On October 22, 2019 A-Alpha Bio, a biotechnology startup that helps pharmaceutical companies characterize protein interactions for accelerated drug development, reported that it has raised $2.8M from leading science-focused venture capital firms and angel investors (Press release, A-Alpha Bio, OCT 22, 2019, View Source [SID1234636897]). The round was led by OS Fund and also includes AME Cloud Ventures, Boom Capital, Madrona Venture Group, Sahsen Ventures, Washington Research Foundation, and leading biotech angel investors. Since 2017, A-Alpha Bio has been supported by CoMotion, the University of Washington’s collaborative innovation hub, the National Science Foundation, and the Bill and Melinda Gates Foundation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A-Alpha Bio has developed a genetically engineered platform technology, called AlphaSeq, for measuring interactions between proteins that can be used to discover and optimize life-saving drugs. AlphaSeq was invented and developed by A-Alpha Bio’s founders Drs. David Younger and Randolph Lopez, and Scientific Advisors, Drs. David Baker and Eric Klavins, at the University of Washington (UW). AlphaSeq enables the measurement of millions of interactions between proteins with high quantitative accuracy.

"While there are many methods available for screening large biomolecular libraries for a particular binding activity, there are few approaches for assessing in parallel the very large number of possible interactions between biomolecules in two large libraries," said David Baker, who serves as Head of the Institute for Protein Design at the University of Washington and Scientific Advisor to A-Alpha Bio. "A-Alpha Bio’s exciting technology now provides a way to not only quantitatively measure the interactions between all pairs of molecules in two libraries, but also the effect of small molecules and other perturbations on these interactions."

Pharmaceutical companies are pursuing increasingly challenging targets, which often require binding to multiple proteins or specificity between closely related proteins. Drug development currently requires iterative screening against one target at a time. This approach is slow, costly, and often ineffective at producing successful therapeutics. AlphaSeq will allow drug developers and researchers to radically accelerate their screening against thousands of disease targets in a single experimental step.

"A-Alpha Bio’s platform is plug-and-play for partners, facilitating read-outs on drug potency and effectiveness in a much shorter time-frame, solving an important challenge for pharma companies," said Jeff Klunzinger, Co-Founder and General Partner of OS Fund. "We are confident David Younger, Randolph Lopez and the A-Alpha Bio team will be able to accelerate discovery of multi-target protein drugs, such as multi-target antibodies, and small-molecule protein interaction modulators."

The seed financing announced today will support research operations to validate AlphaSeq with many high-impact disease targets, including those for oncology and infectious diseases, and allow A-Alpha Bio to begin drug discovery and optimization partnerships with pharmaceutical companies.

"We are thrilled to have the backing of synthetic biology experts, pharmaceutical industry veterans, and seasoned company builders who will add a tremendous amount of value," said Dr. David Younger, Co-Founder and CEO of A-Alpha Bio. "We have assembled a powerful group of investors, led by OS Fund, who share our passion for disrupting the pharmaceutical industry with breakthrough innovations in synthetic biology."

This funding comes following an announcement earlier this year that A-Alpha Bio was awarded a Bill & Melinda Gates Foundation grant to support a feasibility study for the discovery and optimization of therapeutics to protect developing world infants from intestinal pathogens.

On October 22, 2019 SQZ Biotechnologies (SQZ), a cell therapy company developing innovative treatments for multiple therapeutic areas, reported that the company’s Investigational New Drug (IND) application for SQZ-PBMC-HPV, a novel cellular immunotherapy of antigen presenting cells (APCs) has been cleared after submission to the U.S. Food and Drug Administration (FDA) (Press release, SQZ Biotech, OCT 22, 2019, View Source [SID1234553405]). The trial is investigating the cell therapy comprised of SQZ-engineered APCs to treat HPV+ tumors, titled SQZ-PBMC-HPV. Marking the first program to enter the clinic for the company, SQZ-PBMC-HPV is also the first trial advancing into the clinic in the SQZ-Roche collaboration developing APCs for oncology.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Armon Sharei, PhD, founder and chief executive officer of SQZ, noted, "The FDA’s clearance of our IND is a pivotal moment for the company. SQZ has potential to bring novel cell therapies to patients addressing high unmet medical needs, and this important milestone marks the first clinical translation of our platform."

