On December 3, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)- based DNA manufacturing and nucleic acid-based technologies, reported that it will report its fourth quarter and full fiscal year 2021 financial results after market close on Thursday, December 9, 2021 (Press release, Applied DNA Sciences, DEC 3, 2021, View Source [SID1234596447]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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On December 3, 2021 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported a research collaboration with University of Bern, to advance the development of the Company’s wholly owned acute myeloid leukemia (AML) candidate, MP0533, into the clinic (Press release, Molecular Partners, DEC 3, 2021, View Source [SID1234596446]). MP0533 is a DARPin designed to engage CD3 on T cells and target AML cells by the tumor associated antigens (TAAs) CD33, CD123 and CD70. The collaboration aims to leverage Molecular Partners’ proprietary DARPin technology and the University of Bern group’s expertise in AML, and specifically in leukemic stem cells (LSC), a hard-to-target cancer progenitor cell population.

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"AML is a fast-progressing cancer with a high mortality rate. Current treatments carry high safety risks and can be very harsh, especially for older and frail patients. Our preclinical results so far show MP0533 to be highly specific, fast acting and with a wide therapeutic window, and we hope these traits will translate well for patients in need," said Nicolas Leupin, M.D., Ph.D., Molecular Partner’s CMO. "Our new collaboration with the Bern team provides us with access to advanced AML methodologies and patient samples, and, more importantly, guidance from two of the world’s leading AML researchers, who have previously helped develop anti-CD70 antibodies to the clinic and can share from their invaluable experience."

The Bern team is led by Prof. Adrian Ochsenbein, M.D., Chairman, Department of Medical Oncology, and Prof. Carsten Riether, Ph.D., who study the interaction of immune cells and leukemic cancer cells to develop improved immunotherapies for different types of cancer. Prof. Ochsenbein won the prestigious 2016 Otto Naegeli Prize for breakthrough research on CD70/CD27 signaling with therapeutic potential for cancer patients. The two professors’ main research focus is the so-called LSC. These cells are considered the origin of the disease and responsible for relapse after successful chemotherapy. Under the agreement, the researchers will work with Molecular Partners to investigate the effect and mechanism of action of the Company’s DARPin candidate T-cell engager (TCE) in AML, using in vitro and in vivo models, as well as patient samples.

"The main reason AML is so hard to treat is a small population of therapy-resistant leukemia stem cells, which drives the relapse of the disease after initial successful treatment. Novel therapies will have to aim at targeting and eliminating these treatment-resistant LSCs," said Professor Ochsenbein. "We are excited to join forces with Molecular Partners to work to evaluate this novel therapeutic option. Hopefully, emerging therapeutics like MP0533 will be able to provide a much-needed solution for AML patients."

About Molecular Partners’ acute myeloid leukemia (AML) program
Molecular Partners’ T-cell engager (TCE) programs leverage the cell surface protein CD3 as a powerful immune activator, complemented by novel control mechanisms designed to help direct CD3-mediated cytotoxicity with heightened precision. Molecular Partners first TCE candidate is being developed as a unique multi-specific treatment for AML. Its component DARPin modules are designed to deliver a deeper attack on a broader range of highly variable tumor cells while lowering the risk to healthy cells. This may allow Molecular Partners to significantly shift the therapeutic window for TCE use in AML and potentially avoid the trade-off between effective dosage and safety that other therapeutic developers have had to make.

About Molecular Partners’ Immuno-oncology Product Candidates
Molecular Partners is developing several candidates designed to activate the immune system to fight cancer while reducing damage to healthy cells. These candidates use multiple novel DARPin technologies potentially applicable against a wide range of tumor types, including DARPin candidates with the ability to restrict immune activation to the tumor microenvironment, the ability to target intracellular disease-associated proteins, and multiple novel control mechanisms for immune activation designed to direct immune attack to the right cells, at the right place, and at the right time. These capabilities can be combined during candidate design through the inherent modularity of the DARPin platform, to provide precise control over immune activation and potentially enable more effective cancer immunotherapies.

On December 3, 2021 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported that the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include ZEJULA (niraparib) as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) following a response to platinum-based chemotherapy, regardless of biomarker status (Press release, Zai Laboratory, DEC 3, 2021, View Source [SID1234596445]).

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"A key part of Zai Lab’s mission is to bring transformative medicines to patients in China," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The inclusion of ZEJULA in the NRDL for first-line maintenance treatment of ovarian cancer is an important step in achieving that mission. We are grateful for this action by the NHSA to make ZEJULA more accessible to Chinese patients with ovarian cancer."

"NHSA reimbursement will increase ZEJULA’s availability for many patients in need across China," said William Liang, Chief Commercial Offer. "It is the only PARP inhibitor approved as monotherapy for first-line and recurrent maintenance therapy for ovarian cancer patients regardless of biomarker status in China. This action underscores ZEJULA’s clinical value for a broad range of ovarian cancer patients."

In November 2021, Zai Lab announced that the Phase 3 PRIME study of ZEJULA as maintenance therapy met its primary endpoint and demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit with a manageable safety profile in Chinese patients with newly diagnosed advanced ovarian cancer following a response to platinum-based chemotherapy, regardless of biomarker status.

In December 2020, ZEJULA was included in the NRDL as a maintenance treatment of adult patients with platinum-sensitive, recurrent ovarian cancer.

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China, with over 55,000 newly diagnosed cases and 37,000 deaths in China annually1. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. New agents that prolong the duration of response following platinum-based treatment and delay the relapse of ovarian cancer will benefit patients with ovarian cancer in China.

Globocan 2020.

About ZEJULA (niraparib)

ZEJULA (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the maintenance treatment of adult patients with advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first- and second-line platinum-based chemotherapy.

Zai Lab has completed several studies in Chinese patients with ovarian cancer:

In November 2021, Zai Lab announced positive topline results from the company’s Phase 3 PRIME study of ZEJULA as maintenance therapy for Chinese patients with first-line platinum-responsive, advanced ovarian cancer, regardless of biomarker status.

In September 2020, Zai Lab announced that ZEJULA demonstrated a significant PFS benefit with an improved safety profile in the company’s Phase 3 NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer, regardless of biomarker status.

A Phase 1 pharmacokinetic (PK) study of ZEJULA was conducted in Chinese patients with ovarian cancer.

ZEJULA is also being evaluated in China in a Phase 1b/2 study in combination with tebotelimab (PD-1 x LAG-3 DART molecule) for advanced gastric cancer, triple negative breast cancer, biliary tract cancer, and endometrial cancer.

Zai Lab has a collaboration and license agreement with GSK for the development and commercialization of ZEJULA in mainland China, Hong Kong, and Macau.

On December 3, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate in virtual investor meetings and present at The JMP Securities Hematology and Oncology Summit that will be held December 6-7, 2021 (Press release, Hookipa Biotech, DEC 3, 2021, View Source [SID1234596444]).

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Corporate Presentation: Tuesday, December 7, 2021 at 1:20 PM EST

The webcast of the presentation will be available within the Investors & Media section of HOOKIPA’s website at View Source An archived replay will be accessible for 30 days following the event.

On December 3, 2021 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the publication of preclinical research of zunsemetinib in pancreatic cancer in the peer-reviewed journal Science Translational Medicine, on December 1, 2021 (Press release, Aclaris Therapeutics, DEC 3, 2021, View Source [SID1234596443]).

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The article, entitled "The MK2/Hsp27 axis is a major survival mechanism for pancreatic ductal adenocarcinoma under genotoxic stress," presents the results from a preclinical study using patient-derived cell lines and an autochthonous pancreatic ductal adenocarcinoma mouse model that evaluated the role of MK2, as well as the impact of zunsemetinib (ATI-450), Aclaris’ investigational oral MK2 inhibitor, in pancreatic cancer. This study was a multi-year collaboration between Aclaris and Washington University School of Medicine, led by the laboratory of Dr. Kian-Huat Lim, MD, PhD, Associate Professor in Oncology and Dr. Patrick Grierson, MD, PhD, Assistant Professor in Oncology.

In the study, Dr. Lim and his team identified the MK2/HSP27 axis as an important resistance mechanism resulting in pancreatic tumor cell survival following exposure to components of FOLFIRINOX chemotherapy – the current standard-of-care treatment for pancreatic cancer. His team also demonstrated that DNA damage induced by FOLFIRINOX chemotherapy components upregulated tumor necrosis factor alpha (TNFa) in pancreatic cancer cells, which had the dual effect of impacting cell death and cell survival, and that the selective inhibition of MK2 downstream of TNFa signaling abrogated survival through blocking HSP27 activation and beclin1 mediated autophagy, which allowed TNFa to execute its pro-death mechanism. With this understanding, his team then showed that mouse survival in an autochthonous KPPC model of pancreatic cancer was statistically significantly (p<0.001) extended when dosed with zunsemetinib in combination with FIRINOX (a murine version of FOLFIRINOX).

"This study introduces a new MK2-targeted approach for the treatment of pancreatic cancer," said Dr. Lim. "We are very excited about the potential of this therapeutic combination and believe it should be advanced into clinical trials to determine whether MK2 inhibition can strengthen the effect of mainstay FOLFIRINOX chemotherapy in patients with pancreatic cancer without incurring additional side effects."

Based on these results and clinical data generated from Aclaris’ clinical development program with zunsemetinib, Aclaris is considering a future clinical program for the treatment of patients with pancreatic cancer using one of Aclaris’ other MK2 inhibitor drug candidates.

The authors of the article are Patrick M. Grierson, Paarth B. Dodhiawala, Yi Cheng, Timothy Hung-Po Chen, Iftikhar Ali Khawar, Qing Wei, Daoxiang Zhang, Lin Li, John Herndon, Joseph B. Monahan, Marianna B. Ruzinova, and Kian-Huat Lim, and the article can be accessed here: View Source