Strand Therapeutics Awarded Two Phase I NIH SBIR Grants to Advance Programmable, Long-Lasting mRNA Therapeutics for Melanoma and Breast Cancer

On August 4, 2021 Strand Therapeutics, a privately held developer of next-generation, programmable mRNA therapeutics for cancer immunotherapy and other diseases, reported that the company was awarded two Phase I Small Business Innovation Research (SBIR) grants from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to develop mRNA-based therapeutics for melanoma and triple negative breast cancer (TNBC) (Press release, Strand Therapeutics, AUG 4, 2021, View Source [SID1234585745]). The total funding amount awarded to Strand is approximately $800,000.

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!

While there have been advances in the development of treatment options for melanoma, the number of diagnoses continues to increase. Furthermore, standard of care using anti-PD-1 immunotherapy has been limited with not all patients responding to the therapy. To address this need, the first award granted to Strand will support the development of programmable mRNA circuits that express cytokines which regulate the activation of immune cells, to stimulate an adaptive immune response as a neoadjuvant therapy for melanoma.

TNBC is an aggressive form of breast cancer, accounting for 10-15% of all cases, and is another cancer indication in need of more targeted and effective medicines. Patients have a poor prognosis with limited treatment options. While checkpoint inhibitor therapies including anti-PD-1 antibodies have improved outcomes in patients, only a small percentage respond to this treatment strategy. The second award will allow Strand to engineer synthetic self-replicating mRNA therapies expressing locally-acting cytokines with the goal of improving anti-PD-1 therapy responses.

"It is well known that cytokines can be utilized to achieve an anti-tumor effect in cancer patients. However, treatment strategies that involve cytokines can be highly toxic, and therefore, its efficacy can be limited. To that end, we can use our programmable, self-replicating mRNA therapeutic platform to localize cytokine expression that will potentially enable more precise and longer-lasting anti-cancer immune responses," said Jake Becraft, PhD, co-founder and CEO of Strand. "This generous support from NIH’s NCI will enable us to create synthetic mRNA-based therapeutics that can be safer and more effective than currently available treatment options for both melanoma and breast cancer patients."

Gamida Cell Announces the Date of Its Second Quarter 2021 Financial Results and Webcast

On August 4, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that the company will host a conference call and live audio webcast on Wednesday, August 11, 2021, at 8:00 a.m. ET to review its second quarter 2021 financial results and provide an update on the company (Press release, Gamida Cell, AUG 4, 2021, View Source [SID1234585744]).

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!

Management will discuss the company’s progress during the quarter, including advances in the development of omidubicel, which has the potential to be the first approved cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant, following the planned BLA submission in the fourth quarter of 2021. Gamida Cell will also provide an update on its pipeline of NAM-enabled natural killer (NK) cell therapies, including GDA-201 and genetically-modified NK cell constructs. The Company is planning an IND submission to support the initiation of a Phase 1/2 clinical study of cryopreserved, off-the-shelf GDA-201 in patients with follicular and diffuse large b-cell lymphomas.

The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 9949715. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

Schrödinger and Zai Lab Announce a Global R&D Collaboration in Oncology

On August 4, 2021 Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported a global discovery, development and commercialization collaboration focused on a novel program in oncology targeting DNA damage response (Press release, Schrodinger, AUG 4, 2021, View Source [SID1234585743]).

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!

"With an established track record of developing and commercializing therapeutics in oncology, Zai Lab is an ideal partner for Schrödinger on this project," said Karen Akinsanya, Ph.D., executive vice president, chief biomedical scientist and head of discovery R&D at Schrödinger. "Together, we will aim to accelerate and expand our focus on targeted DNA damage response inhibition, which is emerging as an important therapeutic strategy for a broad range of cancers. Additionally, the structure of this collaboration provides us with the opportunity to gain development and commercial expertise and the potential to participate more significantly in the downstream value of the program."

"We are pleased to be collaborating with Schrödinger, a recognized leader in physics-based computational drug discovery," said Alan Sandler, M.D., president and head of global development, oncology, at Zai Lab. "This program will complement our existing discovery efforts in the DNA damage response pathway in addition to potential combinatorial approaches within our pipeline, such as with the PARP inhibitor Zejula."

The research program will be conducted jointly by the Schrödinger and Zai Lab scientific teams. The companies will be responsible for their own research program expenses, and under the terms of the collaboration agreement, Zai Lab will make an upfront payment to Schrödinger to help fund Schrödinger’s share of research costs. Following the selection of a development candidate, Zai Lab will assume primary responsibility for global development, manufacturing and commercialization. The agreement provides Schrödinger co-development and co-commercialization rights in the U.S. If Schrödinger elects to co-fund clinical development of a product candidate under the collaboration, it will be entitled to 50 percent of the profits, if any, from the commercialization of such product candidate in the United States. Schrödinger will also be eligible to receive up to approximately $338 million in preclinical, clinical, regulatory and sales-based milestone payments. Additionally, Schrödinger is entitled to receive royalties on net sales outside the U.S.

PanTher Therapeutics Receives Ethics Approval to Initiate Phase 1 Clinical Trial of PTM-101 in Australia; Announces Appointment of Chief Medical Officer; Establishes Clinical Advisory Board

On August 4, 2021 PanTher Therapeutics (PanTher), a privately held oncology company revolutionizing the treatment of solid tumors with its proprietary treatment platform designed for direct, localized, and sustained delivery of proven and novel therapeutic agents, reported that it received approval from the Human Research Ethics Committee (HREC) to open a Phase 1 clinical trial of PTM-101 in Australia (Press release, PanTher Therapeutics, AUG 4, 2021, View Source [SID1234585742]). PTM-101 is being developed for the treatment of pancreatic 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!

