Rubius Therapeutics to Present Trials in Progress Poster on the Phase 1 Clinical Trial of RTX-321 for HPV 16-Positive Cancers at the 2021 American Society of Clinical Oncology Annual Meeting

On May 19, 2021 Rubius Therapeutics, Inc. (Nasdaq:RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics, reported that the Company will present a Trials in Progress poster presentation for its lead artificial antigen-presenting (aAPC) cell program, RTX-321, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4-8, 2021 (Press release, Rubius Therapeutics, MAY 19, 2021, View Source [SID1234584706]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Trials in Progress poster presentation will summarize the proposed mechanism of action of RTX-321, preclinical observations to date and the clinical trial design, including translational medicine methodology, for the Company’s ongoing Phase 1 clinical trial of RTX-321 for the treatment of HPV 16-positive cancers, including cervical cancer, anal cancer, and head and neck cancer.

Poster Title: A Phase 1 Study of RTX-321, an Engineered Red Blood Cell as an Artificial Antigen-Presenting Cell Expressing HLA-A*02 with the HPV-16 E7 Peptide and 4-1BB Ligand with Membrane-Bound IL-12 for the Treatment of HPV 16-Positive Cancers
Session Title: Poster Session: Developmental Therapeutics—Immunotherapy
Abstract Number: TPS2664
Date and Time: Friday, June 4, 2021 at 9:00 AM ET on the ASCO (Free ASCO Whitepaper) website, View Source

About HPV 16-Positive Cancers
Human papillomavirus (HPV) 16 is associated with approximately 70 percent of cervical cancers, approximately 40 percent of head and neck squamous cell carcinoma (HNSCC) arising in the oropharynx, approximately 25-40 percent of HNSCC arising in other locations and approximately 80-85 percent of anal cancers. A critical need remains for better treatment options for advanced HPV 16-associated cancers. The prognosis remains poor for patients with metastatic disease with few treatment options beyond the first-line setting.

About the RTX-321 Clinical Trial
Rubius Therapeutics is enrolling patients in a Phase 1 open-label, multicenter, monotherapy dose escalation, first-in-human study of RTX-321 for the treatment of patients that are HLA-A*02:01-positive with persistent, recurrent, or metastatic, unresectable, HPV 16-positive cancers, including unresectable cervical cancer (squamous, adeno, or adenosquamous histology), head and neck squamous cell carcinoma (including of the nasal and oral cavities, larynx, hypopharynx, nasopharynx, and oropharynx) and squamous cell cancer of the anal canal that is not amenable to curative therapy. The purpose of the trial is to determine the safety and tolerability, recommended Phase 2 dose and pharmacology, and antitumor activity of RTX-321. For more information about the Phase 1 clinical trial of RTX-321, please visit clinicaltrials.gov (NCT04672980).

About RTX-321
RTX-321 is an allogeneic, off-the-shelf aAPC therapy product candidate that is engineered to induce a tumor-specific immune response by expanding antigen-specific T cells. RTX-321 expresses hundreds of thousands of copies of an HPV peptide antigen bound to major histocompatibility complex class I proteins, the costimulatory molecule 4-1BBL and the cytokine IL-12 on the cell surface to mimic human T cell-APC interactions.

NuCana Reports First Quarter 2021 Financial Results and Provides Business Update

On May 19, 2021 NuCana plc (NASDAQ: NCNA) reported that financial results for the first quarter ended March 31, 2021 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAY 19, 2021, View Source [SID1234584207]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of March 31, 2021, NuCana had cash and cash equivalents of £78.6 million compared to £87.4 million as of December 31, 2020. NuCana continues to advance its various clinical programs and reported a net loss of £9.8 million for the quarter ended March 31, 2021, as compared to a loss of £4.0 million for the quarter ended March 31, 2020. Basic and diluted loss per share was £0.19 for the quarter ended March 31, 2021, as compared to £0.12 per share for quarter ended March 31, 2020.

"We are very pleased with our momentum in 2021," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "In January, we presented data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) from the NuTide:302 study demonstrating NUC-3373’s encouraging efficacy signals and favorable safety profile in patients with advanced colorectal cancer. Among the efficacy-evaluable population, a disease control rate of 62% was achieved. In addition, NUC-3373 was well tolerated with no hand-foot syndrome or neutropenia as well as lower rates of diarrhea, mucositis and stomatitis as compared to historical data for 5-FU and capecitabine in the frontline treatment of patients with colorectal cancer."

