Market Newsdesk

The Zephyr Valve
Helps COPD/Emphysema Patients Breathe Easier Without the Risk of Major Surgery
¹

REDWOOD CITY, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) — As part of COPD Awareness Month, Pulmonx Corporation is announcing that over 20,000 patients have been treated worldwide with their Zephyr® Endobronchial Valves (Zephyr Valve), the first FDA-approved minimally-invasive treatment for severe emphysema, a form of COPD. The Zephyr Valve has been shown to deliver significant benefits to patients with emphysema, including improvements in lung function, exercise capacity and quality of life.¹ The valves are placed via bronchoscopy, with no incision or cutting, so these benefits are achieved without the risks of traditional surgical options.

“The Zephyr Valve treatment represents a major advancement in the field of bronchoscopy and can be truly life changing for patients with advanced disease,” states Dr. D. Kyle Hogarth, MD, Professor of Medicine and Director of Bronchoscopy at the University of Chicago Medical Center. “Before this option, many COPD/emphysema patients struggled to breathe despite maximum medical therapy. Endobronchial valves are the first option we have had to help patients breathe easier and re-engage with life without the risks of major surgery. The Zephyr Valve is quickly becoming a standard of care for patients with advanced COPD/emphysema.”

Despite taking the best available medications, many patients with emphysema, a common form of COPD, suffer from hyperinflation of their lungs where air becomes trapped in the lungs, preventing fresh air from entering and thereby causing severe shortness of breath. Patients with hyperinflation have difficulty doing even the simplest tasks like showering or walking up a flight of stairs. The Zephyr Valves reduce lung hyperinflation by allowing trapped air to escape and preventing new air from entering that diseased lobe. This allows the healthier parts of the lung to function better and results in patients being able to breathe more easily and experience less shortness of breath.¹

“Our corporate mission is to improve the lives of patients with severe COPD/emphysema, so we are very excited about achieving this significant milestone of treating more than 20,000 patients,” said Glen French, President and Chief Executive Officer. “Hundreds of hospitals in the US and abroad now offer our Zephyr Valves, so we are on our way to enabling many patients to breathe easier in the years to come.”

“Helping patients breathe easier changes not only their immediate quality of life, but also breaks the cycle of deterioration that comes from inactivity and can contribute to a higher-quality of life long-term,” states D.J. (Dirk-Jan) Slebos, MD, Professor of Interventional Pulmonology, University of Groningen, The Netherlands. “My patients report that they are back to being more active and participating in hobbies like gardening and biking that, before the valves, had become too difficult because of the disease.”

Patients treated with the Zephyr Valves report experiencing significantly more days when their symptoms were “better” and fewer days that were “worse” over 12 months compared to the control group.² Cumulative clinical data suggests that patients treated successfully with endobronchial valves, like the Zephyr Valve, have increases in the BODE Index (a multi-dimensional health status scoring system for patients with COPD) that have been associated with survival benefits.^3–10 The Zephyr Valve treatment is included in national and global treatment guidelines for COPD including an ‘Evidence A’ rating from The Global Initiative for Chronic Obstructive Lung Disease (GOLD).

About Pulmonx

Pulmonx Corporation (NASDAQ: LUNG) is a commercial-stage medical technology company that provides minimally invasive treatment for patients with severe emphysema, a form of COPD. The Pulmonx solution, which is comprised of the Zephyr Endobronchial Valve, the Chartis^® Pulmonary Assessment System and the StratX^® Lung Analysis Platform, is designed to treat severe emphysema/COPD patients who, despite medical management, are still profoundly symptomatic. Pulmonx received FDA pre-market approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, with over 80,000 valves used to treat more than 20,000 patients. For more information on the Zephyr Valves, please visit www.MyLungsMyLife.com. For more information on the company, please visit www.Pulmonx.com.

Pulmonx, Chartis®, StratX®, and Zephyr® are registered trademarks of Pulmonx Corporation.

Forward Looking Statements

This release contains forward‐looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “look forward,” confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward‐looking statements and include, without limitation, statements about Pulmonx’s ability to treat a greater number of patients and deliver significant benefits to patients. Forward‐looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward‐looking statements are based on Pulmonx’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward‐looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the company’s products, the ability to obtain and maintain reimbursement codes for its products, and the company’s ability to procure and maintain required regulatory approvals for its products. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Pulmonx’s filings with the Securities and Exchange Commission (SEC), including the Company’s quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2020 filed with the SEC and available at www.sec.gov. Pulmonx does not undertake any obligation to update forward‐looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward‐looking statements contained herein. 

