On May 20, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company developing proprietary, intratumoral products to kill tumors and increase immune system recognition of cancers, reported two poster presentations to be made at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4 to 8 (Press release, Intensity Therapeutics, MAY 20, 2021, View Source [SID1234580395]).

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Title: A Phase 1/2 Study of Intratumoral INT230-6 Alone (IT-01) or in Combination with Pembrolizumab [KEYNOTE-A10] in Adult Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors Refractory to Therapy
Authors: El-Khoueiry, A.B., et al.
Session: Developmental Therapeutics – Immunotherapy
Session type: Poster Session
Abstract: 2592

Title: Early Results of Intratumoral INT230-6 Alone or in Combination with Ipilimumab in Subjects with Advanced Sarcomas
Authors: Ingham, M., et al.
Session: Sarcoma
Session type: Poster Session
Abstract: 11557

"INT230-6 is a novel, proprietary, locally-delivered anti-cancer product candidate that has shown very promising clinical results as monotherapy in a basket study of patients with advanced and refractory disease," said Lewis H. Bender, President and CEO of Intensity Therapeutics. "We are excited that ASCO (Free ASCO Whitepaper) has offered us the opportunity to share our encouraging results in two presentations. The data to be reported in our first poster will update our safety and efficacy results for patients receiving INT230-6 alone or in combination with pembrolizumab. The second presentation details preliminary results of INT230-6 with or without ipilimumab to treat sarcomas, a complex cancer type with high unmet medical need."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells.

About Intensity Therapeutics’ Clinical Studies

INT230-6 is currently being evaluated in several Phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination INT230-6, with Bristol Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized, controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

On May 20, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating virtually in the following investor conferences (Press release, Guardant Health, MAY 20, 2021, View Source [SID1234580394]).

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William Blair 41st Annual Growth Stock Conference
Fireside Chat on Tuesday, June 1st at 12:00 p.m. Pacific Time / 3:00 p.m. Eastern Time
Goldman Sachs 42nd Annual Global Healthcare Conference
Fireside Chat on Tuesday, June 8th at 12:00 p.m. Pacific Time / 3:00 p.m. Eastern Time
Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

On May 20, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that the company will present data from its Phase 2 clinical trial of PEN-221 at the 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting occurring virtually June 4-8, 2021 (Press release, Tarveda Therapeutics, MAY 20, 2021, View Source [SID1234580393]).

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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

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PEN-221 is a miniature drug conjugate consisting of a peptide ligand that is highly selective in targeting the somatostatin receptor 2 (SSTR2), joined through a cleavable linker to the potent cytotoxic payload DM1. The Phase 2 trial assessed the safety, tolerability, pharmacokinetics, and preliminary efficacy of PEN-221 in well differentiated neuroendocrine tumors (NETs) and small cell lung cancer. The data being presented include safety and efficacy outcomes for patients enrolled in the gastrointestinal mid-gut NETs cohort.

"We are encouraged by the safety and efficacy results of our Phase 2 trial, which showed that PEN-221 was well tolerated and exceeded its clinical efficacy goals in patients with GI mid-gut neuroendocrine tumors," said Brian Roberts, President and Chief Executive Officer of Tarveda. "We look forward to presenting the results of the study at this year’s ASCO (Free ASCO Whitepaper) Annual meeting and to further evaluating PEN-221 in GI mid-gut neuroendocrine tumors."

Details of the poster presentation are as follows:

Title: The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 results.
Abstract Number: 4110
Date: Poster presentation available on demand beginning on June 4, 2021 at 9:00 AM ET

On May 20, 2021 ITM AG, a leading radiopharmaceutical company, reported that it will host a virtual symposium titled, "New Approaches for Targeted Radionuclide Therapy in Precision Oncology" as an ancillary event in parallel to the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, ITM Isotopen Technologien Munchen, MAY 20, 2021, View Source [SID1234580392]). The symposium will feature renowned key opinion leaders in the field and will be held on Friday, June 4th, 2021 from 9.30 am – 11.00 am ET / 3.30 pm – 5.00 pm CEST.

