On July 16, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that its licensing partner Specialised Therapeutics Asia (STA) has received marketing approval of NERLYNX (neratinib) in Malaysia from the Drug Control Agency (DCA), under Malaysia’s Ministry of Health (MOH) (Press release, Puma Biotechnology, JUL 16, 2020, View Source [SID1234561988]). NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.

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!

STA Chief Executive Officer Carlo Montagner said, "This approval in Malaysia represents the fifth STA approval of NERLYNX for commercialization, after approvals in Australia, New Zealand, Singapore and Brunei. These approvals, along with pending regulatory submissions in the Philippines and other Southeast Asian regions, will extend the reach of this medicine to patients who were previously underserved."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The commercial strategy implemented by Specialized Therapeutics in Australia and the successful market entry into additional countries throughout Southeast Asia support our commitment to expanding access to NERLYNX to breast cancer patients around the world. Addressing recurrence in HER2-positive breast cancer patients remains paramount for Puma and our global partners."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On July 16, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for the second quarter 2020 following the close of market on Thursday, August 6, 2020 (Press release, Illumina, JUL 16, 2020, View Source [SID1234561987]).

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!

On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time), Francis deSouza, President and Chief Executive Officer, and Sam Samad, Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, August 6, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both with Conference ID 4194447. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On July 16, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, July 31, 2020 to discuss its second quarter operating results (Press release, ImmunoGen, JUL 16, 2020, View Source [SID1234561986]). Management will also provide a brief update on the business.

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!

Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 4388395. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

On July 16, 2020 Zikani Therapeutics, a company leveraging its unique TURBO-ZMTM platform to develop novel ribosome modulating agents (RMAs) for the treatment of rare, nonsense mutation-driven diseases, reported the appointment of Vijay Modur, M.D., Ph.D., as its Chief Scientific and Medical Officer to lead the company in advancing its ribosome-modulating scientific platform into the next stage of drug development (Press release, Zikani Therapeutics, JUL 16, 2020, View Source [SID1234561985]).

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!

Dr. Modur was previously Global Project Head in Rare Disease Clinical Development at Sanofi-Genzyme where he oversaw key functions responsible for advancing venglustat for the treatment of conditions caused by lysosomal dysfunction and other investigational therapies for several rare diseases, many with the potential for accelerated approval. Before joining Sanofi-Genzyme, Dr. Modur served as Chief Medical Officer and Vice President of Translational Research for HTG Molecular. Dr. Modur previously held clinical development leadership roles at Novartis and Merck.

"Zikani’s top priority is to advance its current nonsense mutation readthrough programs from lead optimization to candidate selection for first in human clinical trials following the positive, pre-clinical data demonstrated in multiple disease areas," said Sumit Aggarwal, President and CEO, Zikani Therapeutics. "We’re optimistic about the opportunity to impact diseases with limited or no treatment options including: APC mutant colon cancer, familial adenomatous polyposis (FAP), class 1 cystic fibrosis, and recessive dystrophic and junctional epidermolysis bullosa (RDEB and JEB), and Vijay’s experience and leadership will strengthen our capabilities to pursue this important work," added Aggarwal.

"Zikani has focused its technology on where it holds the most promise and with the addition of Vijay is building a leadership team that will advance the company into the next phases of preclinical and clinical development," said Alan Walts, Ph.D., Executive Chairman of Zikani’s Board of Directors.

Dr. Modur earned his MBBS at Karnatak University, Dharwad, India and his Ph.D. in Experimental Pathology at the University of Utah. He completed his residency at Washington University, St. Louis where he served as Chief Resident, Laboratory Medicine. Dr. Modur is board certified in Clinical Pathology.

"The promise of impacting rare diseases through such novel technology that builds upon the science of modulating protein translation is compelling," said Modur. "The TURBO-ZMTM technology platform and the proof of cellular concept demonstrated across multiple disease states provides a compelling approach to treating rare diseases. I’m excited to join the team and look forward to making an impact on behalf of patients," added Modur.

Ribosomal RNAs form the translation machinery that generates function proteins from genetic sequences. Ribosome modulation provides a therapeutic approach to addressing a number of diseases, but the development of disease-specific ribosome modulators has been a challenge.

On July 16, 2020 Oncorus, Inc., a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported a clinical trial collaboration agreement with Merck (NYSE:MRK), known as MSD outside of the United States and Canada, through a subsidiary to evaluate the combination of Oncorus’ ONCR-177 with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as part of an ongoing Phase 1 study of ONCR-177 in adult patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors (Press release, Oncorus, JUL 16, 2020, View Source [SID1234561984]). ONCR-177, Oncorus’ lead product candidate, is an intratumorally administered oncolytic Herpes Simplex Virus (oHSV) viral immunotherapy being developed for the treatment of multiple solid tumor indications.

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 pleased to enter into this clinical collaboration with Merck, as we believe the mechanisms of ONCR-177 and KEYTRUDA are highly complementary," said Theodore (Ted) A. Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, to activate T cells, while ONCR-177 is designed to elicit an immunogenic cell death and stimulate T cells and additional key cells within both the innate and adaptive immune systems to drive a lasting and systemic anti-tumor response. Combining these two approaches has the potential to enhance antitumor immunity, and form immunologic memory against tumors. It also may help more patients become responders to immunotherapy."

As announced today by Oncorus, the Phase 1 study underway is an open-label, multi-center, dose escalation and expansion trial designed to evaluate the safety and tolerability and to determine the recommended Phase 2 dose as well as preliminary anti-tumor activity of ONCR-177 alone and in combination with KEYTRUDA.

Upon determination of the recommended Phase 2 dose, the study will then enroll patients to histology- specific expansion cohorts to demonstrate safety and initial efficacy of ONCR-177 as a monotherapy and in combination with KEYTRUDA, in addition to enabling biomarker exploration. The expansion cohorts will enroll patients with solid tumors who are refractory to, ineligible for, relapsed from and/or intolerant of standard of care treatment or have a disease for which no standard of care exists, including patients with breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and melanoma.

For more information on the study, please visit: View Source

About ONCR-177

Oncorus has designed its proprietary oHSV Platform to develop improved intratumorally administered viral immunotherapies that have enhanced potency without sacrificing safety, a challenge that has been encountered by earlier generation programs in this class. ONCR-177 is designed to mount a powerful, multidimensional attack on cancer; it induces immunogenic cancer cell death and ignites innate and adaptive immunity to drive a lasting and systemic anti-tumor response. In addition to its oncolytic activity, ONCR-177 is armed with five immunomodulatory transgenes: IL-12, CCL4, FLT3LG, and antagonists of clinically proven immune checkpoints PD-1 and CTLA-4. This represents a greater payload capacity than viral immunotherapies that are either currently approved or in clinical development.

In preclinical studies, ONCR-177 was shown to stimulate multiples arms of the immune system, drive abscopal activity and prolong survival while limiting systemic exposure to transgene products, such as IL-12, that cannot be safely dosed systemically due to toxicities.

ONCR-177 retains full replication competency to enable potent tumor cell killing. It also incorporates two highly innovative approaches — the use of microRNA target sequences and a proprietary mutation engineered in an HSV-1 protein, known as UL37 — to allow for tumor-specific replication, which restricts viral activity to tumor cells while sparing normal tissues.