Media Contact:

Meghan Oreste
617-823-1441
[email protected]

Investor Contact:

Brian Johnston
Gilmartin Group
[email protected]

_______________

1.	Criner G. et al. Am J Respir Crit Care Med. 2018; 198 (9):1151–1164.
2.	Dransfield M. et al. Ann Am Thorac Soc. 2020 Jul; 17 (7):829-838.
3.	Criner, GJ, Delage, A, Voelker, K, Hogarth, DK, et al. Improving Lung Function in Severe Heterogenous Emphysema with the Spiration Valve System (EMPROVE). A Multicenter, Open-Label Randomized Controlled Clinical Trial. Am J Respir Crit Care Med, 2019; 200(11), 1354–1362.
4.	Kemp, SV, Slebos, DJ, Kirk, A, Kornaszewska, M, Carron, K, Ek, L, & Briault, A. A multicenter randomized controlled trial of Zephyr endobronchial valve treatment in heterogeneous emphysema (TRANSFORM). Am J Respir Crit Care Med, 2017; 196(12), 1535–1543.
5.	Valipour, A, Slebos, DJ, Herth, F, Darwiche, K, Wagner, M, Ficker, JH, & Eberhardt, R. Endobronchial valve therapy in patients with homogeneous emphysema. Results from the IMPACT study. Am J Respir Crit Care Med, 2016; 194(9), 1073–1082 and data on file.
6.	Klooster, K, ten Hacken, NH, Hartman, JE, Kerstjens, HA, van Rikxoort, EM, & Slebos, DJ. Endobronchial valves for emphysema without interlobar collateral ventilation. N Engl J Med, 2015; 373(24), 2325–2335.
7.	Welling J et al. Patient Selection for Bronchoscopic Lung Volume Reduction. International Journal of Chronic Obstructive Pulmonary Disease 2020; 15, 871–881.
8.	Gompelmann et al. Survival after endoscopic valve therapy in patients with severe emphysema. Respiration 2019; 97(2), 145-152.
9.	Garner et al. Survival after endobronchial valve placement for emphysema: A 10-year follow-up study. Am J Respir Crit Care Med. 2016; 194(4), 519-521.
10.	Klooster et al, Improved Predictors of Survival after Endobronchial Valve Treatment in Patients with Severe Emphysema Letter to the editor, American Journal of Respiratory and Critical Care Medicine Volume 195 Number 9 | May 1, 2017.

CAMBRIDGE, Mass., Nov. 30, 2020 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (Nasdaq: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced the appointment of Arvin Yang, M.D., Ph.D., as Senior Vice President and Chief Medical Officer effective immediately. Dr. Yang succeeds Dirk Huebner, M.D., who has stepped down as Chief Medical Officer but will remain with the Company until January 15, 2021, to assist with a smooth transition.

“We are excited to welcome Arvin to our leadership team as we enter this next crucial and exciting stage for Mersana,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “Arvin’s deep experience in leading late-stage global registration trials combined with his early stage and immuno-oncology experience will be instrumental in guiding the advancement of XMT-1536 into the planned fast-to-market registration-enabling study as well as driving the rest of Mersana’s first-in-class innovative pipeline.”

Dr. Yang spent over a decade at Bristol Myers Squibb in various roles with increasing responsibility for the clinical development of oncology and immuno-oncology therapies. Most recently, he was Vice President and Head of Clinical Hematology, where he was responsible for the clinical development of the late stage hematology pipeline. Before that, he was Vice President and Development Lead for Melanoma and GU cancers, and played a critical role in the global approval of nivolumab and nivolumab plus ipilimumab combinations in a number of indications. Earlier, he was responsible for the nivolumab and ipilimumab life-cycle clinical development plans including those in gynecological cancers. Finally, he has held leadership roles overseeing a pipeline of early clinical programs as well as roles in medical affairs. Dr. Yang received his M.D. and Ph.D. from Rutgers Robert Wood Johnson Medical School and completed training in internal medicine at Beth Israel Deaconess, Harvard Medical School and in oncology at Memorial Sloan-Kettering Cancer Center.

