On November 11, 2019 Akeso Biopharma ("Akeso") reported that results of phase 1 study of its first-in-class bispecific drug candidate AK104, in patients with advanced solid tumors in 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") (Press release, Akeso Biopharma, NOV 11, 2019, View Source [SID1234550866]). AK104 is a novel, tetrameric bispecific antibody targeting both PD-1 and CTLA-4.

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Dr. Ben Markman, MBBS(Hons) FRACP from Monash Health, Australia gave the oral presentation at the SITC (Free SITC Whitepaper) Single Agent Phase 1 Clinical Trials Session chaired by Dr. Helen Chen from National Cancer Institute and Dr. Naiyer Rizvi of Columbia University Medical Center. "AK104 has shown excellent tolerability so far with encouraging signs of anti-tumor activity. I very much look forward to tracking the further development of this exciting tetrameric bispecific antibody targeting PD1 and CTLA4", commented Dr. Ben Markman.

Updated results from Phase 1a study (NCT03261011):

AK104 showed encouraging anti-tumor activities across a range of tumor types.
– Among 25 PD-1/L1 naïve response-evaluable patients administrated with ≥ 2 mg/kg AK104, ORR: 24% ( DoR ranging from 2+ to 11.1+ months); DCR: 44%.
AK104 had an acceptable safety profile. Early data suggested that AK104 may have improved tolerance compared with the combination of a PD-1 inhibitor and CTLA-4 inhibitor.
– With 55 patients enrolled, most common treatment-related AE includes rash, infusion reaction, nausea, and fatigue.
– ≥ Grade 3 treatment-related AE (TRAE) rate was 11% with only one Grade 4 event reported. Grade 3 immune-related AE (irAE) rate was 3.6%.
AK104 commenced a Phase 1a study in patients with advanced solid tumors in Australia in October 2017, received NMPA IND approval in May 2018, and IND approval from the FDA in April 2019. AK104 is currently in Phase Ib/II clinical trials globally for multiple indications and has exhibited promising clinical safety and efficacy results in monotherapy and combination therapy.

Details of the material used in oral presentation can be found at SITC (Free SITC Whitepaper) website.

About AK104

AK104 is a potential next-generation, first-in-class humanized IgG1 tetrameric bi-specific antibody drug candidate that is based on Akeso’s proprietary "TETRABODY" technology and simultaneously targets two immune checkpoint molecules: PD-1 and CTLA-4. PD-1 and CTLA-4 co-express in tumor infiltrating lymphocytes (TILs), but not in normal peripheral tissues. AK104 is in a tetrameric form, which is designed to bind to PD-1 and CTLA-4 simultaneously to achieve the efficacy of PD-1 and CTLA-4 combination blockade with lowered toxicity.

On November 11, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the third quarter ended September 30, 2019 (Press release, Compugen, NOV 11, 2019, View Source [SID1234550882]).

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"Our first presentation of clinical data last week at SITC (Free SITC Whitepaper) 2019 is an important milestone for Compugen," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are encouraged by the initial signals of anti-tumor activity seen with COM701, a first-in-class PVRIG inhibitor, in the monotherapy dose escalation arm of the study treating a very challenging patient population. We believe these results lay a promising foundation for our ongoing and future studies and that our biomarker-driven strategy which focuses on indications we prioritized as most relevant to the PVRIG pathway has the potential to maximize the clinical impact of COM701. We look forward to testing our clinical hypotheses as we advance COM701 to the next stages of our Phase 1 study."

Dr. Cohen-Dayag continued, "In addition to our progress with COM701, we have advanced COM902, our anti-TIGIT antibody, closer to the clinic with the IND clearance received from the FDA. Initiating clinical trials with our second internally developed asset next year will be another important milestone, and we are particularly enthusiastic given the COM902 preclinical data that were also presented at SITC (Free SITC Whitepaper) last week, which further demonstrated that together with a PVRIG inhibitor these two complementary assets have the potential to synergistically address a biologically meaningful axis and possibly improve patient outcomes. Including the Bayer collaboration program targeting ILDR2, COM902 marks the third program to be evaluated in the clinic addressing new drug targets we discovered. We are proud of this remarkable achievement and remain committed to advancing our computationally discovered programs to possibly expand cancer immunotherapy treatment options for patients unresponsive or refractory to existing therapies."

Recent Corporate Highlights

Presented preliminary clinical findings from the ongoing Phase 1 trial of COM701 in patients with advanced solid tumors at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019)
COM701 was well-tolerated with no dose-limiting toxicities observed.
Initial signals of anti-tumor activity were observed in the heavily pretreated, all comers patient population enrolled in the study.
Presented trial-in-progress data at SITC (Free SITC Whitepaper) 2019 from the Phase 1 study evaluating COM701 as a monotherapy and in combination with Opdivo (nivolumab)
No dose-limiting toxicities were observed through the third dose level of COM701 with Opdivo.
Enrollment for the eighth dose level of COM701 monotherapy as well as the fourth dose level of COM701 with Opdivo are ongoing at IV Q4 weeks schedule.
Announced Investigational New Drug (IND) application clearance by the U.S. Food and Drug Administration (FDA) for COM902. A Phase 1 trial in patients with advanced malignancies is expected to begin in early 2020.
Presented new preclinical data on COM902 at SITC (Free SITC Whitepaper) 2019, supporting its potential role as a cancer immunotherapy treatment in combination with COM701 and PD-1 inhibitors.
Granted EPO Patent No. EP3347379 by The European Patent Office, which covers the composition of matter and use of COM902.
Granted U.S. Patent No. 10,351,625 by the U.S. Patent and Trademark Office, which covers the method of use of COM701 in combination with any anti-PD-1 antibody.
Financial Results

R&D expenses for the third quarter ended September 30, 2019, were $4.3 million, compared with $7.8 million for the comparable period in 2018. The decrease in R&D expenses was primarily due to the decrease in preclinical activities related to COM902, most of which were completed in 2018, and the cost reduction measures announced by the Company in the first quarter of 2019.

Net loss for the third quarter of 2019 was $6.5 million, or $0.1 per basic and diluted share, compared with a net loss of $3.1 million, or $0.05 per basic and diluted share, in the comparable period of 2018.

As of September 30, 2019, cash, cash equivalents, short-term bank deposits and restricted cash totaled $47.6 million, compared with $45.7 million as of December 31, 2018. The Company has no debt.

Conference Call and Webcast Information

The Company will hold a conference call today, November 11, 2019, at 8:30 am ET to review its third quarter 2019 results and SITC (Free SITC Whitepaper) poster presentations. To access the conference call by telephone, please dial 1-888-668-9141 from the United States, or +972-3-918-0609 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On November 11, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the third quarter of 2019 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 11, 2019, View Source [SID1234550937]).

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"The FibroGen team achieved many milestones over the past few months, culminating with the positive Phase 3 results for roxadustat reported at the American Society of Nephrology conference last week in Washington, D.C.," said Jim Schoeneck, Interim Chief Executive Officer, FibroGen. "This set of global studies covered the spectrum of chronic kidney disease anemia and is believed to be the largest and most comprehensive ever reported. We expect the positive cardiovascular safety data, comparing roxadustat to placebo in non-dialysis patients and to epoetin alfa in patients on dialysis, along with the superior efficacy results, can serve as the basis for regulatory approval in the U.S. and other jurisdictions. We plan to submit an NDA in the U.S. by the end of this quarter for both dialysis and non-dialysis patients with our partner AstraZeneca, and an MAA in Europe by the end of first quarter 2020 by our partner Astellas, followed by submissions to other regulatory authorities.

