On June 14, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Cullgen Inc. (President and CEO: Ying Luo, Ph.D., "Cullgen") reported a research collaboration and exclusive option agreement to discover multiple innovative protein degraders (Press release, Astellas, JUN 14, 2023, View Source [SID1234632719]).

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, the two companies aim to develop multiple targeted protein degraders by combining Cullgen’s proprietary uSMITE targeted protein degradation platform featuring novel E3 ligands with Astellas’ drug discovery capabilities. Cullgen and Astellas will collaboratively conduct joint research to identify clinical development candidates. Astellas will then have an exclusive option of exclusively license the rights for clinical development and commercialization of the protein degrader compounds identified during the research activities. Cullgen will have the option during the initial stages of clinical development to participate equally in the costs, profits and losses, and to co-promote partnered products in the U.S. for the lead program, previously identified by Cullgen as a cell cycle protein degrader for the treatment of breast cancer and other solid tumors.

"Targeted Protein Degradation is one of the Primary Focuses of Astellas*1," said Adam Pearson, Chief Strategy Officer at Astellas. "We hope this collaboration will bring synergies between the two companies’ cutting-edge research, and will ultimately lead to the expansion of Astellas’ portfolio and development of new therapeutics for patients with significant unmet medical needs."

"We are excited to enter into this strategic collaboration with Astellas using our novel E3 ligands which we discovered in-house," Ying Luo, President and CEO at Cullgen said, "We are looking forward to working with Astellas to advance more targeted protein degraders into clinical development."

Astellas will provide Cullgen an upfront payment of $35M USD. Cullgen is also entitled to receive an additional $85M USD upon Astellas’ exercise of the license option with respect to the lead program. Total compensation to Cullgen could exceed $1.9 billion if Astellas exercises all of its license options and all milestones for all programs are achieved. Cullgen is also eligible to receive royalty payments from Astellas on any potential commercial sales.

On June 14, 2023 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") reported the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration ("FDA") for PEMRYDI RTU (Press release, Amneal Pharmaceuticals, JUN 14, 2023, View Source [SID1234632713]). This product is the first and only ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration. This injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. The Company expects to launch this product in the first quarter of 2024 with a J-Code from the Centers for Medicare & Medicaid Services.

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 believe PEMRYDI RTU, the first ready-to-use version of a key oncology injectable, will offer a meaningful advantage in this improved presentation. By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk for medication errors. This approval represents another high-value product for our growing injectables portfolio which we expect to launch with a J-code for PEMRYDI RTU," said Harsher Singh, SVP of Amneal Biosciences.

PEMRYDI RTU is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Adverse effects reported with PEMRYDI RTU include myelosuppression, renal failure, skin toxicity, and radiation recall. For full prescribing information, see package insert located here.

According to IQVIA, U.S. annual sales for pemetrexed for the 12 months ended March 2023 were $532 million.

On June 14, 2023 Biocept, Inc. (Nasdaq: BIOC) ("Biocept" or the "Company"), a leading provider of molecular diagnostic assays, products and service, reported that management will present at the Maxim Group Virtual Healthcare Conference hosted by M-Vest on Tuesday, June 20 at 9:00 a.m. Eastern time (6:00 a.m. Pacific time) (Press release, Biocept, JUN 14, 2023, View Source [SID1234632712]). Biocept’s discussion will be hosted by Maxim Group Senior Research Analyst Michael Okunewitch.

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!

Registration information to become an M-Vest member for access to the live and archived presentation webcast is posted to Events & Presentations section of the Biocept website.

On June 14, 2023 Vyriad, Inc., announces an expansion of a Phase 1 investigator-initiated trial at Mayo Clinic evaluating the safety and efficacy of Voyager-V1 (VSV-hIFNbeta-NIS) in patients with peripheral T-cell lymphoma (PTCL) following encouraging initial results (Press release, Vyriad, JUN 14, 2023, View Source [SID1234632710]). Voyager-V1 is an investigational therapy being co-developed with Regeneron Pharmaceuticals, Inc., to treat patients with recurrent or treatment resistant cancers. It is an oncolytic virotherapy designed to target and dissolve cancer cells and stimulate the patient’s immune system in hopes of preventing recurrence.

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 expansion of this Phase 1 program is an important step toward delivering targeted genetic medicines to patients with resistant PTCL," said Stephen J. Russell, MD, Ph.D., Vyriad’s chief executive officer and chief scientific officer. "Early Phase 1 results offered an indication that a single infusion of Voyager-V1 has the potential to provide significant benefit to patients with PTCL, a cancer with a generally poor prognosis."

PTCLs comprise a diverse group of uncommon and aggressive diseases in which the patient’s T cells become cancerous. PTCLs are a varied group of diseases that are not well understood. Techniques to distinguish and study the various subtypes of PTCL have only recently been developed.2 Current first-line therapies for patients with PTCL can be curative, but most patients will experience a recurrence of the disease.

Funding for the trial is provided by Regeneron, the National Institutes of Health, and Vyriad. The trial is being conducted at Mayo Clinic Rochester and Mayo Clinic Arizona. For more information on the Phase 1 study please visit Clinical Trials.Gov/study/NCT03017820.

On June 14, 2023 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova" or "the Company"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported preclinical data on narazaciclib at the 17th International Conference on Malignant Lymphoma (ICML), which is taking place in Lugano, Switzerland, through June 17, 2023 (Press release, Onconova, JUN 14, 2023, View Source [SID1234632708]).

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!

Data from the Josep Carreras Leukaemia Research Institute expanded on a prior presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, showing that narazaciclib’s antitumor activity against mantle cell lymphoma (MCL) cell lines was superior to that of the FDA-approved CDK 4/6 inhibitors palbociclib and ribociclib, and similar to that of the FDA-approved CDK 4/6 inhibitor abemaciclib. Combining narazaciclib with the FDA-approved Bruton’s tyrosine kinase inhibitor ibrutinib led to synergistic increases in antitumor activity against both ibrutinib-sensitive and ibrutinib-resistant MCL cell lines. In addition, treatment with narazaciclib combined with ibrutinib led to significant inhibition of tumor growth and significant reductions in malignant B cell infiltration into the bone marrow in multiple chicken embryo chorioallantoic membrane xenograft models of MCL.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, commented, "The data being presented at ICML provide further evidence of narazaciclib’s potential to combine synergistically with a wide range of therapeutic classes, derived from its ability to inhibit CDK 4, 6, and additional kinases involved in cancer cell survival and metastasis. This differentiated kinase inhibitory profile also confers expansive therapeutic potential across a variety of indications and may enable narazaciclib to overcome the efficacy limitations and safety concerns of currently marketed CDK 4/6 inhibitors. Given ibrutinib is the standard-of-care in mantle cell lymphoma, the preclinical results showing narazaciclib improving antitumor responses in combination represents a promising development that speaks to its potential therapeutic utility in this high unmet need indication. We look forward to discussing our data throughout ICML as we continue to evaluate additional opportunities for clinical studies with narazaciclib and advance our ongoing Phase 1/2a combination trial of narazaciclib plus estrogen blockade in endometrial cancer."

The ICML poster, titled, "Prolonged cell cycle arrest by the CDK 4/6 antagonist narazaciclib restores ibrutinib response in preclinical models of BTKi-resistant mantle cell lymphoma," is currently available to registered attendees of ICML via the conference’s e-poster gallery. The poster will also be displayed during the in-person poster sessions being held throughout the conference. A copy of the poster will be available on the "Scientific Presentations" section of the Onconova website following the conclusion of the conference.