"SQZ APCs have the potential for broad impact in the oncology space. A cell therapy targeting solid tumors without the need for immune or myeloablative pre-conditioning could possibly shift the paradigm for patients," said Oliver Rosen, MD, chief medical officer of SQZ. "The preclinical data underpinning this program have shown significant tumor reduction driven by high CD8 T cell infiltration into the tumor microenvironment, alongside a favorable preclinical safety profile. We are looking forward to translating this into potentially meaningful results for patients."

The Phase 1 multi-center trial (NCT04084951) is sponsored by SQZ and will enroll in multiple cohorts to assess SQZ-PBMC-HPV as both monotherapy and in combination with Roche’s checkpoint inhibitor, atezolizumab. HLA-A*02+ patients with recurrent, locally advanced or metastatic HPV16+ head & neck, cervical, anal, penile, vulval and vaginal cancers are all eligible for the study.

About SQZ-PBMC-HPV

SQZ-PBMC-HPV is an autologous cell therapy product precisely engineered via SQZ’s Cell Squeeze platform to target HPV+ cancers. It is the first product stemming from the 2018 collaboration expansion between Roche and SQZ to develop SQZ-APCs for oncology. The SQZ APC platform is designed to present tumor antigens to the body’s endogenous CD8 T cells. By enabling presentation of the appropriate target, this approach can potentially induce powerful CD8 T cell responses in patients to attack their tumors.

On October 22, 2019 Intrepida Bio, Inc. reported as a company dedicated to the discovery and development of medicines that modulate the innate immune system to fight cancer and other diseases reported an initial $9.5 million equity investment from Sofinnova Investments and Canaan will fund investigational new drug (IND) application-enabling studies of Intrepida’s lead oncology program (Press release, Intrepida Bio, OCT 22, 2019, View Source [SID1234550283]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Intrepida Co-founders Joel F. Martin, Ph.D., president and chief executive officer, and Olivier Laurent, Ph.D., chief scientific officer, together with Biouniversa s.r.l., established Intrepida with worldwide rights to develop the technology based on the unique targets BAG3 and its receptor IFITM-2.

Tumors use BAG3 – IFITM-2 signaling to create an environment that promotes tumor growth and stymies the immune system from attacking the tumor. BAG3 expression is particularly strong in pancreatic ductal adenocarcinoma (PDAC), where it was detected in every single patient tested1, and high levels of BAG3 were associated with poor prognosis1. Intrepida’s anti-BAG3 antibodies block this pathway, eliminating a tumor’s pro-growth environment while encouraging the immune system to attack the tumor2. By blocking BAG3, these antibodies broadly affect an array of mechanisms that support and protect the tumor.

The prospect of BAG3 as an anti-cancer target was discovered and preclinically validated by the team at Biouniversa, led by Dr. Maria Caterina Turco, professor at the University of Salerno and chairwoman of the Intrepida Scientific Advisory Board. "In vivo and in vitro studies demonstrate that Intrepida’s anti-BAG3 antibodies slow tumor growth, decrease metastases and improve survival," said Joel Martin, Ph.D., co-founder, president and chief executive officer of Intrepida Bio. "We’ve seized this exceptional opportunity to fully develop these compounds with a goal to begin clinical trials with our lead candidate IB001 in 2021."

"Joel and Olivier searched for and found truly novel, validated targets that alter the body’s first line of defense – the innate immune system – to fight disease. I am confident the Intrepida team will conduct a rigorous program to build the clinical evidence around BAG3," said Mike Powell, Ph.D., general partner at Sofinnova Investments and chairman of the Intrepida Board of Directors.

In addition to Dr. Powell, existing Intrepida directors include David Kabakoff, Ph.D., executive partner of Sofinnova; Nina Kjellson, general partner at Canaan; Ellen Lubman, chief business officer at Impel NeuroPharma; and Dr. Martin. New directors include Elizabeth Robinson, Ph.D., co-founder and vice chairman of Indaco Venture Partners SGR and Giovanni Rizzo, Ph.D., chief executive officer of Biouniversa. Biouniversa’s original investors, Indaco Venture Partners and Vertis SGR, have joined Intrepida’s investor syndicate. The Indaco and Vertis investments were led by Dr. Robinson and Mauro Odorico, respectively.

