On July 14, 2021 BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments, reported that it will present two poster presentations at the Society for Neuro-Oncology: Basic and Translational Omics of Brain Tumors and Their Microenvironment Conference, on July 15th and 16th, 2021 (Press release, Berg, JUL 14, 2021, View Source [SID1234584860]).

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The first presentation, entitled "Interrogative Biology: Unraveling insights into causal disease drivers by use of a dynamic systems biology and Bayesian AI to identify the intersect of disease and healthy signatures", will emphasize the features of BERG’s proprietary Interrogative Biology Platform. Specifically, the presentation will focus on how BERG’s platform combines Bayesian AI analytics and patient-derived biological samples to generate an unbiased, data-informed network for identifying targets and biomarkers for disease interception, providing the opportunity to better understand and monitor human health in real-time.

The second presentation, entitled "Delivery of Ubidecarenone (BPM 31510) to mitochondria effectuates metabolic reprogramming and redox activated apoptosis in Glioblastoma" will further detail the platform’s utility in biological data-driven clinical development for GBM, including insights on anti-cancer effects of its BPM 31510. The presentation will highlight the use of BERG’s platform in generating comprehensive digital maps of a GBM model in response to BPM 31510 treatment and, in turn, the novel insights leading to potential mechanisms underlying BPM 31510 efficacy in GBM, including targeting mitochondrial function, influencing intermediary metabolism and activation of apoptosis.

"Brain cancers, such as GBM, are destroying patients and their families," said Dr. Niven R. Narain, CEO, President and Co-founder of BERG. "Using Interrogative Biology to guide the development of BERG’s BPM 31510 has allowed us to position the drug for this highly metabolic and aggressive cancer in an effort to potentially address a serious unmet need in medicine."

GBM is a destructive type of brain cancer often recognized for its steep morbidity and mortality rates. There are no effective treatment options for the vast majority of patients available in the marketplace, thus substantiating the urgent need for novel therapeutic approaches to improve outcomes for this disease. BPM 31510 is a unique therapeutic modality, that specifically targets cell metabolism and shifts the cancer’s glycolytic dependency toward mitochondrial oxidative phosphorylation. When applied, it induces oxidative stress and causes cell death, specifically of cancer cells.

"BERG’s pioneering research to deepen our understanding and treatment of GBM continues to be a game changer across the industry," said Dr. Eric J. Nestler, Director of Friedman Brain Institute at Icahn School of Medicine at Mount Sinai and Board director for BERG. "The Interrogative Biology Platform is leading the charge to digitize biology for the future of healthcare, and will empower patients to take back control of their personal care."

Details of BERG Abstracts:

Abstract #: CSAO-1: Interrogative Biology: Unraveling insights into causal disease drivers by use of a dynamic systems biology and Bayesian AI to identify the intersect of disease and healthy signatures – View Source
Abstract #: OMRT-13: Delivery of Ubidecarenone (BPM 31510) to mitochondria effectuates metabolic reprogramming and redox activated apoptosis in Glioblastoma – View Source
The Abstracts are available online and the Posters will be available to registered 2021 SNO Basic and Translational Omics of Brain Tumors and Their Microenvironment Conference attendees starting Thursday, July 15, 2021.

On July 14, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies (Press release, Lipocine, JUL 14, 2021, View Source [SID1234584842]).

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Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware. Additionally, both parties have reached an agreement on the interference proceedings captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 presently pending in the U.S. Patent and Trademark. The terms of the settlement remain confidential.

On July 14, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported it will host a conference call to discuss financial results for the quarter ended June 30, 2021, and provide a corporate business update on Wednesday, August 4, 2021, at 4:30 pm EDT/ 2:30 pm MT (Press release, Ampio, JUL 14, 2021, View Source [SID1234584861]).

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The conference call will also be available from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

On July 13, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it has submitted a New Drug Application (NDA) to the Taiwan Food and Drug Administration (TFDA) for selinexor, a first-in-class XPO1 inhibitor, for three indications: in combination with bortezomib and dexamethasone (XVd), or in combination with dexamethasone (Xd) for the treatment of patients with relapsed and/or refractory multiple myeloma (RRMM); and as monotherapy in adult patients with relapsed and/or refractory diffuse large B-cell lymphoma (rrDLBCL), including DLBCL arising from follicular lymphoma, who have received at least two lines of systemic therapy (Press release, Antengene, JUL 13, 2021, View Source [SID1234584826]).

