On March 31, 2021 World-renowned cancer research and treatment center City of Hope reported that it has received a $50 million gift from Lennar Foundation, the charitable arm of homebuilder Lennar Corporation (Press release, City of Hope, MAR 31, 2021, View Source [SID1234577452]). This transformational gift of hope is the largest single philanthropic contribution to City of Hope Orange County. It will expedite the health care organization’s bold plans to invest $1 billion to develop and operate a comprehensive cancer campus in Irvine, California, and establish an Orange County network of advanced cancer care and research that will speed groundbreaking treatments directly to a community with growing needs.

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 future 190,000-square-foot Lennar Foundation Cancer Center at City of Hope Orange County will be located on 11 acres at Five Point’s Great Park in the heart of Irvine. It will bring best-in-class cancer care, pioneering research and lifesaving treatments to the county’s 3.2 million residents. Construction is already underway on the comprehensive cancer center, which will open in 2022. In addition, Orange County’s only hospital dedicated exclusively to treating and curing cancer will open at City of Hope Irvine in 2025.

City of Hope’s presence in Orange County offers local access to City of Hope’s National Cancer Institute-designated comprehensive cancer center with world-renowned cancer physicians and researchers who are singularly focused on finding better treatments and cures.

Lennar Foundation Cancer Center at City of Hope Orange County will bring to the region a host of distinguishing services, including:

Local access to more than 1,000 physicians and researchers who are transforming laboratory breakthroughs into targeted treatments that offer the best hope for patients
Access to hundreds of clinical trials that make 21st century treatments available to cancer patients meeting clinical criteria soon after they are developed.
A range of treatment options — from chemotherapy to immunotherapy and more — for combatting even the most aggressive cancers
New ways for preventing and treating cancer in its early stages, including highly targeted genomics and precision medicine breakthroughs
Nationally recognized supportive care programs rooted in more than a century of compassionate caregiving to help patients and their families overcome the psychosocial issues that can accompany a serious illness
As the country emerges from the COVID-19 pandemic, Lennar Foundation’s extraordinary contribution underscores the importance of investing in local health care resources and increasing access to leading-edge care. For Orange County, it is a reminder that cancer does not stop, and that City of Hope’s mission is more important than ever.

Lennar has a long history in Orange County of developing thriving communities, including helping form the vision for a world-class recreation and lifestyle destination. This gift is an extension of this longstanding commitment to improving lives in the regions Lennar helps shape. A portion of the gift to City of Hope is designated to support clinical translational research between City of Hope and the Sylvester Comprehensive Cancer Center of the University of Miami, thus uniting two organizations supported by Lennar’s generosity who share similar goals in developing new treatments and cures for patients with cancer.

City of Hope and Sylvester Comprehensive Cancer Center serve two of the most diverse areas in the United States. Both organizations are committed to conducting high-impact research that addresses the cancer burden in their communities. This gift will enable collaborative, translational science that will drive innovation and catalyze timely and necessary progress towards health equity.

Lennar Foundation’s gift to City of Hope is a generous continuation of Lennar’s longstanding support of the comprehensive cancer center. Jon Jaffe, co-chief executive officer and co-president of Lennar Corporation, is a member of City of Hope’s Construction Industries Alliance Leadership Advisory Council, which raises funds for cancer treatment and research. In recognition of his contributions, Jaffe was awarded City of Hope’s highest honor — The Spirit of Life Award in 2004.

City of Hope Newport Beach, the first phase of City of Hope Orange County’s expansion, opened in early 2020, providing Orange County residents first-time local access to world-renowned physicians backed by the powerful City of Hope network. City of Hope plans to open other clinical network locations across the region.

Supporting quotes

Robert Stone, president and CEO, City of Hope
Helen and Morgan Chu Chief Executive Officer Distinguished Chair

"This is the start — and it is a monumental start — to show the nation that our work in Orange County will catalyze incredible achievements in health care. Visionary donors and volunteers have been foundational to City of Hope’s 108-year history, and we are deeply grateful to the Lennar Foundation for their extraordinary contributions and longstanding support. With this gift, we will achieve the nexus of unsurpassed medical expertise, future-focused communities, groundbreaking technology and innovation, all for the single purpose of saving lives. This partnership supports a system of care delivery that provides state-of-the-art treatments, the latest scientific and medical discoveries, and unprecedented access that will serve as a model across the country."

