On December 6, 2022 SQZ Biotechnologies Company (NYSE: SQZ) reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s Enhanced Antigen Presenting Cell (eAPC) candidate for the treatment of HPV16+ advanced or metastatic solid tumors (Press release, SQZ Biotech, DEC 6, 2022, View Source [SID1234624853]). Fast Track Designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment currently exists or where the treatment in discovery may be better than what is currently available.

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The SQZ eAPC platform is the company’s second-generation cell therapy platform which simultaneously delivers five different mRNAs—each encoding for a different protein which plays a part in stimulating key T cell activation signals required to generate an immune response against tumors—to four different cell types.

The company also presented clinical data from its ongoing Antigen Presenting Cells (APC) and eAPC clinical trials at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress. Data also demonstrated that its APC and eAPC therapeutic candidates were well-tolerated among patients treated in its trials. Manufacturing of the cell product took less than 24 hours, and the median viability of all lots, in both clinical trials, was greater than 90 percent.

In the SQZ eAPC clinical trial, scans showed stable disease as the best overall response for two out of four evaluable patients in low dose Cohort 1. A positive ELISpot response for the E7 antigen was observed in one of these patients and correlated with prolonged stable disease. This patient remains on treatment.

"Receiving FDA Fast Track Designation underscores the significant potential of our SQZ eAPC candidate, which is designed to generate an even more powerful immune response than our APC candidate," said Marshelle Smith Warren, M.D., Chief Medical Officer at SQZ Biotechnologies. "The initial safety and tolerability data presented at ESMO (Free ESMO Whitepaper)-IO today supports our recent portfolio prioritization decision to focus on our eAPC program. In addition to the clean safety profile, we were pleased to observe stable disease in two of the four evaluable patients in the eAPC trial. The team is working diligently to add more eAPC sites to our study to achieve our goal of a highest-dose monotherapy data readout by the middle of 2023."

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Major Findings from Clinical Research:

Poster #183P: COMMANDER-001: Initial safety data from a phase I/II dose escalation/expansion study of SQZ-eAPC-HPV, a cell-based mRNA therapeutic cancer vaccine for HPV16+ solid tumors

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All patients in Cohort 1 completed the 28-day dose limiting toxicity (DLT) period without experiencing a DLT. No related serious adverse events were reported
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Of the four patients enrolled in Cohort 1, two patients (50%) experienced a best overall response of stable disease, including one patient who had a pronounced pharmacodynamic response with prolonged stable disease
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Cell collection to product release took approximately 1 week. One year’s worth of SQZ-eAPC-HPV, the maximum amount of drug able to be administered on study, was able to be manufactured for all patients in Cohort 1
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Median viability of all lots was 94%

Poster #191P: Preliminary biomarker and safety results of SQZ-PBMC-HPV at recommended phase II dose (RP2D) in monotherapy and combination with checkpoint inhibitors in HLA A*02+ patients with recurrent, locally advanced, or metastatic HPV16+ solid tumors

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Data suggests SQZ-PBMC-HPV is capable of stimulating an anti-tumor immune response in a subset of patients. As observed in patient 17 (presented at ESMO (Free ESMO Whitepaper)-IO 2021), increased CD8 tumor infiltration in conjunction with a reduction of E6 (and E7) expressing cells in the presence of elevated MHCI expression is consistent with a biomarker signature of antigen-specific killing
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SQZ-PBMC-HPV is considered safe and well-tolerated at RP2D both in monotherapy and in combination with checkpoint inhibitors. The safety profile consisted of mostly low grade (grades 1 and 2) non-specific AEs, only one patient experienced serious adverse events (unrelated to SQZ-PBMC-HPV), and no dose-limiting toxicities observed
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All batches produced under cGMP yielding multiple cryopreserved doses in <24hrs with about 1 week collection-to-release time. Product characterization confirmed antigen presentation and high viability in all patient batches

About SQZ-eAPC-HPV

SQZ Enhanced Antigen Presenting Cells (eAPC) are derived from peripheral blood mononuclear cells (PBMCs), which are primarily composed of monocytes, T cells, B cells, and NK cells, and engineered with various mRNA encoding for multiple target antigens and immuno-stimulatory signals, including CD86 and membrane-bound IL-2 and IL-12. The company has presented preclinical findings showing that SQZ eAPCs have generated robust T cell responses in human in vitro and in vivo models. Additionally, it was demonstrated preclinically that HPV16-encoding mRNA delivery to PBMCs stimulated CD8+ T cells across a range of HLA haplotypes, supporting eAPC clinical development in broader HPV16+ patient populations.

COMMANDER-001 Trial Design

SQZ-eAPC-HPV is being evaluated in a Phase 1/2 clinical trial (COMMANDER-001) for the treatment of HPV16+ advanced or metastatic solid tumors. The clinical candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with pembrolizumab, an immune checkpoint inhibitor. The study consists of two parts. The first part is designed to assess safety and tolerability of multiple doses of SQZ-eAPC-HPV in treatment-experienced patients, following a dose-escalation scheme for monotherapy, and a dose de-escalation for the combination with pembrolizumab.

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The second part of the study will assess clinical response of SQZ-eAPC-HPV in combination with pembrolizumab in immune checkpoint inhibitor treatment-naïve patient populations.

About SQZ-PBMC-HPV
SQZ-PBMC-HPV is the company’s Antigen Presenting Cell (APC) autologous cell therapy clinical candidate and is derived from peripheral blood mononuclear cells (PBMCs), primarily composed of monocytes, T cells, B cells, and NK cells, and engineered with tumor specific E6 and E7 peptide antigens. It received FDA fast track designation in April 2022. In December 2021, the company presented clinical data at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress that included a checkpoint refractory head-and-neck cancer patient who demonstrated a radiographic, symptomatic, and immune response in the monotherapy cohort of the Phase 1/2 clinical trial.

SQZ-PBMC-HPV-101 Trial Design

SQZ-PBMC-HPV is being evaluated in a Phase 1/2 clinical trial for the treatment of HPV16+ advanced or metastatic solid tumors. Patients must be positive for the human leukocyte antigen serotype HLA-A*02. The investigational candidate, which targets E6 and E7 oncoproteins, is being studied as a monotherapy and in combination with immuno-oncology agents. The study’s primary outcome measures in the monotherapy and combination phases of the trial include safety and tolerability. Antitumor activity is a secondary outcome measure in both the monotherapy and combination phases of the trial, and manufacturing feasibility is a secondary outcome measure in the monotherapy phase of the trial. The monotherapy phase of the study includes escalating dose cohorts with a dose-limiting toxicity (DLT) window of 28 days and is designed to identify a recommended phase 2 dose. The planned combination phase of the study will include SQZ-PBMC-HPV and checkpoint inhibitors. DLT will be measured over 42 days. Patient enrollment is expected to be discontinued by the end of the year with a transition to the currently enrolling COMMANDER-001 trial featuring the second-generation SQZ eAPC candidate for the treatment of HPV16+ advanced or metastatic solid tumors.

About Human Papillomavirus Positive Cancers

Human papillomavirus (HPV) is one of the most common viruses worldwide and certain strains persist for many years, often leading to cancer. According to the Centers for Disease Control (CDC), in the United States HPV+ tumors represent 3% of all cancers in women and 2% of all cancers in men, resulting in over 39,000 new cases of HPV+ tumors every year. HPV infection is larger outside of the U.S., and according to the International Journal of Cancer, HPV+ tumors account for 4.5% of all cancers worldwide resulting in approximately 630,000 new cases every year. According to the CDC, HPV infection plays a significant role in the formation of more than 90% of anal and cervical cancers, and most cases of vaginal (75%), oropharyngeal (70%), vulval (70%) and penile (60%) cancers.

