Massive Bio Raises $9 Million To Scale Growth and Fuel Global Expansion of AI-Enabled Oncology Clinical Trial Platform

On June 3, 2022 Massive Bio, Inc., a leader in precision medicine and artificial intelligence (AI) enabled patient-centric clinical trial enrollment, reported that it raised $9 million co-led by Revo Capital and Kenan Turnacıoğlu PaigeAI, with additional participation from DEG – Deutsche Investitions- und Entwicklungsgesellschaft mbH, the German Development Finance Institution (Press release, Massive Bio, JUN 3, 2022, View Source [SID1234615501]).

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This investment will enable the company to further scale its operations globally, invest in marketing, and launch additional non-status quo products in oncology clinical trial enrollment with its data-rich platform. The company’s clinical research business launched in late 2019, and the financing round builds on another exponential growth year for Massive Bio, with 60,000 cancer patients and 26 enterprise customers. 88 percent of those customers are large pharmaceutical companies and CROs. Massive Bio has expanded to 12 countries with a global workforce of 70 employees in the past 12 months.

Massive Bio Co-founder and CEO Selin Kurnaz stated, "We are building a category-defining company in the oncology ecosystem by engineering patient enrollment value chain, and we are excited by the unwavering support from our new and existing investors, who have seen our exponential organic growth, strong ROI to our clients and unique value proposition to patients and oncology ecosystem." Dr. Kurnaz added "We are significantly different than the companies at our stage, cost-efficient and generating consistent revenue and client growth despite the economic downturn, relying mostly on customer demand to fuel our growth. Our passion, dedication, perseverance, and smart work has led to the company’s success and expansion in 12 markets without a sales force or marketing. Having the financial support, healthcare expertise, and global coverage of investors such as DEG and Kenan, along with heavy technology expertise of our existing investors like Revo Capital will help us execute our goals globally and at an accelerated scale."

With tens of thousands active cancer clinical trials globally, and dozens of biomarkers and precision oncology molecules, Massive Bio aims to use AI and patient-centric concierge services at scale to reach cancer patients across the world and accelerate the oncology research and development infrastructure. Massive Bio had recently announced the launch of its NASA-style Oncology Clinical Trial Command Center (OCTCC) to disrupt and accelerate trial enrollment, the launch of its 100K Cancer Clinical Trial Singularity Program aimed at matching 100,000 cancer patients in real-time to cutting-edge clinical trials using its AI-based technology, website, and apps across iOS and Android platforms, and was included in the 2022 NYC Digital Health 100 which showcases the most exciting health start-ups in the New York region.

"Massive Bio has an impressive track record of landing and expanding on pharmaceutical customers while being relentless on execution. We were impressed with the highly motivated and mutually complementary founders’ team that has the courage to solve large and complex problems with minimal capital and resources and we felt that we can bring their dream into action together in an accelerated fashion with our capital, domain expertise and highly qualified network. They have the potential to transform the oncology research industry and become a world-changing company", said Kenan Turnacıoğlu, who is the co-lead of the round and new board member of Massive Bio.

"Our AI-enabled clinical trial and precision oncology therapy-finding technology along with our real-time patient-empowering approaches are key to solving the problem in clinical trial enrollment in cancer pharmaceutical biotech pipeline, and we have successfully proven the necessary market fit, product deliverables, ongoing demand and expansive network effects to meet our clients’ and investors’ confidence in our platform’s success" said Arturo Loaiza-Bonilla, M.D., Co-Founder of Massive Bio. "This vote of trust from investors is the product of our relentless efforts for constant growth, best use of technology and data to deliver to each client, and to optimize systems to automate processes efficiently, while expanding our innovation stack, network development and portfolio verticals, with a keystone strategy of being a hub to allow the sustainability of the digital networks we keep and thrive upon", added Loaiza-Bonilla.

"After working with Massive Bio for the past two years and seeing how its AI-powered end-to-end platform streamlined clinical trial recruitment while providing important insights to its pharma customers, we are proud to lead the round for the company’s next phase" said Cenk Bayrakdar, Founding Partner and Managing Director at Revo Capital.

DEG’s Dr. Tilman Kruse, Global Head of Early Growth & Venture Capital, and Anna Winter, Investment Manager Private Equity & Venture Capital and deal team leader, commented: "At DEG, we are impressed how Massive Bio has created a successful technology-driven business which has an enormous impact on people: As a global investor with a mandate to improve health and living conditions as part of the UN-Sustainable Development Goals (SDG), we are particularly proud to support Massive Bio’s further international expansion to improve access to new cancer treatments and clinical trials around the world, helping cancer patients globally. We are grateful to the founders and the entire cap table for smooth, trustful, and efficient cooperation on this round which enables Massive Bio to scale up and address its global Total Addressable Market (TAM)."