Stuart Miller, executive chairman, Lennar Corporation

"At Lennar, we are committed to building communities, and we are pleased to support City of Hope to help build the future of cancer care. Together, we are building a state-of-the-art center for advanced cancer care and research that will make a difference in the lives of so many by turning science into practice and hope into reality."

Nicole Petersen Murr, grateful Orange County patient

"City of Hope saved my life. My family and I will be forever grateful to my doctor and care team. Anyone who has heard the words ‘You have cancer’ knows how those words change your life and affect every piece of it. I want everyone who hears those words to have the same compassionate care and access to the latest treatments that I had. Having City of Hope in Orange County changes everything for cancer patients — present and future. I’m so grateful to have this world-renowned care in my own community."

Annette M. Walker, president, City of Hope Orange County

"This generous gift of hope is a historic moment for City of Hope. Thank you to Lennar Foundation, which is united in our vision and understands the urgency of our work, helping us ensure that our promise to Orange County will be fulfilled. We are building a place of hope and healing that will serve residents of Orange County and beyond for generations to come. Every one of us has been touched by cancer and we want all who are impacted by this disease to know we are here for you, your family, friends and neighbors."

Jon Jaffe, co-chief executive officer and co-president, Lennar Corporation

"City of Hope is a leader in the treatment of and race to find a cure for cancer, and it’s gratifying to know that, with this gift, we will make a positive impact by expanding access to care and advancing the research that will treat, prevent and ultimately eliminate cancer — we hope this contribution will encourage other philanthropic leaders to support City of Hope in the fight against cancer."

Kristin J. Bertell, chief philanthropy officer, City of Hope

"This important contribution is a clear demonstration of the power of philanthropy to accelerate positive changes in health care delivery, spur advances in science, research and treatment, and give real hope to patients, families and communities. Lennar Foundation’s generosity continues a long philanthropic legacy that is the cornerstone of our history. There is no doubt that this gift will have a long-lasting impact, and we look forward to engaging the community to make the vision for Orange County and the future of cancer care a reality."

For more information on the progress of City of Hope’s Orange County expansion and its first clinical network location in Newport Beach, please visit CityofHope.org/OC.

On March 31, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria,reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2020 (Press release, BiomX, MAR 31, 2021, View Source [SID1234577451]).

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!

"2020 was a tremendous year of growth for BiomX, as we expanded our pipeline with programs in cystic fibrosis and atopic dermatitis, both designed to address unmet medical needs," said Jonathan Solomon, Chief Executive Officer of BiomX. "Fueled by the rapid development capabilities of our novel BOLT platform, we are excited to announce today that we have selected two new phage cocktail candidates, BX004 and BX005, for cystic fibrosis and atopic dermatitis, respectively."

Mr. Solomon added, "2021 is poised to be a year of multiple potential value inflection points for BiomX, due to anticipated efficacy data readouts from two Phase 2 clinical studies, BX001 in subjects with mild-to-moderate acne and BX004 in subjects with cystic fibrosis. Due to the historic safety of phage therapies and the cutting-edge capabilities of our BOLT platform, we are accelerating toward additional efficacy readouts by mid-2022 for our inflammatory bowel disease and atopic dermatitis programs, which are large market opportunities. We believe phage could play a substantial role in the growing field of microbiome therapies."