"Pancreatic tumors are notoriously difficult to treat, which is why pancreatic cancer has the highest mortality rate of all major cancers with a 5-year relative survival rate of just 10%," said Laura Indolfi, CEO and Co-Founder of PanTher Therapeutics. "Approval for this first-in-human trial of our lead candidate, PTM-101, brings us one step closer in our journey to deliver effective treatments for the deadliest, most difficult-to-treat cancers."

The company also announced today the appointment of J. Marc Pipas, MD, as Chief Medical Officer and the establishment of its clinical advisory board, composed of key opinion leaders with specific expertise in pancreatic cancer and other solid tumors. Dr. Pipas, a veteran gastrointestinal (GI) oncologist and clinical trialist who has assisted in the development of multiple oncology agents from Phase 1 trials through commercialization, will direct PanTher’s clinical development programs.

Dr. Pipas is a graduate of SUNY-Health Science Center at Syracuse, and completed his Residency at the Medical University of South Carolina, followed by a Fellowship in Medical Oncology at Dartmouth. He spent more than 20 years at Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, where he was promoted to Full Professor and served as Director of the GI Oncology Program, and Interdisciplinary Pancreas Cancer Clinic. He also spent several years as Director of the Office of Clinical Research at the Norris Cotton Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, and Director of the Hematology-Oncology Fellowship program.

Following his academic career, Dr. Pipas joined Merrimack Pharmaceuticals as Vice President, Medical Director, where he was involved in program development of ONIVYDE, which received approval from the U.S. Food and Drug Administration for pancreatic cancer and was subsequently sold to Ipsen Pharmaceuticals for $1 billion. Dr. Pipas also served as Executive Medical Director, Clinical Development, for H3 Biomedicine, a subsidiary of Eisai Pharmaceuticals, where he focused his energies on Phase 1 Oncology drug trials in GI and breast cancer.

"PanTher’s unique approach to tackling difficult-to-treat deadly cancers has the potential to change the way oncologists approach patients with solid tumors," said Dr. Pipas. "I am excited to join PanTher at this important moment in the company’s development and look forward to working with the team to capitalize on the strong preclinical data and advance this potentially life-saving platform."

"Dr. Pipas has dedicated his career to bringing new therapies to the clinic, and we are thrilled to have him join the PanTher team," said Indolfi. "He brings a deep commitment to patients that fully aligns with our mission to empower oncologists to treat patients with life-threatening cancers by unlocking a drug’s full potential through targeted treatment at the tumor site."

Dr. Pipas will also chair PanTher’s newly established clinical advisory board, which will play an active role in guiding the company’s long-term strategy and pipeline development. He will be joined by four prominent key opinion leaders with extensive experience in GI oncology:

Thomas E. Clancy, MD, FACS, is co-director of the Pancreas and Biliary Tumor Center and Medical Director of Multispecialty Surgical Oncology at the Dana-Farber/Brigham and Women’s Cancer Center in Boston. His clinical interests include GI malignancies, pancreatic and liver tumors, and minimally invasive surgery. Dr. Clancy is also an Assistant Professor of Surgery at Harvard Medical School, where he received his Doctor of Medicine.
Jason Fleming, MD, is chair of the Department of Gastrointestinal Oncology at Moffitt Cancer Center in Tampa, Florida. Dr. Fleming’s previous roles include Chief of Pancreas Surgery and Professor with tenure in the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center and scientific and medical advisory board member for the Pancreatic Cancer Action Network (PanCAN). Dr. Fleming has received several notable honors for his work, including the President’s Faculty Recognition Award for Outstanding Contribution to the University of Texas MD Anderson Cancer Center.
Timothy B. Gardner, MD, is Director of the Gastroenterology & Hepatology Fellowship Program and Director of Pancreatic Disorders at Dartmouth-Hitchcock Medical Center. He is also Medical Director of the Islet Cell Transplant Program and is associate professor of medicine at Dartmouth’s Geisel School of Medicine. He specializes in gastroenterology and hepatology with particular focus in endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound, liver disease, malabsorptive disease, and pancreatic disease.
Theodore (Ted) Sunki Hong, MD, is an accomplished physician-scientist at Massachusetts General Hospital in Boston, where he serves as Director of Gastrointestinal Radiation Oncology and Co-Director of the Tucker Gosnell Center for Gastrointestinal Cancers. In addition to practicing medicine, Dr. Hong conducts research involving targeted therapies for the treatment of GI cancers.

Gennao Bio to Participate in 2021 Wedbush PacGrow Healthcare Conference

On August 4, 2021 Gennao Bio, a privately held genetic medicines company developing first-in-class, targeted nucleic acid therapeutics, reported that management will participate in the 2021 Wedbush PacGrow Healthcare Conference, being held virtually from August 10-11, 2021 (Press release, Gennao Bio, AUG 4, 2021, View Source [SID1234585741]). The details are as follows:

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!

Event: 2021 Wedbush PacGrow Healthcare Conference
Panel: So Let it Be (Re)Written – Updates in Gene Modulation
Location: Virtual
Date: Tuesday, August 10, 2021
Time: 9:10 AM ET

Members of the Gennao Bio management team will also host investor meetings during the conference.

A live webcast of the panel discussion will be available on the company’s website at www.gennao.com. A replay of the webcast will also be available for 30 days shortly after the conclusion of the event.