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PerkinElmer Supports PROXIDRUGS Consortium Aimed at Advancing Targeted Protein Degradation/PROTAC Drugs

On April 21, 2021 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported that it is serving as a provider and co-developer of assays, instrument solutions and expertise for the PROXIDRUGS Consortium which is zeroing in on research for proximity drugs or PROTACs (PROteolysis Targeting Chimeras) (Press release, PerkinElmer, APR 21, 2021, View Source [SID1234578345]). PROTACs are a new class of drugs that take advantage of the body’s own cell protein recycling system to fight disease by tapping into the 80% of disease-relevant proteins that are currently untargeted by today’s available therapeutics. Led by Goethe University in Frankfurt, Germany, the Consortium includes researchers from the Technical University of Darmstadt, the Fraunhofer Institute for Translational Medicine and Pharmacology, and global pharmaceutical companies based in Frankfurt’s Rhine-Main region.

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The research project, starting October 2021, aims to streamline novel drug target validation by putting disease-relevant proteins in close proximity with key enzymes (such as E3 ligases) so that they can be marked for destruction and recycled by the cells’ natural shredding capabilities.

To help in these efforts, PerkinElmer will provide the consortium with no-wash AlphaLISA and HTRF immunoassay technologies and expertise in protein labeling as well as assay design; EnVision multimode plate readers; high content imaging technologies such as the Opera Phenix and Operetta CLS platforms; and data analysis and informatics tools like TIBCO Spotfire software. These PerkinElmer offerings will give PROXIDRUGS scientists a highly sensitive and accelerated discovery platform with rich data delivery and high throughput for both live and dead cell research.

Commenting on this groundbreaking research and collaboration, Alan Fletcher, SVP of Life Sciences at PerkinElmer said, "With only 20% of disease-relevant proteins currently being targeted by classical, small molecule drugs, new research approaches, such as PROTAC drug discovery, hold immense and exciting potential. We are delighted to be able to contribute our expertise and technologies to assist in the innovative work of the PROXIDRUGS Consortium as it seeks new ways to help unlock and tackle the vast majority of proteins behind widespread diseases such as cancer, neurological disorders, and cardiovascular, inflammatory and infectious conditions."

The PROXIDRUGS consortium is led by Ivan Đikić of Goethe University Frankfurt who also commented on the importance of forming alliances across organizations to help advance novel drug discovery and development, "Successful translation of biomedical research requires strong collaboration and convergence of industry and academic expertise. Our work with PerkinElmer within the PROXIDRUGS consortium is a good example of that. PerkinElmer’s expertise and innovation in assay development is of utmost importance and will help to create new insights for our discovery efforts."

The PROXIDRUGS Consortium was recently selected for funding by the German Federal Ministry of Education and Research as part of a highly competitive "Clusters4Future" competition.

Sermonix Pharmaceuticals Project With Huntsman Cancer Institute Researcher to Investigate Potential Effects of Lasofoxifene on ESR1 Mutations in Endometrial Cancer

On April 21, 2021 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, reported a preclinical collaboration with researcher Jay Gertz, Ph.D., to examine the potential effects of lasofoxifene, Sermonix’s lead investigational drug, on endometrial cancer (Press release, Sermonix Pharmaceuticals, APR 21, 2021, View Source [SID1234578341]).

The project will investigate the effects of lasofoxifene on unique models of endometrial cancer that carry ESR1 mutations. Lasofoxifene has shown novel activity in ESR1 mutations, and Sermonix is currently enrolling patients in two Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) studies within the breast cancer arena.

"Sermonix is committed to exploring ESR1 mutations across gynecological tumor types and examining lasofoxifene’s potential to serve the unmet medical needs of more women fighting cancer," said Barry Komm, Ph.D., chief scientific officer of Sermonix. "The unique ESR1 model system is state-of-the-art for this exploration and Dr. Gertz is an esteemed partner with whom it is an honor for Sermonix to collaborate."

Dr. Gertz is a cancer researcher at Huntsman Cancer Institute and associate professor of oncological sciences at the University of Utah. His lab studies how transcription regulation is altered in cancer with a particular focus on the roles of steroid hormone signaling in endometrial and breast cancers.

"The Gertz Lab has a major emphasis in advancing the study of new drugs for endometrial cancer, an aggressive disease with limited treatment options," said Dr. Gertz. "We look forward to learning more about the efficacy of lasofoxifene in the context of ESR1-mutated endometrial cancer."

About Lasofoxifene
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

Bladder cancer study results accepted for publication in Nature Communications

On April 21, 2021 Hamlet Pharma reported that the report of the phase I/II bladder cancer trial has been accepted for publication in Nature Communications; a leading international journal (Press release, HAMLET Pharma, APR 21, 2021, View Source;utm_medium=rss&utm_campaign=bladder-cancer-study-results-accepted-for-publication-in-nature-communications [SID1234578330]).

