On July 8, 2024 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in Virtual Targeted Protein Degradation Day hosted by UBS (Press release, Bristol-Myers Squibb, JUL 8, 2024, View Source [SID1234644706]).

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Robert Plenge, M.D., Ph.D., Executive Vice President, Chief Research Officer and Head of Research, will take part in a fireside chat on Monday, July 15, 2024. He will answer questions about the company beginning at 11:00 a.m. ET.

Investors and the general public are invited to listen to a live webcast of the session by visiting View Source An archived edition of the session will be available following its conclusion.

On July 8, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update on the Company’s clinical progress and plans for expansion (Press release, Bio-Path Holdings, JUL 8, 2024, View Source [SID1234644705]).

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"The Bio-Path team continues to work diligently toward advancing our important clinical work and have made meaningful progress in a number of areas critical to each program’s success," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "With the increased clinical data that we have generated, we are now able to develop the biomarkers needed to incorporate into our oncology studies. In addition, we have completed preparations for preclinical work to support advancing prexigebersen as a potential treatment for obesity. In tandem, we are designing development plans for first-in-human clinical studies in this expansive global market for weight loss."

"The incremental advances that we are making across these programs collectively push our DNAbilize platform closer to delivering these medicines to patients. Moreover, we are continuing to see the broader potential of our platform beyond oncology and look forward to realizing its potential across multiple indications, starting with obesity," continued Mr. Nielsen.

Clinical Program Overview

Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials. Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity.

Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program. The emerging role of biomarkers has enhanced cancer development over the past decade and has become a more common companion to many oncology programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on recent interim data for safety and efficacy, the Company plans to pursue next development steps by applying molecular biomarkers to future patient selection for enrollment into the Phase 2 clinical trial. Outcomesfor these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile remain suboptimal with a median survival of only five to ten months.

The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration (FDA) review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months.

Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late stage pancreatic cancer.

In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The drug venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax. AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities.

Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College. In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end.

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer).

Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin. Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i.

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug (IND)-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication.

On July 8, 2024 APEIRON Biologics AG ("APEIRON"), a leading Austrian biotech company, reported that its shareholders have entered into a definitive agreementto sell their APEIRON shares to US-based Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) for USD 100 million (Press release, Apeiron Biologics, JUL 8, 2024, View Source [SID1234644704]). APEIRON shareholders are also entitled to additional consideration based on future commercial and regulatory events and to up to USD 28 million if QARZIBA royalties exceed certain predetermined thresholds by either 2030 or 2034 respectively. The agreement has been approved by the Supervisory Board of APEIRON and the Board of Directors at Ligand. The transaction is subject to a 30-day shareholder objection period and other customary closing conditions and is expected to close in July 2024.

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Concurrently, Ligand has also committed to investing up to USD 4 million in invIOs Holding AG ("invIOs"), a spin-off of APEIRON. The proceeds will help invIOs to finance the research and development of three innovative early-stage immuno-oncology assets.

APEIRON is entitled to royalties and milestone payments on these assets. This transaction is also expected to close in July 2024. APEIRON, known for its innovative approaches in immuno-oncology, received marketing approval from the European Medicines Agency for APN311 (dinutuximab beta, QARZIBA) in 2017 for the treatment of high-risk neuroblastoma in patients aged twelve months and above.

Peter Llewellyn-Davies, CEO of APEIRON, said: "We have spent more than twenty years translating academic research into therapeutic products for diseases with high unmet needs. This is a historic moment for APEIRON and its shareholders. We are excited that Ligand has recognized the importance of our work and the long-term potential of QARZIBA. Today’s sale demonstrates the great value of APEIRON’s research and is a strong recognition of the achievements of APEIRON’s founders, researchers and all employees."

He continued: "The sale of APEIRON also is an encouraging signal for the entire Austrian biotechnology industry, it underlines the great potential of Austria’s research-driven biotechnology companies. This acquisition by Ligand also represents one of the largest exits of a private Austrian biotech company in the last few years."