“Mersana’s XMT-1536 is poised to make a meaningful difference for people living with ovarian cancer. I am excited about the opportunity to work with the talented Mersana team to bring this important medicine to patients,” said Dr. Yang. “I am equally excited about the potential of the NaPi2b target in non-small cell lung cancer adenocarcinoma, Mersana’s robust pipeline of early-stage candidates developed using innovative and differentiated ADC platforms, and the potential of these candidates to make a significant impact in the lives of people living with cancer.”

“I would also like to take this opportunity to thank Dirk for his many contributions at Mersana. Over the past two years, Dirk has played a significant role in bringing XMT-1536 to proof of concept in ovarian cancer and in building a strong clinical development team. I wish him all the best in his future endeavors,” added Anna Protopapas.

About Mersana Therapeutics

Mersana Therapeutics is a clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms to rapidly develop novel ADCs with optimal efficacy, safety and tolerability to meaningfully improve the lives of people fighting cancer. Mersana’s lead product candidate, XMT-1536, is in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma. XMT-1592, Mersana’s second ADC product candidate targeting NaPi2b-expressing tumors, was created using Mersana’s customizable and homogeneous Dolasynthen platform and is in the dose escalation portion of a Phase 1 proof-of-concept clinical study. The Company’s early stage programs include a B7-H4 targeting ADC, as well as a STING-agonist ADC developed using the Company’s Immunosynthen platform. In addition, multiple partners are using Mersana’s Dolaflexin platform to advance their ADC pipelines.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of federal securities laws. These forward-looking statements are not statements of historical facts and are based on management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning the Company’s business strategy and the design, progression and timing of its clinical trials. Forward-looking statements generally can be identified by terms such as “aims,” “anticipates,” “believes,” “contemplates,” “continues,” “could,” “estimates,” “expects,” “goal,” “intends,” “may,” “on track,” “plans,” “poised,” “possible,” “potential,” “predicts,” “projects,” “seeks,” “should,” “target,” “will,” “would” or similar expressions and the negatives of those terms. Forward-looking statements represent management’s beliefs and assumptions only as of the date of this press release. The Company’s operations involve risks and uncertainties, many of which are outside its control, and any one of which, or combination of which, could materially affect its results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that may materially affect the Company’s results of operations and whether these forward-looking statements prove to be correct include, among other things, that preclinical testing may not be predictive of the results or success of ongoing or later preclinical or clinical trials, that the development and testing of the Company’s product candidates and new platforms will take longer and/or cost more than planned, and that the identification of new product candidates will take longer than planned, as well as those listed in the Company’s Annual Report on Form 10-K filed on February 28, 2020, with the Securities and Exchange Commission (“SEC”), the Company’s Quarterly Report on Form 10-Q filed on May 8, 2020, with the SEC and subsequent SEC filings. In addition, while we expect that the COVID-19 pandemic might adversely affect the Company’s preclinical and clinical development efforts, business operations and financial results, the extent of the impact on the Company’s operations and the value of and market for the Company’s common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, physical distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Contact:

Investor & Media Contact
Sarah Carmody, 617-844-8577
[email protected]

With More than $20M Committed in Digital Ads, ads4change Offers Affordable Access to the World’s Top Websites; Helps Cause-Related Organizations Change the World

ROCKVILLE, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) — ads4change, the first cause-related digital advertising platform, today announced its official launch. Offering access to ad space on the world’s top websites, the company helps social organizations harness the power of digital advertising to broaden their reach and help deliver on their long-term missions of driving change across the world. Created by Mark Levin, chief executive officer (CEO) of Consumable, the leading content discovery platform, and social innovator, Steph Cantor, ads4change already has more than $20M committed in digital ads and growing.

“Billions of digital ad impressions are wasted every day,” said Mark Levin, co-founder of ads4change and CEO of Consumable. “We saw this as an opportunity and a way to meaningfully give back. Now, through ads4change, social impact organizations can increase brand awareness on the world’s top websites and do so affordably.”

Through its relationship with Consumable, ads4change has the unique opportunity to pass through significant benefits to its customers. They gain access to the world’s largest media publishers, the Comscore 500, which ensures outreach to as many people as possible. They also experience 90 percent savings over what they might spend with traditional media platforms. Additionally, customers have access to personalized data tracking to help manage their campaigns in real time.