Mr. Griffith continued: "In April, we were excited to present five posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. NUC-3373 maintained the encouraging 62% disease control rate in the efficacy-evaluable population in the NuTide:302 study. The poster also detailed three patients who experienced reductions in their target lesions of 40%, 28% and 15% and several patients who achieved a longer progression-free survival on NUC-3373 than they had on their prior therapy. We also presented additional clinical data from the ongoing Phase I study of NUC-7738. These data demonstrated NUC-7738’s encouraging anti-cancer activity and favorable tolerability profile. Three case studies described patients who achieved tumor volume reductions and prolonged stable disease on NUC-7738. Other AACR (Free AACR Whitepaper) posters showed NUC-3373-treated colon cancer cells are able to activate a natural killer cell response and described how NUC-7738 was designed to overcome the key cancer resistance mechanisms which have prevented the clinical development of its parent nucleoside analog, 3’-deoxyadenosine. Overall, these presentations highlighted the potential of our ProTides to significantly improve the treatment outcomes for patients with cancer."

Mr. Griffith concluded: "We are excited with the progress we have made so far in 2021. We remain focused on continuing to drive recruitment across all of our ongoing studies, including our Phase III study of Acelarin plus cisplatin in patients with biliary tract cancer as well as initiating new studies, including our second Phase III study evaluating NUC-3373 in combination with other agents for patients with colorectal cancer. We look forward to providing additional updates as we go through 2021."

Anticipated 2021 Milestones

Acelarin is a ProTide transformation of gemcitabine. In 2021, NuCana expects to:
Complete recruitment sufficient to enable the first interim analysis in 2022 of the Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.

NUC-3373 is a ProTide transformation of the active anti-cancer metabolite of 5-FU. In 2021, NuCana expects to:
Report data from the Phase Ib study (NuTide:302) of NUC-3373 in combination with other agents with which 5-FU is typically combined, such as leucovorin, oxaliplatin and irinotecan in patients with advanced colorectal cancer;
Initiate and report data from a Phase Ib expansion / Phase II study of NUC-3373 in combination with other agents for patients with colorectal cancer;
Initiate a Phase III study of NUC-3373 in combination with other agents for patients with colorectal cancer; and
Report data from the Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.

NUC-7738 is a ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine. In 2021, NuCana expects to:
Report data from the Phase I study (NuTide:701) of NUC-7738 in patients with advanced solid tumors; and
Initiate a Phase II study of NUC-7738 in patients with solid tumors.

BERGENBIO ASA: RESULTS FOR THE FIRST QUARTER 2021

On May 19, 2021 BerGenBio ASA (OSE:BGBIO), BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported its results for the first quarter of 2021 (Press release, BerGenBio, MAY 19, 2021, View Source [SID1234583868]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A presentation and live webcast by BerGenBio’s senior management will take place at 10.00 am CEST today, please see below for details.

Operational Highlights – first quarter of 2021 (including post-period end)

COVID-19

Update from investigational Phase II trials assessing bemcentinib in hospitalised COVID-19 patients

Latest data from BGBC020 and ACCORD2 show bemcentinib was well tolerated in hospitalised COVID-19 patients

Recruitment closed in BGBC020 trial assessing bemcentinib in COVID-19 at 96% of target enrolment, with a total of 115 patients enrolled in the Phase II study
ACCORD2 study stopped recruitment at 50% due to a reduction in UK COVID-19 incidence, and to permit a prompt analysis of data
In May 2021 we reported Ventilator Free Survival of 90% in COVID-19 patients treated with bemcentinib plus standard of care, vs 72% in the patients treated with standard of care, in a patient subset with increased disease severity, representing more than 50% of the hospitalised patients in the study.
Survival benefit for patients receiving bemcentinib was numerically greater than for those receiving standard of care only, 96% vs 91% respectively.
Preclinical bemcentinib COVID-19 data presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI)

Bemcentinib demonstrated potent antiviral effects in preclinical SARS-CoV-2 and other coronavirus models
Non-Small Cell Lung Cancer 

