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."

On July 5, 2024 Zhiyi Biotech, a clinical-stage biotech leading in discovery and development of LBPs (live biotherapeutic products), reported positive results from a Phase 1 clinical trial in U.S. of SK10 (Press release, Guangzhou Zhiyi Biotech, JUL 5, 2024, View Source [SID1234644693]). SK10 is an innovative heat-killed Bacteroides fragilis product for Chemotherapy-induced Diarrhea (CID).

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This was a randomized, double-blind, placebo-controlled, sequential dose-escalation clinical study to evaluate the safety and tolerability of SK10 in healthy adult subjects. A total of 24 healthy subjects were enrolled in the study. All dose groups of SK10 were generally safe and well tolerated. All the TEAEs (treatment-emergent adverse event) were mild in severity without dose-dependent increase.

This promising result lays the foundation for SK10 as a potential novel drug for CID patients.

About SK10:

SK10, the first Bacteroides fragilis-based LBP obtained FDA IND approval, is also the first LBP of Next-generation probiotics developed by Chinese biotech company that approved for clinical trials by FDA. Studies have shown that SK10 can ameliorate 5-FU induced injury via mitochondrial apoptotic BCL2/BAX pathway, reduce inflammatory cytokines, and enhance mucosal barrier function, thereby effectively inhibiting the inflammatory response of intestinal epithelial cells induced by chemotherapy and the associated diarrhea symptoms.

Meanwhile, heat-killed Bacteroides fragilis has better safety in cancer patients and better commercialization performance.

About CID:

Cytotoxic drugs or targeted therapy can cause drug-associated diarrhea. However, available drugs for CID are limited. For example, loperamide, as a short-term symptomatic treatment, and octreotide, an intravenous/subcutaneous injection, serious adverse effects have been reported for both drugs. Hence the need for effective drugs is urgent.

On July 5, 2024 Hinova Pharmaceuticals Inc. (688302.SH), a leading biopharmaceutical company dedicated to developing innovative cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HP518, an investigational drug for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC) (Press release, Hinova Pharmaceuticals, JUL 5, 2024, View Source [SID1234644692]). This designation is intended to expedite the development and review process for drugs that address serious conditions and fill an unmet medical need.

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About HP518

HP518 is a potent PROTAC AR degrader showing efficacy in AR+ TNBC. In preclinical IND-enabling studies, HP518 has demonstrated promising antitumor activity in AR+ TNBC animal models, showcasing significant tumor reduction and a favorable safety profile. The molecular subforms of TNBC are particularly aggressive forms of breast cancer that lack targeted treatment options, accounting for approximately 15-20% of all breast cancer cases, and are characterized by the absence of estrogen and progesterone receptors and HER2 expression. Notably, a significant proportion of TNBC cases (up to 50%) express the androgen receptor, highlighting the potential impact of AR-targeted therapies like HP518.

HP518 is an oral AR PROTAC protein degrader that degrades both wild-type AR and clinically relevant AR ligand-binding domain (LBD) mutants including L702H. Phase 1 clinical trial in Australia achieved several long term PSA50 and partial responses (PR), demonstrated HP518’s promising efficacy and acceptable safety profile in mCRPC patients. The clinical Phase 1/2 trial of HP518 for patients with mCRPC in China is ongoing.

FDA Fast Track Designation

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Fast Track designation enables more frequent communication with the FDA to discuss the drug’s development plan and ensures eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

"We are thrilled to receive Fast Track designation from the FDA for HP518," said Dr. Yuanwei Chen, Chief Executive Officer of Hinova. "This designation underscores the significant need for new treatment options for patients with TNBC and highlights the potential of our investigational therapy to make a meaningful impact on this devastating disease. The discovery of HP518’s novel mechanism of action provides new hope for effective treatment. We look forward to working closely with the FDA to advance HP518 through the clinical development process as efficiently as possible."

Next Steps

Hinova plans to update in near future the existing IND (IND 164902) for TNBC development. The company is committed to accelerating the development of HP518 and bringing this promising therapy to patients in need.