On June 2, 2022 Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) reported a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop, and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR (Press release, Boehringer Ingelheim, JUN 2, 2022, View Source [SID1234654032]). Boehringer Ingelheim aims to use these antibodies to direct therapeutic effector mechanisms such as antibody-drug conjugates (ADCs) and T-cell engagers exclusively to tumor cells, and to that end develop a range of highly targeted cancer treatments.

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"Boehringer Ingelheim believes that these promising antibodies in-licensed from A*STAR will help us advance potent therapeutic candidates against key molecular cancer targets," says Clive R. Wood, Senior Corporate Vice President and Global Head of Discovery Research at Boehringer Ingelheim and continues: "We look forward to developing these assets for a broad range of cancers with the goal to deliver breakthrough opportunities for patients."

Boehringer Ingelheim is pioneering a range of versatile therapeutic platforms in order to develop innovative medicines that target the tumor directly (tumor cell-directed therapies) or that enable the immune system to target the tumor (immune cell-targeted therapies). One tumor cell-directed modality is antibody drug conjugates, which allows for delivery of toxins directly into tumor cells. Another is T-cell engagers facilitating direct contact between T-cells and tumor cells, leading to T-cell-mediated killing of the tumor. Both technologies are directed towards markers on the surface of cancer cells, also known as antigens, in order to attack tumor cells but spare healthy tissues.

The innovative antibodies from A*STAR can potentially enable the development of safer, more efficacious therapies as they selectively bind to antigens that are highly expressed on tumor cells but are absent on normal healthy tissues.

Under the terms of the agreement, Boehringer Ingelheim will be responsible for further research, preclinical and clinical development as well as commercialization of targeted cancer therapies using the antibodies from A*STAR. A*STAR may receive payments totaling >100 million EUR in upfront and success-based development and commercialization milestones.

The technology used to identify the unique A*STAR antibodies resulted from a multi-institutional collaboration in Singapore. A*STAR’s Genome Institute of Singapore (GIS) and Institute of Bioengineering & Bioimaging (IBB) generated antibodies which exclusively target antigens that were initially identified from gastric cancer cells. Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by A*STAR, then optimized the antibodies and confirmed their applicability to a range of other solid cancers. EDDC also demonstrated the utility of these antibodies in directing different therapeutic modalities selectively to cancer cells.

Professor Damian O’Connell, Chief Executive Officer of EDDC, says, "As Singapore’s national drug discovery and development platform, EDDC is proud to translate great science in Singapore into valuable assets that can enable the precise treatment of cancer. We believe that Boehringer Ingelheim, with its broad expertise and technologies, is the right partner to maximize the potential of these antibodies for the development of safer, more targeted therapies for cancer patients."

Professor Tan Sze Wee, Assistant Chief Executive (Enterprise) of A*STAR, says, "These antibodies were developed in Singapore through close collaboration across multiple institutions. There was also strong support by the Singapore Gastric Cancer Consortium. The agreement is testament to the best-in-class research taking place in Singapore. Cancer is a devastating disease, and we hope the fruits of our research can improve patient outcomes."

Professor Patrick Tan, Executive Director of GIS, says: "We are excited at this development in the research ecosystem’s continuous inroads in cancer treatments and therapies. IBB developed the initial antibody technologies with the support of GIS and SGCC, who identified the tumor-associated targets, and EDDC who optimized the antibodies. Such multidisciplinary collaborations maximize the value and impact of A*STAR’s research for potential patient outcomes."

On June 02, 2022 Transition Bio, Inc., a microfluidics-driven drug discovery platform company using biophysical sciences and artificial intelligence tools to map and modulate biomolecular condensates, reported its $50 million Series A financing, led by Northpond Ventures and joined by Taiho Ventures, Bristol Myers Squibb and Magnetic Ventures (Press release, Transition Bio, JUN 2, 2022, View Source [SID1234648795]). Lifeforce Capital, the lead investor from the Company’s seed financing, also participated and was joined by other existing seed investors.