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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

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The interactive live-session will explore the latest science and clinical practices driving Targeted Radionuclide Therapy to the forefront of the precision oncology field. Participating experts will lead critical examinations and discussions surrounding topics including the current and future potential of Targeted Radionuclide Therapy in cancer therapy and diagnostics, its application in hard-to-treat indications such as gastroenteropancreatic-neuroendocrine tumors (GEP-NETs) and novel developments in the field, including ITM’s proprietary precision oncology pipeline.

The full scientific program and registration form are available on ITM’s website.

Scientific Program and Participating Experts:

Welcome & introduction
Richard L Wahl, MD, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO, U.S.
The potential for state-of-the-art Targeted Radionuclide Therapy & diagnostics and future applications
Richard L Wahl, MD, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO, U.S. (15 min)
The clinical management of NETs – a multi-disciplinary team approach
Jennifer A Chan, MD, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, U.S. (15 min)
Leveraging the latest developments in somatostatin receptor-positive tumors to generate novel therapeutic opportunities
Thorvardur R Halfdanarson, MD, Mayo Clinic, Rochester, MN, U.S. (15 min)
ITM’s precision oncology pipeline
Mona M Wahba, MD, MSM, ITM, Munich, Germany (15 min)
Discussion & closing remarks
Speakers will be available for a Q&A session at the end of the event.

The symposium will be available via a live webcast. A replay of the event will also be available on ITM’s website.

The symposium is not sponsored, endorsed, or accredited by ASCO (Free ASCO Whitepaper), CancerLinQ, or Conquer Cancer the ASCO (Free ASCO Whitepaper) Foundation.

On May 20, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that expanded tumor response data and overall survival data from the Phase 2a portion of the ongoing Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM) patients, will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 4-8 (Press release, VBI Vaccines, MAY 20, 2021, View Source [SID1234580391]).

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The e-poster presentation will highlight patient-specific tumor response data and improvement in overall survival (OS) compared to historical controls across both study arms:

Study arm 1 : VBI-1901 + granulocyte-macrophage colony-stimulating factor (GM-CSF)
6-month and 12-month OS : 80% (n=8/10) and 60% (n=6/10), respectively
2 partial responses (≥ 50% tumor reduction) and 2 stable disease observations – 40% disease control rate
1 patient still on protocol
Study arm 2 : VBI-1901 + GSK’s AS01B adjuvant system
6-month OS : 89% (n=8/9) – 12-month OS not yet reached
5 stable disease observations – 50% disease control rate
1 patient still on protocol
With few options for recurrent GBM patients, historical control data have demonstrated overall survival to be ~60% at 6-months and ~30% at 12-months after treatment with a monotherapy.1

Presentation details and schedule are as follows:

Abstract #: 2047
Abstract Title: Evaluation of GM-CSF and AS01B adjuvants in a Phase 1/2a trial of a therapeutic CMV vaccine (VBI-1901) against recurrent glioblastoma (GBM)
Presenter: Patrick Y. Wen, M.D., Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, Professor of Neurology at Harvard Medical School, and investigator of VBI’s Phase 1/2a study of VBI-1901
Session: Poster Session: Central Nervous System Tumors
Poster Access: June 4-8, 2021

The e-poster presentation will include a 5-minute pre-recorded presentation from Dr. Wen, available On Demand to meeting attendees from 9 AM ET on Friday, June 4.

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

Phase 1 (Part A)
Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent GBM patients with any number of prior recurrences.
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0 µg.
Enrollment completed in December 2018.
Phase 2a (Part B)
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase.
This phase is a two-arm study, enrolling 10 first-recurrent GBM patients in each vaccinated group, assessing 10.0 µg of VBI-1901 in combination with either GM-CSF or GSK’s proprietary AS01 adjuvant system as immunomodulatory adjuvants.
Enrollment of the 10 patients in each adjuvant group is complete.
VBI-1901 is administered intradermally when adjuvanted with GM-CSF and intramuscularly when adjuvanted with GSK’s AS01 adjuvant system. Patients in both phases of the study receive the vaccine immunotherapeutic every four weeks until tumor progression.

About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.