On August 26, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the quarter ended June 30, 2021 (Press release, Can-Fite BioPharma, AUG 26, 2021, View Source [SID1234586935]).

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Corporate and Clinical Development Highlights Include:

Can-Fite Entered into Development and Commercialization Agreement in $3 Billion Veterinary Osteoarthritis Market – Can-Fite entered into a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use. The canine osteoarthritis market is projected to reach $3 billion by 2024.

Can-Fite Received a Notice Allowance in China for its NASH Patent – During the second quarter, Can-Fite received a Notice Allowance in China for its patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This patent, which has subsequently been issued to Can-Fite, addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, to reduce liver fat particularly in patients with NASH.

Patent Filed for A3AR-based Cannabis Compounds in the Treatment of Liver Diseases – Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis, which is associated with NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Phase III Psoriasis Study Nears Completion of Enrollment – The Phase III Comfort study completed enrollment of 75% of planned patients during the second quarter, with full enrollment expected in the coming weeks. The study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla) in patients with moderate to severe plaque psoriasis. Topline results are expected Q1 2022.

Phase II COVID-19 Study Expands into Europe – Can-Fite’s ongoing Phase II study, under a U.S. FDA protocol, has been enrolling patients in Israel and expanded enrollment into Europe during the second quarter. The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in 40 patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.

Phase IIb NASH Study Receives Clearance from Israeli Ministry of Health – Can-Fite received clearance from the Israeli Ministry of Health to commence a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. Patient enrollment is expected to commence Q3 2021, ahead of the prior expected start date of Q4 2021. The Company expects to expand the study to additional clinical sites in Europe. A prior Phase IIa clinical trial of Namodenoson in the treatment of NASH met study endpoints showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has completed preparatory work for its pivotal Phase III study and plans to submit its study protocol and plans to Institutional Review Boards (IRBs) at potential clinical sites. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival.

Fortified Balance Sheet

On June 30, 2021 Can-Fite had approximately $7.5 million in cash, cash equivalents, and short-term deposits. The Company closed an additional $10 million registered direct offering in August 2021.

"We expect multiple milestones in the coming months including topline results from our Phase III psoriasis study, in addition to the commencement of our pivotal Phase III in liver cancer and Phase IIb in NASH. We believe positive topline results may lead to further expansion of our global distribution strategy which has included significant non-dilutive funding," stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2021 were $0.39 million compared to revenues of $0.40 million during the six months ended June 30, 2020. The decrease is considered immaterial.

Research and development expenses for the six months ended June 30, 2021 were $3.81 million compared with $7.05 million for the same period in 2020. Research and development expenses for the first half of 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first six months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first six months of 2021. We expect research and development expenses will increase through 2021 and beyond.

General and administrative expenses were $1.89 million for the six months ended June 30, 2021 compared to $1.45 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees. We expect general and administrative expenses will remain at the same level through 2021.

Financial income, net for the six months ended June 30, 2021 was $0.20 million compared to financial expense, net of $0.12 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investment.

Can-Fite’s net loss for the six months ended June 30, 2021 was $5.09 million compared with a net loss of $8.23 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of June 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $7.53 million as compared to $8.26 million at December 31, 2020. The decrease in cash during the six months ended June 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma which were offset by Company’s operating activity.

The Company’s consolidated financial results for the six months ended June 30, 2021 are presented in accordance with US GAAP Reporting Standards.

On August 26, 2021 Celdara Medical, LLC (Celdara), The New Hampshire Academy of Science (NHAS), and Crossroads Academy reported the opening of the Fanger Center (Press release, Celdara Medical, AUG 26, 2021, View Source [SID1234586956]). The Fanger Center is an adaptable, cutting-edge facility that functions dually as the Crossroads Academy middle school by day and a New Hampshire Academy of Sciences STEM lab outside of school hours, enabling afterschool, holiday, and summer use. This unique collaboration makes the Fanger Center accessible to STEM-interested middle- and high-school students across the region through NHAS Programs, which include need-based financial aid. Constructed on the Crossroads Academy campus in Lyme, NH, the purpose-built facility was supported by Celdara and named after Dr. Michael Fanger, who co-founded Celdara Medical in 2008 with Dr. Jake Reder. The new facility, designed for chemistry, biology, mathematics, engineering, and computer science, is available to students across New Hampshire and Vermont. An outdoor ribbon cutting ceremony was held today for students and teachers to celebrate the start of the school year in the new space.

