On May 19, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies, reported that additional data from its Phase 1/2a study of PBCAR0191, the Company’s first generation, off-the-shelf allogeneic CAR T candidate targeting CD19 will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting being held virtually June 4-8, 2021 (Press release, Precision Biosciences, MAY 19, 2021, View Source [SID1234580255]).

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Abstracts are available and can be viewed on the ASCO (Free ASCO Whitepaper) web site at www.asco.org. Additional data including updated response rates, safety, and durability will be presented at the ASCO (Free ASCO Whitepaper) meeting.

Title: Preliminary safety and efficacy of PBCAR0191, an allogeneic, off-the-shelf CD19-targeting CAR T product, in relapsed/refractory (r/r) CD19+ NHL
Poster Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia, Abstract 7516
Date/Time: Friday, June 4, 2021 at 9:00 a.m. ET
Presenting Author: Bijal Shah, M.D., Moffitt Cancer Center

By February 1, 2021, 13 patients with R/R non-Hodgkin lymphoma (NHL) met study eligibility criteria and had received PBCAR0191 dose level 3 at 3×106 or equivalent with either standard lymphodepletion (sLD) (n=6)1 or enhanced lymphodepletion (eLD) (n=7)2. Of these patients, 77% had aggressive lymphomas and 62% had four or more courses of prior treatment. PBCAR0191 continued to demonstrate an acceptable safety profile with no cases of graft versus host disease, no cases of Grade ≥ 3 cytokine release syndrome, and no cases of Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome.

"These results continue to confirm the activity of PBCAR0191 with strategies that mitigate rejection, and we look forward to sharing additional data in the poster and on our hosted conference call on June 4," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "While we continue to advance PBCAR0191 through its Phase 1/2a study, we eagerly await the clinical start of our next-generation, immune evading stealth cell technology with PBCAR19B, which includes modifications designed to enhance CAR T persistence and delay allogeneic immune rejection by T cells and natural killer cells."

Company-Hosted Conference Call and Web Cast Information
Precision will host a conference call and webcast on Friday, June 4, 2021 at 8:00 a.m. ET to review the most recent interim clinical data for PBCAR0191. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 5647916. Participants may access the live webcast and the accompanying presentation materials on Precision’s website www.precisionbiosciences.com in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precision’s website.

On May 19, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported updated data from the Company’s ongoing Phase 1/2 study evaluating ADXS-503 in combination with KEYTRUDA which will be presented as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting (Press release, Advaxis, MAY 19, 2021, View Source [SID1234580272]). ADXS-503 is the first drug construct from the ADXS-HOT off-the-shelf, cancer-type specific, immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

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"These early results, which include a disease control rate of 44% in the first 9 evaluable patients treated with ADXS-503 as an add on therapy at progression with pembrolizumab, are particularly encouraging given the durable nature of disease control in 3 patients," said Suresh Ramalingam, M.D., Roberto C. Goizueta Chair for Cancer Research, Director, Division of Medical Oncology and Deputy Director of the Winship Cancer Institute at Emory University School of Medicine. "The translational results from the study provide interesting insights on the potential mechanism of action by which the addition of ADXS-503 may may be effective in this patient population."

Ken Berlin, Chief Executive Officer of Advaxis, said, "We are encouraged by these updated results which continue to support the potential of ADXS-503 to enhance and/or restore sensitivity to checkpoint inhibitors. The clinical activity observed to date in this challenging patient population, combined with a favorable safety profile, suggest that ADXS-503 may be an important new off-the-shelf immunotherapy treatment option. We look forward to continued progress in the clinic with our ADXS-HOT products which includes the ongoing Phase 1/2 study of ADXS-503 in NSCLC, and the expansion of the program to our planned Phase 1 Study of ADXS-504 for the treatment of early prostate cancer."

Key presentation highlights:

Highlights from the poster presentation titled, "A phase 1 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in patients with metastatic non-small-cell lung cancer (NSCLC) progressing on pembrolizumab as last therapy" presented by Missak Haigentz, M.D., Section Chief of Hematology and Oncology at Morristown Medical Center and Medical Director of Hematology and Oncology for Atlantic Health, and Study Investigator, include:

10 patients have been treated with ADXS-503 as an add on therapy to patients failing pembrolizumab as last therapy with 10 patients evaluable for safety and 9 patients evaluable for efficacy

Combination therapy was well tolerated with no DLTS or added toxicity of the two drugs. Grade 1 and 2, transient and reversible events included chills, fever, fatigue, in approximately half of the patients

The Disease Control Rate (DCR) was 44% (4/9)

Clinical benefit was durable, with an observed partial response (PR) and stable disease (SD) sustained for over a year, and another observed SD lasting over 6 months. An additional PR was maintained for approximately 4 months

Biomarker data demonstrate that patients who seem to achieve clinical benefit include those with PD-L1 expression ≥50%, secondary resistance disease to pembrolizumab and those who show proliferation and/or activation of NK and CD8+ T cells within the first weeks of therapy

Translational studies show:

Antitumoral T-cell responses elicited against hot-spot mutation antigens and/or tumor associated antigens (TAAs)

Emergence of naive CD8+ Tcell clones, suggesting reactivity against novel antigens

Induction of proliferation and/or activation of pre-existing CD8+ T-cell clones, including PD-1 upregulation

Enrollment in Part B of the ongoing study will continue to further evaluate the clinical benefit and immune effects of adding on ADXS-503 to patients progressing on pembrolizumab
The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed. Part B with ADXS-503 (1 X108 CFU) in combination with KEYTRUDA is currently enrolling its efficacy expansion for up to 18 patients at dose level 1 (1 X108 CFU + KEYTRUDA) with the potential to proceed to dose level 2 (5 X108 CFU + KEYTRUDA) at a later date. Part C, which is evaluating ADXS-503 in combination with KEYTRUDA (1 X108 CFU + KEYTRUDA) as a first line treatment for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy is currently enrolling patients.

About ADXS-HOT
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

On May 19, 2021 HiberCell, a biotechnology company developing therapeutics focused on preventing cancer relapse and metastasis, reported that it has completed a Series B financing round for gross proceeds of $67.4 million (Press release, HiberCell, MAY 19, 2021, View Source;utm_medium=rss&utm_campaign=hibercell-closes-67-4-million-series-b-financing-and-secures-30-million-debt-facility-from-hercules-capital [SID1234580288]). Concurrent to this financing, HiberCell closed on a $30 million debt facility with Hercules Capital, Inc. (NYSE: HTGC).

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The Series B round included new investors Huizenga Capital Management, Monashee Investment Management, funds managed by Tekla Capital Management LLC, Hercules Capital, Mount Sinai Innovation Partners and other undisclosed investors. Returning investors, including ARCH Venture Partners, Magnetic Ventures, Bristol Myers Squibb, Trinitas Capital, and others from the Series A syndicate, also participated in the round. HiberCell will use the proceeds of the Series B financing and debt facility to support the clinical development of novel therapeutics targeting stress biology and innate immunity to address the role these play in prevention of cancer recurrence and metastasis.

"We are excited to have the support of these sophisticated investors, who understand that delaying or preventing cancer relapse and metastasis requires that we rethink cancer and understand the mechanistic drivers of cancer progression," said Alan Rigby, Ph.D., Co-Founder and Chief Executive Officer of HiberCell. "Their backing is a testament to the potential of our unique development strategy that includes: therapeutic reprogramming of the tumor immune microenvironment and modulation of innate adaptive stress responses that endow cancer cells with survival advantages. We are enthusiastic about our progress and look forward to advancing our clinical pipeline: driving Imprime PGG into two new Phase 2 trials, while generating first in human safety, tolerability and pharmacokinetic data in a Phase 1a trial with our PERK inhibitor HC-5404."

"HiberCell has taken a pioneering approach to an evolving cancer paradigm through demonstratable expertise in defining and harnessing adaptive stress biology as well as innate immune activation with a focus on tackling cancer relapse, metastatic disease, and tumor dormancy," said Rene Mora, MD-PhD, Portfolio Manager of Monashee Investment Management. "Addressing these mechanisms represents an unmet and promising area of anticancer drug development. We look forward to working with the company as it continues to move its differentiated pipeline forward with a focus on fighting the most common cause of cancer mortality: relapse and metastasis."

On May 19, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported updated 90-day efficacy, safety and pharmacokinetic data from its ongoing multicenter Phase 1 clinical trial of JSP191, the company’s first-in-class anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation (Press release, Jasper Therapeutics, MAY 19, 2021, View Source [SID1234580304]). Data from the dose-finding part of the study showed that conditioning with a single dose of JSP191 0.6 mg/kg prior to low dose radiation and fludarabine in preparation for transplantation was well tolerated in all six patients and led to successful transplant as evidenced by full chimerism and elimination of measurable residual disease (MRD) in five of six patients. The findings will be presented by lead investigator Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine, in a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held online from June 4-8. The abstract is available now on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

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"We are very encouraged by the updated efficacy and safety results from this Phase 1 clinical study, which is the first to evaluate JSP191 in combination with non-myeloablative conditioning for older patients with MDS or AML. These data are consistent with pre-clinical work that demonstrated the capacity of JSP191 to target myelodysplastic cells and synergize with low doses of radiation. While hematopoietic cell transplantation is curative in these patients, its use is limited in older and frail patients because of the toxicity associated with standard-of-care myeloablative conditioning agents," said Kevin N. Heller, M.D., Executive Vice President, Research and Development, of Jasper Therapeutics. "Based on this data and feedback from the FDA, we have now opened the dose-expansion phase of the study at the recommended Phase 2 dose. We anticipate announcing topline data in the first half of next year. We continue to evaluate JSP191 as a conditioning agent in multiple additional diseases, including our ongoing clinical trial in severe combined immunodeficiency (SCID), our upcoming study in refractory autoimmune disease and with our partnerships with the NIH and Stanford in sickle cell disease and Fanconi anemia. We believe that JSP191 addresses key limitations of current conditioning regimens and potentially may expand the number of patients with devastating diseases who could be cured with hematopoietic stem cell therapy."