"The achievements of APEIRON and today’s strategic exit are impressive proof of the potential and innovative strength of the Austrian biotechnology landscape," added Manfred Reichl, Chairman of the Supervisory Board of APEIRON Biologics. "I would like to thank the leadership team at APEIRON, the founders and the research teams for their work and overachievement. I also would like to thank our former Vice-Chairman Rainer Burian, who represented more than 90 shareholders of APEIRON Biologics in negotiating the deal together with APEIRON’s CEO, Peter Llewellyn-Davies, and his team. We will continue the development of outstanding innovative cancer treatments within Apeiron’s sister company invIOs Holding AG."

Ligand Pharmaceuticals is a US-based biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing their technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. "We are pleased to partner with APEIRON on this transaction," said Todd Davis, CEO of Ligand.

"The APEIRON team has done great work in immuno-oncology and rare diseases, and QARZIBA is the only immunotherapy for high-risk neuroblastoma marketed across Europe and in other parts of the world. We believe this drug will be a meaningful contributor to our commercial royalty portfolio." Baker McKenzie represented the APEIRON shareholders and DORDA served as APEIRON’s legal counsel. McDermott Will & Emery and E+H Rechtsanwälte served as Ligand’s legal counsels.

About QARZIBA

QARZIBA is a monoclonal antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells. Dinutuximab beta was approved by the European Medicines Agency in 2017 for the treatment of high-risk neuroblastoma in patients aged twelve months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease.

Dinutuximab beta was originally discovered by EMD Lexigen Research Center and ultimately developed by the Children’s Cancer Research Center (CCRI) and European Neuroblastoma Research Network (SIOPEN) for the treatment of high-risk neuroblastoma. APEIRON in-licensed dinutuximab beta from CCRI and SIOPEN in 2011, and upon completing the clinical development, out-licensed the exclusive global commercialization rights to EUSA Pharma (UK) Limited in 2016. QARZIBA is marketed outside of mainland China by the global pharmaceutical company EUSA Pharma (UK) Limited., which was acquired by Recordati S.p.A. in 2022.

On July 8, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that Abeona’s Chief Executive Officer, Vish Seshadri, Ph.D., M.B.A., and Chief Commercial Officer, Madhav Vasanthavada, Ph.D., M.B.A., will participate in a virtual fireside chat at the Stifel Virtual Cell Therapy Forum on Tuesday, July 9, 2024 at 9:45 a.m. Eastern Time (Press release, Abeona Therapeutics, JUL 8, 2024, View Source [SID1234644702]).

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A live webcast of the fireside chat will be available on the Investors section of the Abeona website under "Events" at View Source The webcast will be archived for 30 days.

On July 7, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing both first- and best-in-class therapies for hematological malignancies, reported that its novel BCR-ABL1 tyrosine kinase inhibitor (TKI), olverembatinib, has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of the People’s Republic of China for the treatment of adult patients with tyrosine kinase inhibitors (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs (Press release, Ascentage Pharma, JUL 7, 2024, View Source [SID1234644697]). This approval marks another major milestone for olverembatinib following initial approvals granted to the drug in the Chinese mainland for the above indications.

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Olverembatinib, a novel drug developed by Ascentage Pharma with support from the National Major New Drug Development program, is the first third-generation BCR-ABL1 inhibitor approved by China’s National Medical Products Administration (NMPA). As a potential global best-in-class drug that can effectively target BCR-ABL1 and a spectrum of BCR-ABL1 mutants, including the T315I mutation, clinical trial results of olverembatinib have already been included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of CML.[1] Olverembatinib is being jointly commercialized in China by Ascentage Pharma and Innovent Biologics. All lead drug candidates are being studied as they are an investigational drug and not approved in the US.

"Olverembatinib has the potential to be a global best-in-class drug. We are glad that the drug is set to benefit patients with CML in Macau, China, with the approval marking another major milestone in the clinical development of olverembatinib," said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. "Since its inception, Ascentage Pharma has steadfastly committed to its mission of addressing unmet clinical needs in China and around the world. We are confident that over time, olverembatinib and our other investigational drugs will bring greater benefits to more patients globally."