On September 20, 2022 Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported that it has entered into an asset purchase agreement and a sub-license agreement with SillaJen, Inc. for Basilea’s novel kinase inhibitor, BAL0891, a potential first-in-class mitotic checkpoint inhibitor, that drives aberrant tumor cell division leading to tumor cell death (Press release, Basilea Pharmaceutica, SEP 20, 2022, View Source [SID1234625345]).

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Basilea in-licensed BAL0891 in 2018 from the Dutch precision medicine company NTRC. Under the asset purchase agreement Basilea is selling its intellectual property rights generated under the license and collaboration agreement with NTRC. In addition, Basilea is sub-licensing its rights and obligations under the license and collaboration agreement with NTRC to SillaJen.

Adesh Kaul, Chief Financial Officer of Basilea, said: "We are pleased to have found in SillaJen an experienced oncology partner for the further development of BAL0891. This transaction marks an important step on our path to be a focused anti-infectives company. We are proud to have advanced BAL0891 through preclinical development to the start of clinical studies. The unique inhibition profile of BAL0891, targeting both TTK and PLK1 kinases, differentiates the compound and offers the potential for development in multiple cancers. Through the structure of the transaction we continue to participate in the long-term value creation potential of this promising program."

Jaegyeong Kim, MD, CEO at SillaJen, Inc. stated: "We are excited to acquire the rights to BAL0891. This agreement for a first-in-class anti-cancer drug, demonstrates our commitment to enhance lives of patients suffering from advanced solid tumors. In addition to our leading pipeline of Pexa-Vec, and the next generation SJ-600 series of oncolytic virus modalities, we are committed to advance and further develop medicines that will address the greatest unmet needs in cancer treatment. We hope to successfully deliver these products and help alleviate the burden of cancer patients worldwide."

Under the terms of the agreement, Basilea will receive upfront and near-term milestone payments of USD 14 million. Basilea is also eligible to receive further payments of up to approximately USD 320 million upon the achievement of predefined development, regulatory and sales milestones and tiered royalties on net sales starting in the single digit range going up to double-digits. Basilea remains responsible for making milestone and royalty payments to NTRC according to the license and collaboration agreement with NTRC.

In February this year Basilea announced its intention to focus on becoming a leading anti-infectives company and therefore to separate its oncology assets. Basilea has already made significant progress in the implementation of the new strategy and expects no material expenses related to oncology activities beyond 2022. Basilea is on track to achieve sustainable profitability from 2023.

Basilea updates its full-year 2022 financial guidance. It expects higher total revenues of CHF 116 to 122 million (previously CHF 106 to 112 million), an improved operating result of CHF -10 to -15 million (previously CHF -20 to -25 million) and improved cash flow from operating activities of CHF 0 to -5 million (previously CHF -10 to -15 million).

About SillaJen, Inc.

SillaJen, Inc. (KOSDAQ:215600) is one of the leading biotech companies in the development of oncolytic vaccinia immunotherapy. It is headquartered in Seoul, South Korea, with research center and satellite offices in Busan, South Korea and San Francisco, CA. SillaJen, Inc. is conducting Phase 2 trials for the treatment of renal cell carcinoma with the company’s lead pipeline, Pexa-Vec. The company is also developing intravenous injectable oncolytic vaccinia virus pipelines (SJ-600 series) to be more applicable and efficacious against various tumors. Additional information about SillaJen, Inc. is available at www.sillajen.com.

About BAL0891

BAL0891 is a first-in-class mitotic checkpoint inhibitor that pushes cells through mitosis without adequate time for correct chromosome segregation. This results in aberrant tumor cell division leading to tumor cell death. The compound is a unique dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1). Both kinases collaborate in activating the mitotic spindle assembly checkpoint (SAC), a cell division mechanism regulating correct chromosome alignment and segregation. The dual action of BAL0891 leads to a rapid disruption of the SAC driving cells through mitosis before the chromosomes are properly aligned, leading to premature cell division and tumor cell death. BAL0891 has shown anti-proliferative activity across diverse tumor cell lines in vitro and single agent efficacy in in-vivo models of solid human cancers. BAL0891 was in-licensed from NTRC in 2018.