At 90 days after transplant, MRD as measured by cytogenetics, karyotype and next-generation sequencing was negative (undetected) in five patients and reduced in one patient, and full chimerism (greater than 95%) was observed in five of the six patients. One patient had secondary graft failure with no evidence of relapse at 90 days. JSP191, when added to low-dose radiation and fludarabine, was well tolerated in all six patients; the protocol allows for subjects to receive the conditioning regimen in an outpatient setting. No infusion reactions, treatment-related toxicities such as oral mucositis or evidence of acute graft versus host disease were reported. Pharmacokinetic data showed that serum levels of the JSP191 0.6 mg/kg dose were consistent among study participants as evaluated up to 14 days post-infusion.

Phase 1 Study Design

The open-label, multicenter Phase 1 study (JSP-CP-003) is evaluating the safety, tolerability and efficacy of adding JSP191 to the standard conditioning regimen of low-dose radiation and fludarabine among patients age 65 to 74 years with MDS or AML undergoing hematopoietic cell transplantation. Patients were ineligible for full myeloablative conditioning. The primary outcome measure of the study is the safety and tolerability of JSP191 as a conditioning regimen up to one year following a donor cell transplant. Secondary endpoints include engraftment and donor chimerism, MRD clearance, non-relapse mortality, event-free survival and overall survival.

About MDS and AML

Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.i Both are diseases of the elderly with high mortality. Each year, about 29,000 patients are diagnosed with MDS and approximately 42,000 patients are diagnosed with AML in the G7 countries for which approximately 2,500 patients with MDS and approximately 8,000 people with AML receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Jasper is currently enrolling in two clinical trials for acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS) and severe combined immunodeficiency (SCID) and expects to begin enrollment in three additional studies in 2021 for severe autoimmune disease, sickle cell disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

On May 19, 2021 ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, announced today three abstracts have been selected for poster presentations at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held virtually June 4-8, 2021 (Press release, ADC Therapeutics, MAY 19, 2021, View Source [SID1234580320]).

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"We are pleased that research from our lead programs will be shared with the oncology community at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting," said Jay Feingold, MD, PhD, Senior Vice President and Chief Medical Officer of ADC Therapeutics. "On the heels of the accelerated FDA approval of ZYNLONTA (loncastuximab tesirine-lpyl), we continue to advance our deep pipeline to deliver next-generation ADC therapies to patients with hematologic and solid tumor cancers."

Poster Presentation Details

Title: Duration of response to loncastuximab tesirine in relapsed/refractory diffuse large B-cell lymphoma by demographic and clinical characteristics: Subgroup analyses from LOTIS 2
Track: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: On demand beginning June 4 at 9 a.m. EDT
Presenter: Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University
Abstract Number: 7546

Title: Phase 3 randomized study of loncastuximab tesirine plus rituximab versus immunochemotherapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): LOTIS-5
Track: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Date/Time: On demand beginning June 4 at 9 a.m. EDT
Presenter: Mehdi Hamadani, MD, Professor of Internal Medicine at the Medical College of Wisconsin, Division of Hematology & Oncology
Abstract Number: TPS7574

Title: A Phase 1b, open-label, dose-escalation study to evaluate camidanlumab tesirine (Cami) as monotherapy in patients (pts) with advanced solid tumors
Track: Developmental Therapeutics—Immunotherapy
Date/Time: On demand beginning June 4 at 9 a.m. EDT
Presenter: Igor Puzanov, MD, Clinical Professor of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo
Abstract Number: 2556

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death. The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The FDA approval was based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with r/r DLBCL following two or more prior lines of systemic therapy. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with very difficult to treat disease, including patients with high-grade B-cell lymphoma. The trial also enrolled patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, and patients who had stem cell transplants and CAR-T therapy prior to their treatment with ZYNLONTA. Results from the trial demonstrated an overall response rate (ORR) of 48.3% (70/145 patients), which included a complete response (CR) rate of 24.1% (35/145 patients) and a partial response (PR) rate of 24.1% (35/145 patients). Patients had a median time to response of 1.3 months. At the most recent data cut-off for patients enrolled in the trial, the median duration of response (mDoR) was 12.58 months. In a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, gamma-glutamyltransferase increased, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea and musculoskeletal pain. In LOTIS-2, the most common (≥10%) grade ≥3 treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), gamma-glutamyltransferase increased (17.2%) and anemia (10.3%).

ZYNLONTA is being evaluated in combination for earlier lines of therapy and as a monotherapy in other B-cell malignancies.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami, formerly ADCT-301) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload killing the cell. This applies to CD25-expressing tumor cells, and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma (HL), as well as in a Phase 1a/1b clinical trial in patients with relapsed or refractory HL and non-Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.