Updated data from the Phase II bemcentinib combination study (BGBC008) in refractory non-small cell lung cancer (NSCLC) presented at the annual World Conference on Lung Cancer (WCLC)

Data from cohort B (in refractory patients previously treated with PD-L1 or PD-1 checkpoint inhibitor (CPI) as monotherapy) showed that bemcentinib is well-tolerated and may reverse acquired resistance to checkpoint inhibition
Completed enrolment of cohort C1 in Phase II bemcentinib combination study in refractory NSCLC

Enrolment of 13 patients into cohort C1 (second line patients refractory to first line treatment with CPIs in combination with chemotherapy) of bemcentinib / pembrolizumab combination study
Tilvestamab

First patient dosed in Phase Ib trial of anti-AXL antibody tilvestamab (BGB149)

Study aims to determine safety, tolerability and recommended phase 2 dose of tilvestamab in patients with platinum resistant high-grade serous ovarian cancer
Financial Highlights – first quarter of 2021

(Figures in brackets = same period 2020 unless otherwise stated)

Revenue amounted to NOK 0.0 million (NOK 0.0 million)
Total operating expenses were NOK 83.4 million (NOK 56.2 million), reflecting the increased level of activity related to new clinical trials and organizational expansion
Operating loss of NOK 83.4 million (NOK 56.2 million)
Cash and cash equivalents amounted to NOK 659.4 million (NOK 721.6 million at year end 2020)
Richard Godfrey, Chief Executive Officer of BerGenBio, commented:

"Against the continued backdrop of the COVID-19 pandemic, there has understandably been a great deal of interest in the progress of our clinical programme investigating bemcentinib as a potential treatment. While vaccine rollouts in some areas of the world have been proving successful, the severity of the virus’ impact in India, Brazil and elsewhere, combined with the very real risk that vaccine-resistant strains could emerge, clearly show that there remains an urgent need for effective therapeutic interventions, alongside vaccines.

While we are pleased to be playing a role in the continued effort against COVID-19, BerGenBio’s primary focus remains the continued clinical development of bemcentinib as a treatment for cancer indications including acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS) and non-small cell lung cancer (NSCLC). We remain well financed, have a clear strategy and our organisation is developing to meet the demands of late-stage drug development and delivering value for our shareholders."

Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET and be webcast live.

Webcast link: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20210519_1

The Q1 2021 Financial report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

Dana-Farber researchers present key studies at ASCO annual meeting

On May 19, 2021 Dana-Farber Cancer Institute researchers reported that they are presenting dozens of research studies at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Dana-Farber Cancer Institute, MAY 19, 2021, View Source [SID1234580471]). The studies will be presented during the virtual program on June 4-8, 2021. ASCO (Free ASCO Whitepaper) is the world’s largest clinical cancer research meeting, attracting more than 30,000 oncology professionals from around the world.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Toni K. Choueiri, MD, the director of the Lank Center for Genitourinary Oncology at Dana-Farber, will present results from the randomized, double-blind, phase III KEYNOTE-564 trial evaluating pembrolizumab versus placebo after surgery in patients with renal cell carcinoma (abstract LBA5) during ASCO (Free ASCO Whitepaper)’s Plenary Session on Sunday, June 6, 2021, 1:00pm-4:00pm ET. The plenary session features five studies deemed to have the greatest potential impact on patient care.

F. Stephen Hodi, MD, the director of the Melanoma Center and Center for Immuno-Oncology at Dana-Farber is co-senior author on the RELATIVITY-047 study evaluating combination treatment with two immunotherapies (relatlimab plus nivolumab) versus nivolumab alone in first-line treatment for patients with advanced melanoma (abstract 9503). Findings from the RELATIVITY-047 study will be presented during the Melanoma/Skin Cancers Oral Abstract Session on Sunday, June 6, 2021, 8:00am-11:00am ET. The study is included in the ASCO (Free ASCO Whitepaper) Press Program.

Other key research shows new treatments and diagnostic advances in lung cancer, leukemia, head and neck cancer, pediatrics, and many others. Some of the research highlights include:

Antibody drug conjugate shows promise against non-small cell lung cancer resistant to targeted therapy

An antibody fused to a targeted drug has produced impressive results in a Phase I clinical trial involving patients with advanced non-small cell lung cancer (NSCLC) whose tumors had become resistant to a standard targeted therapy. Dana-Farber’s Pasi A. Jänne, MD, PhD, is lead author of the study.

