On January 12, 2020 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported a business update for the fourth quarter 2019 and preliminary, unaudited key financials for its financial year 2019 (Press release, Hansa Biopharma, JAN 12, 2020, View Source [SID1234553036]).

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The company will be participating in the JP Morgan Global Healthcare Conference in San Francisco from January 13 to 16, 2020.

2019 Fourth Quarter Business Highlights

The European Medicines Agency (EMA) is reviewing a Marketing Authorization Application for imlifidase in Europe. Hansa Biopharma submitted responses to the Day 120 questions on December 22, 2019 and the review process is on track. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in the second quarter of 2020, followed by a potential decision by the European Commission during the summer 2020.

Hansa Biopharma met with the FDA on November 20th and agreed on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the United States. Hansa will conduct a randomized, controlled clinical study in a well-defined population of approximately 50 patients with the highest unmet medical need to demonstrate the clinical benefit of imlifidase in the context of the U.S. Kidney Allocation System. It is expected that the outcome of this study will support submission of a Biologic License Application (BLA) by 2023.

"Our primary focus in 2020 is to obtain conditional approval of imlifidase in the EU, ensure a successful launch in Europe, and initiate a randomized, controlled clinical study in the US to support a future filing of a BLA in the United States", says Søren Tulstrup, President and CEO, Hansa Biopharma.

Hansa Biopharma has submitted an abstract with long term outcomes of desensitization with imlifidase to the Cutting Edge of Transplantation, CEOT, an annual congress arranged by the American Society of Transplantation on March 5-7, 2020. The long term data indicate that the graft survival for this study population of highly sensitized and cross match positive population was overall comparable to data reported in the literature with other desensitization methods and the general transplantation patient population. Desensitization with imlifidase may provide highly sensitized patients, who are unlikely to find an HLA compatible donor, access to deceased donor organs, potentially reducing mortality and time on the waiting list.

Clinical pipeline update

Anti-GBM (Anti-Glomerular Basement Membrane antibody disease):

Hansa Biopharma has enrolled 14 of targeted 15 patients to date in a phase 2 study to evaluate the safety and efficacy of imlifidase in patients with severe Anti-GBM.
Anti-GBM is an ultra-rare disease affecting one in a million annually with the majority of the patients losing their kidneys, requiring chronic dialysis and kidney transplantation.
Six patients were recruited during the last six months and the Company expects to complete enrollment during the first quarter of 2020 and data read out in the second half of the year.
GBS (Guillain Barré Syndrome)

The first two patients (out of 30) with Guillain Barré Syndrome, GBS, were treated in a phase 2 study with imlifidase.
GBS is an acute autoimmune attack on the peripheral nervous system, which affects 1 in 100,000. GBS is a severe disease where up to 22 % of the patients end up in ICU needing respiratory support.
Six clinics across France and the UK are open for recruitment and the Company expects to complete enrollment during the first half of 2021.
AMR (Antibody Mediated Rejection)

2 out of targeted 30 patients enrolled in a phase 2 study in Antibody Mediated Rejection, AMR, a challenge to long term graft survival after kidney transplantation.
Six clinics are recruiting across the US, Europe and Australia. The Company expects to complete enrollment towards the end of 2020.
Key Financials (preliminary, unaudited)

For the financial year 2019, total Operating loss is expected at approx. SEK 360 million. As of December 31, 2019 the company had a cash position (incl. short-term investments) of SEK 601 million, which is expected to finance Hansa’s operations at least through 2020.

SEK million

Q4 2019

FY 2019

SG&A expenses

-53

-167

R&D expenses

-58

-193

Operating profit/loss

-110

-360

Cash and short-term investments Dec 31, 2019

601

601

The Q4-2019 interim report including audited financials will be published on February 6, 2020.

On January 12, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival (PFS) in an interim analysis (Press release, Innovent Biologics, JAN 12, 2020, View Source [SID1234553035]).

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Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), sintilimab in combination with ALIMTA and platinum demonstrated a statistically significant improvement in PFS compared with placebo in combination with ALIMTA and platinum, which met the pre-defined efficacy criteria. The safety profile of sintilimab in this trial was consistent with previously reported studies, and no new safety signals were identified.

Relevant data will be presented at an upcoming medical conference. Based on the IDMC recommendations, Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) in China in the near future.

Professor Li Zhang, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, stated: "In 2019, the National Cancer Center published Chinese data on lung cancer from 2015, showing an incidence of 20 percent and a mortality rate of about 27 percent, ranking it first among all cancer types. Patients who have nsqNSCLC without sensitive EGFR mutation or ALK rearrangement need more treatment options. Treatment with an anti-PD-1 monoclonal antibody in combination with chemotherapy may bring a greater survival benefit to this patient population. We are glad to see that these findings from this trial of sintilimab met the predefined primary endpoint in the interim analysis."

"So far, Tyvyt is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List. It was officially approved by the NMPA on December 24, 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after at least second-line system chemotherapy," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent. "Currently, we have several phase 3 randomized clinical trials ongoing in lung cancer. With the encouraging result of ORIENT-11 we anticipate that sintilimab has the potential to benefit more patients with lung cancer and provide more time with their families."

"We are excited about these results, which show Tyvyt plus ALIMTA and platinum significantly delayed disease progression in this patient population. This study is another example of the joint commitment from Lilly and Innovent to provide new treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, investigators and clinical trial sites that are participating in the study, and to our colleagues from Innovent. We look forward to bringing this new treatment option to Chinese lung cancer patients."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with ALIMTA and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitive EGFR mutation or ALK rearrangement (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The other secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA and platinum every 3 weeks for up to 4 cycles, followed by either sintilimab or placebo plus ALIMTA maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, rendering the patients with no chance of radical resection. Meanwhile, even after radical surgery patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China are nonsquamous subtype and 50 percent of nsqNSCLC are without sensitive EGFR mutation or ALK rearrangement. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection), an innovative drug jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after at least second-line system chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. Tyvyt is the only PD-1 inhibitor with global quality that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including eight registration or pivotal clinical trials.

On January 12, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), an advanced phase biotechnology company developing new T-cell based cancer immunotherapies, and Cellectis (Paris: ALCLS) (NASDAQ: CLLS) (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical phase biopharmaceutical company specializing in the development of immunotherapies based on genetically modified allogeneic CAR-T cells (UCART), reported that they have the signing of a research partnership and an exclusive global license agreement granting at Iovance a license for certain applications of Cellectis TALEN technology to develop tumor infiltrating lymphocytes (TIL) which have been genetically modified to create more powerful cancer therapies (Press release, Iovance Biotherapeutics, JAN 12, 2020, View Source [SID1234553033]).

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This global license grants Iovance Biotherapeutics the exclusive use of TALEN technology targeting several genes to modify TILs for therapeutic purposes in various types of cancer. The financial conditions of this license provide for payments from Iovance Biotherapeutics to Cellectis at the development, regulatory and sales stages, as well as royalties on the net sales of TIL products modified using TALEN technology.

"We are delighted to collaborate with Cellectis to apply the TALEN genome editing technology to Iovance’s TIL products. We believe that we can genetically modify the TILs to obtain an anti-cancer product that is more reactive to tumors, "explains Maria Fardis, President and CEO of Iovance Biotherapeutics. "We plan to bring a modified TIL therapy using TALEN technology to the clinic as soon as possible. "

"We are delighted to work with Iovance and are convinced that the application of our TALEN technology to its TIL-based products will generate better treatments for various types of cancer," added André Choulika, President and CEO of Cellectis. "Patients remain the primary concern of our company and we sincerely hope that this collaboration will find more effective solutions for those who need them." "

On January 12, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study (Press release, Zymeworks, JAN 12, 2020, View Source [SID1234553032]). Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib.

