On June 2, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq:RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that members of its senior management team will participate in a fireside chat at the 42nd Annual Goldman Sachs Virtual Global Healthcare Conference on Wednesday, June 9 at 3:50 p.m. Eastern Time (Press release, Repare Therapeutics, JUN 2, 2021, View Source [SID1234583410]).

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A live webcast of the fireside chat can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days.

On June 2, 2021 Harvard University reported that it has granted an exclusive license to biotechnology company Obatala Sciences to commercialize innovations that enable the study of human fat tissue in vitro (Press release, Obatala Sciences, JUN 2, 2021, View Source [SID1234583408]). Harvard Office of Technology Development and Obatala, which manufactures stem cell and hydrogel products to enable next-generation therapeutics discovery, announced the agreement today .

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Obatala Sciences operates in the organ-on-a-chip or microphysiological system industry, a fast-growing scientific field that enables pharmaceutical companies to better model human response to therapies, in comparison to traditional laboratory approaches. The licensed Harvard technology, an adipose-on-a-chip, provides a method of obtaining adult-size fat tissue cells for study in vitro and enables the testing of weight loss and cancer-targeting therapeutics without the need for testing in animals. The adipose chips can respond to starvation and simulated meals, and they demonstrate key hormonal activity that is a hallmark of adipose as a functional organ. This ground-breaking technology provides a more accurate and dynamic model of human tissue in its diseased state compared to traditional two-dimensional culture.

The adipose chips were developed by researchers led by Kit Parker, PhD, the Tarr Family Professor of Bioengineering and Applied Physics at Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) and Associate Faculty member of Harvard’s Wyss Institute for Biologically Inspired Engineering. Parker’s lab at Harvard SEAS developed and demonstrated novel methods of culturing human fat cells to model a diseased state in vitro. The findings were published, for example, in the journal Lab on a Chip (2020). The worldwide license agreement with Harvard enables Obatala to make the technology widely available for researchers’ use in drug discovery and R&D.

As a key part of its mission, Obatala promotes diversity in clinical research with the goal of speeding up the development of better therapies for diseases like obesity, diabetes, and cancer, which disproportionately affect minority populations. The company has rapidly grown to establish a robust pipeline of stem cells, unique human-derived hydrogels, and media products that combine to mimic tissue from patients of specific populations.

"We are elated to be able to expand access to transformational research tools from Harvard that may help speed up the research and discovery of better treatments for patients who are traditionally excluded from clinical trials and those who need them the most," said Obatala Sciences CEO Trivia Frazier, PhD, MBA. "The adipose chip technology provides us another crucial tool to promote diversity in research and improve outcomes for all patients. Organ-on-a-chip technology is revolutionary and may forever change the way we approach drug discovery on a global scale."

"I am excited for the translation opportunity that the license to Obatala represents for these technologies developed in the Disease Biophysics Group at Harvard," Parker said. "Trivia and I have talked for almost a year now and share a vision of how organs on chips can enable innovation in the pharma and biotech industries, and how the spin-off technologies represent new therapeutic opportunities in and of themselves. I’m hopeful that my lab’s innovations in tissue engineering may lead to numerous impactful uses of synthetic adipose, including this effort to accelerate the development of better treatments for disease."

Frazier, a New Orleans native, said Obatala is the first life sciences firm based in New Orleans that is run by an African-American woman. To date, Obatala has received more than $2 million in federal funds to support the commercialization of its hydrogels and media products, and it has made history as the first minority female-owned firm to raise over $1 million in institutional funds to grow a biotechnology enterprise in Louisiana.

The license agreement with Harvard, Frazier said, will help Obatala expand its offerings of microphysiological systems that biomedical researchers can use to mimic various tissues throughout the human body. In consideration for the license, the university has received equity in the company and is eligible to receive royalties on resulting products. The license agreement also includes global access provisions, in keeping with Harvard’s longstanding commitment to promote equitable access to technologies of significant public health benefit in developing countries.

On June 2, 2021 Proteros biostructures GmbH ("Proteros") reported that it has signed an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to jointly discover and develop novel small molecules for the potential treatment of various types of cancer (Press release, AstraZeneca, JUN 2, 2021, View Source [SID1234583407]).

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The collaboration brings together Proteros’ discovery capabilities which are tailored to unlock even the most technically challenging drug targets with AstraZeneca’s expertise in target biology and medicinal chemistry to jointly discover novel lead compounds which will be further developed, manufactured, and commercialized by AstraZeneca.

Under the agreement, AstraZeneca will provide research funding and Proteros will be eligible for success-based research, development, and commercial milestone payments up to 62 million EUR plus tiered royalties on annual net sales.