“We understand that nonprofits and social enterprises face the biggest digital marketing challenge – no budget,” said Steph Cantor, co-founder of ads4change. “We also know that building awareness is mission critical for their success. We are excited to provide a low cost, big impact digital advertising solution, and there’s no better feeling than knowing we will help transform these organizations.”

The company has already begun onboarding a number of leading global nonprofits, and more details are forthcoming on how ads4change is working with these clients to help change the world.

About ads4change

Established in 2020, ads4change is the first cause-related digital advertising platform that helps social enterprises and non-profits amplify their missions and change the world.

Learn more at www.ads4change.com. Follow us on LinkedIn, Facebook and Twitter at @ads4change and on Instagram at @ads4change_digitalad.

About Consumable

Launched in 2016, Consumable, the leading content discovery platform, has revolutionized online advertising by integrating premium on-demand video and audio entertainment within digital ads, delivering a more engaging experience that creates value for publishers, advertisers, and consumers alike.

This year, Consumable was selected by Inc. magazine for the 2020 Inc. 5000, placing #38. Consumable also ranked #32 on Deloitte’s Technology Fast 500™.

For more information, please visit www.consumable.com.

PR Contact:
Kate Alexander
For ads4change
201-638-3946
[email protected]

• Patient screening and dosing ongoing in Turkey and Hungary
  
• Topline data expected in Q2 2021 for the Combination Trial

DELRAY BEACH, Fla., Nov. 30, 2020 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that the first two patients have been dosed in Turkey for its Phase 2 trial evaluating its investigational drug, MS1819, in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT), for the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF).

“In the midst of a global pandemic and unpredictable obstacles, we are very encouraged to see our Combination therapy trial moving forward at one of the clinical testing sites in Turkey,” said James Sapirstein, President & CEO of AzurRx.  Mr. Sapirstein continued, “We expect to release topline results in the second quarter of next year. We are optimistic the results will build on the encouraging data we received earlier this year and hope we will be one step closer to improving the lives of thousands of patients suffering from cystic fibrosis.”

Earlier last month, the Company reported that additional clinical sites were activated in Turkey, which follows Hungary as the second country where patients have been screened and dosed in the Combination trial.  As of today, there are five sites activated in Turkey that are currently screening for patients.

The Phase 2 Combination Trial, open-label, multicenter study is assessing the safety and efficacy of MS1819 administered over 15 days in immediate release capsules in increasing doses of 700mg, 1,200mg and 2,240 mg per day, in combination with a patient’s daily dose of PERT.  Previously reported results on the initial five patients in the trial revealed that the combination therapy led to clinically meaningful improvements in the primary efficacy endpoint, the coefficient of fat absorption (CFA), and improvements in the key secondary endpoints, including body weight, stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea (excessive amounts of fat in the feces).

About the MS1819 Combination Therapy Trial

The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially-available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs^(1,2).  Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival. Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function^(3,4).

A combination therapy of PERT and MS1819 has the potential to: (i) correct macronutrient and micronutrient maldigestion; (ii) eliminate abdominal symptoms attributable to maldigestion; and (iii) sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in Q2 2021.

About MS1819

MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products.

About AzurRx BioPharma, Inc.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a biopharmaceutical company specialized in the research and development of non-systemic biologics for gastrointestinal disorders. The Company is focused on the development of its lead drug candidate, MS1819. AzurRx is currently conducting two Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial, and the Combination therapy trial, consisting of MS1819 in conjunction with porcine-derived pancreatic enzyme replacement therapy, the current standard of care. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. Additional information on the Company can be found at www.azurrx.com.

Forward-Looking Statements

This press release may contain certain statements relating to future results which are forward-looking statements. These statements are not historical facts, but instead represent only the Company’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial such as the interim results presented will be indicative of the final results of the trial. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results, including those related to the clinical development of MS1819, the results of its clinical trials, and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including, but not limited to delays in clinical trial recruitment and participation are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

For more information:

AzurRx BioPharma, Inc.
1615 South Congress Avenue
Suite 103
Delray Beach, Florida 33445
Phone: (646)-699-7855
[email protected]

Investor Relations contact:

LifeSci Advisors, LLC. 
Hans Vitzthum, Managing Director 
1 International Place, Suite 1480 
Boston, MA 02110 
Phone: 617-430-7578 
[email protected]

References

(1) Freedman, S.D., Am. J. Manag. Care, 2017; 23: S2220-S228
(2) Littlewood, J. et al, 2006, Pediatric Pulmonology, 2006, 41:35-49
(3) Engelen, M. et al, 2014, Curr. Opin. Clin. Nutr. Metab. Care; 17(6):515-520
(4) Vandenbranden, S.L. et al, 2012, Pediatric Pulmonology, 2012; 47(2): 135-143

• The ERJ Paper shows major effects on biomarkers in IPF, linked to mortality and to fall in FVC
• The inhaled GB0139 significantly reduced key plasma biomarkers from baseline vs placebo over 2 weeks
• GB0139 is being investigated in the 450 patients, 52 week GALACTIC-1 Phase 2b/3 trial in IPF

BOSTON and COPENHAGEN, Denmark, Nov. 30, 2020 (GLOBE NEWSWIRE) — Galecto, Inc., a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, announced today the publication of a paper detailing full results from a phase 2a study of GB0139 in Idiopathic Pulmonary Fibrosis (IPF) in the peer-reviewed publication European Respiratory Journal.

The study highlights the effect of inhaled GB0139 in IPF patients on the plasma levels of highly relevant disease biomarkers, in particular YKL-40 and CCL-18, which have been shown to have prognostic significance in IPF (YKL-40 linked to IPF mortality and CCL-18 linked to fall in lung function – FVC). These and several other biomarkers (PDGF-B, PAI-1, Galectin-3) were reduced in a dose dependent fashion from baseline in a consistent and statistically significant manner, with the strongest effects in the 10 mg dose group compared to placebo.

Hans Schambye, CEO of Galecto, said: “We are excited that the study showed that with intervention with our inhaled small molecule therapy GB0139 in the lungs of IPF patients, we see fast onset and major reduction in a series of biomarkers known as drivers of lung fibrosis and linked to IPF mortality. GB0139’s concerted and marked impact on these biomarkers support its potential to make a significant difference in the treatment of IPF, and we are looking forward to advancing it further through clinical development and potentially to market.”

GB0139, an inhaled small molecule inhibitor of galectin-3, a protein known to play a central role in fibrosis in several organs, has received Orphan Drug Designation (ODD) from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of IPF. The EMA cited clinically relevant biomarker data, in particular the significant reduction of YKL-40 in IPF patients, as a justification for the ODD designation. GB0139 was shown to be safe and well tolerated in healthy subjects and IPF patients in the phase 2a trial, and dose dependently suppressed expression of galectin-3, a protein known to play a central role in fibrosis in several organs, on alveolar macrophages.

“The availability of multiple biomarkers of IPF pathogenesis means physicians can not only monitor the progression of disease but also differentiate the effects of different treatments. The lockstep reduction in five biomarkers – PDGF-BB, PAI-1, Galectin-3, CCL18 and YKL-40 – in patients treated with TD139, but not with placebo, is an encouraging early sign that will require clinical confirmation,” said Toby Maher, one of the authors of the paper and Professor at Royal Brompton Hospital, Imperial College London and University of Southern California.

Galecto is now investigating GB0139 (formerly TD139) in the Phase 2b/3 GALACTIC-1 clinical trial in IPF. The trial is a pivotal size, randomized, double-blind, multicenter, parallel, placebo-controlled study across more than 100 centers in the U.S., the EU, and Canada, designed to evaluate the efficacy and safety of GB0139 in 450 subjects with IPF over 52 weeks.

About Galecto

Galecto is a clinical stage biotechnology company with advanced programs in fibrosis and cancer centered on galectin-3 and LOXL2. The company’s pipeline includes an inhaled galectin-3 modulator currently in phase 2b for the potential treatment of idiopathic pulmonary fibrosis, as well as two assets about to move into phase 2 targeting myelofibrosis, NASH and oncology. The Company is incorporated in the U.S. and has its operating headquarters in Copenhagen, Denmark.

Further information can be found at www.galecto.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto’s focus, GB0139’s potential, plans for clinical development and potential to market, and Galecto’s product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto’s expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto’s product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto’s filings with the Securities and Exchange Commission, including its Registration Statement on Form S-1. These forward-looking statements represent Galecto’s judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
For more information, contact:

Galecto Inc.	LifeSci Advisors (media)
Hans Schambye, CEO Jon Freve	Mary-Ann Chang
+45 70 70 52 10	+44 7483 284 853
[email protected]	[email protected]

FOSTER CITY, Calif., Nov. 30, 2020 (GLOBE NEWSWIRE) — GridGain^® Systems, provider of enterprise-grade in-memory computing solutions based on Apache^® Ignite^®, today announced it is hosting or participating in multiple online conferences, webinars and virtual meetups taking place in December and January 2020. GridGain will use these events to share unique insights into the latest in-memory computing technology developments, trends and strategies. GridGain has also posted on-demand videos of multiple November 2020 events on the company’s website.

“We have seen soaring interest in our events over the last few months as more companies of every size look to push their digital transformations forward,” said Terry Erisman, Executive Vice President of Corporate Development at GridGain Systems. “Our team of experts is always excited to share their wealth of information about how in-memory computing can support highly performant, massively scalable applications and enable vital new infrastructure strategies, such as digital integration hubs and HTAP.”

Webinars

• 
  How to Deploy Change Data Capture Using Debezium in Apache Ignite and GridGain
  
  – December 2, 2020 – Evgenii Zhuravlev, GridGain Customer Solutions Team Lead, will explain how Kafka with Debezium and GridGain connectors enables change data capture (CDC)-based synchronization between third-party databases and GridGain clusters. Webinar attendees will learn how to deploy such an architecture by configuring a Debezium Connector and a GridGain Certified Kafka Connector.

• 
  Apache Ignite Workshop: Developing Applications That Are Easy to Manage
  
  – 
  December 9, 2020 – Alexey Kukushkin, GridGain Professional Services Consultant, will discuss how to develop applications that are easy to manage, including the various methods for using Apache Ignite to develop manageable applications and the monitoring and managing tools that Apache Ignite provides.

• 
  Learn How Our Managed Services Offering Deploys GridGain and Apache Ignite in the Cloud
  
  – January 13, 2021 – Andrey Alexandrov, GridGain Senior Software Engineer, will guide attendees through the internal workings of GridGain Nebula, a managed services offering for Apache Ignite and GridGain. The session will provide a brief overview of the solution’s technology stack and architecture and live examples of how to use GridGain Nebula to accelerate platform deployment and configuration in public clouds.

• 
  Distributed Application Development Training: Approaches for User Authentication
  
  – On Demand – Denis Mekhanikov, GridGain Client Service Lead, reviews the various approaches to storing and using authentication data in distributed applications. Moving from the simplest to the most complex models, Mekhanikov outlines the pros and cons of each approach, and gives special attention to one of the most popular approaches to distributed sessions—single sign-on.

• 
  How to Leverage the Grid
  
  
  G
  
  
  ain Operator for Kubernetes to Deploy Apache Ignite
  
  – On Demand – Alexander Shapkin, GridGain Software Engineer, demonstrates the difference between in-memory clusters and persistent clusters, how to move step by step through the configuration, and how to use The GridGain Operator for Kubernetes to deploy Apache Ignite in AWS. 

Virtual


Meetups

• 
  In-Memory Computing Essentials for Java Developers and Architects with Java.IL
  
  –
  November 30, 2020 – Denis Magda, GridGain Vice President of Developer Relations in R&D and Apache Ignite Committer and PMC Member, will introduce the fundamental capabilities of distributed, in-memory systems and will demonstrate how to tap into a cluster’s resources and how to negate any negative impact that the network might have on the performance of applications.

• 
  Apache Ignite Talks
  
  – December 8, 2020 – Ken Cottrell, GridGain Solution Architect and Mikhail Antonov, platform owner of the core banking system at Raiffeisen Bank, Russia, will co-host a meetup for the Apache Ignite community to learn more about how Apache Ignite is used for Raiffeisen Bank’s backend and how to work with Ignite compute grid and Drool. 

Conferences

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  – December 4, 2020 – Denis Magda, GridGain Vice President of Developer Relations in R&D and Apache Ignite Committer and PMC Member, will present, “In-Memory Computing Essentials for Java Architects and Developers”. The session will introduce software engineers and architects to the fundamental capabilities of distributed, in-memory systems and provide guidance on how to tap into a cluster’s resources.
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  n-Memory Computing Summit
  
  
  2020 Virtual Worldwide Conference
  
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  On Demand
  – The In-Memory Computing Summit is the only industry-wide event focusing on the full range of in-memory computing technologies and solutions. Nearly 1,100 people representing 581 organizations from 53 countries registered for the late October conference to hear speakers from Dell, IBM, Intel, M&T Bank, MemVerge, Oracle, Target, ScaleOut Software, GridGain and more discuss the latest in-memory computing technologies and best practices. All conference keynote and breakout session video recordings are available on-demand.