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"We are excited to have such a high-quality group of investors alongside us as we apply and expand our one-of-a-kind predictive approach to analyzing and modulating biomolecular condensates," said Greg Miller, chief executive officer of Transition Bio. "The technology and tools we have built – and the data we are generating – are unmatched in capability and scale, and the pace and depth of our progress across all areas of the company has been extraordinary. Our team is uniquely suited to harness the fundamental and largely untapped biology of condensates which is at the center of many disease pathways."

The capital raised will accelerate the progress made to date with the Company’s novel Condensomics platform. This platform utilizes microfluidics to drive high-throughput generation of proprietary data to enable machine learning-guided condensate target identification and drug discovery. The funding allows rapid expansion of the technology by scaling up the platform and translating the science across a variety of targets and disease areas.

In addition, Shilpi Arora, Ph.D., joined Transition Bio as senior vice president of discovery research and brings extensive experience in leading multiple aspects of drug discovery, target identification and validation, pharmacology and translational sciences from previous roles in both academia and the biotech industry. Prior to joining Transition Bio, Shilpi was vice president of discovery and translational biology at Exo Therapeutics and previously held roles at X-Chem Pharmaceuticals, Constellation Pharmaceuticals and the Translational Genomics Research Institute.

Transition Bio also announced updates to its board of directors. Shaan C. Gandhi, M.D., D.Phil., director and head of the biotechnologies group at Northpond Ventures, has been appointed to the Company’s board. In addition, Alfred W. Sandrock, Jr., M.D., Ph.D., chief executive officer of Voyager Therapeutics and former head of research and development at Biogen, has been appointed to the board as an independent director. Co-founders Kelly Martin and Samuel Cohen, Ph.D., will continue to serve on the board as executive chairman and director, respectively.

"The Northpond team has been engaging with condensate biology for a long time. The encouraging data and caliber of people involved drive our collaboration with Transition Bio," said Dr. Gandhi. "The experience and creativity of the founders, management team and scientists, as well as the progress with the platform, convince us that Transition Bio will develop therapeutic approaches that will address significant unmet medical needs."

"The right tools are essential to translate this evolving biological space into meaningful therapeutics. I have been impressed with the Transition Bio team’s methodical and thoughtful approach to rapidly identify small molecules which can impact an expanse of human diseases," commented Dr. Sandrock.

"On behalf of the founders, we are delighted and amazed by how far the team has come in such a short period of time," said Mr. Martin. "This financing is a testament both to the underlying scientific foundation, created through the tremendous work and innovation of Dave Weitz and Tuomas Knowles over the past decade, as well as to the talented team of dedicated and enthusiastic professionals working with us in the U.S., U.K. and beyond. In addition, we welcome Al and Shaan to the board and look forward to benefiting from their unique skills and experiences."

Transition Bio launched in September 2020 with a seed round led by Lifeforce Capital.

On June 2, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a trial to investigate the ERK1/2 inhibitor ERAS-007 in combination with a KRAS G12C inhibitor in KRAS G12C-driven non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (Press release, Erasca, JUN 2, 2022, View Source [SID1234639378]).

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"We look forward to ERAS-007 being evaluated in this trial, based in part on ERAS-007’s ability in preclinical studies to robustly shut down oncogenic signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "This trial not only helps to broaden the therapeutic development of ERAS-007, but also complements the patient subgroups within our ongoing HERKULES-2 and HERKULES-3 master protocols. Additionally, it may provide proof-of-concept data supporting the addition of ERAS-007 as a treatment option to overcome RAS/MAPK resistance with KRAS G12C inhibitors. We look forward to potentially partnering with the team to explore the therapeutic potential of this combination."

Ryan Corcoran, M.D., Ph.D., Director of the Gastrointestinal Cancer Center Program at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School, added, "While adaptive feedback mechanisms can overwhelm MEK inhibitors, ERK inhibitors potentially can overcome drug resistance mechanisms that involve reactivation of RAS/MAPK pathway signaling. We look forward to evaluating whether the ERK1/2 inhibitor ERAS-007 has the potential to overcome feedback mechanisms and help address the limited efficacy of single agent KRAS G12C inhibitors."