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Antengene has submitted New Drug Applications (NDAs) for selinexor in multiple Asia Pacific markets including China, Australia, South Korea, and Singapore, and was granted Priority Review status by China’s National Medical Products Administration (NMPA) and Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS). This NDA submitted in Taiwan marks another milestone in Antengene’s expansion in the APAC markets and the company’s effort to address the unmet clinical needs of patients with hematologic malignancies.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented: "Within just nine months, we have submitted NDAs in six APAC markets, demonstrating our commitment to addressing the unmet needs of patients in the APAC region. Our seasoned team has a wealth of experience and depth of insight in product registration and commercialization in the Asia Pacific markets. I am confident that Antengene will deliver on our promise to bring our portfolio of innovative therapies to patients in the APAC markets."

"Selinexor is an anti-tumor drug with a highly novel mechanism of action. It has been approved by the FDA for three indications in two tumor types (MM and DLBCL) in less than two years, demonstrating its broad anti-tumor effects," said Kevin Lynch, Chief Medical Officer of Antengene. "Selinexor treatment in combination with dexamethasone still has 25.3% overall response rate (ORR) in patients who have failed five established therapies (penta-refractory) myeloma; and for patients with multiple myeloma who received at least one prior line of treatment, the median progression-free survival (PFS) is 13.9 months, which is significantly higher than that of the control group receiving bortezomib-based standard of care. In the subgroup analysis, patients who are 65 years or older, with renal insufficiency or high-risk cytogenetics can still achieve significant benefits from the XVd regimen. These are patients who are otherwise very difficult to treat. Finally, selinexor monotherapy can enable patients with rrDLBCL to obtain deep and durable responses with a median duration of response of 23.0 months for patients with complete response. We are therefore very optimistic about the potential efficacy benefits of selinexor combination regimens in DLBCL."

Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI) have entered into an exclusive collaboration and license agreement for the development and commercialization of selinexor and other two XPO1 inhibitors, and a PAK4/NAMPT inhibitor in 17 APAC markets including Mainland China.

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm, is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of RRMM and in June 2020 approved selinexor as a single-agent for the treatment of rrDLBCL. In December 2020, selinexor also received FDA approval as a combination treatment (XVd) for MM after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with RRMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of adult patients with RRMM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five late-stage clinical trials of selinexor in China for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma.

On July 13, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it has received approval from the Bioethics Committee of the Medical University of Karol Marcinkiewicz in Poznań (Ethics Committee) as well as an allowance from the Polish Department of Registration of Medicinal Products (URPL) for a protocol amendment for its Phase 1/2 evaluating Annamycin for the treatment of subjects with acute myeloid leukemia (AML) that is refractory to or relapsed after induction therapy (Press release, Moleculin, JUL 13, 2021, View Source [SID1234584811]).

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Annamycin is the Company’s next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML. Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. The Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases.

"Based on the preliminary data seen demonstrating clinical benefit for patients receiving a full course of treatment in the 240 mg/m2 cohort and the recommendation from our medical advisors on the dose limiting toxicity criteria, we are pleased to have Ethics Committee approval and the allowance from the URPL to amend the protocol for future patients. This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study. Our team is committed to advancing this important clinical program forward and to potentially address the limitations with current treatment options for AML patients," commented Walter Klemp, Chairman and CEO of Moleculin.

The Phase 1/2 AML trial in Poland remains ongoing and is currently dosing patients at 240 mg/m2. Under the previous protocol transient elevated liver enzymes (AST and ALT) observed in two patients were considered a dose limiting toxicity (DLT), which investigators believe would inappropriately limit the potential for continued dose escalation. The amendment to the Annamycin clinical trial protocol allows for a change in the DLT criteria as it relates to transient grade 3 elevations and allows dosing of three additional patients in the 240 mg/m2 cohort. If no DLT (as defined by the new criteria) is experienced with these next three patients, the Company plans to escalate dosing in new cohorts by 30 mg/m2 instead of the 60 mg/m2 previously planned, and with a de-escalation of 15 mg/m2 at the DLT dose if future patients experience a DLT.

The results from the Phase 1 portion of the Company’s U.S. Phase 1/2 clinical trial of Annamycin for the treatment of AML met its primary endpoint and demonstrated a clean safety profile with no evidence of cardiotoxicity when delivered to patients at or below the lifetime maximum anthracycline dose established by the FDA. To date, an independent expert assessment of the absence of cardiotoxicity in the first 19 patients treated with Annamycin in both the Company’s U.S. and European Phase 1 clinical trials in which an independent expert concluded that he "does not see evidence of cardiotoxicity."

Moleculin Biotech expects to continue reporting cohort topline results from the ongoing Phase 1/2 study for treatment of AML and to report the study’s topline results in the second half of 2022. Annamycin has been granted Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML.