On January 10, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has entered into two clinical trial collaboration and supply agreements with Merck (known as MSD outside of the United States and Canada) to evaluate the combination of Gilead’s Trop-2 targeting antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC) (Press release, Gilead Sciences, JAN 10, 2022, View Source [SID1234598522]). As part of the collaboration, Merck will sponsor a global Phase 3 clinical trial of Trodelvy in combination with KEYTRUDA as a first-line treatment for patients with metastatic NSCLC. Additionally, the companies recently established an agreement whereby Gilead will sponsor a Phase 2 signal-seeking study evaluating combinations that include pembrolizumab in first-line NSCLC.

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"We’re excited to broaden our clinical collaborations with Merck to investigate Trodelvy in combination with KEYTRUDA in another cancer where there is tremendous need for novel combinations to help improve patient outcomes," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "This partnership builds on our ambition of providing alternatives to traditional chemotherapy with Trodelvy containing regimens across some of the most difficult-to-treat cancers."

NSCLC is the most common type of lung cancer and accounts for up to 85% of cases. It is an aggressive disease with poor prognosis. Although there has been significant progress in recent years in the treatment of the disease, there is a still a major unmet need for patients with only 25% of patients surviving beyond five years.

Trodelvy is an antibody-drug conjugate that specifically targets Trop-2 expressing cells to enable local delivery of a cytotoxic payload that selectively kills the targeted cells. The combination of Trodelvy with an immune-stimulating agent such as KEYTRUDA could provide a new treatment option for a broader set of patients with first-line metastatic NSCLC.

The use of Trodelvy for the treatment of NSCLC is investigational, and the safety and efficacy for this use have not been established or approved by any regulatory agency globally. In the United States, Trodelvy is approved for the treatment of second-line metastatic triple-negative breast cancer (TNBC),and has additionally been approved under the accelerated approval pathway for the treatment of metastatic urothelial cancer (UC) in adults who have received certain prior therapies. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for additional Important Safety Information for Trodelvy.

Everest Medicines will also participate in the global Phase 3 study in Asia through its existing collaboration agreement with Gilead.

These agreements follow a collaboration, established in October 2021, to investigate Trodelvy in combination with KEYTRUDA as first-line treatment for people with locally advanced or metastatic triple-negative breast cancer (TNBC).

The use of Trodelvy for the treatment of NSCLC and the use of Trodelvy in combination with KEYTRUDA for any use is investigational, and the safety and efficacy for these uses have not been established or approved by regulatory agency globally.

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

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer (including both NSCLC and small-cell lung cancer (SCLC)) is the second most common cancer in both men and women and is the leading cause of cancer death, making up approximately 25% of all cancer deaths. NSCLC is the most common type of lung cancer and accounts for up to 85% of cases. It is an aggressive disease with poor prognosis, and the relative five-year survival rate is 25%.

About Trodelvy

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland. Trodelvy is also under multiple regulatory reviews worldwide, including in Singapore and China through our partner Everest Medicines. Trodelvy continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

U.S. Indication for Trodelvy

In the United States, Trodelvy is indicated for the treatment of:

Adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
U.S. Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

Severe or life-threatening neutropenia may occur. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold Trodelvy until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to Trodelvy.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 61% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 47% of patients. Febrile neutropenia occurred in 7%. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever.

Diarrhea: Diarrhea occurred in 65% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion medication is recommended. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 66% of all patients treated with Trodelvy and Grade 3 nausea occurred in 4% of these patients. Vomiting occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.

ADVERSE REACTIONS

In the ASCENT study (IMMU-132-05), the most common adverse reactions (incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPHY study (IMMU-132-06), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite, constipation, vomiting, abdominal pain, and rash. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.

Please see full Prescribing Information, including BOXED WARNING.

On January 10, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported Pascal Touchon, President and Chief Executive Officer of Atara, will present the Company’s 2021 accomplishments across strategic priorities and key upcoming catalysts at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12 at 2:15 p.m. PST / 5:15 p.m. EST (Press release, Atara Biotherapeutics, JAN 10, 2022, View Source [SID1234598521]).

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"Atara made significant progress in 2021, including presentation of positive data from our pivotal Phase 3 ALLELE study and EU regulatory submission for tab-cel; new data confirming our conviction for ATA188 as the first investigational therapy to potentially reverse disability in progressive multiple sclerosis, now further validated by FDA Fast Track designation; and promising early safety and persistence data for our potentially best-in-class allogeneic CAR T portfolio that does not require TCR or HLA gene editing," said Pascal Touchon, President and Chief Executive Officer of Atara. "With the interim analysis from our EMBOLD study of ATA188, a planned BLA submission and the potential groundbreaking EU approval for tab-cel, the first ever allogeneic, off-the-shelf T-cell therapy to reach this stage, 2022 will be an exciting year for Atara and patients in significant need."

Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

Continued progress with the U.S. Food and Drug Administration (FDA), including productive engagement with CBER and a Type B CMC meeting scheduled for Q1 2022
Atara plans to complete the Biologics License Application (BLA) submission for patients with EBV+ PTLD in Q2 2022
U.S. approval of BLA for patients with EBV+ PTLD anticipated in H1 2023
Following successful interactions with EMA, Atara submitted a Marketing Authorization Application (MAA) for tab-cel in patients with EBV+ PTLD, the first ever for an allogeneic, off-the-shelf T-cell therapy, in November 2021. With the granting of Accelerated Assessment, the Company anticipates a decision regarding EU approval in Q4 2022
First presentation of positive data from the pivotal Phase 3 ALLELE study, reinforcing the transformative potential of tab-cel, as an oral session at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021
Data demonstrated a 50% objective response rate (ORR) and durability of response with 89% of patients responding to treatment surviving after one year, compared with 32% in non-responders
In a second oral presentation at ASH (Free ASH Whitepaper), longer term data from Phase 2 and Expanded Access Protocol (EAP) studies showed two-year survival benefit of over 86% in responders whether they achieved a complete response (CR) or partial response (PR) and median OS of 54.6 months
Continued favorable tab-cel safety profile and no new safety signals with more than 180 PTLD patients treated to date
EBV+ PTLD is a rare and potentially life-threatening cancer that may occur following a solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). For patients with EBV+ PTLD, the median survival is only 0.7 to 4.1 months after failure of initial therapy. There are currently no EMA- or FDA-approved treatments indicated for these patients
Tab-cel for Potential Additional Indications

Enrollment is continuing at sites in the potential label expansion multi-cohort Phase 2 study evaluating six patient populations within EBV+ immunodeficiency-associated lymphoproliferative diseases (IA-LPDs) and other EBV-driven diseases
First data from the multi-cohort study planned to be presented in 2023
ATA188 for Progressive Multiple Sclerosis (MS)

FDA has granted Fast Track designation for ATA188 in non-active primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (SPMS), two populations with high unmet medical need and limited treatment options
A Fast Track designation expedites the review of drugs filling an unmet medical need to treat serious conditions to get important therapies to patients faster; once received, this designation allows early and frequent communication with FDA throughout the development and review process
Atara is continuing to make good progress enrolling the Phase 2 randomized, double-blind, placebo-controlled dose-expansion EMBOLD study evaluating the efficacy and safety of ATA188 in patients with progressive MS
A formal interim analysis is planned for Q2 2022, including efficacy and safety, to optimize the likelihood of success in Phase 2 and confirm current development strategy
Following the interim analysis, the Company will communicate next steps for the program, including rationale, while still maintaining the integrity of the study
Atara plans to conduct pivotal Phase 3 studies at the conclusion of the Phase 2 study and is actively exploring partnership opportunities
One Phase 3 study will focus on non-active SPMS, for which no approved therapies currently exist in U.S. or EU
A separate study will focus on non-active PPMS, which has very few treatment options in most countries and approved therapies are of limited efficacy
The vast majority of people with PPMS and SPMS have non-active disease
Overall, increasing research activity and support within the academic community for the hypothesis of EBV as a driver of MS pathogenesis
CAR T Programs

Atara continues to advance our CAR T programs in liquid and solid tumors, which include a differentiated approach to allogeneic cell therapy, with no gene editing of the T-cell receptor (TCR) and next generation CAR technologies to enhance expansion and persistence of functional T cells
ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

Global strategic collaboration for ATA2271 and ATA3271 with Bayer continues to progress well with advancement of the mesothelin-partnered CAR T immunotherapy programs
Data presented at ESMO (Free ESMO Whitepaper)-IO in December 2021 showed promising early safety and persistence of armored CAR T, ATA2271, in patients with advanced mesothelioma; infusions for the first two patient cohorts have now been completed
Atara is continuing to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD-1 dominant negative receptor (DNR) and 1XX CAR co-stimulatory signaling domain technologies for patients with advanced mesothelioma, and expects a filing in Q4 2022
ATA3219 (B-cell Malignancies)

Atara continues to advance development of ATA3219, a potential best-in-class allogeneic CD19 CAR T therapy that does not require TCR or human leukocyte antigen (HLA) gene editing, leveraging our next-generation 1XX CAR co-stimulatory signaling domain and allogeneic EBV T-cell platform
New pre-clinical data (on file) demonstrated optimized version of ATA3219 with an enhanced memory phenotype, leads to both strong proliferative potential and potent antitumor activity supporting a best-in-class profile
Atara expects to submit an IND for B-cell malignancies in Q4 2022
A live audio webcast of the presentation will be available by visiting the Investors & Media – News & Events section of atarabio.com on Wednesday, January 12, at 5:15 p.m. EST / 2:15 p.m. PST. An archived replay of the webcast will be available on the Company’s website for 30 days following the live presentation. A new corporate presentation will be available on Monday, January 10 at 8:30 a.m. EST / 5:30 a.m. PST.

On January 10, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported the appointment of Eric Ostertag as Executive Chairman and the transition of current President and Chief Business Officer, Mark Gergen, to the role of Chief Executive Officer effective as of February 1, 2022 (Press release, Poseida Therapeutics, JAN 10, 2022, View Source [SID1234598520]). The Company also provided a summary business update and 2022 preview.

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Poseida announces President Mark Gergen to serve as CEO, effective 2/1. Eric Ostertag named Executive Chairman. $PSTX
"For the last four years, Mark and I have worked closely to build Poseida into the organization it is today, making tremendous progress on a wide variety of initiatives which includes taking the company public in 2020, and preparing for the next wave of growth that lies ahead," said Eric Ostertag, M.D., Ph.D., Chief Executive Officer of Poseida Therapeutics. "Going forward, Mark will assume the overall leadership of the company while I will focus on high-level strategy, intended to maximize the value of our differentiated genetic engineering platforms and product candidates. In addition to continuing to chair the board of directors, I will also work to expand and further develop our scientific advisory boards."

As Poseida’s founder and CEO, Ostertag directed the Company’s spin out in early 2015 from parent company Transposagen Biopharmaceuticals, Inc., a biotechnology company that commercialized gene editing technology in research applications. Ostertag also founded Transposagen, where he was CEO from 2003 to 2015. Ostertag earned his M.D. and Ph.D. from the University of Pennsylvania. Under his leadership, Poseida grew to over 250 employees, raised significant private capital and successfully completed an IPO in 2020. The Company has also built a significant global intellectual property portfolio; received FDA clearance on four Investigational New Drug (IND) applications for novel cell therapies, dosing over 100 patients in clinical trials; and established multiple collaborations, including the recently announced gene therapy collaboration with Takeda Pharmaceutical Company Limited ("Takeda"), which has a potential total value of up to $3.6 billion.

"It is a privilege to take on the role of CEO and lead the organization as we continue our progress toward our mission to redefine cell and gene therapy. The partnership Eric and I have built in guiding the company will continue," said Mark Gergen, Poseida’s President and Chief Business Officer. "I am very excited about 2022 and the opportunities we will have to differentiate our platforms in both cell and gene therapy. We are highly focused on getting to key inflection points on our solid tumor and allogeneic CAR-T programs as well as advancing our gene therapy efforts, including those associated with our recent collaboration with Takeda."

Gergen joined Poseida in February 2018, serving as Chief Business Officer and Chief Financial Officer before being appointed President and Chief Business Officer in July 2020. During his career in the biotech and pharmaceutical industries, Gergen has provided strategic leadership to companies as they scale, grow, and execute on the promise of their technologies. Before joining Poseida, he held key leadership roles including that of Senior Vice President and Chief Operating Officer of Halozyme, Inc., Executive Vice President and Chief Operating Officer at Mirati Therapeutics, Inc. and as Senior Vice President of Corporate Development at Amylin Pharmaceuticals, Inc. He has also served in senior management positions at CardioNet Inc., Advanced Tissue Sciences, Inc., and Medtronic, Inc. Gergen received a J.D. from the University of Minnesota Law School and a B.A. in business administration from Minot State University in North Dakota.

Both Ostertag and Gergen will continue to serve as members of the Company’s Board of Directors.

Business Update and 2022 Preview

Annual R&D Day
The Company will soon host its second annual R&D Day, scheduled for Wednesday, February 23, 2022. Dr. Ostertag will lead the event, featuring presentations highlighting the current product pipeline, advancements in early discovery and research programs, and detailing novel next generation approaches and technology applications. To register for the webcast, please visit the Investor Relations section of the Poseida website.

P-PSMA-101 Autologous CAR-T for Prostate Cancer
A Phase 1 trial evaluating P-PSMA-101, the Company’s autologous CAR-T candidate for the treatment of metastatic castrate resistant prostate cancer (mCRPC) is ongoing. Initial clinical data was presented in late August 2021 at the CAR-TCR Summit demonstrating encouraging early results at low doses in this difficult to treat patient population with high unmet need. The Company will be presenting additional data during the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium taking place February 17-19, 2022, in a poster titled, "Phase 1 study of P-PSMA-101 CAR-T cells in patients with metastatic castration-resistant prostate cancer (mCRPC)."

P-BCMA-ALLO1 Allogeneic CAR-T for R/R Multiple Myeloma
The Phase 1 trial of P-BCMA-ALLO1, an allogeneic CAR-T product candidate for the treatment of relapsed refractory multiple myeloma, is currently initiating with a clinical data update expected later in the year. In addition to the continued product manufacturing at the current contract manufacturing organization, the Company is exploring a parallel path to enable manufacturing of P-BCMA-ALLO1 at its in-house GMP manufacturing pilot plant in San Diego, following successful manufacturing runs of the allogeneic CAR-T product candidate P-MUC1C-ALLO1.

P-MUC1C-ALLO1 Allogeneic CAR-T for Solid Tumors
The Company announced on December 20, 2021 that the IND submitted for the P-MUC1C-ALLO1 product candidate had been cleared by the FDA. The Phase 1 clinical trial start-up is underway and will evaluate P-MUC1C-ALLO1 in various solid tumors, including breast, ovarian, lung and colorectal cancers. P-MUC1C-ALLO1 is manufactured at the Company’s in-house GMP manufacturing pilot plant in San Diego. Initial clinical data from P-MUC1C-ALLO1 is expected to be presented at a scientific meeting this year.

Dual P-CD19CD20-ALLO1 Allogeneic Car T for B-cell Malignancies
Due to the prioritization of the lead allogeneic programs and the focus on achieving associated milestones in 2022, the Company is shifting expectations for an IND filing of its first dual CAR-T program from the end of 2022 into 2023.

P-OTC-101 In Vivo Liver Directed Gene Therapy for OTC
The Company’s leading internal gene therapy program, P-OTC-101, an in vivo liver-directed gene therapy for ornithine transcarbamylase (OTC) deficiency, continues with IND enabling activities and evaluation of both a fully nanoparticle delivery approach as well as a hybrid nanoparticle/AAV approach. A decision of whether to pursue the fully nanoparticle or hybrid approach going forward is expected by mid-year.

Partnerships and Collaborations
The Company’s research collaboration with Takeda focused on non–viral in vivo liver- and HSC- directed gene therapies is underway. The collaboration, announced in October 2021, provides validation of Poseida’s genetic engineering technology and approach. In 2022, the Company will continue to evaluate and explore additional opportunities for collaboration and partnership enabled by the breadth and versatility of the piggyBac, Cas-CLOVER, nanoparticle and other technology platforms.

On January 10, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) (Press release, Neoleukin Therapeutics, JAN 10, 2022, View Source [SID1234598519]). The agreement will allow for the evaluation of safety and efficacy of Neoleukin’s NL-201, a de novo protein designed to mimic the therapeutic activity of natural cytokines IL-2 and IL-15, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in an ongoing Phase 1 trial.

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Neoleukin will evaluate NL-201 plus pembrolizumab as part of the company’s ongoing Phase 1 trial in patients with advanced, relapsed or refractory solid tumors. Up to 132 patients will be enrolled in the combination arm of the study. The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity.

"Neoleukin is excited to collaborate with Merck, one of the world’s leading immuno-oncology companies," said Priti Patel, MD, Chief Medical Officer at Neoleukin. "Our prior preclinical studies demonstrated that the combination of NL-201 and an anti-PD-1 antibody was well-tolerated and showed promising antitumor activity compared to either drug alone as monotherapy. We see this combination of drugs as having exciting potential to benefit patients with relapsed or refractory solid tumors in the future. This combination arm, alongside the NL-201 monotherapy arm of the NL-201-101 study, is a key component of our evolving NL-201 program."

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

About NL-201
NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

On January 10, 2022 Vyant Bio, Inc. ("Vyant Bio", "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that it is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) diseases (Press release, Vyant Bio, JAN 10, 2022, View Source [SID1234598518]). Today, Vyant Bio announced that it will be participating in the H.C. Wainwright Bioconnect Conference. The event is being held virtually from January 10-13, 2022. Registered attendees can access the recorded presentation on-demand (24×7) for the duration of the conference.

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Conference Date: January 10-13, 2022 (Monday-Thursday)
On-Demand Starts: 7:00 am ET – Monday, January 10, 2022
On-Demand Ends: 7:00 pm ET- Thursday, January, 13, 2022
Registration: View Source

During the presentation, Vyant Bio’s Chief Executive Officer, Jay Roberts, and Chief Scientific Officer, Robert Fremeau, Ph.D., will be discussing key highlights from 2021 and the scientific, business and strategic outlook for 2022. The presentation will be an archived recording will be made available in the Investors’ section of the Vyant Bio website.

If you are an institutional investor and would like to participate in this event please, click on the following link (View Source) to register for the H.C. Wainwright Bioconnect Conference. Once your registration is confirmed, you will be prompted to log into the conference website and will be able to request a one-on-one meeting with the Company.

Vyant Bio will also be available for virtual outside 1:1 meetings after the H.C. Wainwright Bioconnect Conference. Please contact Jennifer K. Zimmons, Ph.D. at [email protected] or +1 917.214.3514 for scheduling.