The paper is entitled "Bladder cancer therapy using a conformationally fluid tumoricidal peptide complex" and has been accepted for publication in Nature Communications. The Nature journals are extremely competitive and only accept innovative science of highest quality and with significant interest for a discerning audience. The journals are widely read, with a high impact.

The paper analyses the structure of the Alpha1H complex, characterizes its tumor killing effects and describes the successful clinical trial of Alpha1H in patients with bladder cancer. A detailed analysis of primary and secondary end points is provided and differences between the Alpha1H treated patients and the placebo group are described for several crucial efficacy variables. Alpha1H triggered significant shedding of tumor cells in patients, who received the treatment (p< 0.0001 compared to the placebo group) and reduced the tumor size (p<0.04), illustrating its potent effects.

The treatment is also shown to be safe, as no drug-related side effects were observed. The publication offers interested readers a detailed understanding of the molecular properties and promising clinical effects, inspiring further development of Alpha 1H as a new potential drug for patients with bladder cancer.

"Publishing in Nature journals is an important quality stamp and an excellent way to spread the news of our clinical advances" says Catharina Svanborg, founder, CMO and chairman of the board of Hamlet Pharma Ltd.

"This is a very important milestone, inspriring us to continue the clinical development of Alpha1H with full speed" says Mats Persson, CEO of Hamlet Pharma Ltd.

Q1 Market Conditions Report 2021

On April 21, 2021 Each quarter, Locust Walk reported compile key statistics and trends on strategic transactions and financings (Press release, Locust Walk Partners, APR 21, 2021, https://www.locustwalk.com/q1-market-conditions-report-2021/?utm_source=rss&utm_medium=rss&utm_campaign=q1-market-conditions-report-2021 [SID1234578329]). Our 2021 Q1 Report: Global Trends in Biopharma Transactions applies the latest data to analyze current activities in the life sciences deal landscape. 2020 was a record year for financings across the globe and that trend continued into Q1 2021 for public and private financings alike. With a red hot capital markets environment, we’ve pondered whether or not the traditional route of early stage collaborations will remain as a mainstay for high-growth biotechs in the near-term. Join us for a webinar as we have an open discussion about that topic. We look forward to following the trend lines in Q2. A few more key insights across geographies in Q1 2021:

United States

Biotech indices underperformed the broader markets in Q1, likely over concerns around potential drug pricing reform and movement out of biotech and into "reopening" stocks
The US biopharma IPO momentum of 2020 carried into the first quarter of 2021, surpassing Q3 and Q4 2020 in both deal volume and aggregate value and with new IPOs outpacing the performance of key biotech indices
Total biotech SPAC IPO values reached nearly $2B in Q1 suggesting the SPAC trend is not slowing down. Multiple sponsor firms have backed 2nd SPACs prior to completion of their target acquisition from their first
Public and private financing activity remains notably robust, as companies seek to take advantage of the open IPO window and growing interest from private investors
Q1 closed out a record quarter for private financings, and 2019/2020 biopharma IPOs continue to perform well in the public markets, suggesting investors are bullish long-term on new biopharma opportunities
Strong deal flow among both licensing and M&A deals demonstrate sustained interest in strategic transactions despite dwindling total deal values
Europe

Vaccines, albeit with significant logistical hurdles, bring hope to recovering the "old normal" in the European Union at the end of this year. Throughout Q1 2021, Moderna’s, AstraZeneca’s and Janssen’s COVID-19 vaccines were approved by the EMA
Private financing in European biopharma companies keeps with last year’s uninterrupted growth trend, amounting a total of ~$1.4B in Q1 2021
European biopharma IPOs had a great year start as well, with 4 IPOs over $100M on the Nasdaq and several smaller IPOs on other global exchanges. In contrast, only one IPO took place in Q4 2020
European licensing deals saw a slight increase in deal value in Q1 2020, while M&As significantly decreased in Q1 with only 3 completed deals
Japan

The Japanese stock market is off to a bullish start in 2021, as the Nikkei 225 Index reached the 30,000 mark for the first time in over 30 years
The pharma and biotech sector had a strong performance in Q1 2021 alone (+8% and +16%, respectively), but overall growth of the two sectors since the beginning of 2020 is below market
The volume of deals in 2021 is at the similar pace as 2020, largely due to a dominant quarter by Takeda, who struck 6 deals including 2 over $1B in total deal size
Following a strong year in venture financing in 2020, Q1 2021 was even stronger: 8 deals with aggregate value of $67M which is more than double the value in Q1 2020
China

Slow quarter for the Chinese stock market, as the SSE Composite Index was down 1.7% in Q1 2021 and average share price of top Chinese pharma companies was flat for the second consecutive quarter
In-licensing deal volume in 2021 is similar as Q1 the previous year, but with larger value: 22 in-licensing deals were closed including 20 deals with over $50M in total deal size and 15 with over $5M upfront payment
Out-licensing activities continues in 2021, including 2 deals over $1B, both of which involving anti-PD-1 antibodies
Venture financing for biotech companies continue to exceed previous levels, as 47 companies raised capital for an aggregate total of $3B in Q1 alone, already surpassing full year values in 2018 and 2019
Locust Walk is a global life science transaction firm. Our integrated team-based approach across capabilities, geographies, and industry segments delivers the right products, the right partners, and the most attractive sources of capital to get the right deals done for biopharma and life science companies.

