On September 15, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported that the Company has entered into a $40 million non-dilutive secured debt financing agreement with Kreos Capital, a leading provider of innovative and flexible debt solutions to equity-backed, pan-European and Israeli high-growth companies in the technology and healthcare sectors (Press release, BioLineRx, SEP 15, 2022, View Source [SID1234619570]).

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Per the terms of the agreement, the first tranche of $10 million was made available to BioLineRx upon execution of the definitive agreement, subject to customary conditions to closing. The remaining $30 million will be made available in two additional tranches subject to the achievement of pre-specified milestones. The tranches are available for drawdown at BioLineRx’s discretion at various time points through October 1, 2024.

Each tranche carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. The interest-only periods are subject to possible extension based on certain pre-defined milestones. Borrowings under the financing will bear interest at a fixed rate of 9.5% per annum (~11.0%, including associated cash fees). In addition, Kreos will be entitled to mid-to-high single-digit royalties on Motixafortide sales, up to a pre-defined cap. No warrants were issued by BioLineRx in connection with this financing.

BioLineRx intends to use the available funds from this agreement, together with cash on-hand, to support an aggressive commercial launch for Motixafortide in autologous stem cell mobilization for multiple myeloma patients, if approved, while it continues to evaluate U.S. commercialization strategies. BioLineRx recently submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval for this underserved hematology/oncology indication.

"We are very pleased to have the support of Kreos Capital, a well-known and highly regarded healthcare investor, as we prepare to transition to a commercial stage company next year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Kreos has been a very supportive partner in the past, having assisted with critical debt financing in 2018 as we further increased our stake in, and commitment to, the development of Motixafortide. Having successfully satisfied that obligation, we are fortunate to again be working with a team that is already very familiar with our Company and our lead program."

"Access to this non-dilutive funding, at terms that we believe are favorable to the Company, allows us to prepare for a robust launch of Motixafortide, if approved, while we continue to evaluate different U.S. commercialization alternatives. This will help ensure that multiple myeloma patients across the U.S. have broad access to this new and highly effective mobilization agent as quickly as possible," Mr. Serlin concluded.

"At Kreos, we have established a track record of investing in therapeutics companies that drive true innovation, and we believe Motixafortide, if approved, has the potential to quickly become the standard of care in stem cell mobilization for the benefit of providers, patients and payers," stated Chris Church, Principal at Kreos. "We look forward to working closely with BioLineRx as it works toward achieving its regulatory and post-launch commercial goals."

As of June 30, 2022, BioLineRx reported cash and cash equivalents of $43.2 million.

On September 15, 2022 Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, reported that its senior management team will be attending and hosting meetings at the following investor and scientific conferences in the fourth quarter of 2022 (Press release, Ariceum Therapeutics, SEP 15, 2022, View Source [SID1234619569])

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Terachem 2022: The Fourth International Symposium on Technetium and Other Radiometals in Chemistry and Medicine
14-17 September 2022, Forum Brixen, Bressanone, Italy

9th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC)
22-24 September 2022, Klinikum der Universität München, Munich, Germany

Optimum 14th Annual Healthcare Investor Conference
6 October 2022, Wellcome Collection, London, UK

European Association of Nuclear Medicine (EANM) 35th Annual Congress
15-19 October 2022, Barcelona International Convention Centre, Barcelona, Spain

BIO-Europe 2022
24-26 October 2022, Leipzig Messe, Leipzig, Germany

4th Targeted Radiopharmaceuticals EU Summit Europe
6-8 December 2022, Leonard Royal, Amsterdam, Netherlands

Presentation by: Chief Executive Officer, Manfred Rüdiger, Ariceum Therapeutics
Title: New Life for Satoreotide-The Antagonist Moves
Date & Time: 6 December, 12.00pm CET

European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Annual Congress
7-9 December 2022, Palexpo exhibition centre, Geneva, Switzerland

On September 14, 2022 Vernalis Research ("Vernalis"), a fully owned subsidiary of HitGen Inc., and Contera Pharma A/S ("Contera") reported a strategic drug discovery collaboration on an undisclosed target (Press release, Vernalis, SEP 14, 2022, View Source;utm_medium=rss&utm_campaign=vernalis-research-a-fully-owned-subsidiary-of-hitgen-inc-and-contera-pharma-a-s-announce-a-strategic-collaboration-in-the-field-of-rna-targeting-small-molecules-in-neurology [SID1234621490]).

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Under the terms of the agreement, Vernalis and Contera will use their respective expertise in fragment and structure-based drug design and RNA-based drug development within neuroscience to design small molecules against a particularly challenging target for a rare neurologic disorder. All costs of activities until a predefined milestone will be shared between the partners. Should that first stage of the collaboration be successful, the partners will have the option to extend the collaboration and Vernalis will be entitled to receive research funding, downstream milestones and royalties on candidates resulting from the partnership. Contera will be responsible for development and commercialization of these candidates. The partners also have the option to extend the collaboration beyond the initial target.

Mike Wood, Managing Director of Vernalis said: "This strategic partnership marks the entry of Vernalis into the exciting field of RNA-targeting small molecules. We are extremely pleased to work with Contera on this promising target and we look forward to expanding our collaboration to multiple targets in the field of neurology."

Kenneth Vielsted Christensen, CSO of Contera, said: "We are pleased to announce this agreement which marks the expansion of our drug discovery efforts within the exciting field of RNA therapeutics. RNA-targeting small molecules is an area of high attention and entering this field will allow us to broaden both our target and indication space. The partnership with Vernalis, which is at the forefront of drug discovery innovation, enables us to drug previously undruggable neurology targets by adding small molecules targeting RNA to our existing in-house ASO and siRNA capabilities. Vernalis, a world leader in drug discovery, is a strong partner and the perfect match for us in our efforts to discover and develop novel RNA therapeutics for patients suffering from neurological disorders".

Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen Inc., commented: "It is pleasing to see this collaboration between Vernalis and Contera. Targeting RNAs by small molecules or RNAi has become an exciting approach to developing innovative medicines for many diseases affecting human health. The technologies and expertise available at Vernalis and HitGen are highly relevant in this field. I look forward to seeing further progress from the collaboration.

On September 14, 2022 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it has received an Issue Notification from the U.S. Patent and Trademark Office for a new patent which covers MN-166 (ibudilast) for the treatment of glioblastoma (Press release, MediciNova, SEP 14, 2022, https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-issue-notification-new-patent-covering-mn [SID1234619587]).

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This new patent is expected to expire no earlier than February 2039. The allowed claims cover a method of treating a patient diagnosed with glioblastoma or recurrent glioblastoma, wherein the patient expresses unmethylated MGMT, using MN-166 (ibudilast) in combination with one or more other therapeutic agents including temozolomide (TMZ), carmustine, bevacizumab, procarbazine, hydroxyurea, irinotecan, lomustine, nimotuzumab, sirolimus, mipsagargin, cabozantinib, onartuzumab, patupilone (epothilone B), and recombinant oncolytic poliovirus (PVS-RIPO). The allowed claims cover a wide range of doses of MN-166 (ibudilast) as well as the other therapeutic agents. The allowed claims also cover different types of glioblastoma including classical glioblastoma, proneural glioblastoma, mesenchymal glioblastoma, and neural glioblastoma.

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, "We are very pleased to receive the issue notification for this new patent as it offers additional coverage compared to our other two patents covering glioblastoma. We have an ongoing clinical trial of MN-166 in combination with temozolomide for the treatment of recurrent glioblastoma at the Dana-Farber Cancer Institute, Harvard Medical School. Results of our glioblastoma animal model study showed that median survival was longer in the group that received combination treatment with MN-166 plus temozolomide compared to the group that received the standard treatment of temozolomide alone, and this data was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Encouragingly, the FDA granted orphan-drug designation to MN-166 as adjunctive therapy to temozolomide for the treatment of glioblastoma based on this data."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

On September 14, 2022 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, reported shared a case report detailing the first-ever known finding of a durable complete response that could be characterized as complete clinical remission in a metastatic estrogen receptor-positive (ER+)/HER2- breast cancer patient with an ESR1 mutation after prior CDK4/6 inhibitor treatment upon participation in any single-agent hormonally based therapy (Press release, Sermonix Pharmaceuticals, SEP 14, 2022, View Source [SID1234619585]).

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The case report, "Durable Complete Remission of Metastatic ER+/HER2- Breast Cancer After Lasofoxifene Therapy," was initially shared Sept. 9 at the ninth-annual Metastatic Breast Cancer Research Conference in Park City, Utah. Lasofoxifene is Sermonix’s lead investigational drug.

The durable complete response (CR) was reported during Sermonix’s Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study. The open-label, randomized study evaluated the efficacy of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation and progression-free survival as the primary endpoint. Top-line ELAINE 1 data was presented Sept. 10 during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 in Paris. Although not statistically significant, the results of the study numerically favored lasofoxifene.

The patient was recruited to the ELAINE 1 study and started treatment on Dec. 16, 2020. Her first radiological assessment, eight weeks after lasofoxifene initiation via PET-FDG scan, revealed no pathological uptake in her pleural lesions, a sum diameter of 14 mm (55% reduction) and significant reduction of the bony lesion in the ilium with no new pathological findings. Scans at Week 16 revealed further improvement up to complete radiological disappearance of all measurable and non-measurable lesions. Radiological complete response was maintained at 80 weeks (June 29, 2022).

"Achieving a complete response in metastatic breast cancer with endocrine treatment post CDK4/6 inhibitor is exceedingly uncommon, particularly with single-agent endocrine therapy," said Dr. Einav Nili Gal-Yam, M.D., Ph.D., ELAINE 1 principal investigator and head of the Breast Oncology Institute at Chaim Sheba Medical Center in Ramat Gan, Israel. "This is a very gratifying result, pointing to lasofoxifene’s potentially significant role in addressing the unmet needs of patients with ESR1 mutations. We look forward to the continued clinical development of this drug."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.