On October 12, 2023 MimiVax, Inc., a biotechnology company focused on the development of glioblastoma vaccine therapy, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MimiVax’s SurVaxM vaccine being studied for the treatment of newly diagnosed glioblastoma (nGBM) (Press release, MimiVax, OCT 12, 2023, View Source;utm_medium=rss&utm_campaign=mimivax-granted-fast-track-designation-from-fda-for-survaxm-for-newly-diagnosed-glioblastoma [SID1234635886]).

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A randomized, blinded placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 11 cancer centers across the USA (Roswell Park Comprehensive Cancer Center, Miami Cancer Institute, Cleveland Clinic, Dana-Farber Cancer Institute, Overlook Medical Center, Norton Cancer Institute, Fred Hutchinson Cancer Center, Texas Oncology, NYU, Northwell Health and UCSF). See clinicaltrials.gov for enrollment details and locations. Positive Final Data from the previous Phase 2a Study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51% of patients receiving SurVaxM survived at least 2 years and 41% survived at least 3 years. The median Overall Survival of 25.9 months with nGBM in this study is considerably higher than would be expected with standard therapy alone. MimiVax is focused on completing the Phase 2b SURVIVE study and securing funding necessary to bring SurVaxM through the FDA approval process. Glioblastoma is a rare disease with great unmet medical need. SurVaxM was developed to bring a paradigm shift to a field with few advances in recent years.

"The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," said Michael Ciesielski, CEO of MimiVax. "This designation is a key component in our journey to help patients with glioblastoma to live longer."

Fast Track is a process designated to facilitate the development and expedite the review of drugs to treat serious medical conditions and fulfill unmet medical need. Significant benefits of FTD include:

Enhanced access to the FDA including opportunities for more frequent meetings and direct consultation throughout the remaining development of SurVaxM.
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
FTD also allows for a ‘rolling review’ in which MimiVax may submit completed sections of the SurVaxM NDA as they become available, rather than at the end development.

On October 12, 2023 mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) has reported an exclusive licensing agreement with Amneal Pharmaceuticals, Inc. (NYSE: AMRX), an integrated specialty pharmaceutical company powered by a robust U.S. generics business, to commercialize two denosumab biosimilars in the U.S. market (Press release, mAbxience, OCT 12, 2023, View Source [SID1234635885]).

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Denosumab is a monoclonal antibody drug that inhibits bone reabsorption. It is indicated for two major categories of therapy: bone metastasis from various forms of cancer and prevention of bone pain and fractures, including osteoporosis-related injuries.

Under the terms of the agreement, mAbxience will conduct the full development of the two biosimilars candidates and manufacture them in its state-of-the-art, Good Manufacturing Practice (GMP)-approved facilities, while Amneal will guide the products through regulatory approval and have exclusive commercialization rights in the United States. The financial terms of the transaction were not disclosed.

This partnership with Amneal not only bolsters mAbxience’s footprint in the U.S. market, but also fortifies the successful collaboration with Amneal, initiated in 2018 with an exclusive agreement for bevacizumab.

"We are thrilled to strengthen our partnership with Amneal through this second agreement, marking a significant step forward in our shared mission to enhance global health. This collaboration will bring two world-class biosimilars for the treatment of bone diseases and oncology to patients across the U.S., reinforcing our commitment to ensuring worldwide access to high-quality, life-enhancing treatments. Together with Amneal, we continue to make strides in offering affordable and accessible healthcare solutions, contributing positively to public health and solidifying our presence in the global biosimilar space," said Emmanuelle Lepine, Chief Executive Officer, mAbxience.

"Our goal is to be a top five player in the U.S. biosimilar space, similar to our leadership position in U.S. retail generics. Biosimilars represent the next wave of affordable medicines and these new product opportunities are aligned with our strategy to provide high quality, essential therapies," said Harsher Singh, Senior Vice President, Amneal Biosciences. "Our first three commercial U.S. biosimilars are doing very well as our excellent commercial team drives uptake in these competitive categories. We are pleased to partner again with mAbxience on these next two biosimilar candidates, which deepens our pipeline and expands our presence in oncology."

According to IQVIA, U.S. annual sales for Prolia and XGEVA for the 12 months ended August 2023 were approximately $4.4 billion.

The American Cancer Society estimates that in 2023, there will be over 1.9 million new cancer cases diagnosed. Beyond cancer, in the United States, the incidence of bone diseases is a growing concern. In 2010, it was estimated that a staggering 10.2 million adults were diagnosed with osteoporosis, with women constituting over 80% of this demographic[1]. This alarming trend is set to continue, with projections indicating a 310% increase in hip fractures for men and a 240% rise for women by 2050[2], a grave consequence of osteoporosis. This scenario underscores the palpable urgency for effective and accessible treatments to mitigate the impact of these conditions on the lives of millions. The commitment to advancing healthcare solutions for oncology and bone diseases remains paramount, aiming to significantly reduce its incidence and provide a better quality of life for all.

On October 12, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that two abstracts have been accepted for poster presentation on Kineta’s immuno-oncology therapies at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting to be held November 1-5, 2023, in San Diego, California and virtually (Press release, Kineta, OCT 12, 2023, View Source;utm_medium=rss&utm_campaign=kineta-announces-kva12123-and-anti-cd27-agonist-antibody-abstracts-accepted-for-poster-presentations-at-society-for-immunotherapy-of-cancer-sitc-2023 [SID1234635884]).

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Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta, will be presenting posters with new clinical data on KVA12123, the company’s VISTA blocking immunotherapy currently being evaluated in a Phase 1/2 clinical trial in patients with advanced solid tumors, as well as new preclinical data on Kineta’s anti-CD27 agonist antibody program.