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"The NHAS has a mission to further the work of scientists and future scientists in New Hampshire by providing a forum for scientific discussion, interaction, and collaboration," notes NHAS Executive Director, Dr. Peter Faletra. "The Fanger Center provides an expanded space for students from all our communities to engage in authentic scientific research with teachers and STEM professionals through an apprenticeship model. NHAS intends to be a main hub for STEM opportunities in the states of NH and VT, with The Fanger Center serving as its flagship STEM research Center. Accessibility is core to our efforts; it is our goal to ensure that motivated students can attend, independent of their financial means."

Crossroads Head of School, Mr. Dan Morrissey, adds: "At Crossroads Academy, our faculty set children on learning journeys in every field of discovery, teaching them that knowledge and virtue – strong minds and kind hearts – can change the world. Like Dr. Fanger, our community is eager to create a better future and is continually exploring ways to do so. The inauguration of the Fanger Center on our 30th Anniversary represents our continued investment in thought leadership and innovation. We are thrilled that the region’s middle and high school students will have the opportunity to engage in high quality curricular and extra-curricular science and engineering research through our unique partnership with NHAS."

The Fanger Center is a replicable and scalable model for schools worldwide and builds upon the success of the current NHAS STEM lab. In addition to regional STEM outreach programs, teacher training and authentic research experiences for students, the existing NHAS STEM lab has resulted in over 100 students from 15 regional schools publishing their research with the American Junior Academy of Science and presenting their work at the annual meetings of the American Association for the Advancement for Science (AAAS). The Fanger Center expands the existing 1,200 square feet of biology lab space to include an additional 2,500 square feet of lab space, in addition to offices, conference spaces, and future-ready maker spaces, all focused on the physical sciences, computer science and engineering.

"Mike and I founded Celdara to transform the work of leading scientists into products and services that can help humanity. Mike gave immeasurably to the field of scientific education, as a mentor, entrepreneur, and academician. Increasing equitable access to educational opportunities and investing in STEM leaders of the future is a wonderful way to honor Mike’s legacy. Some of the next generation of leading scientists, mathematicians, and engineers will find their inspiration here," said Jake Reder, co-founder and CEO of Celdara Medical.

In 1981, Dr. Fanger joined Dartmouth Medical School’s Immunology Program, creating a world-renowned Department of Microbiology and Immunology, for which he served as Chairperson for a decade. As an entrepreneur, Dr. Fanger cofounded the pioneering biotechnology company Medarex, generating technology which created nearly half of the human antibodies approved to date. Two Medarex medicines ignited the immunoncology revolution, providing hope for previously incurable patients and saving thousands of lives. In 2018, Drs. Jim Allison and Tasuku Honjo received the Nobel Prize in Medicine for their pioneering work that led to these world changing Medarex drugs.

"Mike’s impact in the biotech industry is the stuff of legend, but for the many of us that he inspired, his teaching, counselling, advising, mentoring and friendship may be even more impactful. These virtues are a big part of why we are honoring his legacy with this Center. My hope is that every student who passes through these doors will learn something about Mike and realize that they too can be great by doing good," said Reder.

On August 26, 2021 Boan Biotech reported that Boyounuo (Bevacizumab Injection), an self-developed anticancer biologic, has been approved by China’s National Medical Products Administration for the treatment of hepatocellular carcinoma (HCC) (Press release, Boan Biotech, AUG 26, 2021, View Source [SID1234595077]). It is the fourth indication approved for Boyounuo, with the first three indications being for advanced, metastatic or recurrent non-small-cell lung cancer, metastatic colorectal cancer, and recurrent glioblastoma. The latest approval gives liver cancer patients a new treatment option and will enable Boyounuo to serve a broader patient population.

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Liver cancer is a common malignancy in China, and the disease has a high morbidity and a high mortality rate. HCC is the most common form of liver cancer, accounting for around 90% of all cases . According to data from the World Health Organization’s International Agency for Research, 910,000 new cases of liver cancer were reported worldwide in 2020, of which 410,000 occurred in China, accounting for over 45% of the world total. In China, liver cancer has become the second most deadly form of cancer: 390,000 deaths were reported in 2020, close to the number of new cases the same year . The 5-year survival rate for liver cancer patients in China was only 12.1% , indicating high incidence and low survival. The disease severely affects life and health of China’s population and places a significant healthcare burden on society and patient’s families.

Due to its insidious onset, most liver cancer patients have already reached the middle to late stage of the disease at the time of initial diagnosis, when radical surgery is no longer a treatment option. The prognosis, especially for patients with unresectable HCC, is poor: patients have few options for systemic treatment and the 1-year survival rate after diagnosis is less than 50% . Bevacizumab in combination with atezolizumab is the first first-line treatment for advanced HCC to achieve positive results in more than a decade. The combination therapy overcomes common factors which lead to poor prognosis of HCC by leveraging a unique mechanism of immunotherapy together with the regulatory effects of anti-angiogenic therapy on the immune microenvironment. Compared to first-line therapies for HCC prior to this combination, patients with advanced unresectable HCC who receive the combination therapy are able to live longer and enjoy better quality of life. Bevacizumab in combination with atezolizumab is also the first approved first-line immune combination therapy for unresectable HCC and has been listed as a first-line treatment option for liver cancer by several authoritative guidelines in China and around the world with the best level of evidence and the highest level of recommendation.

Boyounuo is an anti-VEGF humanized monoclonal antibody injection developed by Boan Biotech. It is a biosimilar to Avastin. Comparative clinical studies have shown that Boyounuo is highly similar to Avastin in terms of PK characteristics, efficacy, safety and immunogenicity.

Dr. Dou Changlin, R&D President and COO of Boan Biotech, said, "We are delighted to see the approval of another indication for Boyounuo. Bevacizumab is one of the standard therapies used in the treatment of malignant tumors. We anticipate that Boyounuo will help serve more patients and contribute to the better management of cancers in China."

On August 26, 2021 Herantis Pharma Plc ("Herantis"), focusing on disease modifying therapies for debilitating neurodegenerative diseases, reported its half yearly financial report for the period January 1 – June 30, 2021 (Press release, Herantis Pharma, AUG 26, 2021, View Source;results-for-the-first-half-year-january-1—june-30–2021,c3403498 [SID1234586902]). It is available on Herantis’ website (Financial information). Investors, analysts and media are invited to a webcasted live call today at 10:30 EEST / 9:30 CEST.

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To register for Herantis’ 1H 2021 Financial Report live call

Register Here: Herantis’ 1H 2021 Financial Report Live Call

Webinar ID: 235-655-763

Questions can be submitted throughout the webcast event.

Following the webcast of the live call, a recording will be available on Herantis Pharma’s website (www.herantis.com).

Herantis transformed into a pure play CNS biotech company –

Highlights January – June 2021:

Strategic data drive decision taken to fully focus all company resources on Herantis’ CDNF and xCDNF assets, thus becoming a pure play CNS (central nervous system) biotech company.
Selected HER-096 as the xCDNF candidate to take forward into further development for the treatment of Parkinson’s Disease (PD) and other neurodegenerative diseases, an important milestone for the company. HER-096 was selected based on clear and compelling preclinical data including that it:
Effectively penetrates the Blood-Brain-Barrier (BBB)
Potently protects neurons and restores their functional phenotype
Significantly reduces aggregation of the toxic protein alpha-synuclein and the associated neuroinflammation
Restores proteostasis
A study showing CDNF’s therapeutic effects in alpha-synuclein-based animal models was published in Molecular Therapy, a leading scientific journal. This study provides new insight in how CDNF affects alpha-synuclein pathology on the molecular and cellular level.
Entered into an agreement with Nanoform Finland Plc. The collaboration provides for formulation proof-of- concept studies to combine Herantis’ CDNF therapy for Parkinson’s disease, with Nanoform nanoparticle technology.
Two presentations summarizing the results from the Phase I-II First-In-Man Clinical Trial of CDNF in PD were presented at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases, AD/PD 2021.
The clinical trial results from Phase II study investigating Herantis’ patented gene therapy Lymfactin, for the treatment of Breast Cancer Related Lymphedema (BCRL), were inconclusive. The primary purpose of the trial was to determine whether there was an additional benefit of Lymfactin treatment in combination with lymph node transfer surgery, compared to surgery alone. While both treatment groups experienced clear clinical benefits, the trial did not establish additional treatment benefit for Lymfactin in combination with surgery, compared to surgery alone. Strategic decision taken to seek out-licensing partners for the Lymfactin program.
Hilde Furberg was elected to the Board of Directors
Hilde brings 35+ years of global leadership experience both as a Board member and through her years in global sales, marketing, strategy and management in the international Pharma/Biotech industries
Former European Head of Rare Disease Europe/GM and Senior VP Rare Diseases EMEA at Genzyme/Sanofi Genzyme
Successful R&D investor day held in June. Link to the event: Herantis’ Virtual R&D Investor Day 2021
Presented novel evidence of biological and biomarker impact in humans from the CDNF Phase 1 clinical study

Summary and outlook for 2021:

The new Herantis is a pure play CNS company, and the programs are fully focused on disease modifying therapeutics to address the unmet need in Parkinson’s disease and other neurological illnesses. During the remainder of 2021 we will continue executing our roadmap as we aim to complete formulation activities for the new CDNF administrations routes, and continue strengthening the preclinical proof of concept data for HER-096 (xCDNF).