The trial evaluated the safety and effectiveness of patritumab deruxtecan, an antibody drug conjugate consisting of an antibody targeting the protein HER3 and an inhibitor of the topoisomerase 1 enzyme, in 57 patients whose NSCLC carried an EGFR gene mutation but no longer responded to EGFR-targeting drugs. Patients who become resistant to such drugs and to platinum-based chemotherapy usually have few treatment options.

After a median treatment time of 5.5 months, 39% of the participants had a confirmed clinical response to the conjugate – a reduction in tumor size or extent. Among these patients, the median progression-free survival was 8.2 months. The antitumor effect occurred in patients whose resistance to EGFR inhibitors arose from a range of molecular mechanisms and in those with no clear identifiable resistance mechanism.

The most common severe side effects were decreased blood platelet counts, lowered counts of neutrophils (a type of white blood cell), and fatigue – all consistent with previous safety studies.

The results have prompted investigators to open a Phase 2 trial of the conjugate for patients with EGFR-mutant NSCLC whose disease has become resistant to EGFR-targeting drugs and chemotherapy.

Title: Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor-resistant, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC)

Abstract: 9007

Presenter: Pasi A. Jänne, MD, PhD

Session/Time: Oral Abstract Session: Lung Cancer – Non-Small Cell Metastatic; Broadcasting: June 4, 1:00pm-4:00pm

PET scans following initial treatment help many patients with bulky early-stage Hodgkin lymphoma avoid radiotherapy

Many early-stage patients with bulky classic Hodgkin lymphoma (cHL) can avoid radiotherapy treatment and still have excellent outcomes, according to a clinical study in which treatment was adapted to findings on PET imaging. Bulky disease – characterized by large tumors typically in the center of the chest – is associated with poorer outcomes in cHL and is traditionally treated with radiotherapy following chemotherapy. However, radiation treatment to the chest can have long-term toxic effects including an increased risk of breast cancer and heart problems.

The results, presented by Ann LaCasce, MD, MMSc, of Dana-Farber, included 94 patients with stage IA-IIB cHL and disease bulk greater than 10 cm or .33 maximum intrathoracic diameter on chest X-ray. Patients received two cycles of chemotherapy (ABVD) and then underwent PET imaging. Patients whose disease showed uptake less than liver on interim PET scan (PET2-) – 78% of the patients — received four additional cycles of chemotherapy, but no radiotherapy. Patients classed as PET2+ received intensified chemotherapy with four cycles of escBEACOPP plus radiation therapy.

The estimated progression-free survival (PFS) was 93.1% in the PET2- patients and 89.7% in PET2+ patients. With a median follow-up of 5.5 years, estimated 3-year overall survival was 98.6% in PET2- patients and 94.4% in PET2+ patients. (Overall survival was not a primary or secondary outcome of the study).

The investigators said the PET-adapted approach achieved excellent PFS outcomes "that allowed omission of radiotherapy in 78 percent of patients." The PET2+ patients who received BEACOPP and radiotherapy "did not have inferior outcomes."

Title: CALGB 50801 (Alliance): PET adapted therapy in bulky stage I/II classic Hodgkin lymphoma (cHL)

Abstract: 7507

Presenter: Ann S. LaCasce, MD, MMSc

Session/Time: Oral Abstract Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia; Broadcasting: June 7, 11:30am-2:30pm

Additional cycle of pembrolizumab before surgery improves response rates in locally advanced head and neck cancer

Increasing neoadjuvant pembrolizumab from one to two cycles prior to surgery improved pathological response rates in patients with surgically resectable locally advanced, HPV-negative head and neck squamous cell carcinoma, reported Ravindra Uppaluri, MD, PhD, Dana-Farber/Brigham and Women’s Cancer Center. A previous study in which patients (36 total) received one neoadjuvant cycle of pembrolizumab followed by surgery two to three weeks later yielded a 22% rate of >50% pathologic response (tumor cell death and other evidence of response designated as pTR-2) and a 22% pTR-1 rate (10-49% pathologic response). The new report was on a 28-patient phase 2 trial in which patients received two cycles of pembrolizumab 42 and 21 days prior to surgery. Twelve of 28 patients (43%) experienced a pTR-2 and four (16%) of these patients had a major pathologic response including 1 complete response at the primary site.