On December 6, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology reported that ROLVEDON (eflapegrastim-xnst) has been added to the latest National Comprehensive Cancer Network Supportive Care Guidelines (NCCN Guidelines) in oncology for Hematopoietic Growth Factors (Press release, Spectrum Pharmaceuticals, DEC 6, 2022, View Source [SID1234624849]). The NCCN Guidelines provide recommendations for the appropriate use of growth factors in the clinical management of febrile neutropenia (FN) and now include ROLVEDON as a treatment option under Management of Neutropenia: G-CSFs for Prophylaxis of Febrile Neutropenia and Maintenance of Scheduled Dose Delivery.

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"We are pleased with the rapid inclusion of ROLVEDON in the NCCN guidelines as an appropriate option for cancer patients who are at risk for febrile neutropenia." said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "The NCCN guidelines are a standard resource for determining the best course of treatment and supportive care for people living with cancer. The inclusion in the NCCN guidelines further reinforces the clinical profile of ROLVEDON and is an important milestone for the program."

The NCCN is a not-for-profit alliance of 32 leading cancer centers devoted to patient care, research, and education. The NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine. For more information visit: View Source

About ROLVEDON

ROLVEDON (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.

Please see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com.

Indications and Usage

ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

Limitations of Use

ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Important Safety Information

Contraindications

ROLVEDON is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim or filgrastim products. Reactions may include anaphylaxis.
Warnings and Precautions

Splenic Rupture

Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute Respiratory Distress Syndrome (ARDS)

ARDS can occur in patients receiving rhG-CSF products. Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ROLVEDON in patients with ARDS.
Serious Allergic Reactions

Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue ROLVEDON in patients who experience serious allergic reactions.
Sickle Cell Crisis in Patients with Sickle Cell Disorders

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue ROLVEDON if sickle cell crisis occurs.
Glomerulonephritis

Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation. Evaluate and consider dose reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis

White blood cell (WBC) counts of 100 x 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during ROLVEDON therapy. Discontinue ROLVEDON treatment if WBC count of 100 x 109/L or greater occurs.
Thrombocytopenia

Thrombocytopenia has been reported in patients receiving rhG-CSF products. Monitor platelet counts.
Capillary Leak Syndrome

Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor and give standard symptomatic treatment, which may include a need for intensive care.
Potential for Tumor Growth Stimulatory Effects on Malignant Cells

The granulocyte colony-stimulating factor (G-CSF) receptor through which ROLVEDON acts has been found on tumor cell lines. The possibility that ROLVEDON acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which ROLVEDON is not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of rhG-CSF products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aortitis

Aortitis has been reported in patients receiving rhG-CSF products. It may occur as early as the first week after start of therapy. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) without known etiology. Discontinue ROLVEDON if aortitis is suspected.
Nuclear Imaging

Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
Adverse Reactions

The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.
Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received ROLVEDON. The adverse reaction requiring permanent discontinuation in 3 patients who received ROLVEDON was rash.
To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch

On December 6, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that SELLAS’ highly selective CDK9 inhibitor, GFH009, will be evaluated in pediatric solid tumors and leukemia models through the National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program (Press release, Sellas Life Sciences, DEC 6, 2022, View Source [SID1234624847]).

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GFH009 testing through the program involves a two-phase research plan for pharmacokinetics (PK) and efficacy in pediatric tumors. In the first phase, PIVOT principal investigators will conduct PK experiments to confirm the appropriate dose and route administration for GFH009. In the second phase, monotherapy in vivo efficacy testing for GFH009 will be performed by PIVOT investigators. Studies will be supported through cooperative agreement grants from the NCI to the seven PIVOT research programs performing the testing and a centralized coordinating center.

"Participation in the NCI PIVOT Program provides an extensive and invaluable level of expertise in preclinical pediatric cancer testing and we are excited that we were granted this program after a diligent review process. In addition to being a source of non-dilutive funding for our GFH009 program, we also believe this discovery work could ultimately support a path to a rare disease pediatric voucher," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are optimistic that the significant anti-tumor activity of GFH009 recently demonstrated in in vitro and in vivo models will be mirrored in PIVOT’s pediatric studies, allowing us to further expand our GFH009 clinical development program to include pediatric tumor types," continued Dr. Stergiou.

