On August 16, 2022 Prescient Therapeutics (ASX: PTX), a clinical stage oncology company developing personalised cancer therapies, reported that it has entered a manufacturing services agreement with specialist cell therapy manufacturer, Q-Gen Cell Therapeutics (Q-Gen), to produce its OmniCAR cell lines for upcoming clinical trials, with initial work now commenced (Press release, Prescient Therapeutics, AUG 16, 2022, View Source [SID1234618443]).

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!

As Prescient advances the development of its next-generation OmniCAR programs for acute myeloid leukemia (AML); Her2 positive solid cancers and glioblastoma multiforme, the encouraging progress of the OmniCAR AML program makes it likely be the first OmniCAR program to enter clinical studies.

Manufacturing will take place at Q-Gen’s dedicated Brisbane facility, which produces autologous and allogeneic cell therapies for local and international pharmaceutical companies and academic research groups. Q-Gen is the cell therapy manufacturing arm of the QIMR Berghofer Medical Research Institute and is one of Australia’s leading producers of cell-based medicines. Prescient has commenced the technology transfer process for OmniCAR-T cell manufacturing.

CAR-T therapies involve isolating T cells from a cancer patient and inserting new genetic material into them so that they express a new chimeric antigen receptor capable of recognising cancer cells, before being re-infused into the patient. By contrast, OmniCAR T cells will express a universal immune receptor (SpyCatcher), which can bind with any separate SpyTagged targeting ligand. Thus, OmniCAR cells can potentially address any cancer by incorporating binders to any cancer antigen. This modularity also enables other important and novel characteristics to overcome limitations faced by conventional CAR-T therapies, including post-infusion control of T cell activity and antigen re-direction.

This agreement with Q-Gen covers production and delivery of autologous OmniCAR-T cells for clinical trials. Material conditions of the contract include transduction of T cells with SpyCatcher lentivirus; arming of OmniCAR T cells with SpyTagged binders; and associated quality measures. This agreement will also incorporate CellPryme-M into the manufacturing process of OmniCAR T cells. The agreement lasts up to 5 years, with provision for earlier cessation or extension as per typical commercial terms.

Q-Gen’s General Manager, Andrew Masel, commented "We are excited to be working with Prescient Therapeutics on what we see as a unique cell therapy platform. The team at Q-Gen is looking forward to working closely with Prescient to produce the product for clinical trials here at the QIMR Berghofer Medical Research Institute."

Prescient’s CEO and Managing Director Steven Yatomi-Clarke said, "Prescient is working steadily towards our first in human studies of OmniCAR, which will be an important milestone for the Company. This important agreement secures Prescient’s crucial supply of OmniCAR cells for our clinical trials and ensures we are producing the best possible cell therapy products for doctors and patients living with hardto-treat cancers."

In January Prescient received accreditation by the Office of the Gene Regulator enabling the company to conduct clinical trials in Australia involving gene-edited cells such as OmniCAR.

On August 16, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported the publication of preclinical data in Blood Advances, the open-access journal of the American Society of Hematology (ASH) (Free ASH Whitepaper), highlighting the effects of NKTR-255, a novel polymer-conjugated human IL-15, on natural killer (NK) cell function and proliferation in multiple myeloma (MM) (Press release, Nektar Therapeutics, AUG 16, 2022, View Source [SID1234618438]).

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!

"These findings published today in Blood Advances demonstrate the promising anti-tumor activity of IL-15 in engaging natural killer cell biology in indications with immunosuppressive tumor microenvironments as in multiple myeloma," said Nikhil C. Munshi, MD, Professor of Medicine at Harvard Medical School, Director of Basic and Correlative Science at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "Among other immune cells, the NK cell expansion and improved function induced by NKTR-255 is contributing to more effective control of multiple myeloma tumor growth, raising a potential scope for synergism with other anti-MM therapies such as anti-CD38 antibodies."

The Dana-Farber team analyzed in vitro pharmacological properties of NKTR-255 in engaging the IL-15 pathway and stimulating NK cells against MM cells. The research also looked at the anti-tumor activity of combining NKTR-255 with the anti-CD38 antibody, daratumumab, in vitro and in vivo.

"The published data demonstrate that NKTR-255 not only enhances antitumor responses of human NK cells against MM target cells, but also increases ex vivo expression of NK activating receptors and adhesion molecules. Furthermore, studies in a humanized MM mouse model show that NKTR-255 enhances in vitro antibody-dependent cellular cytotoxicity (ADCC) of NK cells and synergizes with daratumumab to reduce MM cell growth," said Mariateresa Fulciniti, Ph.D., the senior author on this manuscript at Dana-Farber. These preclinical findings support Nektar’s robust clinical development program for NKTR-255 and further evaluation of the novel immunotherapeutic approach in MM, alone or in combination with monoclonal antibodies or potentially with other immunomodulatory drugs.

