On December 20, 2022 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions reported that collaborators at the Quantum Leap Healthcare Collaborative reported today that the Company’s oral paclitaxel plus encequidar in combination with a PD-1 inhibitor and carboplatin has graduated in the triple-negative subgroup of high-risk early-stage breast cancer (Press release, Athenex, DEC 20, 2022, View Source [SID1234625436]). Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia. Quantum Leap Healthcare Collaborative anticipates presenting these results at upcoming national meetings in Q2 of 2023.

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"We are very pleased that the Oral Paclitaxel combination regimen graduated from this prestigious program which has brought exciting and innovative treatments to neoadjuvant breast cancer patients. This study confirms our finding of less neuropathy for Oral Paclitaxel compared to intravenous paclitaxel in our metastatic breast cancer study. It’s reassuring to see that Oral Paclitaxel regimen was not associated with increased febrile neutropenia relative to the intravenous paclitaxel regimen in a well-conducted U.S. study," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "We will explore different opportunities to maximize the value of Oral Paclitaxel."

Please refer to View Source for more information.

On December 20, 2022 Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), Seagen Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the U.S. Food and Drug Administration (FDA) has accepted for Priority Review supplemental Biologics License Applications (sBLAs) for PADCEV (enfortumab vedotin-ejfv) and KEYTRUDA (pembrolizumab) for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy (Press release, Astellas, DEC 20, 2022, View Source [SID1234625434]). The respective applications are intended to expand both labels for PADCEV and KEYTRUDA. The agency set a Prescription Drug User Fee Act (PDUFA) goal date for each application of April 21, 2023

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"We look forward to working closely with the FDA as we seek potential accelerated approval for this combination in the hopes that it can be another treatment option for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas.

The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020. The respective sBLAs are supported by efficacy and safety data from the phase 1b/2 EV-103 trial (NCT03288545, also known as KEYNOTE-869) Dose Escalation/Cohort A and Cohort K. Results from Dose Escalation/Cohort A were published in the Journal of Clinical Oncology.1 Results from Cohort K were presented in a late-breaking session at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.2

"Urothelial cancer, the most common type of bladder cancer, is associated with poor survival in the advanced stage," said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. "The investigational results from our clinical development program support the combination of PADCEV and KEYTRUDA as a potential treatment for this patient population."

Please see Important Safety Information at the end of this press release for both drugs, including a warning and precaution for immune-mediated adverse reactions for pembrolizumab and BOXED WARNING for PADCEV (enfortumab vedotin-ejfv) for serious skin reactions.

"Despite advancements in treatment options, approximately half of advanced bladder cancer patients in the U.S. are ineligible for cisplatin-based chemotherapy, and these patients need new options. We are encouraged by the investigational results of the combination of PADCEV and KEYTRUDA for this patient population and are fully committed to work to bring this new approach forward to patients," said Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories.

Astellas, Seagen and Merck are further investigating enfortumab vedotin plus pembrolizumab in the ongoing phase 3 EV-302 study (NCT04223856, also known as KEYNOTE-A39), evaluating the clinical benefit for the investigational treatment combination in patients with previously untreated advanced urothelial cancer. The trial is intended to serve as the confirmatory trial for the potential accelerated approval in the U.S. and serve as the basis for global registration.

The studies are part of an extensive program evaluating this combination in multiple stages of urothelial cancer, including two phase 3 clinical trials in muscle-invasive bladder cancer in EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE-905).

On December 20, 2022 Abbott (NYSE: ABT) reported that it will present at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 10, 2023 (Press release, Abbott, DEC 20, 2022, View Source [SID1234625435]). Robert B. Ford, chairman and chief executive officer, will present at 11 a.m. Central time.

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A live webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available later that day.

On December 20, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported an expanded clinical development plan for VB10.16, the Company’s wholly-owned cancer vaccine, for the treatment of HPV16-positive cancers with high unmet need (Press release, Nykode Therapeutics, DEC 20, 2022, View Source [SID1234625430]). Nykode Management will host a webcast today, December 20, 2022, to discuss the development plan at 11 a.m. CET (in Norwegian) and 4 p.m. CET/10 a.m. ET (in English).

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VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The drug candidate has reported interim data from VB-C-02, a Phase 2 trial in heavily pre-treated cervical cancer patients. The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses that were associated with clinical responses.

"Today we announce our expanded VB10.16 development plan underlining our confidence in the product candidate’s potential to treat a broad group of HPV-related cancer patients with significant unmet need. These indications constitute a large potential market opportunity for Nykode. Our potential registrational trial strategy disclosed today in advanced cervical cancer could provide a fast path to making VB10.16 available to patients. I am excited by our ambitious VB10.16 development plans and our recently signed agreements supporting the development. We remain committed to taking full advantage of the potential of VB10.16 and Nykode’s technology platform," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics.

Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics, stated: "The interim results from our C-02 Phase 2 trial show the ability of VB10.16 to improve clinical outcomes in heavily pretreated patients with advanced cervical cancer. Our next trial in advanced cervical cancer will focus on patients who failed first line treatment including checkpoint inhibitor treatment. In this patient group with limited treatment options and a significant unmet need, we aim for a potential registrational trial."

Expanded VB10.16 Clinical Development Plan

Cervical Cancer
Nykode is planning to conduct a single arm trial, VB-C-04, with potential registrational intent in 2 nd line immune checkpoint inhibitor refractory advanced cervical cancer patients. The trial will be conducted in the United States and initiated in the fourth quarter of 2023.

Head and Neck Cancer
Nykode is planning to conduct an open-label, dose-finding, single arm Phase 1b/2a trial of VB10.16 in combination with pembrolizumab in patients with first line HPV16-postive, recurrent or metastatic squamous cell head and neck cancer as described in Nykode’s announcement on December 6, 2022. The trial, VB-C-03, will evaluate the overall response rate, safety, tolerability, and antigen specific immune response of the combination therapies. Nykode expects to enroll patients in Europe during the first half of 2023.

Basket Trial
Nykode expects to collaborate on an investigator-initiated basket trial to evaluate VB10.16 in combination with a PD-L1 inhibitor in patients diagnosed with HPV16-positive anal, penile, vaginal and/or vulvar cancer who are no longer eligible for curative treatments. The trial is expected to enroll patients with both PD-L1 positive and PD-L1 negative tumors. Nykode will continue to study VB10.16 in patients with PD-L1 negative tumors to investigate VB10.16’s potential for a dedicated trial in such a patient population.

Webcast
Investors and analysts are invited to join a webcast presentation of the VB10.16 development plan conducted by Michael Engsig, Chief Executive Officer, and Klaus Edvardsen, Chief Development Officer, today, December 20, 2022 at:

11 a.m. CET / 5 a.m. ET which will be conducted in Norwegian
4 p.m. CET / 10 a.m. ET which will be conducted in English

The slide presentation and live and archived webcast can be accessed in the Investors section of the Company’s website at View Source

41st Annual J.P. Morgan Healthcare Conference

Nykode Management will present at the 41st Annual J.P. Morgan Healthcare Conference, taking place January 9-12, 2023, in San Francisco, California.

About VB10.16

VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers. The cancer vaccine is designed based on Nykode’s Vaccibody technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported positive interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses were associated with
clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses.

On December 20, 2022 GlyTherix Ltd ("GlyTherix"), an Australian immuno-oncology company reported an MTA & Option License with Adcendo ApS ("Adcendo"), a Danish biotech company focused on the development of breakthrough antibody-drug conjugates (ADCs) for the treatment of underserved cancers, to develop an Antibody Drug Conjugate (ADC) against the innovative solid tumor target GPC-1 (Press release, Glytherix, DEC 20, 2022, View Source [SID1234625402]).

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Under the terms of the agreement, Adcendo’s planned pre-clinical ADC development program will be based on GlyTherix’s lead anti-GPC-1 monoclonal antibody, Miltuximab.

Brad Walsh, CEO of GlyTherix, said: "Initial studies have demonstrated a strong patient safety profile with no adverse events from relevant doses of the antibody. We are very excited to be partnering with Adcendo to further develop our antibody candidate. Successful pre-clinical studies have the potential to lead to a licensing agreement to clinically develop and globally commercialize the anti-GPC-1 ADC for several hard-to-treat solid tumor indications."

Michael Pehl, CEO of Adcendo, said: "We are delighted to be partnering with GlyTherix as we continue to develop ADCs for the treatment of underserved cancers. The GlyTherix team has accomplished outstanding work in ensuring a deep understanding of the target in solid tumors and developing Miltuximab. GPC-1 is a highly suitable target for ADCs and our collaboration is a great opportunity to bring a novel treatment option to patients with hard-to-treat solid tumor cancers while we are building and advancing a pipeline of highly differentiated ADCs at Adcendo."