The NCI-supported PIVOT program is a comprehensive program to systematically evaluate novel agents against genomically characterized pediatric solid tumor and leukemia models at eight participating research institutions. By supporting a more reliable agent prioritization process, the PIVOT program contributes to the goal of accelerating discovery of more effective treatments for children with cancer.

Each PIVOT principal investigator has expertise in preclinical testing of childhood cancer in vivo models. These models utilize patient derived xenografts, many of which are refractory to current standard of care treatments, from high-risk childhood cancers and have undergone comprehensive genomic characterization to demonstrate close resemblance to genetic alterations seen in the respective human cancers. Research strategies are based on a substantial body of data showing that preclinical testing in the appropriate pediatric cancer models, combined with expertise on relative drug exposures tolerated in mice and humans, provides powerful insights into likely clinical utility of investigational agents.

PIVOT Program participating institutions and relevant pediatric cancer models are as follows:

Jackson Laboratory which serves as PIVOT Coordinating Center
St. Jude Children’s Research Hospital for soft tissue sarcomas including rhabdomyosarcoma
MD Anderson Cancer Center for osteosarcoma
University of Texas Health Science Center San Antonio for Ewing sarcoma rhabdomyosarcoma, kidney, and liver cancers
Memorial Sloan Kettering Cancer Center for pediatric sarcomas and other solid tumors
Children’s Hospital of Chicago for orthotopic CNS tumors
Children’s Cancer Inst Australia for acute lymphoblastic leukemia
Children’s Hospital of Philadelphia for neuroblastoma

On December 6, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that it will present early clinical results from its Phase 1 clinical trials of P-MUC1C-ALLO1 and P-BCMA-ALLO1 at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, taking place in Geneva, Switzerland and online from December 7-9, 2022 (Press release, Poseida Therapeutics, DEC 6, 2022, View Source [SID1234624846]).

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"These early data being presented at ESMO (Free ESMO Whitepaper) I-O for our first two fully allogeneic programs reinforce our belief that our technology and approach have the potential to deliver differentiated off-the-shelf CAR-T cell therapies to patients fighting cancer," said Mark Gergen, Chief Executive Officer of Poseida Therapeutics. "While it is still quite early in both trials, we have seen encouraging responses in both P-MUC1C-ALLO1 and P-BCMA-ALLO1 at the lowest doses as well as favorable tolerability. As we look ahead, we are excited to continue enrolling patients at higher dose levels and explore additional strategies to optimize the therapeutic index, including redosing, cyclic dosing, novel preconditioning regimens and combination therapies. We look forward to providing updates at a medical meeting in 2023."

Both posters will be presented at ESMO (Free ESMO Whitepaper) I-O on Thursday, December 8, 2022 at 12:30-1:15 PM CET in Foyer ABC at the Palexpo Exhibition Centre in Geneva and are now available on the Poseida website at www.poseida.com.

In the poster titled "Development of an allogeneic CAR-T targeting MUC1-C (MUC1, cell surface associated, C-terminal) for epithelial derived tumors" (abstract #407, presentation 46P), David Oh, M.D., Ph.D., Assistant Professor, University of California, San Francisco, will highlight:

As of the cutoff date of November 14, 2022, the study had dosed seven patients with epithelial-derived cancers, including esophageal, colorectal, breast, pancreatic and prostate carcinomas, of which four were evaluable for response.
Only one patient with breast cancer has been dosed to date; this patient with HR+, HER2- breast cancer, with four prior lines of treatment, achieved a partial response at a dose of 0.75×106 cells/kg.
Two other patients with heavily pretreated gastrointestinal tumors (colorectal and pancreatic cancer) achieved stable disease at a dose of 0.75×106 cells/kg and 2×106 cells/kg each.
P-MUC1C-ALLO1 was safe and well tolerated, with no DLTs, CRS, GVHD or ICANS.
"We are very encouraged by these early data highlighting initial safety and tolerability as well as signs of clinical activity of P-MUC1C-ALLO1 even at very low doses," said Dr. Oh, an investigator on the trial. "Importantly, for a novel target such as MUC1-C it has been a key focus to monitor for any evidence of on-target off-tumor toxicity, and we are pleased that we have not observed any such significant toxicity to date. Overall, we believe that these data support MUC1-C as a target with the potential to address the significant unmet need in patients with advanced carcinomas. We look forward to continuing to evaluate the safety, efficacy and durability of responses as we continue to enroll additional patients into the study."