On November 20, 2022 Elicio Therapeutics reported that it received a $2.8 million grant from the Gastro-Intestinal Research Foundation (GIRF) in Chicago to fund research for two therapeutic cancer vaccines (Press release, Elicio Therapeutics, SEP 20, 2022, View Source [SID1234623980]).

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On September 20, 2022 Cellistic, the cell therapy development and manufacturing business of Ncardia BV, and Celyad Oncology (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported a transaction whereby Cellistic will acquire Celyad Oncology’s Good Manufacturing Practice (GMP) grade cell therapy manufacturing capability, including the existing facility and all related personnel (the "Manufacturing Business Unit") (Press release, Celyad, SEP 20, 2022, View Source [SID1234623187]).

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Under the terms of an asset purchase agreement between Celyad Oncology and Cellistic, Cellistic agreed to acquire Celyad Oncology’s Manufacturing Business Unit in Mont-Saint-Guibert, Belgium, for a total consideration of €6 million. Celyad Oncology’s experienced manufacturing team will join Cellistic. The transaction is subject to a number of customary conditions precedent and is anticipated to close in the fourth quarter of this year.

"We at Cellistic are incredibly excited to welcome this uniquely talented team into our organization," said Stefan Braam, founder and CEO of Cellistic. "We’re bringing aboard a group of people whose passion and capabilities align incredibly well with our vision for the future of cell therapy. As a joined force, we have the talent and resources to further accelerate work on our proprietary platforms and the capability to enable Cellistic’s partners to bring iPSC-based allogeneic cell therapies to patients faster."

Michel Lussier, co-founder and interim CEO of Celyad Oncology, said, "We have focused our efforts on an allogeneic approach for the past few years and our manufacturing facility and staff has been a key element to enable many of our past trials, but has been underutilized in recent years as we mainly used the facility for our autologous candidates. Our current allogeneic programs are better suited for outsourced manufacturing. Through existing materials manufactured at Celyad, we have ensured the means to continue our clinical programs with cryopreserved cells until 2024. Based on this strategy, we are confident that this decision to transfer our manufacturing facility and the staff to Cellistic, who is the perfect company for such an agreement, will allow us to further execute on our business goals in the future."

Cellistic will invest substantial capital into the newly acquired 11,000 square foot facility, which will be optimized for its iPSC-based allogeneic cell therapy platforms and processes creating the world’s first purpose built facility to support customers from cell reprogramming and master cell banking through clinical trial material manufacturing. A team of more than 30 manufacturing, quality and related personnel from Celyad Oncology, all with substantial cell therapy manufacturing and immune-oncology experience, will join Cellistic as part of this transaction.

Celyad Oncology will provide additional guidance on the future business strategy of the Company in the fourth quarter of this year.

On September 20, 2022 ATOMIC reported that Retrospective data showed how common central nervous system metastases are among patients with non-small cell lung cancer and ALK or ROS1 alterations who have been treated with tyrosine kinase inhibitors (Press release, ATOMIC, SEP 20, 2022, View Source;utm_medium=rss&utm_campaign=industry-news-brain-mri-surveillance-needed-for-tkl-treated-alk-or-ros7-positive-nsclc [SID1234623183]).

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"I’m really excited about this study because it’s a collaboration between 12 sites across North America, including one in Canada," Melina Marmarelis, MD, assistant professor of medicine at University of Pennsylvania remarked about a presentation from the ASCO (Free ASCO Whitepaper) Annual Meeting. "It’s a retrospective cohort study of patients with ALK and ROS1 alterations in non-small cell lung cancer. It’s one of the biggest retrospective studies out there."

Academic Thoracic Oncology Medical Investigators ConsortiumThe study collaborators came from 12 Academic Thoracic Oncology Medical Investigators Consortium (ATOMIC) sites.

"This is a cohort of patients starting in 2003 all the way to 2021," Marmarelis said. "This will allow us to really look at treatment patterns and the effect of sequential therapies, in particular, on things like brain metastases."

The final analyses included 566 patients with ALK (n = 464) and ROS1 (n = 102) alterations. In the ALK group, 92% (n = 426) received a TKI at some point during therapy and 86% (n = 88) in the ROS1 group. TKI was first line therapy for 262 patients with the ALK alteration and for 48 patients with ROS1.

The most common first line TKI was crizotinib (Xalkori, Ffizer) for both ALK and ROS1 alterations, followed by alectinib (Alecensa, Genetech) for ALK and lorlatinib (Lorbrena, Pfizer) for ROS1. The second most common initial TKI was alectinib for ALK and entrectinib (Rozlytrek, Genentech) for ROS1. For patients with ALK alterations, the median follow-up time was 31.1 (95% CI, 27.6-35) months and 32.6 (95% CI, 25.7-39.6) months for patients with ROS1 alterations.

According to the abstract, the median overall survival from start of the first TKI was 53.3 months for ALK alterations ( 95% CI, 40-68.9) and 42 months for ROS1 alterations ( 95% CI, 31.8-not reached). Prior to receiving first line therapy, 321 patients had available brain imaging. Of these patients, 40% with ALK alterations, (n = 105) and 39% with ROS1 (n = 23) had CNS disease.

"We zeroed in on brain metastases for this presentation and showed that they are still very prevalent among patients with ALK and ROS1 alterations," Marmarelis said. "In particular, with the earlier TKis such as crizotinib, patients are more likely to develop a new brain metastasis while on treatment as opposed to some later-generation TKis."

Among patients without previous CNS disease, brain metastases developed at 24 months in 14.4 % ( 95% CI, 6.1-26.1) of patients in the ALK group who received other TKI’s compared with 48.9% ( 95% CI, ) who received crizotinib. For patients in the ROS1 group, 47.4 % ( 95% CI, 27.9-64.6) developed brain metastases at 24 months. Treatment discontinuation of first TKI occurred a median 11.2 months for ALK alteration and 10.8 months for ROS1.

"What this really shows is that even with later-generation TKis, brain metastases are common and routine surveillance with brain MRis should be included in the treatment of these patients," Marmarelis concluded.

Source: Marmarelis, ME, et al. Treatment patterns and outcomes in ALK or ROS1 altered NSCLC: An ATOMIC Registry Study. Presented at: ASCO (Free ASCO Whitepaper) Annual Meeting; June 3-7, 2022; Chicago.

Acknowledgements: Helio.com / HemOnc Today, by Marley V. Ghizzone

On October 20, 2022 SYnAbs reported a research collaboration program to discover novel therapeutic antibodies against challenging G Protein Coupled Receptor (GPCR) targets (Press release, Domain Therapeutics, SEP 20, 2022, View Source [SID1234622452]).

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For Domain Therapeutics, this collaboration aims at diversifying its proprietary portfolio of immunotherapies with biologics to deliver therapeutic solutions against tumors triggering GPCR-mediated immunosuppression. Under the terms of the agreement, Domain Therapeutics retains exclusive worldwide rights to validate, optimize, develop and commercialize any therapeutic antibodies discovered in the course of the collaboration.

For SYnAbs, the goal is to further optimize its technologies capable of generating highly specific antibodies targeting epitopes that are difficult to express in their native and functionally active conformation.

SYnAbs approach consists in immunizing species with peptides and its proprietary syngeneic cell lines, all mixed with its in-house adjuvant in order to neutralize the immunotolerance usually developed against highly homologous transmembrane targets and benefit from a natural in-vivo maturation.

SYnAbs is also the developer of the rat-LOU species, a species known to be a high responder against haptens and which has the unique ability to naturally generate autoantibodies. This animal is already the source of several therapeutic antibodies such as Siplizumab (licensed to MedImmune, Phase III), LO-CD2b (Preclinical Tox), LO-TACT- 1, anti-CD25 (Phase I/II) and more recently SYnC3aR, a blocking mAb to hC3aR anaphylatoxin receptor.

Under the terms of the agreement, SYnAbs will utilize its know-how and proprietary technologies combined with Domain Therapeutics deep expertise in GPCRs and immuno-oncology to identify novel high-potential drug candidates. Domain will be responsible for the preclinical and clinical development of the jointly discovered antibodies and for a potential partnership with a third party company according to Domain Therapeutics strategy.