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"The initiation of this Phase 2 trial and collaboration with Pfizer mark significant milestones in our progress towards establishing ZW25 as the foundational HER2 therapy in multiple regimens across breast and other cancers," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. "Together, ZW25 and palbociclib have the potential to improve anti-tumor activity and minimize side effects for people living with advanced HER2‑positive, HR-positive breast cancer."

This Phase 2 clinical trial is a multicenter, open-label, two-part study (clinicaltrials.gov: NCT04224272). Part one of the study will evaluate the safety and tolerability of ZW25 in combination with palbociclib and fulvestrant and identify the recommended doses (RD) of ZW25 and palbociclib. Part two of the study will evaluate anti-tumor activity at the RD level. The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned.

ZW25 is being evaluated within a broad clinical development program in multiple HER2‑expressing cancers, including biliary tract, gastroesophageal adenocarcinoma (GEA), breast, colorectal, and gynecologic cancers. In an ongoing Phase 1 clinical trial, Zymeworks is evaluating ZW25 as a single agent and in combination with chemotherapy as potential treatments for patients with HER2-expressing cancers (clinicaltrials.gov: NCT02892123). For patients with HER2-positive GEA, ZW25 is being studied in a Phase 2 trial as a first-line treatment in combination with standard of care chemotherapy (clinicaltrials.gov: NCT03929666). Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.

About Breast Cancer

Breast cancer occurs when cells of the breast grow uncontrollably. According to the World Health Organization, each year, over 2 million new cases of breast cancer are diagnosed and over 600,000 deaths occur globally. Rates are increasing in nearly every region of the world. For locally advanced or metastatic breast cancer, the American Cancer Society estimates over 271,000 new US cases in men and women this year. About 15 to 20 percent of all breast cancers are positive for human epidermal growth factor receptor 2, or HER2. These cancers make too much HER2 protein, which may cause them to grow more quickly and spread to other parts of the body. Despite the advances with available HER2-targeted therapies, there is still an unmet medical need for people with all HER2-expressing cancers, particularly recurrent or metastatic disease that has progressed after standard of care therapy.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.

On January 12, 2020 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported its strategic priorities and expected upcoming milestones (Press release, Syros Pharmaceuticals, JAN 12, 2020, View Source [SID1234553031]).

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"2019 was marked by significant progress across our pipeline, as Syros redefines the power of small molecules to control the expression of genes," said Nancy Simonian, M.D., Syros’ Chief Executive Officer. "We shared promising clinical data for SY-1425 in newly diagnosed unfit RARA-positive AML patients, as well as exciting preclinical data for SY-5609 that speak to its potential as a best-in-class oral CDK7 inhibitor. We ended the year on a strong note, entering into a collaboration with Global Blood Therapeutics that allows us to expand and accelerate our efforts to bring an oral medicine to market that may provide a functional cure for people living with sickle cell disease or beta thalassemia."

"We are excited to build on this progress in 2020, with multiple milestones expected across our clinical and discovery-stage pipeline," Dr. Simonian continued. "We look forward to advancing SY-5609 into clinical development in the first quarter, and to reporting clinical data for both SY-1425 and SY-5609, including potential proof-of-concept data for SY-1425 in RARA-positive relapsed or refractory AML patients, in the fourth quarter. In parallel, we continue to advance our discovery pipeline in cancer and monogenic disease areas where we believe we have the potential to deliver transformative gene control medicines for diseases that have eluded other genomics-based approaches."

Expected Clinical Milestones

SY-1425

Report potential proof-of-concept data in fourth quarter of 2020 from ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in fourth quarter of 2020 from fully enrolled Phase 2 trial cohorts evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-5609

Initiate Phase 1 trial of SY-5609 in first quarter of 2020 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Report initial safety, tolerability, pharmacokinetic and pharmacodynamic data in fourth quarter of 2020 from dose escalation portion of Phase 1 trial.
Report additional dose escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline

Syros expects to nominate its next development candidate by the end of 2021.
Syros also announced today that the Company’s second monogenic disease program is in myotonic dystrophy type 1.

Financial Guidance
Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities are sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2021 through key clinical milestones for both SY-1425 and SY-5609.