On October 21, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO) and the University of Colorado Anschutz Medical Campus reported a collaboration to advance novel research on genetically driven diseases into therapeutic applications for patients (Press release, BridgeBio, OCT 21, 2020, View Source [SID1234576222]).

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"We are grateful to be collaborating with the University of Colorado Anschutz Medical Campus, which is the largest academic health center in the Rocky Mountain region, a world-class medical destination, and home to one of the leading Personalized Medicine Centers in the country. We are excited to work together to translate life-changing discoveries from the lab into potential medicines for patients," said BridgeBio CEO and founder Neil Kumar, Ph.D.

This collaboration comes on the heels of an eight-month pilot collaboration. Under the new, expanded collaboration, BridgeBio will support early-discovery research already underway in CU Anschutz labs and will accelerate promising therapies into the clinic in order to develop and ultimately commercialize therapies for patients. The collaboration’s structure focuses on close partnership, actionable feedback and joint touchpoints between the BridgeBio and the CU Anschutz research teams.

"This collaboration represents a new model between academia and the pharmaceutical industry. It provides all CU Anschutz faculty with the opportunity to translate cutting edge research in genetic science to patients with unmet needs," said Kimberly Muller, Executive Director of CU Innovations. "BridgeBio is uniquely suited as a collaborator as they combine a novel drug discovery platform, with the processes needed to advance multiple individual therapies simultaneously. Together, we will find, develop and deliver breakthrough medicines for genetic diseases to patients as quickly and safely as possible."

BridgeBio is determined to move away from traditional one-off interactions between drug development companies and research institutions and formalize collaborations that are built on trust, engagement, science and respect. The BridgeBio team is committed to acting responsibly with academic researchers who work around the clock to understand the mechanisms of genetically driven conditions and how we can best treat patients by targeting the disease source.

On October 21, 2020 Context Therapeutics, a clinical-stage biopharmaceutical company dedicated to advancing medicines for hormone driven cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ONA-XR in combination with the antiestrogen anastrozole in patients with recurrent endometrial cancer (Press release, Context Therapeutics, OCT 21, 2020, View Source [SID1234570453]). Sailaja Kamaraju, MD, of the Medical College of Wisconsin, and Kari Wisinski, MD, of the University of Wisconsin Carbone Cancer Center, are the study’s Co-Primary Investigators.

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The Phase 2 trial will include patients who have progesterone receptor positive (PR+), estrogen receptor positive (ER+), HER2 negative (HER2-) metastatic breast cancer who have progressed on prior CDK4/6 inhibitor therapy. Patients will be administered the combination of onapristone extended release (ONA-XR) in combination with the antiestrogen, fulvestrant. The primary endpoint will be overall response rate (ORR), which is the proportion of patients who have either a complete or partial response. To further characterize the activity of ONA-XR, secondary endpoints will include duration of response, clinical benefit rate, and progression-free survival (PFS). In addition, this study will evaluate the safety and pharmacological profile of ONA-XR in these patients, as well as biomarker analyses to explore predictive factors of response to ONA-XR, including activity in patients with ESR1 and PIK3CA mutations.

"Currently, there are limited therapeutic options to treat metastatic breast cancer. Recent preclinical findings, together with Phase 1 study results in patients with metastatic PR+ breast cancers, give us reason to believe that ONA-XR can help these women with PR+ breast cancers," said Tarek Sahmoud, MD, PhD, Chief Medical Officer of Context Therapeutics. [1],[2]. "We believe ONA-XR can make a meaningful difference for patients in the trial."

About Onapristone Extended Release
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers. Preliminary preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin, downregulating cancer stem cell mobilization and blocking immune evasion. ONA-XR is currently the subject of an ongoing Phase 2 clinical trials in progesterone receptor positive breast, ovarian, and endometrial cancers. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.

On October 21, 2020 The board of directors of NeoDynamics AB ("NeoDynamics" or the "Company") reported that an extraordinary general meeting is convened to resolve on a directed new share issue to a limited group of investors (the "Share Issue") (Press release, NeoDynamics, OCT 21, 2020, View Source [SID1234568891]). The subscription price is proposed to be SEK 3.71 per share and is decided through an accelerated bookbuilding process. The Share Issue can bring approximately SEK 90 million before transaction costs to the Company. As a result of the Share Issue, Cardeon Futuring Finance ("Cardeon") – with Chairman of the Board Masoud Khayyami together with the the management team – can become one of the larger shareholders of NeoDynamics. The Dutch company Nyenburgh Holding BV ("NYIP") also participates in the Share Issue.

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NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER OF ANY SECURITIES OF NEODYNAMICS AB (PUBL). PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.

The Share Issue can add a total of 24,243,641 new shares, priced at SEK 3.71 per share. The new shares are priced at a discount of 13.7 percent compared to the closing price of NeoDynamics stock at Spotlight Stock Market on October 21, 2020.

The Company has made the assessment that the subscription price is fair regarding the current industry- and market conditions and that it is in the best interest of both the Company and its shareholders to carry out the Share Issue. The Share Issue is subject to resolution at an extraordinary general meeting to be held on the 19th of November 2020, which will be convened in a separate press release.

The reason to deviate from the shareholders’ pre-emption rights is to ensure the most time and cost-effective financing of the Company’s continued commercialization and widen the number of institutional owners.

The proceeds from the Share Issue will be used to finance ongoing operations. NeoDynamics is planning towards the sale-start of its new ultrasound guided tissue sampling system NeoNovia in UK, Sweden, and Germany by the end of 2020 and in the US during 2021. The system intends to better the process of diagnosing breast cancer.

"NeoDynamics new product, with its micropulse technology, can substantially improve breast cancer diagnosis and establish a new global standard within the field. Cardeon will actively support NeoDynamics in the long run and secure the process of establishing NeoNovia as the future system of high-precision biopsy" – Masoud Khayyami, Chairman Cardeon Futuring Finance.

Cardeon offers funding to innovative and promising Nordic companies in Life Sciences, with the potential to change the global market. Cardeon is the largest shareholder of the publicly traded companies SpectraCure, Lumito, and Prolight Diagnostics. Masoud Khayyami has substantial experience in research, medical, medtech, and biotechnical sectors and solid entrepreneurial experience. He is the CEO of SpectraCure and Chairman of several other companies, including Lumito and Prolight Diagnostics.

Nyenburgh Holding BV is a dedicated investors group within Life Science, based in Amsterdam. NYIP has a strong focus on European biotech and medical companies that develop innovative solutions for people’s health.

"We are glad to welcome a long-term financier as Cardeon, who holds an existing portfolio of innovative companies within the cancer-industry, and we see great synergy possibilities and possible future collaborations on the market for cancer treatment. We also welcome Nyenburgh Holding BV as a new initiated owner" – Anna Eriksrud, CEO NeoDynamics

Through the Share Issue, the Company’s total number of shares can increase by a maximum of 24,243,641 shares, from 36,006,951 to 60,250,592 shares. The share capital can increase by a maximum of SEK 2,424,364.10, from SEK 3,600,695.10 to SEK 6,025,059.20.

In order to finance the Company’s operations until the issue proceeds from the Share Issue has been received by the Company, the Company has entered into a loan agreement with Cardeon regarding a bridge loan (the "Bridge Loan"). The Bridge Loan amounts to a total of SEK 10 million and carries an annual interest rate of 12 percent and a set-up fee of 4 percent of the nominal loan amount. The Bridge Loan, accrued interest and set-up fee are due for payment on December 31, 2020, if repayment has not been made before that date. Repayment of the Bridge Loan, including the set-up fee, to Cardeon is intended to be made by set-off against shares in the Share Issue.

On October 21, 2020 Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, reported the award of a £1 million Smart Grant from the UK’s innovation agency, Innovate UK (Press release, Epsilogen, OCT 21, 2020, View Source [SID1234568793]). Epsilogen will collaborate with King’s College London and use the Smart Grant in a project to further develop the company’s novel cancer immunotherapeutic, EPS 201.

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The project directly follows and is founded upon the outputs from Epsilogen’s previous Biomedical Catalyst Primer grant, which sought to move the Company’s EPS 201 programme closer to the clinic. EPS 201 is a novel IgE-based therapeutic targeting HER2 positive (HER2+ve) solid tumours, harnessing the potent IgE-mediated immune response already showing promise clinically with Epsilogen’s lead drug MOv18-IgE.

EPS201 could address a large unmet need in breast cancer patients with HER2+ve cancers that fail to meet the HER2 expression level needed for Herceptin treatment. Currently, these patients have a five-year survival of less than 70%, which is much lower than that for HER2 negative patients.

Epsilogen’s share of the grant is £0.7m, with the remaining £0.3m being used by King’s to fund the research scientist and laboratory team working on the project.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: "We are proud to have been awarded another grant from Innovate UK for our pioneering work developing IgE-based therapeutics. It is a recognition of our progress to date and the potential that our therapies have in treating patients with cancer. We are looking forward to continuing our very successful collaboration with King’s College London and Professor Karagiannis, whose ground-breaking work is the foundation of the company we are today."

Dr Sophia Karagiannis, Professor of Translational Cancer Immunology and Immunotherapy from King’s College London, commented: "IgE therapies have a clear differentiation from IgG-based therapies, given their completely unique anti-cancer mode of action. Furthermore, EPS 201 has potential to address a large unmet need in breast cancer patients with HER2 positive cancers, making it an ideal candidate for further funding and investigation."

On October 21, 2020 Teneobio, Inc., a clinical-stage biotechnology company developing engineered bispecific antibodies to treat cancer, reported that it has entered into a research collaboration and commercial license agreement with ArsenalBio for the use of Teneobio’s UniDabs, single-domain, human heavy chain only antibodies in Chimeric Antigen Receptor (CAR) T-cell therapy (Press release, TeneoBio, OCT 21, 2020, View Source;utm_medium=rss&utm_campaign=arsenalbio [SID1234568789]).

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Under the terms of the agreement ArsenalBio will have commercial rights to UniDabs against therapy-guiding antigens for one of its proprietary immune cell therapy programs. Teneobio will receive an upfront payment, potential clinical and regulatory approval milestones as well as royalties on commercial sales world-wide.

Omid Vafa, CBO of Teneobio, said, "We are excited that ArsenalBio selected UniDabs as part of its efforts to advance immune cell therapies targeting solid tumors. We believe our UniDab platform for targeted cellular therapies offers unique advantages to support the work underway by the ArsenalBio team." Ken Drazan, CEO of ArsenalBio said, "We continue to make notable progress in our pipeline toward addressing the unmet need and suffering of patients with cancer by developing and advancing a new paradigm of human immune cell therapy design, manufacture, and clinical assessment. The UniDab platform will help contribute to this important work on behalf of patients."