RECENT HIGHLIGHTS AND KEY UPCOMING MILESTONES

Acne-Prone Skin

Earlier this month, BiomX announced the dosing of the first subject in a Phase 2 cosmetic clinical study of BX001 in subjects with mild-to-moderate acne over the course of 12 weeks, a longer duration than the Phase 1 study. Results from 8-week and 12-week timepoints are expected in the third and fourth quarter of 2021, respectively.
In March 2020, BiomX reported positive data from the Phase 1 cosmetic clinical study of BX001 in subjects with acne-prone skin, where BX001 was shown to be safe and tolerable, as well as demonstrated a statistically significant reduction of Cutibacterium acnes levels with the high dose compared to placebo.
Inflammatory Bowel Disease ("IBD") and Primary Sclerosing Cholangitis ("PSC")

In February 2021, BiomX announced positive results from a first-in-human Phase 1a pharmacokinetic study of BX002 in the IBD/PSC program, the first ever clinical study detailing pharmacokinetics of an oral phage therapy under a U.S. Food and Drug Administration ("FDA") IND approved protocol. BX002 demonstrated safety and tolerability with successful delivery of a high concentration of viable phage to the lower gastrointestinal tract, specifically at levels approximately 1,000 times the bacterial burden of the target bacteria, Klebsiella pneumoniae, in IBD and PSC patients as measured in stool.
Based on the Phase 1a study results, BiomX plans to initiate a Phase 1b/2a study with results expected by mid-2022. The Phase 1b/2a study will evaluate the efficacy of BX003 in reducing the intestinal bacterial burden of Klebsiella pneumoniae in target bacteria carriers. In November 2020, the Company consolidated its IBD and PSC programs into one product candidate, BX003, with a broad host range for both indications.
Cystic Fibrosis ("CF")

The Company reported the selection of the phage cocktail candidate, BX004, for subjects with CF, specifically for the treatment of chronic lung infections caused by Pseudomonas aeruginosa, a main contributor to morbidity and mortality in patients with this and other underlying conditions. In preclinical in vitro studies, BX004 was shown to be active against antibiotic resistant strains of Pseudomonas aeruginosa and demonstrated the ability to penetrate biofilm, an assemblage of surface-associated microbial cells enclosed in an extracellular polymeric substance and one of the leading causes for antibiotic resistance.
Phase 2 results of a proof-of-concept clinical study evaluating the safety and efficacy of BX004 in CF patients are expected in the fourth quarter of 2021.
Atopic Dermatitis

The Company reported the selection of the phage cocktail candidate, BX005, for subjects with atopic dermatitis, specifically to target Staphylococcus aureus, a bacterium linked to the development and exacerbation of inflammation in atopic dermatitis. In preclinical in vitro studies, BX005 was shown to be active against over 90% of strains from a panel of Staphylococcus aureus, including antibiotic resistant strains, isolated from the skin of subjects in the U.S. and Europe.
BiomX expects to initiate a Phase 2 proof-of-concept clinical study evaluating the safety and efficacy of BX005 in atopic dermatitis patients in the second half of 2021, with results expected in the first half of 2022.
Colorectal Cancer

BiomX is exploring phage-mediated delivery of therapeutic payloads for the treatment of colorectal cancer, such as immune-stimulating proteins, GM-CSF and IL-15, to target Fusobacterium nucleatum bacteria, which is present within colorectal tumors. In December 2020, BiomX presented preclinical results confirming the presence of Fusobacterium nucleatum in 80% of tumor samples collected from patients with colorectal cancer, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Immuno-Oncology Virtual Congress. The Company has also successfully engineered an IL-15 gene payload into Fusobacterium nucleatum phage.
BiomX previously disclosed data from preclinical models demonstrating that intravenously administered phage has the ability to target bacteria inside colorectal cancer tumors.
Preclinical results from animal studies evaluating use of phage therapy in combination with checkpoint inhibitors are expected in the second and third quarters of 2021.
Corporate and Business Highlights

In September 2020, BiomX entered into a collaboration with Boehringer Ingelheim to utilize BiomX’s XMarker, a microbiome-based discovery platform to potentially identify biomarkers associated with patient phenotypes in IBD.
In October 2020, BiomX announced the appointment of Paul Sekhri and Alan Moses, M.D., to its Board of Directors.
Fourth Quarter and Full Year 2020 Financial Results