About GridGain Systems

GridGain Systems is revolutionizing real-time data access and processing by offering an in-memory computing platform built on Apache^® Ignite^®. Common use cases for the GridGain platform include application acceleration and as a digital integration hub for real-time data access across data sources and applications. GridGain solutions are used by global enterprises in financial services, software, e-commerce, retail, online business services, healthcare, telecom, transportation and other major sectors, with a client list that includes ING, Raymond James, American Express, Société Générale, Finastra, UPS, Hewlett Packard Enterprise, Microsoft, RingCentral, American Airlines, Agilent, and UnitedHealthcareING, Raymond James, American Express, Société Générale, Finastra, IHS Markit, ServiceNow, Marketo, RingCentral, American Airlines, Agilent, and UnitedHealthcare. GridGain delivers unprecedented speed, massive scalability, and real-time data access for both legacy and greenfield applications. Deployed on a distributed cluster of commodity servers, GridGain software can reside between the application and data layers (RDBMS, NoSQL and Apache^® Hadoop^®), requiring no rip-and-replace of the existing databases, or it can be deployed as an in-memory database. For more information, visit gridgain.com.

CONTACT:

Terry Erisman
GridGain Systems
[email protected]
(650) 241-2281

GridGain is a trademark or registered trademark of GridGain Systems, Inc. Apache, Apache Hadoop, Hadoop, Apache Ignite, Ignite, Apache Kafka, Kafka, Apache Spark, and Spark are trademarks of The Apache Software Foundation. All other product and company names herein may be trademarks of their registered owners.

NEW HAVEN, Conn., Nov. 30, 2020 (GLOBE NEWSWIRE) — Kleo Pharmaceuticals, Inc., a targeted immunotherapy company developing fully synthetic bispecific therapies to redirect, enhance or replace antibodies, announced that it will present data on KPMW135, a novel CD3 x CD20 bispecific molecule, created by chemically conjugating a CD3- binder directly to rituximab (Rituxan®) using its multi-targeted antibody therapy enhancer (MATE) platform. Data will be presented at the upcoming 62^nd American Society for Hematology (ASH) annual meeting, being held in a virtual format December 5- 8, 2020.

Details of the electronic presentation are as follows:

Title: KPMW135, a Biosuperior CD3 Bispecific Version of Rituximab Created by a Novel Chemical Conjugation Technology Demonstrates Increased Anti-Tumor Activity by Adding T Cell-Mediated Cytotoxicity Activity to the Existing Mechanisms of Rituximab
Number: 3009
Presenter: Christian Vidal, PhD
Program: Oral and Poster Abstracts
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster III
Time and Location: Monday, December 7, 2020: 7:00 a.m. – 3 p.m. PST
Poster Hall (Virtual Meeting)

Kleo’s MATE platform enables site-directed chemical conjugation with off-the-shelf therapeutic antibodies to rapidly add or improve functionality to existing therapies. By MATE-ing a CD3 binder to rituximab, an anti-CD20 therapeutic monoclonal antibody used to treat B-cell lymphomas and lymphocytic leukemias, Kleo is able to retain rituximab’s existing mechanisms of action while adding potent and specific activation of T cells to destroy the tumor. In addition to oncology applications, the MATE platform is also being used to develop Kleo’s COVID-19 hyperimmune globulin mimic (HGM) therapy.

About Kleo Pharmaceuticals, Inc.

Kleo Pharmaceuticals is a targeted immunotherapy company that develops fully synthetic bispecific therapies to redirect, enhance or replace antibodies. The company was founded on the groundbreaking research of its scientific founder Dr. David Spiegel at Yale University. Kleo’s synthetic immunotherapy platform uses two chemistry-based approaches – antibody-redirecting molecule (ARM) and multi-targeted antibody therapy enhancer (MATE) – that help redirect and stimulate key components of the immune system to eradicate cancer cells and virulent pathogens. Compared to biologic therapies, Kleo’s compounds are smaller and more versatile, allowing for better tumor/tissue penetration, non-immunogenic for improved safety and higher dose levels, more efficient to produce and potentially orally bioavailable. They can be optimized against specified biological targets or combined with existing cell- or antibody-based therapies. Kleo investors include Biohaven Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc. (Nikkei:PPTDF). For more information, visit www.kleopharmaceuticals.com.