Presentation Details:
Title: VISTA-101 – A phase 1/2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, alone and in combination with pembrolizumab in advanced solid tumors
Abstract Number: 780
Date / Time: Saturday, November 4 at 9:00 A.M. – 7:00 P.M. Pacific Time
Location: Exhibit Halls A and B1 – San Diego Convention Center

Title: CD27 is a new promising T cell co-stimulatory target for the cancer immunotherapy – Development and selection of a lead anti-CD27 agonist antibody
Abstract Number: 1357
Date / Time: Friday, November 3 at 9:00 A.M. – 7:00 P.M. Pacific Time
Location: Exhibit Halls A and B1 – San Diego Convention Center

Abstract titles are now available on the SITC (Free SITC Whitepaper) website. Posters will be made available on the Kineta website following presentations at the conference.

On October 12, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported the completion of enrollment in the Phase 1 study of INB-100 in leukemia patients and the initiation of patient enrollment in the Phase 2 clinical trial evaluating INB-400 in newly diagnosed glioblastoma multiforme (GBM) (Press release, In8bio, OCT 12, 2023, View Source [SID1234635883]).

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"These important enrollment milestones reflect our continued pursuit to achieve Cancer Zero by leveraging the power of the immune system to develop therapies to eradicate cancer," said William Ho, Co-founder and CEO. "Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs. We look forward to progressing the INB-400 and INB-100 trials to explore the full potential of gamma-delta T cells as a treatment option for patients with both solid and hematological cancers."

Phase 1 Clinical Trial of INB-100 in Leukemia

Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. This clinical trial assesses the safety of allogeneic gamma-delta T cells from haploidentical related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following hematopoietic stem cell transplantation (HSCT). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS.

In April 2023, the Company presented data at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) showing that 100% of evaluable patients (n=7) treated with INB-100 remained alive, progression-free, and in durable complete remission (CR). As of April 21, 2023, all evaluable patients across Dose Levels 1 and 2 remained on study and in CR, with one patient remaining progression free for over 3 years. Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively. A clinical update with additional enrolled patients will be presented at the 65th ASH (Free ASH Whitepaper) Annual Meeting being held December 9-12, 2023 in San Diego, CA.

Phase 2 Clinical Trial of INB-400 in GBM

The Phase 2 clinical trial of INB-400 (NCT05664243), an autologous, genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in "Arm A" of the study. The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.

INB-400 was granted Orphan Drug Designation by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation. GBM remains a significant unmet need, treatment options and associated outcomes for GBM, a highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months.

About INB-400
INB-400 is IN8bio’s DeltEx chemotherapy resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology. Allogeneic INB-400 will expand the application of DRI gamma-delta T cells into other solid tumor types through the development of allogeneic or "off-the-shelf" DeltEx DRI technology.

About INB-100
INB-100, IN8bio’s DeltEx Allo, is an allogeneic product candidate, initially developed for the treatment of patients with hematologic malignancies undergoing hematopoietic bone marrow transplantation (HSCT). It is currently being evaluated in a Phase 1 dose escalation clinical trial, marking the first clinical trial of an expanded and activated allogeneic gamma-delta T cell immunotherapy.

On October 12, 2023 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT) reported ongoing results from a dose expansion cohort in its Phase 1 combination study of CYT-0851 with capecitabine in patients with platinum-refractory or -resistant ovarian cancer in a late-breaker poster titled "Phase 1 Dose Expansion Results of CYT-0851, a Monocarboxylate Transporter (MCT) Inhibitor, in Combination with Capecitabine in Platinum-Resistant Ovarian Cancer" (Poster: LB_A13) at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) meeting in Boston, Massachusetts (Press release, Cyteir Therapeutics, OCT 12, 2023, View Source [SID1234635882]).

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"The results from the expansion cohort support the initial findings in our Phase 1 dose escalation study of CYT-0851 in combination with capecitabine in ovarian cancer," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir, "confirming a high level of tumor control with an all-oral outpatient regimen that was generally well tolerated."

Phase 1 Study Objectives

The primary objective of the expansion cohort of the ongoing Phase 1 combination study is to determine in advanced platinum-resistant ovarian cancer patients the safety and tolerability of the CYT-0851 plus capecitabine combination. Other secondary objectives included the determination of pharmacokinetic parameters and to characterize the preliminary anti-tumor activity. The poster presents ongoing results for eleven evaluable patients with platinum-refractory or -resistant ovarian cancer treated in this expansion cohort.

Phase 1 Study Ongoing Findings

As of the September 26, 2023 data cutoff, 11 patients with advanced ovarian cancer were treated and evaluable in the capecitabine cohort. Patients were heavily pretreated, with a median of six prior treatment regimens; four patients were platinum-refractory, and seven patients were platinum-resistant. Ten patients were treated with CYT-0851 at the recommended Phase 2 dose of 400 mg daily, and one patient was treated with CYT-0851 at 300 mg daily.

Two patients had a confirmed partial response by RECIST and one additional patient achieved an unconfirmed partial response. Seven patients had stable disease and one patient had progressive disease. The disease control rate was 91% and median progression-free survival was 170 days.

To date, CYT-0851 has exhibited a generally well tolerated safety profile with no unanticipated toxicities observed at clinically active doses. The median treatment compliance was 99%. There were no treatment discontinuations or dose reductions for treatment related adverse events. All treatment related adverse events were mild (Grade 1-2). The most common adverse events were fatigue (46%) and decreased appetite, diarrhea, nausea, palmar-plantar erythrodysesthesia syndrome and vomiting (18%).