On December 28, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, and Cullinan Oncology, a biopharmaceutical company focused on developing a diversified pipeline of targeted oncology and immuno-oncology therapies with transformative potential for cancer patients, reported an exclusive license agreement for the development, manufacturing and commercialization of CLN-081 in Greater China (Press release, Zai Laboratory, DEC 28, 2020, View Source [SID1234573278]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Cullinan Pearl, a Cullinan Oncology company, will receive a $20 million upfront payment, with the potential to receive up to an additional $211 million in development, regulatory and sales-based milestone payments. Cullinan Pearl is also eligible to receive high-single-digit to low-teen tiered royalties based on annual net sales of CLN-081 in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Zai Lab obtains the exclusive right to develop, manufacture and commercialize CLN-081 in Greater China.

"Partnering with Cullinan for their potential best-in-class EGFR inhibitor targeting exon 20 insertion (Ex20ins) mutations provides potential synergies with Zai’s existing lung cancer franchise and further strengthens our disease area stronghold in lung cancer," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "The unmet need in non-small-cell lung cancer with Ex20ins mutations is significant in China, where EGFR mutation rates are some of the highest in the world. Zai looks forward to working closely with Cullinan to address this large unmet medical need."

"Zai Lab is the ideal partner for innovative drug development and commercialization in Greater China, and we are excited to be collaborating with them on CLN-081," said Owen Hughes, Chief Executive Officer of Cullinan Oncology. "Approved EGFR inhibitors do not adequately address exon 20 insertion mutations. We believe that CLN-081, with its encouraging preliminary efficacy and safety data, can address a significant unmet medical need among lung cancer patients with these mutations. We look forward to working with Zai to initiate development of CLN-081 in China as soon as possible."

About CLN-081

CLN-081 is an orally available, small-molecule, next-generation, irreversible EGFR inhibitor designed to selectively target cells expressing mutant EGFR variants. CLN-081 is currently in a Phase 1/2a dose escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with NSCLC harboring EGFR Ex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy.

On December 28, 2020 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, reported financial results for its fiscal year ended September 30, 2020 (Press release, Anavex Life Sciences, DEC 28, 2020, View Source [SID1234573277]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Christopher U Missling, PhD, President and Chief Executive Officer of Anavex said: "Despite all of the new challenges, 2020 was an extraordinary year for Anavex, with significant progress across our portfolio, including our first positive, placebo-controlled, U.S. ANAVEX2-73 (blarcamesine) Rett syndrome trial, a positive Parkinson’s disease dementia trial, and further progress in Alzheimer’s disease. I want to thank the patients, doctors, and the Anavex team who made all of this progress possible. We look forward to building on this momentum with key milestones expected from multiple programs, including data on the ongoing late-stage Rett syndrome trials AVATAR and EXCELLENCE, expanding the clinical biomarker-driven ANAVEX2-73 rare disease program into additional late-stage studies with high unmet medical need, completing the late stage ANAVEX2-73 Phase 2b/3 Alzheimer’s disease trial, and advancing ANAVEX2-73 into clinical disease modifying testing in Parkinson’s disease."

Key Clinical Updates:

Plan to advance the AVATAR adult Rett syndrome study into a pivotal Phase 2/3 clinical trial.
Pipeline expansion for ANAVEX2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need:
Planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.
Planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication.
Phase 2b/3 ANAVEX2-73 Alzheimer’s disease (AD) study currently over 80% enrolled with complete enrollment expected in early 2021.
Planned initiation of ANAVEX2-73 imaging-focused Parkinson’s disease clinical study.
Recent Business Highlights:

In December 2020, Anavex announced top-line results from a U.S. Phase 2 controlled trial of ANAVEX2-73 in adult female patients with Rett syndrome. Primary safety, pharmacokinetics and secondary efficacy endpoints were met, with statistically significant and clinically meaningful consistent improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) and Clinical Global Impression Improvement (CGI-I) scores. Improvements in RSBQ Total scores were correlated with decreases (improvements) in plasma glutamate. Based on the results, Anavex is planning to meet with the FDA to discuss an accelerated approval pathway.
In November 2020, Anavex presented data at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) 2020 Conference, reporting top-line results from the proof-of-concept Phase 2 placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of ANAVEX2-73 in patients in Parkinson’s disease dementia (PDD) compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response to ANAVEX2-73 supporting progression to further development in upcoming Phase 2/3 studies.
In November 2020, Anavex received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application number 16/717,921 expected to remain in force at least until 2037, expanding coverage of treatment methods using its lead drug candidate, ANAVEX2-73, as well as drug candidate ANAVEX1-41 for treating a range neurodevelopmental disorders including Rett syndrome, autism spectrum disorder, Angelman syndrome, cerebral palsy and multiple sclerosis, among other indications.
Financial Highlights:

