On November 21, 2022 Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") reported to share more information with the Company’s shareholders about the proposed merger between the Company and APIM Therapeutics ("APIM") (Press release, Nordic Nanovector, NOV 21, 2022, View Source [SID1234624314]). The Company has scheduled a webcast, including a question and answers session, on Thursday, November 24 at 4.30 CET. Practical details regarding the webcast will be issued in a separate notice. Any questions may be submitted to [email protected].

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The Board of Nordic Nanovector and its advisors reiterates its belief that the merger with APIM is in the best interests of all shareholders. The transaction creates a viable path to future value generation. The largest shareholders in Nordic Nanovector were made insiders and informed about the contemplated transaction ahead of the announcement in accordance with market practice.

The strategic review to explore the Company’s options has concluded that a stand-alone strategy is not a viable option. Through the review, Carnegie Investment Bank ("Carnegie") and the Company have held discussions with over 25 Nordic and international companies. Detailed discussions took place with several players in the health care sector, including companies with Phase 2 assets, with valuations representing higher dilution for Nordic Nanovector shareholders. These discussions were conducted with big pharma and other biotech companies, both listed and privately held. Opportunities for a transaction outside the health care sector, with companies particularly interested in listing on Oslo Børs main market and in the Company’s balance sheet assets, were also investigated.

However, these did not result in terms that were competitive or that recognised an appropriate valuation of the Company.

The proposed recommended merger with APIM brings access to a highly attractive Phase 2 oncology asset in ATX-101, a very experienced CEO and CMO, plus a strong investor base that understands the biotech industry and oncology drug development and will continue to support the new merged company through the next phase of its development. As part of the merger process, APIM and the R&D team at Nordic Nanovector, will evaluate the pipeline of both companies to determine the product development plan of the combined entity. This plan, including anticipated future milestones, will be presented to shareholders in the near future.

The Board urges the shareholders to make their own assessment for their investment decision and participation at the upcoming general meeting, either by proxy, advance voting or personal attendance. Despite the unfortunate circumstances of the Company following the closing of the PARADIGME trial, the Board of director’s opinion is that the proposed transaction is in the best interest of the Company and its shareholders.

Background to the Proposed Merger

The merger, which is backed by the Boards of both companies, is the result of an extensive review that explored a range of strategic options for the Company. The Company believes that this transaction, in this very difficult market environment where many biotech companies are running low on cash, represents an exciting opportunity for all shareholders given the significant and broad potential of ATX-101, a novel anti-cancer peptide currently in Phase 2 trials. In addition, the combined company will have the discovery and development expertise to potentially generate multiple future new drug candidates from its technology platforms.

Nordic Nanovector’s Board has carried out a robust review of its strategic options over the past months in conjunction with Carnegie. Following this review, the Board concluded that a stand-alone strategy was not a viable option given that Nordic Nanovector’s pipeline was centred on preclinical drug candidates that would require significant additional financial resources to advance and create shareholder value. Hence, the Company’s Board believes that the proposed merger with APIM Therapeutics is in the best interests of the Company and all its shareholders. This belief is based on the attractive prospects for the combined company, which is well placed to generate shareholder value.

In addition, the new combined company will also have the support of a group of knowledgeable life science investors including Sarsia Seed AS, Trond Mohn Stiftelsen, Norsk Innovasjonskapital III AS and Investinor Direkte AS.

Advisers

Carnegie Investment Bank is acting as financial advisor to Nordic Nanovector. Advokatfirmaet Selmer AS is acting as legal advisor to Nordic Nanovector and KPMG AS assisted Nordic Nanovector with financial due diligence and a fairness opinion of the exchange ratio.

Advokatfirmaet Schjødt AS is acting as legal advisor to APIM.

On November 21, 2022 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for highly aggressive cancers, reported that four abstracts highlighting CFI-402257 and CFI-400945, the Company’s potent and selective inhibitors of TTK and PLK4, respectively, have been accepted for presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Treadwell Therapeutics, NOV 21, 2022, View Source [SID1234624313]).

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"We are grateful that several abstracts highlighting our TTK and PLK4 inhibitor programs have been selected for presentation," said Dr. Michael Tusche, Treadwell co-CEO. "We look forward to additional data from these studies, as we further characterize the utility of our agents in various breast cancer settings."

On November 21, 2022 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that it has raised $38 million in a Series A financing, led by Longitude Capital and Northpond Ventures, with additional participation from Menlo Ventures (Press release, Opna Bio, NOV 21, 2022, View Source [SID1234624312]). The proceeds will be used to develop novel fragile-X mental retardation protein (FMRP) inhibitors in oncology as well as a diverse portfolio of clinical and preclinical oncology programs acquired from Plexxikon Inc.