"We believe that advances in epigenomic capabilities will bring forward the next wave of innovation in cancer development through the discovery and development of novel small molecules," said Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca. "Proteros’ proprietary discovery platform enables us to screen epigenetic targets in a physiologically relevant setting, supporting accelerated discovery and development of the next wave of anti-cancer medicines."

"We are delighted AstraZeneca has selected Proteros to act as their discovery engine for a number of novel and very relevant oncology targets," said Dr Torsten Neuefeind, Proteros’ CEO. "These types of targets pose a number of challenges that Proteros’ discovery platform is uniquely positioned to overcome."

On June 2, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that on Tuesday, June 1, 2021 the Company entered into a global supply agreement for Vicineum drug substance and drug product with the Company’s partner in China, Qilu Pharmaceutical (Press release, Sesen Bio, JUN 2, 2021, View Source [SID1234583406]).

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Under the terms of the global supply agreement, Qilu Pharmaceutical will be part of the manufacturing network for global commercial supply of Vicineum drug substance and drug product. In February 2021, the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and granted the application Priority Review, with a target Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. The Company anticipates initiating promotion to physicians and patients in the US upon approval, with commercial product supply broadly available to urology clinics by the fourth quarter of 2021.

In December 2020, Sesen Bio entered into a commercial manufacturing and supply framework agreement with Qilu Pharmaceutical in which both parties aligned on key components of the structure of a global supply partnership. The new global supply agreement with Qilu Pharmaceutical builds on the Company’s existing partnership by setting specific terms such as capacity, forecasts, pricing and product delivery. The completion of the global supply agreement expands the Company’s network of world-class partners committed to providing reliable supply of Vicineum worldwide. Sesen Bio is entitled to a $2 million milestone payment upon completion of technology transfer to Qilu Pharmaceutical, which the Company believes is on track for completion in 2021.

"Given the chronic product shortage issues that exist for patients with NMIBC, we have thoughtfully developed what we believe to be a very reliable and robust supply chain with world-class manufacturing partners," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Qilu Pharmaceutical has extensive biomanufacturing expertise and experience supplying products for commercial sale around the world, which positions them well to support the anticipated significant global demand for Vicineum."

Sesen Bio also continues to support Qilu Pharmaceutical in the development and commercialization of Vicineum in China. In March 2021, the Investigational New Drug (IND) application for Vicineum was approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) thereby triggering a $3 million milestone payment to Sesen Bio, which the Company received, net of taxes, on May 24, 2021. The approval of the IND enables Qilu Pharmaceutical to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum for patients in China. It is anticipated that the first patient will be dosed in the trial within the next month. Assuming a successful trial, Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022 with potential approval in China expected in 2023.

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On June 2, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, JUN 2, 2021, View Source [SID1234583405]):

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Jefferies Virtual Healthcare Conference – June 1-4, 2021

June 3, 2021, 2:30 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

Goldman Sachs 42nd Annual Global Healthcare Conference – June 8-11, 2021

June 10, 2021, 2:10 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

2021 Virtual Alpha-1 National Conference – June 10-12, 2021

June 12, 2021 – Javier San Martin, M.D., Arrowhead’s chief medical officer, will deliver an oral presentation

Virtual Dana-Farber Harvard Cancer Center Symposium on HIF, VHL, and Kidney Cancer – June 17, 2021

June 17, 2021 – So Wong, Ph.D., Arrowhead’s senior director of biology, will deliver an oral presentation on the preclinical development of ARO-HIF2

LifeSci Partners Genetic Medicines Summit 2021 – June 22, 2021

June 22, 2021 – Members of Arrowhead management will participate in a fireside chat presentation

The International Liver Congress 2021 – The Annual Meeting of the European Association for the Study of the Liver (EASL) – June 23-26, 2021

Title: ARO-HSD reduces hepatic HSD17B13 mRNA expression and protein levels in patients with suspected NASH
Authors: Edward Gane, et al.
Type: Late-Breaking Poster
Date and Time: June 23, 2021 at 8:00 CEST

Title: Short interfering RNA JNJ-3989 combination therapy in chronic hepatitis B shows potent reduction of all viral markers but no correlate was identified for HBsAg reduction and baseline factors
Authors: Edward Gane, et al.
Type: Oral Presentation
Date and Time: June 25, 2021 at 15:15 CEST

Title: ARO-AAT an investigational RNAi therapeutic demonstrates improvement in liver fibrosis with reduction in intra-hepatic Z-AAT burden
Authors: Pavel Strnad, et al.
Type: Late-Breaking Oral Presentation
Date and Time: June 26, 2021 at 12:15 CEST

28th Annual FSHD Society International Research Congress – June 24-25, 2021

June 25, 2021 – Jonathan Van Dyke, Ph.D., Arrowhead’s senior scientist II of biology, will deliver an oral presentation on the preclinical development of ARO-DUX4

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.