"In addition, roxadustat is now approved for CKD patients with anemia in China and was approved in Japan for anemia in CKD patients on dialysis. Our other clinical programs advanced, as we initiated our roxadustat Phase 2 study to treat anemia in patients receiving chemotherapy and enrolled the first patients in our pamrevlumab Phase 3 programs for both idiopathic pulmonary fibrosis (ZEPHYRUS) and locally advanced pancreatic cancer (LAPIS).

"These major accomplishments demonstrate our commitment to the vision set by FibroGen’s founder and long-time CEO and Chairman, Tom Neff. We mourn his unexpected passing and are grateful for his leadership and rare ability to recognize and advance scientific innovation."

Recent Developments – Roxadustat

Roxadustat is a novel, oral, first-in-class treatment for chronic kidney disease (CKD) patients with anemia, discovered by FibroGen and developed globally in conjunction with our partners AstraZeneca and Astellas. Groundbreaking science on the body’s oxygen-sensing mechanism and adaptation to hypoxia was awarded the 2019 Nobel Prize in Physiology or Medicine and serves as the foundation for the mechanism of action for roxadustat. Roxadustat increases hemoglobin by mimicking the body’s natural response to low oxygen.

American Society of Nephrology Kidney Week Presentations – November 6-9, 2019

Clinical results presented from six roxadustat Phase 3 studies comprising over 8,000 anemia patients with chronic kidney disease, as well as pooled results for patients not on dialysis and on dialysis, including an incident dialysis subgroup

For additional data presented, please see our November 8, 2019 press release. Please also see our website for FibroGen’s ASN presentations

Cardiovascular Safety Confirmed: In both non-dialysis dependent and dialysis dependent CKD anemia patients:

Non-Dialysis Dependent (NDD) (n=4270):

Risk of MACE, MACE+, and all-cause mortality in roxadustat patients was comparable to placebo based on a reference non-inferiority margin of 1.3

NDD results are based on ITT long-term follow-up analysis method agreed with the FDA

Dialysis Dependent (DD) (n=3880):

Risk of MACE and all-cause mortality in roxadustat patients were not increased compared to the active comparator, epoetin alfa

Roxadustat patients had a 14% lower risk of MACE+ than epoetin alfa patients

Incident Dialysis (ID) Subgroup (n=1526): In the clinically important ID subgroup of patients, initiating dialysis within 4 months prior to randomization:

Roxadustat patients had a 30% lower risk of MACE than epoetin alfa

Roxadustat patients had a 34% lower risk of MACE+ than epoetin alfa

Roxadustat patients had a trend towards lower all-cause mortality compared to epoetin alfa

Endpoint definitions, using centrally adjudicated events:

Time to first Major Adverse Cardiovascular Events (MACE), a composite endpoint including all-cause mortality, myocardial infarction, and stroke

Time to first MACE+, referring to MACE plus unstable angina and heart failure requiring hospitalization

Time to all-cause mortality

Primary Efficacy Endpoints Met in all Individual Studies and Pooled Analyses

Met primary efficacy endpoint of mean change in hemoglobin (Hb) from baseline to average Hb weeks 28-52 in each of the six individual studies and in each of the two pooled efficacy analyses

Statistically superior to placebo in the NDD pool

Statistically superior to epoetin alfa in the DD pool

Other Pooled Efficacy Analyses

Non-Dialysis Dependent

In the pooled analysis, roxadustat was superior to placebo, with significantly larger Hb increase than placebo regardless of iron-repletion status at baseline

Roxadustat treatment reduced the need for rescue treatment and red blood cell transfusion (RBC) compared to placebo

Roxadustat slowed the decline in renal function compared to placebo in patients eGFR >= 15

Roxadustat reduced LDL cholesterol

Dialysis Dependent

The larger Hb increase in patients treated with roxadustat vs. epoetin alfa was particularly notable in patients with inflammation (elevated CRP level)

Roxadustat treatment reduced the need for RBC transfusion compared to epoetin alfa

Less IV iron was required in patients receiving roxadustat versus patients receiving epoetin alfa

Other Recent Developments, Recognition and Future Milestones

Roxadustat U.S. and EU Regulatory Timelines

Expect to submit U.S. NDA for roxadustat for the treatment of anemia in CKD patients both on dialysis and not on dialysis this quarter

Astellas expected to submit the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) within the second half of their 2019 fiscal year, ending March 2020

Roxadustat for Anemia in CKD – Approvals and Market Activity

Expanded approval of roxadustat (China tradename: 爱瑞卓) in China to include the treatment of anemia in CKD patients who are not dialysis-dependent

Roxadustat (Japan tradename: Evrenzo) approved in Japan for the treatment of anemia associated with CKD in dialysis patients

First prescriptions written for roxadustat for patients in China

FibroGen booked commercial product revenue for the first time (China)

Roxadustat received the 2019 Dushu Lake Prize 独墅湖杯 in China for "On-Market Innovative Drug with Highest Clinical Value"

Results from the two China Phase 3 studies published in the New England Journal of Medicine (NEJM)

Development Programs

Roxadustat for Anemia in Oncology

Myelodysplastic Syndromes (MDS)

Clinical proof-of-concept study accepted for oral presentation at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Randomized placebo-controlled portion of global Phase 3 study ongoing

Chemotherapy-Induced Anemia (CIA)

Initiated patient dosing in Phase 2 study

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Initiated dosing in the pivotal ZEPHYRUS Phase 3 randomized, double-blind, placebo-controlled study

Pamrevlumab for Locally Advanced Pancreatic Cancer (LAPC)

Initiated dosing in the pivotal LAPIS Phase 3 randomized, double-blind, placebo-controlled study

Pamrevlumab for Duchenne Muscular Dystrophy (DMD)

Expect to meet with the FDA this quarter to discuss clinical development plan

Corporate and Financial

Net loss for the third quarter of 2019 was $49.4 million, or $0.57 net loss per basic and diluted share, compared to a net loss of $42.6 million, or $0.50 net loss per basic and diluted share one year ago

At September 30, 2019, FibroGen had $666.5 million in cash, restricted time deposits, cash equivalents, investments, and receivables

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, November 11, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen third quarter 2019 financial results conference call, and use confirmation number 49132826. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042 (international), and use passcode 4132826.

About Roxadustat

Roxadustat (FG-4592) is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of chronic kidney disease (CKD) patients, including in the presence of inflammation and without a need for supplemental intravenous iron. Roxadustat is currently approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis and approved in Japan for the treatment of anemia in CKD patients on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). The U.S. Food and Drug Administration has granted Orphan Drug Designation to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and LAPC. Across all clinical studies, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

On November 10, 2019 Stone Capital and Biosyngen reported have partnered to establish a Biopharmaceutical Investment Fund in Singapore, the signing ceremony was held in Ascendas One Hub of Sino-Singapore Guangzhou Knowledge City (Press release, Stone Biostatistics, NOV 10, 2019, View Source [SID1234550834]). The key investment targets of the biopharmaceutical fund of US$50 million raised is for Biosyngen biopharmaceutical technology transfer platform and to incubate companies.

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Biosyngen has been an angel investment platform for biopharmaceutical projects, who has formed projects with selected early stage technologies after stringent screening process. This fund allows Biosyngen to take advantage of Singapore pool of talent, technology, regulations, government support and other industrial resources, in particular cell therapy technologies, Biosyngen provides high-efficient incubation support and clinical transformation of the projects. The Company is also taking advantage of the Chinese government’s policy support, environment and the rich clinical trial resources in China. When the projects reach certain level of maturity, they will be further developed and commercialised in China and ASEAN, thereby meeting the needs of both markets.

Mr. Wang Liqun, Chairman of Stone Capital and Director of Biosyngen; Dr. Victor Li Lietao, Founder and CEO of Biosyngen,; and Mr. Wang Shuli, Chairman of Biosyngen attended the event to witness a milestone in the progress of the company. As a well-known successful investor, Mr. Wang expressed his appreciation for Biosyngen on the competency of project transformation over the past three years. He also generously shared his management experience and made suggestions to Dr. Li. Dr. Li expressed his sincere gratitude to Mr. Wang for coming onboard Biosyngen as a Director as this will enhance the function of Biosygnen biopharmaceutical technology transfer platform which will accelerate the business development of Biosyngen.

On November 9, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported the presentation of data from the phase 1 dose-escalation monotherapy study of PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in a late-breaking oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. PRS-343 demonstrated single-agent anti-tumor activity, including partial responses, in heavily pre-treated patients across multiple HER2-positive tumors (Press release, Pieris Pharmaceuticals, NOV 9, 2019, View Source [SID1234550812]). Beyond demonstrating clinical benefit, PRS-343 showed a potent increase in CD8+ T cell numbers and proliferative index in the tumor microenvironment of responders, indicative of 4-1BB agonism on T cells. PRS-343 was safe and well tolerated at all doses and schedules tested.

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"The data presented today demonstrate PRS-343’s potential to make a meaningful difference for patients with tumors that are difficult to treat with currently-available therapies," said Geoffrey Y. Ku, medical oncologist at Memorial Sloan Kettering and the principal investigator for the PRS-343 monotherapy trial. "Beyond today’s presentation, I look forward to sharing some of these case studies at Pieris’ upcoming R&D day alongside emerging data from the study of PRS-343 in combination with atezolizumab."

The ongoing phase 1 first-in-human, open-label multicenter trial has enrolled 53 patients, including 19 patients with gastric cancer, 14 patients with breast cancer, 6 patients with gynecological cancers, and 14 patients with other tumor types. Eleven dose cohorts have been evaluated at a Q3W dosing schedule, with the 11th dose level (8 mg/kg) also being evaluated at a Q2W dosing schedule. Pre- and post- treatment biopsies were obtained from many of the patients. Trial objectives include evaluation of safety and tolerability, characterizing the pharmacokinetic profile, assessing pharmacodynamic and potential immunogenicity effects, and investigating clinical response.

As of the cut-off date of October 23, 2019, 18 patients were evaluable for a response at active dose levels, which began at cohort 9 (2.5 mg/kg).

At the 8 mg/kg Q2W dose level, one patient with stage 4 gastric adenocarcinoma and one patient with stage 4 gynecological carcinoma achieved confirmed partial responses; the remaining patients experienced stable disease, for an overall disease control rate of 100% in this cohort as best response.
Across the remaining active dose levels and schedules, an additional five patients experienced stable disease.
Biomarker data from post-treatment tumor biopsies in patients receiving active dose levels and showing clinical benefit reflected a pronounced increase in CD8+ T cell numbers.
As of the cutoff date, treatment duration across active dose levels is over 30 weeks.
Treatment-related adverse events (AEs) were primarily grade 1 and 2. The most common AEs were infusion related reactions and fatigue. No patients experienced a dose-limiting toxicity and a maximum tolerated dose has not been reached.
"In addition to being the first 4-1BB bispecific to enter the clinic, PRS-343 is our lead immuno-oncology asset, and we believe this dataset serves as early clinical validation of our 4-1BB-targeting immuno-oncology approach and the Anticalin bispecific platform," said Stephen S. Yoder, President and Chief Executive Officer of Pieris. "PRS-343 shows promising signs of efficacy linked to clear biomarker evidence of 4-1BB agonism, in addition to being safe and well tolerated. We look forward to concluding this escalation trial in the near term and initiating an expansion trial informed by the emerging data. We also look forward to initiating clinical development of our 4-1BB/PD-L1 bispecific, PRS-344, with Servier in the first half of next year."