Cash balance and short-term deposits as of December 31, 2020, were $57.1 million, compared to $82.4 million as of December 31, 2019. The decrease was primarily due to net cash used in operating activities. Existing cash, cash equivalents and short-term deposits are expected to be sufficient to fund the Company’s current operating plan and capital expenditure requirements through mid-2022.
Research and development (R&D) expenses, net were $6.5 million for the three months ended December 31, 2020, compared to $5 million for the same period in 2019. R&D expenses, net were $21 million for the year ended December 31, 2020, compared to $13.5 million for the prior year. The full year increase was primarily due to the growth in number of employees, resulting in additional stock-based compensation, salaries and related expenses, and due to manufacturing of candidate products for clinical trials in acne-prone skin and IBD/PSC.
General and administrative (G&A) expenses were $2.6 million for the three months ended December 31, 2020, compared to $4.7 million for the same period in 2019. G&A expenses were $9.3 million for the year ended December 31, 2020, compared to $8.7 million for the prior year. In the fourth quarter of 2019 the expenses included merger-related costs. The full year increase was primarily due to expenses associated with operating as a public company, such as directors’ and officers’ insurance, filing and legal and accounting expenses.
Net loss for the fourth quarter of 2020 was $9.1 million, compared to $9.3 million for the same period in 2019. For the full year 2020 net loss was $30.1 million, compared to $20.6 million for the prior year.
Net cash used in operating activities for the full year 2020 was $24.4 million, compared to $17.6 million in 2019.
Conference Call and Webcast Information

BiomX management will host a conference call and webcast today at 8:00 am ET to report financial results and corporate updates for the fourth quarter and year ended December 31, 2020. To participate in the conference, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). A live and archived webcast of the call will be available on the Investors section of the Company’s website at www.biomx.com

About Phage Therapy

Bacteriophage, or phage, are viruses that target bacteria and are considered inert to mammalian cells. Phage are designed to target and kill specific bacterial species or strains without disrupting other bacteria or the healthy microbiota. BiomX’s phage-based product candidates derive from its proprietary BOLT ("BacteriOphage Lead to Treatment") R&D platform that enables the company to rapidly develop, manufacture and formulate rationally-designed phage combinations ("cocktails") of naturally occurring or synthetic phage to target pathogenic bacteria. The phage cocktails contain multiple phage with complementary functions optimized through in vitro and in vivo testing. (Press release, BiomX, MAR 31, 2021, View Source [SID1234577451])

On March 31, 2021 Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for personalized healthcare based on the EpiSwitch 3D genomics platform, and Agilent Technologies (NYSE: A), a global leader in the life sciences, diagnostics, and applied chemical markets, reported that have signed a supply and resale agreement for the manufacture and sale of the new EpiSwitch Explorer Array Kit ("Kit") (Press release, Oxford Biodynamics, MAR 31, 2021, View Source [SID1234577450]).

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!

Under the terms of the agreement, Agilent will supply a custom-made SurePrint G3 CGH Microarray for the Kit, incorporating OBD’s proprietary 3D genome probes. OBD has exclusive rights for supply and distribution of the Kit.

Harnessing the strengths of Agilent’s microarray technology and OBD’s 3D genomic recognition algorithms, the EpiSwitch Explorer Array Kit provides results at a high throughput, with high resolution in a fraction of the time. The Kit simultaneously interrogates almost 1 million 3D genomic sites, providing over ten times more high-value data points than conventional, costly, time-consuming methods of detection, which are limited by high noise to signal ratio. This creates a highly reproducible, unbiased map, which can be used to identify, evaluate, or monitor 3D genomic biomarkers.

The newly launched Kit, which is for research use only, will enable a new level of whole genome screening, biomarker discovery, and profiling of the 3D genome. It can assist researchers by analyzing the genome’s 3D architecture and the crucial role it plays in gene regulation.

Improved understanding of the 3D genome could have a significant impact on patient diagnosis, prognosis of disease response, and determination of treatment options. The global epigenetics market size is expected to reach over $22 billion by 2025, with the kits segment anticipated to experience the greatest growth (>20% CAGR), driven by this need for biomarker development and accurate detection for personalized medicine [2].

The EpiSwitch platform has already been used to develop the recently launched COVID-19 Severity Test, EpiSwitch CST. Further tests are being developed in other areas including immuno-oncology response, rheumatoid arthritis and prostate cancer [3-8].