Capabilities: cohesive strategy, market analytics, and transaction capabilities
Geographies: global footprint across all key life science geographies
Deal process: one globally-integrated team focused on your entire deal process from strategy through execution

Roswell Park, Wilmot Cancer Institute Collaborate on First Large Study of Immunotherapy in Black Cancer Patients

On April 21, 2021 Roswell Park Cancer Institute reported A new collaboration between two Western New York cancer research leaders will help oncologists learn whether Black and white cancer patients respond differently to a game-changing immunotherapy treatment, and seeks to improve the safety and effectiveness of these newer drugs in diverse populations (Press release, Roswell Park Cancer Institute, APR 21, 2021, View Source [SID1234578322]).

Funded by a two-year, $2.08 million grant from the National Cancer Institute (NCI), with the possibility of additional funding after the initial phase of study concludes, Roswell Park Comprehensive Cancer Center and the University of Rochester’s Wilmot Cancer Institute are working together to fill a major gap in the science around immune checkpoint inhibitors (ICIs).

Direct Cohort
Checkpoint inhibitors — such as nivolumab (Opdivo) and pembrolizumab (Keytruda) — have become standard care for 16 different types of cancer, both early and advanced-stage. They work by blocking signals in the immune system, clearing a path for the body’s natural T cells to kill cancer. Since their approval in 2011, the use of these drugs has skyrocketed and is believed to be partly responsible for a significant drop in U.S. cancer deaths.

Still, there are many opportunities to improve the care of patients who may benefit from ICIs. For example, few people of African ancestry participated in the original clinical trials to evaluate these treatments. The Roswell Park-Wilmot collaborators plan to collect data that will allow them to investigate side effects, toxicities and outcomes among people of African ancestry who take immune checkpoint inhibitors.

The research builds off discoveries from Roswell Park that helped explain why standard treatments are often less effective in patients of African ancestry.

"Checkpoint inhibitors have largely not been studied in Black cancer patients, but our recent findings show that there may be a particular benefit to these immunotherapies for cancer patients of African ancestry — across a variety of cancer types," says Christine Ambrosone, PhD, Chair of Cancer Prevention & Control at Roswell Park and a Co-Investigator on the study.

"Because Black cancer patients tend to have a prevalence of what we call ‘exhausted,’ nonfunctional T cells, we realized they may be more likely to do well on immune checkpoint inhibitors, which target the exhausted T cells to revive them and restore their ability to fight cancer cells," says Song Yao, PhD, Professor of Oncology in Roswell Park’s Department of Cancer Prevention and Control, Co-Principal Investigator on the study. "But we can’t know this without further study, and this new project will tackle that knowledge gap in a large and diverse patient population."

The Wilmot team, under the leadership of Co-Principal Investigator Charles Kamen, PhD, MPH, and Co-Investigator Gary Morrow, PhD, MS, will leverage the center’s position as a hub for the National Community Oncology Research Program (NCORP). Dr. Morrow, a Dean’s Professor of Surgery at the University of Rochester Medical Center, is co-Principal Investigator for the NCORP program, which is supported by a $29 million NCI grant. The NCORP network will allow the researchers to carry out the immune checkpoint study at hundreds of community oncology clinics in the NCORP network across the country. The team also plans to enroll study participants in Western New York.

"Our project is designed to get the full 360 picture of Black patients who receive immunotherapy," says Dr. Kamen. "Not only are we measuring their response to treatment, but we’re also looking at factors like discrimination by providers and health care systems and how often treatment is stopped, so that we have a better understand of equity and access to high-quality care."

The Roswell-Wilmot collaborators have designed a large national study — known as the DiRECT Cohort — that will seek to enlist 600 Black patient volunteers and 1,200 white cancer patients of European ancestry.

Dr. Gary Morrow
Dr. Gary Morrow
"The National Cancer Institute Community Oncology Research Program (NCORP) Research Base we have had at Wilmot for three decades is ideally suited to help direct a large nationwide study like this," said Dr. Morrow. "We’re eager and proud to actively participate in this important research with our longtime colleagues and friends from Roswell."

The project is the first large, national study of diverse patients treated with ICIs.

The researchers will conduct genetic analyses, for example, of the percent African ancestry in each Black patient, as well as social determinants of health, such as access to healthcare, as a predictor of treatment response and toxicities. In addition, they will evaluate how often treatment delays occur among the Black and white patients due to severe side effects, and the short- and long-term treatment outcomes.

Cancer patients at member sites within the Roswell Park Care Network will have access to the study through the participation of study Co-Investigator Igor Puzanov, MD, MSCI, FACP, Senior Vice President of Clinical Investigation at Roswell Park.

The new funds are in addition to the $5.2 million awarded to Roswell Park last year to study these dynamics using data reported to the New York State Cancer Registry.