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Seagen to Host Conference Call and Webcast Discussion of Fourth Quarter and Full Year 2021 Financial Results on February 9, 2022

On January 18, 2022 Seagen Inc. (Nasdaq: SGEN) reported that it will report its fourth quarter and full year 2021 financial results on Wednesday, February 9, 2022 after the close of U.S. financial markets (Press release, Seagen, JAN 18, 2022, View Source [SID1234605516]). Following the announcement, Company management will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and provide a business update.

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Conference call and webcast information:

Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international); conference ID 10163004
Webcast with slides can be accessed at investor.seagen.com. A webcast replay will be archived on the Company’s website.

HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 and Pembrolizumab for Treatment of Head and Neck Cancer and Reports FDA’s Fast Track Designation

On January 18, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, announced that the first patient has been dosed with HB-200 in combination with pembrolizumab for the treatment of 1st-line advanced/metastatic Human Papillomavirus 16 Positive (HPV16+) squamous cell head and neck cancers (HNSCC) in a Phase 2 arm of the ongoing Phase 1/2 trial (NCT04180215) (Press release, Hookipa Pharma, JAN 18, 2022, View Source [SID1234605515]). In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the Company’s novel immunotherapy candidates, single-vector HB-201 and alternating 2-vector HB-202/HB-201, both in combination with pembrolizumab, for the treatment of 1st-line advanced/metastatic HPV16+ HNSCC.

"Given our HB-200 clinical data to date, we believe that combining HB200 with pembrolizumab in earlier line settings has the potential–by inducing unprecedented levels of tumor antigen-specific CD8+ T cells–to overcome the limitations of checkpoint inhibitor monotherapy," said Joern Aldag, Chief Executive Officer at HOOKIPA. "We’re eager to work closely with the FDA through the development process as we hope to bring new options to patients with HNSCC. Fast Track Designation for our lead oncology candidates is a great recognition of the promise of our versatile arenaviral platform to deliver novel immunotherapies which can address unmet needs in cancer."

The Company reiterates its HB-200 program guidance as follows:

Additional Phase 1 monotherapy data in mid-2022;
Initial 1st-line data and post-standard of care (2nd+ line) data, both in combination with pembrolizumab, in 2H 2022;
Initiation of the randomized 1st-line Phase 2 study (pembrolizumab vs. pembrolizumab + HB-200) in 1H 2023.
Fast Track Designation is granted by the FDA for products that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. The designation, which is based on a review of pre-clinical and clinical data, enables early and frequent communication with the FDA through the drug development process, a rolling submission of a New Drug Application, as well as eligibility for Accelerated Approval and Priority Review if relevant criteria are met. Fast Track Designation was granted to the planned Phase 2 randomized trial of HB-201 and HB-202/HB-201 in combination with pembrolizumab for the treatment of 1st-line advanced/metastatic HPV16+ HNSCC.

About HB-202/HB-201
HB-201 and HB-202/HB-201 are HOOKIPA’s lead oncology candidates engineered with the company’s proprietary replicating arenaviral vector platform. Each single-vector compound uses a different arenavirus backbone (Lymphocytic Choriomeningitis Virus for HB-201 and Pichinde Virus for HB-202), while expressing the same antigen, an E7E6 fusion protein derived from HPV16. In pre-clinical studies, alternating administration of HB-201 and HB-202 resulted in a ten-fold increase in immune response and better disease control than either compound alone. HOOKIPA’s HB200 program includes HB-201, which is being tested clinically as a single vector therapy and HB-201 used as an alternating vector combination with HB-202.

About the HB-200 trial (NCT04180215)
This Phase 1/2 clinical trial is an open-label trial exploring different dose levels and dosing schedules in individuals with treatment-refractory HPV16+ head and neck cancers who progressed on standard of care, including check point inhibitors. The trial is evaluating HB-201 as a monotherapy, as an alternating 2-vector therapy with HB-202, and in combination with a PD-1 inhibitor. The primary endpoint of Phase 1 is a recommended Phase 2 dose. Secondary endpoints include safety and tolerability, as well as preliminary efficacy defined by RECIST 1.1. The study also includes exploratory objectives on immunogenicity and pharmacodynamic biomarkers. The Phase 2 part of the trial, assessing HB-201 and HB-202/HB-201 in combination with pembrolizumab in 1st- and post-standard of care (2nd+) line settings, is ongoing.

Alligator Bioscience Announces OPTIMIZE-1 Trial Update: Cohort Fully Dosed with No Adverse Effects Reported

On January 18, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported an update on the on-going OPTIMIZE-1 clinical Phase Ib/II trial with the company’s lead asset, mitazalimab (Press release, Alligator Bioscience, JAN 18, 2022, View Source [SID1234605513]). All patients in the 450 µg/kg cohort have been dosed and there have been no adverse effects related to study medication has been reported. Dosing of the 900 µg/kg cohort has been initiated. The Phase 1b part of the study is expected to be completed during Q1 2022.

OPTIMIZE-1, an open-label, multi-center phase Ib/II study is assessing the safety and efficacy of mitazalimab in combination with chemotherapy, mFOLFIRINOX, in patients with metastatic pancreatic ductal adenocarcinoma. First patient was dosed in Q3 2021 (press release). The study is designed to take full advantage of mitazalimab efficacy and tolerability profile administering higher and more frequent doses than competing molecules. This increases the likelihood of demonstrating clinical benefit to patients as a potential first-line treatment for metastatic pancreatic cancer in combination with mFOLFIRINOX. Patient recruitment is ongoing in sites France and Belgium. The study aims to enrol 67 patients with metastatic pancreatic cancer.

"I am happy to report that we continue to make great progress with our OPTIMIZE-1 trial," comments Søren Bregenholt, CEO of Alligator Bioscience. "We look forward to keeping the market regularly updated as the project advances."

The safety readout for OPTIMIZE-1 is expected to be announced in Q1 2022, with the interim readout in Q4 2022.

ADC Therapeutics Announces Exclusive License with Mitsubishi Tanabe Pharma Corporation to Develop and Commercialize ZYNLONTA® (loncastuximab tesirine-lpyl) in Japan

On January 18, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported it has entered an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA (loncastuximab tesirine-lpyl) for all hematologic and solid tumor indications in Japan (Press release, ADC Therapeutics, JAN 18, 2022, View Source [SID1234605512]).

Under the terms of the agreement, ADC Therapeutics will receive an upfront payment of $30 million and up to an additional $205 million in milestones if certain development and commercial events are achieved. ADC Therapeutics will also receive royalties ranging in percentage from the high teens to the low twenties based on net sales of the product in Japan. MTPC will conduct clinical studies of ZYNLONTA in Japan and will have the right to participate in any global clinical studies of the product by bearing a portion of the costs of the study.

In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to ZYNLONTA as the first and only CD19-targeted ADC as a single-agent treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. A Marketing Authorization Application (MAA) for ZYNLONTA has been validated by the European Medicines Agency (EMA) and is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). ZYNLONTA has also received Orphan Drug designation in Europe for DLBCL. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA in greater China and Singapore. Overland ADCT BioPharma is now conducting a pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China, which is intended to support the anticipated registration of ZYNLONTA in China.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

Tyligand Bioscience Receives IND Clearance from China NMPA for TSN084, a Multi-kinase Inhibitor to Address Tumor Resistance to Targeted Therapies

On January 17, 2022 Tyligand Bioscience, a clinical-stage biotechnology company developing innovative small-molecule therapeutics against drug resistant cancers, reported that its investigational new drug (IND) application of TSN084 has been approved by China’s National Medical Products Administration (NMPA) (Press release, Tyligand Bioscience, JAN 17, 2022, View Source [SID1234644991]).

TSN084 is a first-in-class phosphorylation inhibitor targeting CDK8/19 and several other kinases implicated in tumorigenesis and immune evasions. Phase I enrollment will be conducted at the Cancer Hospital of the Chinese Academy of Medical Sciences and other clinical centers. In Oct 2021, the company has received IND approval from the US FDA for the experimental drug and dose escalation studies are expected to commence soon.

Dr. Tony Zhang, cofounder and CEO of Tyligand Bioscience, commented, "We are excited about this important milestone and the potential of TSN084 for helping patients with tough to treat tumors. Accomplishing this goal is testimonial to the quality and speed of the Tyligand team at transforming novel molecules into quality drug candidates. It is an important step toward testing our approach of selective and simultaneous inhibition of multiple factors responsible for the major hallmarks of cancer."