On August 26, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that results from a global Phase 2 clinical study of balstilimab monotherapy in recurrent/metastatic cervical cancer were published online in the international peer reviewed journal Gynecologic Oncology (View Source) (Press release, Agenus, AUG 26, 2021, View Source [SID1234586936]).

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"Publication of these data marks another significant achievement toward our objective to provide effective therapeutic options to those battling cancer," said Steven O’Day, MD, Chief Medical Officer of Agenus. "These data are drawn from the largest Phase 2 study to date evaluating PD-1 inhibition in advanced cervical cancer patients who have progressed on or after first-line chemotherapy; the results indicate balstilimab’s potential as an effective new therapy."

In the 140 evaluable patients, the objective response rate (ORR) in patients with PD-L1 positive tumors was 20.0% and included 3 patients (3/85, 3.5%) with a complete response and 14 patients (14/85, 16.5%) with a partial response. The median duration of response (DoR) was not reached after a 14.6-month median follow-up. Responses were also observed in the PD-L1 negative population with an ORR of 7.9%. The confirmed ORR for both PD-L1 positive and negative tumors was 15.0% and included 5 patients (3.6%) with a complete response and 16 patients (11.4%) with a partial response. The median DoR was 15.4 months and the disease control rate was ~50%. Notably, responses were observed across histologies, with responses in the squamous cell histology (ORR 17.6%) and in the more difficult to treat adenocarcinoma histology (ORR 12.5%). The safety profile was manageable and consistent with that of currently approved anti-PD-1 antibodies; it also compared favorably to the safety profiles of chemotherapies used in this population. Data from this trial continue to mature.

As discussed in the publication, these data suggest that balstilimab may be a differentiated anti-PD-1 antibody as compared to currently approved PD-1 inhibitors. In the KEYNOTE-158 trial of pembrolizumab, an anti-PD-1 antibody, in the same setting, an ORR of 14.6% was observed in the PD-L1 positive population and no responses were observed in the PD-L1 negative population. In addition, the noted 12.5% response rate of balstilimab in patients with cervical adenocarcinoma is significant as this subpopulation typically does not respond to immunotherapy and represents a growing proportion of advanced cervical cancer cases. Balstilimab thus provides the potential for therapeutic benefit to patient populations that do not typically respond to currently-available immunotherapy, both alone and in combination with other therapies, such as Agenus’ anti-CTLA-4 antibodies zalifrelimab and AGEN1181. Final results from a Phase 2 trial of balstilimab in combination with zalifrelimab in advanced cervical cancer will be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on September 19 from 11:35 – 11:40am ET by David O’Malley, MD.

"The efficacy and safety of balstilimab provides additional evidence of the importance of immune checkpoint blockade in the treatment of recurrent, advanced cervical cancer patients," said David O’Malley, MD, Professor, Department of Obstetrics and Gynecology, The Ohio State University College of Medicine; Director, Division of Gynecologic Oncology, OSUCCC – James; and lead author on the publication. "Furthermore, responses to balstilimab were seen in patients who were PD-L1 positive, PD-L1-negative, bevacizumab pre-treated, and squamous cell and adenocarcinoma histologies. Balstilimab clearly provides clinical benefit in a broad range of cervical cancer patients."

Study Design (NCT03104699)
This was an open-label, single-arm, global Phase 2 clinical trial conducted at 60 sites throughout the United States, Europe, South America, and Australia. Patients were enrolled from November 20, 2017, to April 16, 2020, and received intravenous balstilimab at a dose of 3 mg/kg once every two weeks, given as a 60-minute infusion. Treatment was permitted for up to 24 months, or until disease progression, intolerable toxicity, or investigator/patient decision.

About Balstilimab Monotherapy
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Agenus announced it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) on April 19, 2021, for use in patients with recurrent or metastatic cervical cancer, and the application is under priority review with a target action date of December 16, 2021.