Cash and cash equivalents of $47.6 million as of today and $29.2 million at September 30, 2020, compared to $22.2 million at September 30, 2019.
Net loss of $26.3 million, or $0.45 per share for the year, compared to net loss of $26.3 million, or $0.54 per share in fiscal 2019.
Research and development expenses of $25.2 million for the year, compared to $22.3 million for fiscal 2019.
General and administrative expenses of $5.9 million for the year, compared to $6.8 million for fiscal 2019.
The financial information for the fiscal year ended September 30, 2020 should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.

Conference Call / Webcast Information

The live webcast of the conference call can be accessed online at View Source

To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 50061077, followed by the pound sign (#).

A replay of the conference call will also be available on www.anavex.com.

On December 28, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conference and invited investors to participate by webcast (Press release, Exact Sciences, DEC 28, 2020, View Source [SID1234573274]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

J.P. Morgan Healthcare Conference
Presentation followed by a Q&A session on Wednesday, January 13, 2021 at 2:50 p.m. EST
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On December 28, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab (Press release, Alligator Bioscience, DEC 28, 2020, View Source [SID1234573273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The upcoming Phase II study OPTIMIZE-1 is an open-label, multi-center study assessing the clinical efficacy of mitazalimab in combination with chemotherapy (mFolfirinox) in patients with metastatic pancreatic cancer. The OPTIMIZE-1 study will be performed at several clinics in Europe and encompass up to a total of 66 patients. Inclusion of the first patient is planned during the first half of 2021 and will begin with a run-in period to determine the best dose for the combination with chemotherapy.

"The CTA submission is an important milestone for Alligator, as we are now entering clinical Phase II for the first time. With best-in-class benchmark data presented for mitazalimab during the autumn, I believe that OPTIMIZE-1 has great potential to deliver robust efficacy results in pancreatic cancer", said Per Norlén, CEO of Alligator Bioscience.

The mitazalimab drug candidate has previously reported positive clinical data from two Phase I studies, one performed by Alligator, one performed by Janssen Biotech Inc., displaying a manageable safety profile as well as early signs of efficacy.

On December 28, 2020 Elevar Therapeutics, Inc. ("Elevar"), a fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that it has entered into an exclusive agreement with Inceptua Group ("Inceptua") for the distribution and commercialization of Apealea (paclitaxel micellar) in Europe (Press release, LSK BioPharma, DEC 28, 2020, View Source [SID1234573271]). Apealea has been authorized by European regulatory authorities for use in the European Economic Area in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to announce our partnership with Inceptua to make Apealea (paclitaxel micellar) available to patients with ovarian cancer in Europe," said Alex Kim, Chief Executive Officer of Elevar Therapeutics. "Apealea is the only non-Cremophor based paclitaxel treatment approved in Europe for ovarian cancer, providing a treatment option with a higher paclitaxel dose and shorter infusion time without mandatory premedication versus Cremophor-based paclitaxel. Inceptua’s proven capabilities to develop and commercialize oncology and orphan treatments in Europe make them the ideal partner to accelerate access to Apealea in this important region. This agreement further propels progress for Apealea development and commercialization, an important step in Elevar’s strategy to optimize the value of its portfolio in global markets."

Under the terms of the agreement, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland).

"We are delighted to enter into this agreement with Elevar to commercialize Apealea (paclitaxel micellar) in Europe," said Stefan Fraenkel, Chief Executive Officer of Inceptua. "We believe there is great potential for Apealea to help patients with ovarian cancer who cannot tolerate paclitaxel formulated with Cremophor, and we look forward to leveraging our established sales force, distribution networks, and market access capabilities to bring this important treatment to patients and healthcare providers throughout Europe."

Apealea (paclitaxel micellar) is a non-Cremophor based formulation of paclitaxel. It received marketing authorization from the European Commission in 2018, which was the first approval in Europe for a non-Cremophor EL paclitaxel in ovarian cancer and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA).

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs 1. Globally, it is the third most common cancer among women and has the highest mortality rate 2,3. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly 4,5. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis 6.

About Apealea (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Cremophor EL, is a toxic formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer.