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Anaveon receives CTA approval to start a Phase I/II study to evaluate the safety, dosing and clinical activity of ANV419 in patients with solid tumors

On March 25, 2021 Anaveon, a clinical stage, immuno-oncology company, reported that its Clinical Trial Application (CTA) has been accepted by the Spanish Agency of Medicines and Medical Devices (AEMPS) to conduct a Phase I/II study evaluating the safety and clinical activity of its lead product, ANV419, as a monotherapy in advanced solid tumors (Press release, Anaveon, MAR 25, 2021, View Source [SID1234577156]). The Company will initiate the first two arms of a multi part, first-in-human dose finding study, with the expectation of enrolling the first patient in Q2 2021.

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"Approval to start our first clinical study represents an important validation of our approach and is a significant milestone for Anaveon," said Dr Christoph Bucher, Chief Medical Officer of Anaveon. "Our lead program is a powerful and selective interleukin-2 (IL-2) agonist that is designed to overcome known challenges with tolerability and selectivity of human IL-2, which, if approved, could have wide applicability in a range of cancer indications, as well as in combination with other therapeutics."

ANV419 is a novel IL-2/anti-IL-2 fusion protein with preferential signaling through the IL-2 beta/gamma receptor. It has antibody-like pharmacology, behaviour and stability and selectively stimulates the proliferation of CD8 T cells and NK cells without promoting the expansion of Regulatory T cells (Tregs). In non-human primate studies, ANV419 demonstrated excellent tolerability, a highly favorable safety profile and pharmacokinetics with strong in-vivo expansion of NK and CD8 T cells but not Tregs. No significant changes in body weight or blood pressure were seen at any dose during the entire study period and no signs of capillary leak syndrome were observed.

Anaveon was founded in December 2017 by Andreas Katopodis, previously Director at the Autoimmunity, Transplantation & Inflammation Group at the Novartis Institutes for BioMedical Research and Onur Boyman, Professor and Chair in the Department of Immunology at the University of Zurich. The Company is developing selective IL-2 Receptor Agonists, which have the potential to therapeutically enhance a patient’s immune system to respond to tumors. In the body, human IL-2 stimulates a type of immune cell, called a T-cell, to multiply and become activated. Activated T-cells are able to attack tumors and, consistent with this approach, human IL-2 is already approved as a therapeutic for the treatment of metastatic melanoma and renal cancer; however, due to lack of specificity, human IL-2 has severe, dose-limiting side effects and a short half-life that requires frequent infusions. The lead compound, ANV419, is designed to preferentially signal through the IL-2 beta/gamma receptor and therefore overcome known challenges of human IL-2. This novel type of therapeutic, if approved, could potentially have a wide utility in oncology, including in combination with cell therapies, vaccines, checkpoint inhibitors and radiotherapy.

Can-Fite Reports 2020 Financial Results & Provides Clinical Development Update

On March 25, 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 year ended December 31, 2020 (Press release, Can-Fite BioPharma, MAR 25, 2021, View Source [SID1234577155]).

Clinical Developments and Corporate Highlights Include:

Cash Infusion of $5 Million – During the first quarter of 2021, Can-Fite received $2.75 million in February and March 2021 through warrant exercises and $2.25 million in an upfront payment in March 2021 from a new distribution agreement with Ewopharma.

Out-licensing Deal Worth $42.7 Million with Ewopharma – Can-Fite signed its latest out-licensing agreement with Swiss-based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland. Can-Fite received $2.25 million upfront with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales.

Phase II COVID-19 Study Enrolling Patients – Can-Fite is enrolling 40 patients in its Phase II study under a U.S. Food and Drug Administration (FDA) approved protocol in patients hospitalized with moderate to severe COVID-19. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson twice daily or placebo, and treated for up to 28 days.

Phase III Psoriasis Study Continues to Enroll Based on Positive Interim Analysis – In October 2020, the Independent Data Monitoring Committee for Can-Fite’s Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis reviewed the blinded study data and recommended the Company continue to enroll patients. The majority of costs associated with the Phase III Comfort study have been previously paid.

