC to show this level of effectiveness.

Elevar in September 2022 announced during the annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) that in its Phase 3 CARES 310 study, camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib, a standard first-line treatment for unresectable HCC. The company intends to submit a New Drug Application (NDA) and Biologics License Application for the combination to the FDA during the first half of 2023.

To learn more, view Elevar’s AACR (Free AACR Whitepaper) poster and visit ElevarTherapeutics.com.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include hepatocellular carcinoma (HCC) (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China as a first-line treatment for unresectable HCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Hengrui Pharma, under the brand name Aitan.

On April 18, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology medicine company developing MasterKey therapies designed to overcome limitations of existing therapies by targeting families of oncogenic driver mutations in patients with genetically defined cancers, reported that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an overview of the Company’s MasterKey programs, including BDTX-1535 and BDTX-4933, at the Stifel 2023 Targeted Oncology Days on Tuesday, April 25, 2023, at 11:00 a.m. ET, being held virtually (Press release, Black Diamond Therapeutics, APR 18, 2023, View Source [SID1234630231]).

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A live webcast of the presentation can be accessed by visiting the investors relations section of the Company’s website at: www.blackdiamondtherapeutics.com. A replay of the webcast will also be available and archived for 90 days following the event.