In the poster titled "Phase 1 Study to Assess the Safety and Efficacy of P-BCMA-ALLO1, a Fully Allogeneic CAR-T Therapy, In Patients with Relapsed/Refractory Multiple Myeloma (RRMM)" (abstract #705, presentation 47P), Mehmet Hakan Kocoglu, M.D., Assistant Professor, University of Maryland Medical Center, will highlight:

As of the cutoff date of November 11, 2022, the study had dosed 10 patients with relapsed/refractory (R/R) multiple myeloma, Of these ten patients, six are evaluable for response (all at the lowest dose level of 0.75 X 106 cells/kg).
The response evaluable patients were heavily pre-treated, having received an average of 6.5 prior lines of therapy with a median time since diagnosis of 5 years. Three patients had previously received BCMA-targeted therapy and four patients had high-risk cytogenetics, of which two had p53 deletions.
As of the cutoff date, P-BCMA-ALLO1 achieved a 50% (3/6) overall response rate, with a 66% (2/3) ORR in patients who had previously received BCMA-targeted therapy and a 50% (2/4) ORR in patients with high-risk cytogenetics.
Of the three responders in the first cohort (0.75×106 cells/kg), two patients were partial responses and one patient achieved a very good partial response.
P-BCMA-ALLO1 was extremely well tolerated. There were no cases of CRS, GVHD or ICANS. No DLTs were observed. There was one case of febrile neutropenia.
"To date, P-BCMA-ALLO1 has demonstrated a favorable safety and tolerability profile in patients with R/R multiple myeloma. We have also observed encouraging efficacy signals even at the lowest doses highlighting the potential of Poseida’s proprietary genetic editing platforms in allogeneic cell therapies," said Dr. Kocoglu, an investigator on the trial. "In particular, we have seen responses in patients with p53 mutations, a known marker for aggressive multiple myeloma as well as in patients who had received prior BCMA-targeted therapy. These early results support the potential of P-BCMA-ALLO1 to treat a broad patient population with an off-the-shelf CAR-T therapy and we look forward to continuing enrollment in the study."

About P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in Phase 1 development for multiple solid tumor indications. Poseida believes P-MUC1C-ALLO1 has the potential to treat a wide range of solid tumors derived from epithelial cells, such as breast, ovarian, colorectal, lung, pancreatic and renal carcinomas, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1-C. P-MUC1C-ALLO1 is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both breast and ovarian cancer. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT05239143.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate, partnered with Roche, targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. In vitro and in vivo P-BCMA-ALLO1 preclinical studies showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior anti-tumor efficacy compared to an autologous CAR-T therapy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.

On December 6, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has entered into a clinical collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate Nykode’s wholly-owned lead candidate, VB10.16, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase 1/2a trial in patients with HPV16-positive head and neck cancer (Press release, Nykode Therapeutics, DEC 6, 2022, View Source [SID1234624845]).

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VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The candidate has reported interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses were associated with clinical responses.

"We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented scientific team," stated Agnete Fredriksen, Chief Business Officer & Co-founder of Nykode Therapeutics. "We see great potential for Nykode’s cancer vaccine in combination with MSD’s anti-PD-1 therapy to generate a potent immune response in head and neck cancer and provide a meaningful clinical benefit for patients with late-stage disease."

The open-label, dose-finding Phase 1/2a trial will evaluate the safety, immunogenicity, and anti-tumor activity of VB10.16 in combination with KEYTRUDA in patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. The trial is anticipated to begin enrollment in Europe during the first half of 2023. Under the terms of the agreement, Merck will supply KEYTRUDA. Nykode retains all commercial rights to VB10.16 worldwide.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.