CONTACT INFORMATION
LifeSci Advisors (Investors)
Irina Koffler
646-970-4681
[email protected]

Susan Kinkead (Media)
415-509-3610
[email protected]

ATLANTA, Nov. 30, 2020 (GLOBE NEWSWIRE) — Select Interior Concepts, Inc. (NASDAQ: SIC), a premier installer and nationwide distributor of interior building products, today announced that Bill Varner, CEO, and Nadeem Moiz, COO and CFO, will participate in the Truist 2020 Industrials and Services Summit on Tuesday, December 8, 2020.

SIC will meet with institutional investors at the conference, which is being held virtually. The Company’s investor presentation will be available in the “Investor Relations” section of the Company’s website at https://ir.selectinteriorconcepts.com.

About Select Interior Concepts

Select Interior Concepts is a premier installer and nationwide distributor of interior building products with leading market positions in highly attractive markets. Headquartered in Atlanta, Georgia, Select Interior Concepts is listed on the NASDAQ. The Residential Design Services segment provides integrated design, sourcing and installation solutions to customers, in the selection of a broad array of interior products and finishes, including flooring, cabinets, countertops, window treatments, and related interior items. The Architectural Surfaces Group segment distributes natural and engineered stone through a national network of distribution centers and showrooms under proprietary brand names such as Metroquartz and PentalQuartz. For more information, visit: www.selectinteriorconcepts.com.

CONTACT
:

Investor Relations:

Tully Brown
(470) 548-7370
[email protected] 

NEW HARTFORD, N.Y., Nov. 30, 2020 (GLOBE NEWSWIRE) — Printing & Graphics Association Mid Atlantic (PGAMA) announced today it has entered into a strategic partnership with MetLife, through its insurance consultant Gilroy Kernan & Gilroy, to provide its members with a co-branded Auto and Homeowners program designed specifically for print and graphic arts organizations.

“The mission of PGAMA has always been to provide world class programs and services to its members. Our main goal is to help our members prosper – especially during challenging economic times. During the unprecedented event of COVID-19 and the challenges it has created, many business and individuals seek relief from the effects of this disruptive pandemic as well as the many financial stresses it has created. The PGAMA/MetLife partnership was formed to address some of those financial stresses and to help our members overcome some of the many hurdles that our members and their employees now face.” Jay Goldscher– President, PGAMA

To learn more about details of the program, PGAMA and MetLife will be holding an informative webinar event on Tuesday, January 19th from 10:00 am – 10:30 am EST. Please contact Jay Goldscher, President of PGAMA at 410-319-0900 or via email [email protected] for more information and a link to the event.

About Gilroy Kernan & Gilroy, Inc.

Founded in 1904, Gilroy Kernan & Gilroy (gkgrisk.com) is one of Central New York States oldest and largest independent insurance agencies. Blending innovative insurance solutions with leading-edge strategies, GKG helps individuals and businesses of all types and sizes manage risk. The firm is headquartered at 210 Clinton Road in New Hartford, New York from which it serves clients around the nation and globe. GKG employs a professional staff of over 50 and represents more than 80 insurance carriers. If you would like more information about this topic, please contact Andrew Biernat or email at [email protected].

About
PGAMA

The Printing & Graphics Association Mid Atlantic https://pgama.com is the only regional trade association for the printing industry serving Maryland, Virginia and Washington, D.C. and is an affiliate of PRINTING United Alliance, the largest association dedicated to the printing and graphic industry in North America The mission of the PGAMA is to provide business relationships, expertise and education that ensure the strength and profitability of its member companies in the graphics, print and digital communications industries.

Contact		Andrew Biernat
Telephone		315.624.7819
Email		[email protected]
Website		www.gkgrisk.com

 

NEW YORK, Nov. 30, 2020 (GLOBE NEWSWIRE) — Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Wednesday, December 2, 2020 at 9:15am ET.

The live and archived webcast can be accessed under “Events & Presentations” in the Investor Relations section of the Company’s website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

About Intra-Cellular Therapies

Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.

CONTACT:

Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333

Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006