Dr Jon Burrows, CEO of Oxford BioDynamics, said:

"EpiSwitch is already well validated in pharma biomarker discovery and has proven capable of stratifying patients for many biological indications [3-8]. OBD has previously announced the expansion of its strategic focus [1] to bring the platform to the precision medicine market, starting with the launch of our COVID-19 Severity Test and the upcoming launch of an IO test. Alongside this strategy, we are keen that our technology and knowledgebase are made available for research and development by academic and clinical researchers worldwide."

He added: "Partnering with industry leader, Agilent, gives important third-party validation to our technology and working together will strengthen the commercial offering of our EpiSwitch Explorer Array Kit to the global research community."

Kevin Meldrum, VP/GM of Agilent Genomics said: "Agilent is the premier provider of custom microarrays and we are excited to secure this partnership with Oxford BioDynamics demonstrating how arrays can enable the development of new technologies, such as EpiSwitch, beyond gene expression and CGH."

To accompany the Explorer Array Kit, OBD will also provide access to their online EpiSwitch Portal to enable array data analytics and provide biological context for readouts. This Portal comprises of two applications:

The EpiSwitch Analytical Portal (EAP) – to enable statistical analysis of 3D-array data with a wide range of tools
The EpiSwitch Data Portal (EDP) – to provide options to map data to the genome, allowing integration of analysis with other data types (SNPs, Hi-C, ATAC-Seq Chip-Seq, RNA-Seq, etc.) and biological interpretation
The EpiSwitch Explorer Array Kit is now available to purchase from OBD’s online store: View Source Here, users can also sign up and access the EpiSwitch suite of analytical portals. The Kit is provided with EpiSwitch-optimized sample preparation reagents for analysis of blood, PBMC and primary cell or cell line samples.

On March 31, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, and 4SC AG (FSE Prime Standard: VSC), reported the signing of an agreement under which Immunic will settle its remaining obligation of a 4.4% royalty on net sales of selective oral DHODH inhibitor, IMU-838, for $17.25 million (Press release, Immunic, MAR 31, 2021, View Source [SID1234577449]). The transaction will be payable 50% in cash and 50% in shares of Immunic’s common stock.

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!

Immunic acquired lead program IMU-838 in September 2016 from 4SC AG through an asset acquisition, in exchange for a one-time upfront cash payment, future milestone payments and a royalty on net sales for a certain period. With completion of this transaction, no further payment obligations remain between Immunic and 4SC.

"Execution of this agreement with 4SC is key, as it provides us with 100% of the future sales potential of our lead asset, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Backed by exceptionally strong data generated by our phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS), we are now planning to initiate a phase 3 trial during the second half of this year. We are excited to move our pipeline forward and the acquisition of the royalties will enable us to realize the full market potential of IMU-838, not only as a treatment for RRMS but also as a potential new therapeutic option for ulcerative colitis, Crohn’s disease, COVID-19, and primary sclerosing cholangitis, thereby driving significant future value for our shareholders."

Jason Loveridge, Ph.D., Chief Executive Officer of 4SC, added, "4SC is very pleased to conclude this transaction as it provides non-dilutive financing for our own oncology programs, extending our cash reach well into the second half of 2022. We are expecting exciting data from some key domatinostat programs, such as DONIMI in the neoadjuvant space, in 2021 and this transaction will help us move this and other key studies in Merkel cell carcinoma forward."

On March 31, 2021 Celsion Corporation (NASDAQ: CLSN) ("Celsion" or the "Company"), reported it has entered into definitive agreements with institutional investors for the purchase and sale of 11,538,462 shares of its common stock at a purchase price of $1.30 per share in a registered direct offering, for gross proceeds of $15 million before deducting placement agent fees and expenses (Press release, Celsion, MAR 31, 2021, View Source [SID1234577448]). The closing of the offering is expected to occur on or about April 5, 2021, subject to the satisfaction of customary closing conditions.

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.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

JonesTrading Institutional Services LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-254515) previously filed with the U.S. Securities and Exchange Commission (the "SEC") under the Securities Act of 1933, as amended. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or 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 jurisdiction.