Key findings are summarized below:

NKTR-255 enhances antitumor responses of myeloma derived human NK cells against MM target cells.
NKTR-255 enhances in vitro ADCC of NK cells and synergizes with daratumumab to reduce MM growth in humanized mouse model.
NKTR-255 increases ex vivo expression of NK activating receptors and adhesion molecules.
Augmenting NK cell number and functions shows effectiveness against MM cells in the context of their bone marrow milieu.
The full citation of this article can be accessed here.

About NKTR-255

NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body’s innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response.

Preclinical findings suggest NKTR-255 has the potential to synergistically combine with antibody-dependent cellular cytotoxicity molecules as well as to enhance CAR-T therapies. Nektar has initiated a Phase 1 dose escalation and expansion clinical study of NKTR-255 in adults with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma, as well as a Phase 1/2 clinical study of NKTR-255 in patients with relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer. Nektar is also continuing its oncology clinical collaboration with Merck KGaA and Pfizer Inc. to evaluate the maintenance regimen of NKTR-255 in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma in the Phase II JAVELIN Bladder Medley study. Nektar is also currently designing a Nektar- sponsored Phase II study combining NKTR-255 with approved CAR-T cell therapies in diffuse large B-cell lymphoma, which it aims to initiate in the first quarter of 2023.

On August 16, 2022 Strata Oncology, Inc., a next-generation precision oncology company enabling smarter and earlier cancer treatment, reported that Sarah Cannon Research Institute (SCRI) has joined the Strata Precision Indications for Approved THerapies (Strata PATH) trial (Press release, Strata Oncology, AUG 16, 2022, View Source [SID1234618437]). Researchers will enroll patients at eight SCRI-affiliated sites including:

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!

Florida Cancer Specialists (4 sites)
Genesis Cancer and Blood Institute, Hot Springs, AR
Hematology Oncology Clinic, Baton Rouge, LA
Tennessee Oncology, Chattanooga, TN
Zangmeister Cancer Center, Columbus, OH
Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. A range of therapeutic classes will be evaluated across tumor types, including targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors.

"Strata is thrilled to partner with SCRI to bring new advances and increased options to patients with both late-stage and early-stage cancer," said Dan Rhodes, Ph.D., co-founder and Chief Executive Officer, Strata Oncology. "In the Strata PATH trial, we are investigating how our innovative molecular profiling platform and our novel quantitative RNA algorithms can be used to optimize and expand the use of cancer treatments across therapeutic classes. Partnering with leading organizations like SCRI is integral to expanding the reach of this transformative clinical trial."

"The Strata PATH study aligns with our mission to advance cancer therapies and offer personalized cancer care close to home," said Andrew McKenzie, Vice President, Personalized Medicine, Sarah Cannon Research Institute. "We look forward to leveraging our cutting-edge patient identification strategies to expand access to the latest therapies through the Strata PATH clinical trial."

Patients interested in learning more about the Strata PATH trial can visit ClinicalTrials.gov and search for the Strata PATH Trial identifier: NCT05097599.

About Strata PATH
The Strata Precision Indications for Approved THerapies (Strata PATH) trial, is a 700-patient prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Strata PATH will enroll patients with advanced cancer, as well as patients with early-stage cancer who have evidence of micrometastatic disease after initial treatment. All therapies being evaluated in Strata PATH are FDA-approved in oncology with demonstrated safety profiles in the advanced setting. Enrollment for multiple arms in Stata PATH is based on novel algorithms Strata Oncology developed using its clinical molecular database comprising DNA mutation profiles and quantitative RNA expression data, as well as detailed treatment history and outcome data, from tens of thousands of patients. A range of therapeutic classes will be evaluated in Strata PATH including targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors.

On August 16, 2022 Simcha Therapeutics ("Simcha"), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, reported the appointment of Sanuj Ravindran, M.D., as chief executive officer and director, and Jake Bauer as an independent member and chair of its board of directors (Press release, Simcha Therapeutics, AUG 16, 2022, View Source [SID1234618436]).

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!

Simcha has also expanded its sponsored research agreement with Yale School of Medicine related to cytokine biology in the laboratory of Aaron Ring, Ph.D., M.D., associate professor of immunobiology and Simcha founder. Through this expanded agreement, the company will support research in the Ring Laboratory focused on overcoming biological limitations of native cytokines. Simcha holds an exclusive option to license multiple therapeutic agents resulting from the expanded research agreement.