A Phase 1b clinical proof-of-concept trial will evaluate ERAS-007 in combination with a KRAS G12C inhibitor in patients with NSCLC and CRC harboring a KRAS G12C mutation. Additional preclinical and clinical laboratory research will be conducted to further understand the activity and safety of this combination in these patient populations. The trial will be led by principal investigators Scott Kopetz, M.D., Ph.D., Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Dr. Corcoran, and Pasi Janne, M.D., Ph.D., Professor of Medicine at Harvard Medical School. Drs. Corcoran and Kopetz recently received a grant from Stand Up To Cancer (SU2C).

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. The broad therapeutic potential of ERAS-007 is being investigated initially across four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.

On June 2, 2022 A scientific team, led by the scientific founders of EtiraRx, reported that it has identified a small molecule, ERX-41, as a novel oral therapeutic agent that may have utility in treating multiple solid cancers, including triple negative breast cancer, glioblastoma, ovarian and pancreatic cancers (Press release, EtiraRx, JUN 2, 2022, View Source [SID1234616455]). EtiraRx, headquartered in Biolabs Pegasus Park, plans to initiate clinical trials as early as the first quarter of 2023.

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In the work, published in Nature Cancer, the researchers, led by Drs. Jung-Mo Ahn, Ganesh Raj and Ratna Vadlamudi, identified that ERX-41 dramatically enhances endoplasmic reticulum (ER) stress in cancer cells. Since aggressive cancer cells have higher basal levels of ER stress, the enhanced ER stress induced by ERX-41 is not compensated and causes cancer cell death. Normal cells have low basal of ER stress, can compensate for ERX-41 activity and do not undergo cell death after ERX-41 treatment. Using state-of-the-art molecular approaches, the team identified that the molecular target of ERX-41 is the protein encoded by the lysosomal acid lipase A (LIPA) gene and that pharmacologic inhibition of LIPA by ERX-41 enhances ER stress in cancer cells. The study set the foundation for clinical trials with patients with therapy-resistant cancers that are vulnerable to enhanced ER stress.

Said Dr. Raj, "These discoveries are exciting as they represent a novel approach to targeting the Achilles heel of many aggressive cancers- their vulnerability to enhanced ER stress. Our critical finding was that of a new therapeutic target (LIPA) and its undiscovered role in protein folding. By targeting LIPA with ERX-41, protein folding in the cancer cell was disrupted, causing ER stress and promoting cancer cell death. Our findings indicate the potential for an oral agent with a favorable therapeutic index to effectively treat patients with aggressive cancers, for whom options are limited."

EtiraRx is completing necessary preclinical studies and plans to initiate clinical trials with these compounds, which will take place the first quarter of 2023. Russell Hayward, CEO EtiraRx, said, "ERX-41 has the potential to be a first-in-class oral therapy that kills aggressive therapy-resistant cancers. We are committed to moving these drugs forward to clinical trials and make a difference in the lives of patients with lethal cancers."

On June 2, 2022 CEO Lisa S. Park and COO Michael J. Kim reported that have purchased additional shares in Prestige Biopharma and Prestige Biologics to stabilize stock prices of the two companies (Press release, Prestige BioPharma, JUN 2, 2022, View Source [SID1234616245]). Through Mason Partners, a joint investment company established by CEO Park and COO Kim, the two executive directors bought 137,420 shares of Prestige BioPharma’s stock. In addition, CEO Park and COO Kim bought 19,337 shares and 19,301 shares of Prestige Biologics’ stock respectively. Including the KRW 2 billion stock purchase previously announced on May 23, the two executive directors have purchased KRW 4 billion stock in total so far, and will consider further action to protect the market value of their companies.

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"We are confident with the value of our business and have been putting strenuous efforts towards the development and commercialization of our pipelines. The recent fall in stock price doesn’t reflect the potential value of our companies. We hope the in-house purchase would be a positive signal to the shareholders and help recover our market value. Prestige Biopharma and Prestige Biologics will continue to do the utmost to enhance future values," said Dr. Lisa S. Park, CEO of Prestige Biopharma.

Prestige BioPharma has requested European Medicines Agency (EMA) for re-examination of Marketing Authorisation Application (MAA) for the company’s Herceptin biosimilar HD201. The result is expected to be announced after 120 days. Prestige Biologics is strengthening its business as a global CDMO utilizing its state-of-the-art facilities and patented technologies.