Phase IIb NASH Study Expected to Commence Q4 2021 – Based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson which met its primary endpoint, Can-Fite is working closely with top Key Opinion Leaders in liver disease to complete its study design for a Phase IIb study. Can-Fite expects to commence the study before the end of 2021.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has reached agreements with the U.S. FDA and the European Medicines Agency on the protocol of a pivotal Phase III study for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Should the study meet its efficacy endpoint and be approved by the FDA and EMA, Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients.

"2020 was a pivotal year for Can-Fite as we demonstrated a robust clinical proof of concept for both Piclidenoson and Namodenoson," stated Can-Fite CEO Dr. Pnina Fishman. "We advanced our pipeline and are firmly focused on Psoriasis, NASH, Advanced Liver Cancer, and COVID-19. We continue to collaborate with distribution and out-licensing partners in select territories, thereby securing distribution for our drugs upon approval and generating revenues through upfront money and milestone payments. We are excited to potentially deliver on additional significant milestones in 2021."

Financial Results

Revenues for the year ended December 31, 2020 were $0.76 million, a decrease of $1.27 million, or 63%, compared to $2.03 million for the year ended December 31, 2019. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.

Research and development expenses for the year ended December 31, 2020 were $11.95 million, an increase of $0.98 million, or 8.9%, compared to $10.97 million for the year ended December 31, 2019. Research and developments expenses for the year ended 2020 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the accelerating rate of absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis and for psoriasis. We expect that the research and development expenses will increase through 2021 and beyond.

General and administrative expenses were $2.95 million for the year ended December 31, 2020 a decrease of $0.11 million, or 3.6%, compared to $3.06 million for the year ended December 31, 2019. The decrease is primarily due to the decrease in professional services and travel expenses which was partly offset by an increase in salaries and related benefits and insurance expenses. We expect that general and administrative expenses will remain at the same level through 2021.

Financial expense, net for the year ended December 31, 2020 aggregated $0.3 million compared to $0.6 million for the year ended December 31, 2019. The decrease in financial expense, net was mainly due to a decrease in the revaluation of our short-term investment.

Net loss for the year ended December 31, 2020 was $14.44 million compared with a net loss of $12.62 million for the year ended December 31, 2019. The increase in net loss for the year ended December 31, 2020 was primarily attributable to a decrease in revenues in 2020 and an increase in research and development expenses which were partly offset by a decrease in finance expenses, net.

As of December 31, 2020, Can-Fite had cash and cash equivalents of $8.26 million as compared to $2.69 million at December 31, 2019. The increase in cash during the year ended December 31, 2020 is due to an aggregate of $17.68 million in net proceeds received through a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April, and May 2020 of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activity of $12.06 million.

More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.

Corvus Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results

On March 25, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Corvus Pharmaceuticals, MAR 25, 2021, View Source [SID1234577154]).

"In 2020, we made considerable progress expanding our technology platform to address COVID-19 and other infectious diseases. As a result, we have extended our product development strategy with the initiation of a Phase 3 study of CPI-006 for COVID-19. In a recently completed Phase 1 study, CPI-006 induced robust and prolonged anti-SARS-CoV-2 antibody responses," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "During the year we also co-founded Angel Pharmaceuticals, a new biopharma company in China that is positioned to develop our product candidates in the rapidly growing Chinese market and potentially accelerate our global product development capability. Angel’s first clinical program is expected to kick off with the initiation of a Phase 2 study of CPI-818 for peripheral T cell lymphoma in China. Along with our planned Phase 2 study to evaluate ciforadenant in first-line renal cancer as a triplet combination with pembrolizumab and a tyrosine kinase inhibitor, we are excited to have three mid-to-late stage programs that may provide catalysts for the Company in the near-term."

2021 Key Areas of Focus
Corvus is focused on several potential transformational opportunities in its pipeline in 2021, headlined by the execution of its global Phase 3 study of CPI-006 in COVID-19. The Company is also efficiently advancing its other clinical programs, CPI-818 and ciforadenant, along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:

CPI-006 Phase 3 Study for COVID-19

In February 2021, the Company initiated a Phase 3 registration clinical trial of CPI-006, an anti-CD73 B cell activating antibody, for the treatment of hospitalized patients with mild-to-moderate COVID-19. This randomized, double-blind trial is planned to enroll up to 1,000 patients, who will be randomized into one of three arms and receive either 1.0 mg/kg or 2.0 mg/kg of CPI-006, or placebo. The primary endpoint of the study is the proportion of patients that progress to requiring mechanical ventilation or death within 28 days of dosing. The study will be conducted in the United States, Europe, Latin America and South Africa and will include an interim safety and futility analysis. The Company expects to complete enrollment in the study in the fourth quarter 2021.
Results from the Phase 1 dose escalation (0.3 to 5.0 mg/kg) clinical trial of CPI-006 in 29 hospitalized patients with COVID-19 showed that patients developed sustained high titers of polyclonal anti-SARS-CoV-2 antibodies. As of March 4, 2021, all the patients in the study were discharged from the hospital in a median of three days and no patients progressed to requiring mechanical ventilation. The results from the Phase 1 study were presented in the "Hot Topic Symposium: COVID-19 and Cancer" session at the 2020 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2020.
CPI-818 Phase 2 Study for PTCL in Partnership with Angel Pharmaceuticals

The Company expects that a global Phase 2 trial of CPI-818, a small molecule ITK inhibitor, for the treatment of refractory peripheral T cell lymphoma (PTCL) will be initiated in partnership with Angel Pharmaceuticals.
Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As of March 4, 2021, of seven patients with PTCL, there has been one complete response lasting over 15 months and one partial response lasting for over five months; both responses are ongoing. The interim data was presented at the 62ND American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December 2020.
Angel Pharmaceuticals is a new China-based biopharmaceutical company co-founded by Corvus in October 2020. Angel licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – CPI-006, CPI-818 and ciforadenant – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. The formation of Angel is expected to provide Corvus with clinical study synergies and accelerated timelines, whereby data from patients enrolled in China studies could potentially be used as part of U.S. regulatory submissions as part of a global pivotal study protocol. Corvus currently holds a 49.7% ownership position in Angel Pharmaceuticals, excluding 7% of Angel’s equity reserved for issuance under the Angel employee stock ownership plan.
Ciforadenant Phase 2 Study for Front Line RCC

The Company plans to initiate a Phase 2 trial of ciforadenant, a small molecule antagonist of the adenosine A2A receptor, in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and lenvatinib. The study is planned to be conducted in collaboration with the Kidney Cancer Consortium, is expected to enroll approximately 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies indicate adenosine may be a cause of resistance to current therapies with anti PD(L)-1 and tyrosine kinase inhibitors. Tumor biopsies will be evaluated for expression of the adenosine gene signature.
Financial Results

As of December 31, 2020, Corvus had cash, cash equivalents and marketable securities totaling $44.3 million. This compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019. The cash and investment balance at December 31, 2020 does not include net proceeds of $31.8 million received on February 17, 2021 from the company’s follow-on equity offering with institutional investors. Corvus expects full year 2021 net cash used in operating activities to be between $46 million and $48 million.

Research and development expenses for the three months and full year ended December 31, 2020 totaled $7.2 million and $31.8 million, respectively, compared to $8.9 million and $38.0 million for the same periods in 2019. In the fourth quarter of 2020, the decrease of $1.7 million was primarily due to lower outside costs for ciforadenant and CPI-818 and a decrease in personnel costs, partially offset by an increase in outside costs for CPI-006. For the full year 2020, the decrease of $6.1 million was primarily due to lower outside costs for ciforadenant and CPI-818 and a decrease in personnel and related costs, partially offset by an increase in outside costs for CPI-006.

Gain on deconsolidation of $37.5 million and loss from equity method investment of $0.2 million for the three months and full year ended December 31, 2020 are both the result of the Angel Pharmaceuticals transaction described above.

Net income for the three months ended December 31, 2020 was $27.1 million and net loss for the year ended December 31, 2020 was $6.0 million compared to a net loss of $11.0 million and $46.7 million for the same periods in 2019. Total stock compensation expense for the three months and year ended December 31, 2020 was $1.2 million and $5.7 million, respectively, compared to $1.7 million and $7.3 million for the same periods in 2019.

Sensei Biotherapeutics Reports Full Year 2020 Results and Provides Business Update

On March 25, 2021 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), a clinical-stage immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the full year ended 2020 and provided an update on recent business progress (Press release, Sensei Biotherapeutics, MAR 25, 2021, View Source [SID1234577153]).

"With a strong foundation built in 2020, Sensei has already achieved significant milestones in 2021, highlighted by our upsized initial public offering completed in February. Throughout 2020, we have worked diligently and efficiently to broaden our in-house R&D capabilities to deliver our novel and versatile ImmunoPhage platform and Phortress library to patients," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Looking ahead, we have a well-capitalized foundation on which to further advance our pipeline of immunotherapies based on our proprietary ImmunoPhage platform for the treatment of cancer. We expect to report a large additional subset of data from our ongoing Phase 1/2 study of SNS-301 in SCCHN by year-end, as well as progressing our other personalized, off-the-shelf product candidates."

Recent Business Highlights

Addition to Russell 2000 Index: On March 22, 2021, Sensei was added to the Russell 2000 Index as part of its quarterly IPO additions. The Russell 2000 Index is a subset of the Russell 3000 Index, which measures the performance of the small-cap segment of the U.S. equity market.
Completed Upsized Initial Public Offering – In February 2021, Sensei completed its initial public offering of 8,030,295 shares of common stock, inclusive of the exercise by the underwriters of their option to purchase 1,030,243 shares, at a public offering price of $19.00 per share. Gross proceeds from the IPO were $152.6 million.
Completed Private Financing to Support Pipeline Advancement – In January 2021, Sensei announced a private financing round, co-led by Apeiron Investment Group and Catalio Capital Management, which was subsequently upsized for gross proceeds of $34.5 million.

Presented Data from Ongoing Phase 1/2 Study of SNS-301 in Combination with Pembrolizumab for the Treatment of Locally Advanced Unresectable or Metastatic SCCHN –At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting in November 2020, Sensei presented new data demonstrating that one patient with PD-L1 negative disease achieved a partial response (PR) with a tumor reduction of 43% at week 12 and was confirmed at week 18. Additionally, one patient achieved a stable disease (SD) for more than 4 months following progressive disease (PD) after 10 months of PD-1 blockade treatment prior to study entry, and two patients achieved SD for more than 36 weeks. These data were supportive of earlier data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress in September 2020. Further, immunohistochemical staining of paired pre- and on-treatment biopsies (12 weeks) from the responding patient’s tumor demonstrated a conversion from a PD-L1-negative, poorly inflamed phenotype into an inflamed, PD-L1-positive tumor, characterized by tumor necrosis, and abundant infiltrating immune cells, including CD4, CD8 T cells and macrophages. SNS-301 was well tolerated with no dose-limiting toxicities and observed adverse events (AEs) have primarily been either Grade 1 or 2 and mostly unrelated to treatment.

Advanced the ongoing SNS-301 Phase 1/2 study – Enrollment in Stage 2 of the ongoing Phase 1/2 clinical trial commenced in the first half of 2021, including the initiation of enrollment of the newly opened PD-1 naïve cohort of the study.

Strengthened ImmunoPhage Platform with the Acquisition of Alvaxa Biosciences – In May 2020, Sensei announced the acquisition of Alvaxa Biosciences and its existing camelid nanobody libraries, expertise in nanobody discovery, as well as its partnership with Hope Farms, LLC, a United States Department of Agriculture (USDA) licensed Alpaca farm, for the generation of future alpaca-derived nanobodies, or camelid antibodies that are small, highly-specific antigen-binding domains with high-affinity binding. Nanaobodies are a core component of Sensei’s proprietary ImmunoPhage platform, enabling both precision APC targeting and the delivery of immunomodulatory payloads.

Expanded Executive Team and Board of Directors with Multiple Appointments – Sensei grew its executive management team with the appointments of Anu Hoey as chief business officer, Marie-Louise Fjaellskog, M.D., Ph.D. as chief medical officer, and Robert Pierce, M.D. as chief scientific officer. In addition, Sensei added Deneen Vojta, M.D. to its board of directors.
Multiple Upcoming Anticipated Milestones for 2021 and 2022 Across Pipeline:

Sensei expects to announce multiple updates from its SNS-301 program, a first-in-class cancer immunotherapy designed to overcome immune tolerance and induce robust and durable antigen-specific humoral and cellular responses including:
Initiation of a Phase 2 study in the neoadjuvant setting in combination with durvalumab
Commencement of an additional cohort of the ongoing Phase 1/2 study of HPV-specific E6/E7 ImmunoPhage in combination with SNS-301 and pembrolizumab
Announcement of a large subset of data from the Phase 1/2 study in combination with pembrolizumab for the treatment of locally advanced unresectable or metastatic SCCHN
Sensei expects to submit an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for its SNS-401 program, a personalized ImmunoPhage cocktail for the treatment of Merkel Cell Carcinoma in the first half of 2022.
Sensei expects to initiate IND-enabling studies for its SNS-VISTA, antibody-based therapeutic targeting V-domain Ig suppressor of T cell activation (VISTA) program by year end 2021.
Full Year 2021 Financial Results

Cash Position – Cash and cash equivalents were $16.6 million as of December 31, 2020, as compared to $0.3 million as of December 31, 2019. Total cash and cash equivalents at December 31, 2020 does not include net proceeds of approximately $138.5 million from the company’s upsized IPO in February 2021 or the closing of the company’s final private round of financing in January 2021. Sensei expects the current cash balance to fund operations at least into the second half of 2023.
Research and Development (R&D) Expenses – R&D expenses were $11.9 million for the year ended December 31, 2020, compared to $8.4 million for the year ended December 31, 2019 including costs related to the Alvaxa acquisition. The increase in expenses is primarily attributable to investments being made in early research and development activities and the clinical and preclinical development of SNS-301, SNS-401 and SNS-VISTA.
General and Administrative (G&A) Expenses – G&A expenses were $7.5 million for the year ended December 31, 2020, compared to $4.1 million for the year ended December 31, 2019. The increase is mainly driven by strategic external consulting, legal and recruiting costs, as well as stock compensation.
Net Loss – Net loss was $20.1 million, for the year ended December 31, 2020, compared to $16.7 million for the year ended December 31, 2019.

Magenta Therapeutics to Participate in the Guggenheim Healthcare Talks 2021 Genomic Medicines & Rare Disease Conference

On March 25, 2021 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported that Jason Gardner, D.Phil., President and Chief Executive Officer, is scheduled to participate in a panel discussion at the Guggenheim Healthcare Talks 2021 Genomic Medicines & Rare Disease Conference, being held virtually, on Thursday, April 1st, 2021 (Press release, Magenta Therapeutics, MAR 25, 2021, View Source [SID1234577152]). The panel discussion, Key Advances in Solid Organ and Stem Cell Transplants – Expanding the Market and Moving Away from Lifelong Immunosuppression, will take place at 1:00 p.m. ET.

A live webcast of the panel discussion can be accessed on the Magenta Therapeutics website at View Source The webcast replay will be available for 90 days following the event.