1Expression of the antiapoptotic protein BAG3 is a feature of pancreatic adenocarcinoma and its overexpression is associated with poorer survival. Rosati, Alessandra et al., Am J Pathol. 2012 Nov;181(5):1524-9.
2BAG3 promotes pancreatic ductal adenocarcinoma growth by activating stromal macrophages. Rosati, Alessandra et al., Nat Commun. 2015 Nov 2;6:8695.

On October 22, 2019 OPKO Health, Inc. ("OPKO Health" or the "Company") (NASDAQ:OPK) reported that, subject to market and other conditions, it intends to offer and sell up to $100 million of shares of its common stock (the "Shares") in an underwritten public offering (Press release, Opko Health, OCT 22, 2019, View Source [SID1234542443]). The Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the number of Shares to be issued and sold in the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use the net proceeds received from the offering of the Shares to fund research and development to further develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products and for working capital, capital expenditures, acquisitions and other general corporate purposes.

Jefferies LLC, Piper Jaffray & Co. and Guggenheim Securities, LLC will act as joint book-running managers for the offering.

The offering of the Shares will be made by means of a prospectus supplement to the prospectus forming a part of the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-229400) filed with the Securities and Exchange Commission (the "SEC") on January 28, 2019 and other related documents. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the preliminary prospectus supplement may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, by email at [email protected] or by phone at +1 877 821 7388; Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at [email protected] or by phone: 1-800-747-3924; and Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by email at [email protected] or by phone at +1 212 518 5548. Before you invest, you should read the prospectus supplement and the accompanying base prospectus along with other documents that the Company has filed with the SEC for more complete information about the Company and these offerings.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, the Shares or any other securities, nor will there be any sale of the Shares or any other securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On October 22, 2019 Revolution Medicines, Inc., a clinical-stage oncology company focused on developing targeted therapies to inhibit elusive frontier targets within notorious cancer pathways, reported that preclinical in vivo data on the company’s novel inhibitors of oncogenic RAS(ON) mutants will be presented at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Press release, Revolution Medicines, OCT 22, 2019, View Source [SID1234542428]). Presented findings will highlight the ability of the company’s inhibitors to overcome adaptive resistance mechanisms and drive xenograft regressions in in vivo models. The 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) is being held October 26-30, 2019 in Boston, MA.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Leveraging its proprietary tri-complex technology platform, Revolution Medicines is developing a portfolio of targeted RAS compounds that it believes are the first potent, mutant-selective, cell-active inhibitors of the active, GTP-bound form of RAS, or RAS(ON). Initially, the company is prioritizing four mutant RAS(ON) targets, KRASG12C, KRASG13C, KRASG12D and NRASG12C.

The data on the company’s active RAS(ON) inhibitors will be reported in podium and poster presentations entitled, "Tri-complex inhibitors of the oncogenic, GTP-bound form of KRASG12C overcome RTK-mediated escape mechanisms and drive tumor regressions in vivo." Details of the presentations are as follows:

Podium Presentation #PR10:

Session: Spotlight on Proffered Papers 3
Presenting Author: Christopher Schulze, Ph.D., senior scientist at Revolution Medicines
Date/Time: Tuesday, October 29, 2019, 12:20 – 12:30 p.m. Eastern
Location: Level 3 Ballroom AB Lobby
Poster Presentation #B077:

Session: Poster Session B: MAPK Pathways 1
Presenting Author: Christopher Schulze, Ph.D., senior scientist at Revolution Medicines
Date/Time: Monday, October 28, 2019, 12:30 – 4:00 p.m. Eastern
Location: Level 2 – Hall D
In addition to the presentations on its mutant RAS inhibitors, Revolution Medicines will also report preclinical data from its 4EBP1/mTORC1 program in a poster presentation at the conference. The presented findings will highlight results of the company’s work in identifying a potential biomarker of response to selective mTORC1 inhibitors. Details of that presentation are as follows:

Poster Presentation #B108:

Title: 4EBP3 mRNA as a biomarker of therapeutic response to treatment with mTORC1 inhibitors
Presenting Author: Bianca Lee, Ph.D., scientist at Revolution Medicines
Session: Poster Session B: mTOR/PI3-Kinase
Date/Time: Monday, October 28, 2019, 12:30 – 4:00 p.m. Eastern
Location: Level 2 – Hall D