"With the support of our successful Series B financing and encouraging progress being made with ST-067 in the clinic, Simcha is entering a stage of dynamic growth with even greater opportunity ahead," said Bauer. "I’m thrilled to have joined the company earlier this year, and excited to have recruited Sanuj, a skilled and thoughtful leader, to guide Simcha as it navigates its many potential avenues for growth."

Dr. Ravindran remarked, "Simcha is built on a remarkable scientific foundation and Aaron’s bold vision that patients deserve more than incremental advances. Together these have led to the advancement of a promising first-in-class therapeutic in ST-067, our decoy resistant IL-18 agent; and created a new way forward for IL-18 as a potentially powerful and broadly applicable cancer immunotherapy pathway. As Simcha continues to explore the breadth of ST-067’s potential in the clinic, and as we accelerate the advancement of other engineered cytokines, I feel privileged to build and lead a patient and product focused organization with a commitment to pioneering truly transformational therapies."

Dr. Ravindran has spent more than 20 years in strategic and operational roles across the life science industry, both as an investor and company builder. Most recently, he served as CEO-in-residence at BridgeBio (BBIO) where he was chief executive officer of PellePharm and executive chair of Phoenix Tissue Repair. In these roles, Dr. Ravindran led the companies’ growth, directed strategy, secured significant partnerships, and advanced pipeline programs in oncology and rare skin diseases through mid- and late-stage clinical trials. Before this, he served as chief business officer at aTyr Pharma (LIFE), a clinical-stage protein therapeutics company focused on tRNA synthetases. Prior to that, Dr. Ravindran was senior vice president of corporate development at The Medicines Company (MDCO), where he led multiple transactions totaling more than $2 billion in potential value. He began his biotech career as a venture capitalist for 10 years with Burrill & Company, Radius Ventures, and Asian Healthcare Fund. Dr. Ravindran was previously a practicing physician, board-certified in Internal Medicine, having completed his residency training at Thomas Jefferson University Hospital. He received his bachelor’s degree from Northwestern University, his doctorate in medicine from Jefferson Medical College, and his master’s of business administration from the Kellogg School of Management.

Dr. Ravindran joins Beatrice McQueen, Ph.D., on the Simcha leadership team, who was recently appointed chief operating officer and has led Simcha’s finance and operations since its inception. Dr. McQueen has spent over 20 years in various operational roles, working to advance programs at leading organizations such as Amgen, PPD and Pfizer.

Bauer, having previously served as chief business officer of MyoKardia, is currently a venture partner with ARCH Venture Partners and SR One Capital Management. He and Dr. Ravindran join the Simcha board of directors with existing members Simeon George, M.D., CEO of SR One; Sean Li, Ph.D., of WuXi AppTec; Terry Rosen, Ph.D., CEO of Arcus Biosciences; and Aaron Ring, M.D., Ph.D., founder of Simcha Therapeutics.

On August 16, 2022 Clinical stage drug developer Pharmaxis (ASX: PXS) reported it has now received US$5.0 million (A$ 7.0 million net of applicable withholding taxes) from Aptar Pharma following the exercise of its options to acquire the Pharmaxis Orbital technology as announced on 4 August 2022 (Press release, Pharmaxis, AUG 16, 2022, View Source;utm_campaign=Pharmaxis%20Receives%20Aptar%20Option%20Exercise%20Fees%20of%20US5m&utm_content=Pharmaxis%20Receives%20Aptar%20Option%20Exercise%20Fees%20of%20US5m+CID_70028764d5327ddbe643c5eef231fc83&utm_source=Campaign%20Monitor&utm_term=View%20Full%20Media%20Release [SID1234618435]).

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!

Pharmaxis reported cash funds of A$9 million at 30 June 2022 in its quarterly shareholder update and its expectation of receiving $5 million from its 2022 R&D tax incentive later in the year. The receipt from Aptar increases the Pharmaxis proforma cash balance at 30 June 2022 to A$21 million.

Pharmaxis CEO Gary Phillips said, "Over the past two years the Pharmaxis team has generated a total of $25 million of non-dilutive cash from commercial agreements related to the mannitol business, $2.5 million in Government funding won in competitive grants and R&D tax credits of $10 million1. Funding our business in this manner has only been possible because of the inherent value in our exciting pipeline of small molecule drugs and the mannitol business.

"We continue to look for additional commercial opportunities to advance our pipeline and in the meantime our focus is on delivering data from the phase 1c/2 studies in myelofibrosis and established skin scarring by the end of the year."