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"I’m very excited about our rich drug candidate portfolio, which is focused on targeting immune suppression and other hallmarks of cancer"

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Opna was co-founded by Gideon Bollag, PhD, who was appointed chief executive officer; Douglas Hanahan, PhD, distinguished scholar in the Lausanne Branch of the Ludwig Institute for Cancer Research and emeritus professor at the Swiss Federal Institute of Technology Lausanne (EPFL); and Joseph Schlessinger, PhD, professor of pharmacology at Yale University School of Medicine.

"We are thrilled to be a lead investor in Opna and to support this top-tier team of drug discovery and development experts who bring a strong track record of paradigm-changing cancer drug innovation and value creation," said Patrick Enright, managing director of Longitude Capital.

"I’m very excited about our rich drug candidate portfolio, which is focused on targeting immune suppression and other hallmarks of cancer," said Dr. Bollag. "As a new company, Opna offers that rare combination of a compelling novel drug target as well as a diverse pipeline of preclinical and clinical programs, some of which have shown combinatorial activity in our FMRP models."

Novel FMRP Oncology Discovery Program Suggests Potential for Both Single Agent Use and Combination Therapy

Opna’s launch coincides with a Science* publication from the Hanahan Laboratory EPFL about FMRP’s emerging role as an immuno-oncology target. In the paper, "Aberrant hyperexpression of the RNA binding protein FMRP in tumors mediates immune evasion," Dr. Hanahan showed for the first time that knocking out or knocking down the FMRP gene in cancer cells enables the body to launch an immune response against tumors that are otherwise resistant to immune attack. Opna has an exclusive license for technology associated with FMRP from EPFL.

Previous research has shown that FMRP expression is elevated in certain cancers, including pancreatic, colon, breast, prostate and lung cancer. Importantly, some of these cancers are largely resistant to immune checkpoint therapy, potentially because of suppression of proinflammatory signals associated with elevated FMRP. Data from the Hanahan Laboratory demonstrate that upregulated expression of FMRP in cancer cells suppresses the recruitment and capability of T cells to attack and kill tumors. Consequently, blocking FMRP expression resulted in T cell activation leading to anti-tumor immunity. The data also showed additional anti-tumor benefit when FMRP depletion was combined with immune checkpoint inhibitors.

Acquisition of Plexxikon’s Oncology Assets Rounds Out Diversified Portfolio with Strong IP

As part of Opna’s formation, the company acquired a portfolio of small molecule oncology therapeutics from Plexxikon Inc.

The clinical-stage assets include:

OPN-2853 (formerly PLX2853), a potential best-in-class bromo and extra terminal (BET) domain inhibitor currently in a Phase 1/2 clinical trial in combination with ruxolitinib (Jakafi) for myelofibrosis, a rare myeloid cancer
OPN-7486 (formerly PLX7486), a colony-stimulating factor 1 (CSF1) receptor inhibitor expected to begin a Phase 2 study in 2023
Pre-clinical programs include:

E1A binding protein (EP300) inhibitor
Cluster of differentiation 73 (CD73) inhibitor
Transcriptional enhanced associated domain (TEAD) inhibitor
Opna has assembled a top-tier team of experienced leaders and advisors. The executive leadership team includes:

Gideon Bollag, PhD, chief executive officer. Dr. Bollag previously served as Plexxikon’s chief executive officer. Under his scientific leadership, the team developed two FDA-approved drugs, Zelboraf for metastatic melanoma and Turalio for tenosynovial giant cell tumor (TGCT). Dr. Bollag was also a member of the founding scientific team at Onyx Pharmaceuticals, where he oversaw Onyx support for the discovery of Nexavar and Ibrance. He serves on the external advisory board of the NCI RAS initiative and on the scientific advisory board at Ambagon Therapeutics. Dr. Bollag received his PhD in biochemistry from the University of California, Berkeley.
Reinaldo Diaz, chief business officer. Mr. Diaz brings more than 30 years of investment, financing and business development expertise. He concurrently serves as a venture partner at Longitude Capital and previously served as managing director of Auven Therapeutics, a life sciences private equity firm. He is a member of the board of Inozyme Pharma and Lexeo Therapeutics. Mr. Diaz received his undergraduate and MBA degrees from Harvard University.
Gaston Habets, PhD, chief development officer. Previously, Dr. Habets was senior director of research at Plexxikon, where he helped spearhead the discoveries of Zelboraf and Turalio. Prior to Plexxikon, he held scientific leadership positions at Syrrx and Onyx Pharmaceuticals. Dr. Habets received his PhD in tumor biology from the Netherlands Cancer Institute.
Jackie Walling, MBChB, PhD, chief medical officer. Dr. Walling brings extensive experience in global clinical development of oncology and rare disease drugs, most recently serving as chief medical officer for Plexxikon. She was previously vice president, clinical development at BioMarin. She received her PhD in biology from the University of Southampton, UK and her MBChB from the University of Bristol.
The Opna Board of Directors includes:

Joseph Schlessinger, PhD, chairman of the board, professor of pharmacology at Yale University, current and previous strategic affiliations with Sugen, Plexxikon, Kolltan and Inozyme
Gideon Bollag, PhD, chief executive officer, former CEO of Plexxikon and founding member of Onyx Pharmaceuticals
Patrick Enright, managing director, Longitude Capital
Shaan C. Gandhi, MD, DPhil, director, Northpond Ventures
Douglas Hanahan, PhD, distinguished scholar, Ludwig Institute for Cancer Research, and emeritus professor, Swiss Federal Institute of Technology Lausanne
Brian Pusch, JD, chairman and CEO, Microbes, co-founder of Inozyme Pharma
The Scientific Advisory Board (SAB) includes:

Douglas Hanahan, PhD, chairman of the SAB, distinguished scholar, Ludwig Institute for Cancer Research, and emeritus professor, Swiss Federal Institute of Technology Lausanne (EPFL)
Benjamin Cravatt, PhD, professor, Scripps Research Institute; co-founder of Activx Biosciences, Abide Therapeutics and Vividion Therapeutics
Robert Darnell, MD, PhD, professor and senior physician at Rockefeller University
Frank McCormick, PhD, professor and chair of tumor biology and cancer research, UCSF Cancer Center; current and previous strategic affiliations with Chiron, Onyx, BridgeBio, Olema, Avidity
Joseph Schlessinger, PhD, professor of pharmacology at Yale University, current and previous strategic affiliations with Sugen, Plexxikon, Kolltan and Inozyme
Berta Strulovici, PhD, former director of The Israel National Center for Personalized Medicine at Weizmann Institute of Science, iPierian, Merck & Co

On November 21, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the publication of an abstract highlighting new clinical data for zanidatamab, a HER2-targeted bispecific antibody (Press release, Zymeworks, NOV 21, 2022, View Source [SID1234624311]). Zanidatamab in combination with palbociclib and fulvestrant was well tolerated, with encouraging and durable antitumor activity in heavily pretreated patients with HER2-positive HR+ breast cancer . A poster with an updated and expanded data set will be presented at SABCS taking place in San Antonio, Texas and virtually on December 6-9, 2022.

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Abstract highlights from the February 24, 2022 data cut:

Thirty-four heavily pretreated patients with HER2-positive HR+ breast cancer were treated with zanidatamab in combination with palbociclib and fulvestrant.
The confirmed objective response rate was 34.5% and the disease control rate was 93.1% in 29 response-evaluable patients.
Ongoing durable responses were seen out to 14.9+ months, with 18 patients still on treatment at the time of the data cut.
Treatment-related adverse events were generally consistent with previous reports of zanidatamab and/or chemotherapy regimens, with the majority reported as Grade 1 or 2 in severity.
This regimen has the potential to be a chemotherapy-free treatment option in patients with HER2-positive HR+ metastatic breast cancer.
The abstract is available on the SABCS conference website. The spotlight poster presentation will be available on Friday, December 9 at 7:00 am Central Time (CT) to conference registrants on the SABCS conference website as well as to the general public on the Zymeworks website.

Title: Treatment of HER2-positive (HER2+) hormone-receptor positive (HR+) metastatic breast cancer (mBC) with the novel combination of zanidatamab, palbociclib, and fulvestrant

Lead Author: Santiago Escrivá-de-Romani, MD, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital; Barcelona, Spain

Program Number: PD18-10

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2 and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.

On November 21, 2022 Scorpion Therapeutics, Inc. ("Scorpion"), a pioneering oncology company redefining the frontier of precision medicine through its Precision Oncology 2.0 strategy, reported that it will present preclinical data on STX-478, its potential best-in-class mutant-selective PI3Kα inhibitor, in a poster session at San Antonio Breast Cancer Symposium ("SABCS") in San Antonio, Texas, taking place December 6 – 10, 2022 (Press release, Scorpion Therapeutics, NOV 21, 2022, View Source [SID1234624310]).

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STX-478 is a highly selective, allosteric and CNS-penetrant inhibitor of mutant PI3Kα, designed to improve outcomes in patients harboring tumors with prevalent PI3Kα kinase or helical domain mutations. Scorpion has completed IND-enabling studies for STX-478 and expects to submit an IND application to the U.S. Food and Drug Administration ("FDA") in the first quarter of 2023.

"We are excited to present preclinical data that further support STX-478’s potential as a best-in-class PI3Kα inhibitor and advances its development as a novel therapeutic for the treatment of many solid tumors that are underserved by existing options," said Axel Hoos, M.D., Ph.D., Chief Executive Officer of Scorpion Therapeutics. "Despite PI3Kα being one of the most highly-mutated targets in cancer, currently available therapies suffer from serious limitations, including a lack of wild-type selectivity, which induces metabolic dysfunction and causes dose-limiting toxicities, and an inability to penetrate the central nervous system (CNS), which leaves brain metastases – a common occurrence in solid tumor patients – unaddressed. We are confident that STX-478 can address these challenges through superior monotherapy activity, as well as in combination with relevant co-treatments, without sacrificing tolerability."