Neoadjuvant therapy was well tolerated and clinical outcomes in this advanced disease population were excellent with only one recurrence noted to date. The researchers said the data suggest that the frequency of pathologic responses to neoadjuvant pembrolizumab can be improved by increasing the number of cycles and the treatment interval.

Title: Enhanced pathologic tumor response with two cycles of neoadjuvant pembrolizumab in surgically resectable, locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC)

Abstract: 6008

Presenter: Ravindra Uppaluri, MD, PhD

Session/Time: Oral Abstract Session: Head and Neck Cancer; Broadcasting: June 7, 2:45pm-5:45pm

Molecular profiling of tumor tissue can benefit many young patients with cancer, study suggests

Testing solid tumors for genetic changes that can be targeted by drugs has revolutionized the treatment of many adults with cancer. New research by scientists at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center suggests it can have significant benefits for many younger patients as well.

Alanna J. Church, MD, Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, will present results from the GAIN/iCat2 consortium study, which is evaluating the use of genomic profiling of solid tumors in children and young adults. The report includes data on 345 study participants with molecular profiling, who were diagnosed with solid, non-brain tumors at age 30 or younger. 299 patients (87%) had at least one genomic alteration that could impact the diagnosis, treatment, and prognosis of their disease, the researchers found.

Thirty-one patients were treated with matched targeted therapies and six patients had extraordinary responses to treatment. All patients with extraordinary responses matched to a gene fusion, and 78% of diagnostically significant alterations were fusions.

Molecular tumor profiling has a significant impact on diagnosis and treatment recommendations for young patients with solid tumors. These results emphasize the importance of fusion detection for patients with sarcomas and rare tumors,said Church, the lead author of the study, which was the highest rated pediatric oncology abstract at the ASCO (Free ASCO Whitepaper) conference, and winner of the Conquer Cancer Nachman Award.

Title: Clinical impact of molecular tumor profiling in pediatric, adolescent, and young adult patients with extra-cranial solid malignancies: An interim report from the GAIN/iCat2 study

Abstract: 10005

Presenter: Alanna J. Church, MD

Session Time: Oral Abstract Session: Pediatric Oncology I; Broadcasting: June 5, 10:00am-1:00pm

A full list of Dana-Farber Oral Presentations at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting is available here.

Additionally, Dana-Farber researchers are recipients of ASCO (Free ASCO Whitepaper)’s Special Awards, the Society’s highest honors.

Jennifer A. Ligibel, MD, director of the Leonard P. Zakim Center for Integrative Therapies and Healthy Living and the director of the Center for Faculty Well-Being at Dana-Farber, is the recipient of the Hologic, Inc Endowed Women Who Conquer Cancer Mentorship Award.

Tracy A. Balboni, MD, MPH, FAAHPM, radiation oncologist at Dana-Farber/Brigham and Women’s Cancer Center and a professor of radiation oncology at Harvard Medical School, is the recipient of the Walther Cancer Foundation Palliative and Supportive Care in Oncology Endowed Award. Her award lecture is available for on-demand viewing during the ASCO (Free ASCO Whitepaper) conference, starting June 4, 2021, 9:00am ET.

Read more about this year’s Dana-Farber ASCO (Free ASCO Whitepaper) Special Awards here.

BioRay In-licenses Rights to Brain Cancer Drug from Nascent

On May 19, 2021 BioRay Pharmaceutical, a Taizhou biotech, reported that in-licensed rights to pritumumab, a potential treatment for brain cancer, from Nascent Biotech of San Diego (Press release, Shanghai Bioray Laboratory, MAY 19, 2021, View Source [SID1234580461]). BioRay will pay up to $5 million for global pritumumab rights except for North America and Central America. Pritumumab is a natural human antibody that binds to vimentin, a protein expressed on the surface of epithelial cancers but not healthy cells. BioRay is the biologics subsidiary of China’s Hisun Pharma. In 2019, PAG, a Hong Kong private equity firm, paid $540 million to acquire a 58% stake in BioRay.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!