On July 28, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported the Company will release its second quarter 2022 financial results before the market opens on Thursday, August 11, 2022 (Press release, Synlogic, JUL 28, 2022, View Source [SID1234617090]). The press release will be followed by a conference call at 8:30 A.M. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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!

To access the webcast, please register here. To access the call by phone, please register here and you will be provided with dial in details. You can also access these links on the "Events Calendar" section of the Investors & Media webpage. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

On July 28 Vicinitas Therapeutics, a biotechnology company advancing a proprietary targeted protein stabilization platform to develop novel therapeutics in cancer and genetic disorders, reported that launched with $65 million in Series A financing (Press release, Vicinitas Therapeutics, JUL 28, 2022, View Source [SID1234617106]). The financing was co-led by a16z and Deerfield Management, with participation from Droia Ventures, GV, The Mark Foundation for Cancer Research and the Berkeley Catalyst Fund. Vicinitas Therapeutics is a spin-out company that resulted from the Deubiquitinase Targeting Chimera (DUBTAC) platform, which was developed through an academic-industry research collaboration between the Novartis Institutes for BioMedical Research and researchers at the University of California, Berkeley.

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!

Many diseases, including cancer and monogenic diseases, are often caused by specific proteins that are abnormally degraded and lost from the cell. In cancer, protective tumor suppressors are aberrantly destroyed, allowing cancer cells to circumvent cell death, thus promoting unobstructed cell proliferation. In monogenic disorders, mutations in certain genes cause the resulting protein to become unstable and degraded, which leads to abnormally low levels of the particular protein and the disease pathology. To date, many aberrantly degraded proteins have been considered "undruggable" or intractable to drug discovery efforts, and patients with these diseases would greatly benefit from a therapeutic that stabilizes and restores the levels of these proteins, allowing normal function to be restored.

The DUBTAC platform was developed to therapeutically target these degraded proteins by removing ubiquitin chains (tags on proteins that signal the cell to degrade and eliminate the protein using the cell’s protein disposal system) from specific proteins to stop their degradation and stabilize their levels for therapeutic benefit. DUBTACs, developed through an academic-industry research collaboration between Professor Daniel Nomura, his research group at UC Berkeley and scientists at the Novartis Institutes for BioMedical Research, are bifunctional small molecules consisting of a protein-targeting ligand connected via a linker to a deubiquitinase (DUB) recruiter. In a unique application of induced-proximity biology, DUBTACs bring a DUB into the vicinity of a ubiquitin-tagged protein to remove the ubiquitin chain and subsequently prevent degradation of the target protein.

In a hallmark study published in Nature Chemical Biology, Dr. Nomura, the Nomura Lab and Novartis colleagues discovered covalent allosteric recruiters against OTUB1, a known DUB. They showed that this covalent OTUB1 recruiter could be linked to various protein-targeting ligands to stabilize the levels of aberrantly degraded proteins, including the mutated chloride channel CFTR that causes cystic fibrosis and the tumor suppressor WEE1 kinase in cancer cells.

Vicinitas Therapeutics has exclusively licensed the DUBTAC platform from both UC Berkeley and Novartis and aims to become the leading company in targeted protein stabilization by developing next-generation disease therapies against an entire class of previously inaccessible aberrantly degraded proteins. The company is initially focused on developing therapies in cancer and monogenic diseases.

"We are excited about the potential of the DUBTAC platform to develop novel therapies against therapeutic targets that were previously deemed undruggable and will respond to protein stabilization," said Daniel K. Nomura, Ph.D., founder of Vicinitas Therapeutics and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology, and Nutritional Sciences and Toxicology at UC Berkeley.

"The concept of chemically induced proximity – using multispecific molecules to bring two targets physically together – has yielded notable successes in the field of protein degradation," said Jorge Conde, General Partner at a16z. "Vicinitas is leveraging its proprietary DUBTAC platform to pioneer the emerging space of targeted protein stabilization. This approach has the potential to access highly valued yet currently undruggable proteins and create differentiated therapies that will impact patient lives."

Leadership Team and Formation of Scientific Advisory Board

The Vicinitas Therapeutics team is comprised of scientific leaders from academia and industry who have demonstrated years of commitment and success in the field, and who remain dedicated to advancing science and technology and delivering highly impactful drugs.

Vicinitas Therapeutics’ leadership team includes:

Daniel K. Nomura, Ph.D., Founder and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology and the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology, UC Berkeley; Investigator at the Innovative Genomics Institute
Daniel Marquess, D.Phil, Chief Scientific Officer
Joe Budman, Ph.D., Vice President of Biology
Vicinitas Therapeutics’ board of directors includes:

Jorge Conde, General Partner, a16z
Cameron Wheeler, Ph.D., Partner, Deerfield Management
George Golumbeski, Ph.D., Partner, Droia Ventures
Daniel K. Nomura, Ph.D., Founder and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology and the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology, UC Berkeley; Investigator at the Innovative Genomics Institute
Vicinitas has also established a scientific advisory board, including:

Daniel K. Nomura, Ph.D., Founder and Professor of Chemical Biology in the Departments of Chemistry, Molecular and Cell Biology and the Molecular Therapeutics Division, and Nutritional Sciences and Toxicology, UC Berkeley; Investigator at the Innovative Genomics Institute
Michael Rape, Ph.D., Professor, Department of Molecular and Cell Biology, UC Berkeley; Investigator of the Howard Hughes Medical Institute
Thomas Maimone, Ph.D., Associate Professor in the Department of Chemistry, UC Berkeley
James Olzmann, Ph.D., Associate Professor, Departments of Molecular and Cell Biology and Nutritional Sciences and Toxicology, UC Berkeley; Investigator of the Chan Zuckerberg Biohub
Kevan Shokat, Ph.D., Professor, Department of Cellular and Molecular Pharmacology, UCSF; Investigator of the Howard Hughes Medical Institute
F. Dean Toste, Ph.D., Gerald E. K. Branch Distinguished Professor of Chemistry, UC Berkeley
Angela Koehler, Ph.D., Associate Professor, Biological Engineering, MIT, Associate Director, Koch Institute for Integrative Cancer Research at MIT
"Vicinitas Therapeutics has emerged as a pioneer of targeted protein stabilization, and we’re excited to be a part of the Series A funding," said Cameron Wheeler, Ph.D., Partner at Deerfield Management. "As a therapeutic modality, stabilization has the power to elicit substantial changes to disease biology with relatively minor alterations to target proteins, and we are optimistic about the potential of the DUBTAC platform across oncology, rare and chronic diseases."

On July 28, 2022 Modifi Biosciences reported that the journal Science has published a critical study validating the company’s novel oncology platform based on new classes of molecules that exploit tumor-associated DNA repair defects through direct cancer cell DNA modification (Press release, , JUL 28, 2022, View Source [SID1234629035]). The company closed a $6.4M seed round, which will support IND-enabling studies and expansion of the platform to target cancers with other DNA repair defects. Key investors in this round include HighCape Capital; Connecticut Innovations; Ironwood Capital; the Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society; and Yale Ventures.

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!

"This approach redefines the rules on how to selectively kill cancer cells via direct DNA modification and positions our company as a leader in this emerging field of oncology drug development," said study co-lead author and Modifi Bio co-founder, Ranjit Bindra, MD, PhD. Bindra is the Harvey and Kate Cushing Professor of Therapeutic Radiology at Yale School of Medicine and Scientific Director of the Yale Brain Tumor Center at Smilow Cancer Hospital. "As a brain tumor doctor treating patients for over a decade, my colleagues and I have seen gliomas take the lives of too many patients. Our discovery represents a major step forward in changing the treatment paradigm for this devastating disease, as well as for many other cancers with intrinsic DNA repair defects."

The technology bypasses conventional approaches that indirectly target proteins in cancer cells and demonstrates robust anti-tumor activity in glioma, one of the deadliest forms of brain cancer, while sparing normal tissue. In the Science publication, the group’s new class of molecules were found to be exquisitely active and selective against cancer cells that lack expression of a key DNA repair protein called MGMT (O6-methylguanine methyl transferase).

Approximately half of all glioblastomas and up to 80% of gliomas lack MGMT. Emerging research indicates that MGMT deficiency is seen in many other tumor types, suggesting broad applicability for this strategy in treating cancer.

Modifi Bio is creating a new class of molecules, based on research conducted at Yale, that fragment in cells and induce DNA modifications, which are irreparable in cancer cells with DNA repair defects. Modifi Bio’s compounds are designed to be orally bioavailable and possess favorable drug-like properties, which will allow them to rapidly file an Investigative New Drug application with the U.S. Food and Drug Administration in anticipation of Phase I clinical trials in 2024.

"These molecules are particularly promising as therapeutics because of their ability to directly modify DNA of cancer cells, which we believe will not only be effective in fighting cancer but will also allow us to overcome key resistance mechanisms," said Seth Herzon, PhD, study co-lead author, Modifi Bio co-founder, and the Milton Harris ’29 PhD Professor of Chemistry in Yale’s Faculty of Arts and Sciences.

"Novel treatments for these types of brain cancer are urgently needed. I am enthusiastic that this paradigm-shifting discovery may lead to the first clinically meaningful pharmacological advances in the treatment of glioma in over two decades," said Roger Stupp, MD, a member of the Modifi Bio Scientific Advisory Board, Paul C. Bucy Professor of Neurological surgery, and Chief of Neuro-oncology at Northwestern University. Stupp first published the pivotal studies over 20 years ago, which define the current standard of care for glioma.

The research was conducted at Yale University and the co-first authors of the Science study are Kingson Lin and Susan Gueble. Co-authors are Ranjini Sundaram and Eric Huseman. The technology highlighted in the research has been exclusively licensed to Modifi Bio with support from Yale Ventures. Co-founders of Modifi Bio include Herzon, Bindra, Lin, and Kevin Rakin.

Funding for the research came, in part, from the National Institutes of Health and the Yale Cancer Center. Additionally, Bindra received CureSearch for Children’s Cancer’s Catapult Award. CureSearch’s mission is to end childhood cancer by driving targeted and innovative research with measurable results in an accelerated time frame.

On July 28, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that it will report its second quarter 2022 financial results on Thursday, August 4, 2022 (Press release, Deciphera Pharmaceuticals, JUL 28, 2022, View Source [SID1234617058]).

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!

In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 8:00 AM ET on Thursday, August 4, 2022, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed via this link: https://register.vevent.com/register/BI14cfe386c5004efcba5c94f8783e2435.

A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On July 28, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, JUL 28, 2022, View Source [SID1234617075]):

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!

We believe that the Company is well capitalized with cash balance reported on the Company’s Form 10-Q for the period ending March 31, 2022 of $19.7 million
Current burn rate has been low due to virtual corporate structure and outsourcing strategy
Commencement of Phase III clinical trial, Flamingo-01, is expected to increase burn rate gradually over time as more sites are activated, patient treatment begins, and commercial manufacturing commences
Recent "at the market" (ATM) sale agreement (see description below) entered into on July 12, 2022 with one of the leading biotech investment banks is a flexible financing vehicle designed to be used over time at share prices and quantities of shares at our sole discretion
We intend to use the ATM facility opportunistically in the future and do not presently intend to use the full amount of the ATM facility
We believe that strategic use of the ATM facility could begin our transition to an investment banking syndicate and to fundamental biotech institutional investors to complement the current retail investor base
An update on the Flamingo-01 trial is expected to be provided shortly
An update on the transition from the published Phase IIb data to future publications of open label Phase III data is expected to be provided shortly
About At the Market Sales Agreement

As disclosed in the Prospectus Supplement dated July 12, 2022, an ATM offering may be made from time to time through the investment bank by selling Company stock at the best available market price over time without a price discount and without warrants or additional dilutive financial structure. The number of shares that are sold will fluctuate based on the market price and demand for the Company’s common stock, and any additional conditions set by the Company. It is not possible at this stage to predict the number of shares that will be sold or the gross proceeds to be raised in connection with those sales. There can be no assurance that the Company will sell any shares under or fully utilize this source of financing.

More specifically, each time the Company wishes to issue and sell shares of the Company’s common stock under the sales agreement, the Company will notify the investment bank of the number of shares to be issued, the dates on which such sales are anticipated to be made, any limitation on the number of shares to be sold in any one day and any minimum price below which sales may not be made. The investment bank will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such shares up to the amount specified on such terms on the open market or in block trades.

The Company currently intends to use the net proceeds from this offering for general corporate purposes, which may include, but are not limited to, funding the clinical development and manufacturing and other expenses for GP2, research and development, general and administrative expenses, license or technology acquisitions, and working capital and capital expenditures. The Company may also use a portion of the remaining net proceeds, if any, to acquire or invest in complementary businesses, products and technologies, although there are no current commitments or agreements with respect to any acquisitions as of the date hereof.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.