Sapience Therapeutics Presents Phase 1 Data at ASCO 2022 Including Efficacy Proof-of-Concept with ST101 in Patients with Refractory Solid Tumors

On June 3, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported data from a Phase 1 study demonstrating efficacy proof-of-concept of the Company’s lead program, ST101, in patients with refractory solid tumors (Press release, Sapience Therapeutics, JUN 3, 2022, View Source [SID1234615517]). The data will be presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 5, 2022.

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ST101, a first-in-class peptide antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). The primary objectives of the Phase 1 clinical study were to evaluate the safety and tolerability of ST101 and to determine the recommended Phase 2 dose. Secondary and exploratory objectives included pharmacokinetics (PK), preliminary efficacy (RECIST 1.1), and pharmacodynamic (PD) evaluation. The study used a 3+3 dose-escalation design, with once-weekly IV infusion dosing of ST101 at 0.5, 1, 2, 4, 6, 9 mg/kg or a flat dose of 500 mg.

Phase 1 Study Results:

As of May 5, 2022, 25 patients with multi-metastatic disease that were refractory to standard therapy received a median of 8 weeks of treatment
Three patients show ongoing clinical benefit:
One confirmed PR lasting more than 51 weeks in a patient with cutaneous melanoma
Eight patients with varying histologies had stable disease lasting 9-81+ weeks (2 ongoing)
No DLTs, dose modifications, or serious adverse events (SAEs) related to ST101
Pharmacokinetics and pharmacodynamics support the selection of a 500 mg flat dose as the recommended Phase 2 dose
Dr. Alice Bexon, Sapience’s Chief Medical Officer, commented, "We remain extremely pleased with the safety and efficacy ST101 has demonstrated in Phase 1, with evidence of clinical benefit across the whole dose range explored, particularly at higher doses and in patients with melanoma. The Phase 2 expansion portion of the study is going very well, with all cohorts enrolling, and a confirmed partial response in a patient with recurrent glioblastoma, which is very exciting. We believe that ST101’s unique mechanism of action targeting C/EBPß represents a potentially transformative approach to treating cancer."

+indicates ongoing treatment

SD=stable disease
PR=partial response

Details of the poster presentation at ASCO (Free ASCO Whitepaper) 2022 are as follows:

Abstract Number: 3014
Title: Efficacy proof-of-concept from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ in patients with refractory solid tumors
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session
Date/Time: June 5, 2022, 2:30 PM CDT

Abstracts and full session details can be accessed through the ASCO (Free ASCO Whitepaper) meeting planner: Abstracts | ASCO (Free ASCO Whitepaper) Annual Meeting

About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

Naveris Announces Abstract Accepted for Presentation at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting

On June 3, 2022 Naveris, Inc. reported the presentation of an abstract related to its flagship diagnostic test for TTMV-HPV DNA (NavDx) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place from June 3 through June 7, 2022 in Chicago and virtually (Press release, Naveris, JUN 3, 2022, View Source [SID1234615533]).

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Results of TTMV-HPV DNA testing in the NRG-HN002 phase II clinical trial for patients with p16-positive oropharynx cancer treated with intensity-modulated radiation therapy (IMRT), with or without cisplatin chemotherapy, will be shared in the presentation.

Details of the presentation are as follows:

Oral Presentation
Abstract: 6006
Title: Association of plasma tumor tissue modified viral HPV DNA (TTMV) with tumor burden, treatment type, and outcome: A translational analysis from NRG-HN002.
Presenter: Sue S. Yom, M.D., Ph.D., Professor and Vice Chair, Strategic Advisory, Department of Radiation Oncology; Professor, Otolaryngology-Head and Neck Surgery, Univ. of California San Francisco (UCSF)
Presentation Session Date/Time: The oral presentation will take place on Friday, June 3, 2022 from 3:45 – 6:45 p.m. EDT, during the session titled "Head and Neck Cancer"
Location: In-Person & Live Stream | S406

Following the presentation, the data presented will be available on the Naveris website at View Source

Arcellx Presents Continued Robust Long-Term Responses from its CART-ddBCMA Phase 1 Expansion Trial in Patients with Relapsed or Refractory Multiple Myeloma at the 2022 ASCO Annual Meeting

On June 3, 2022 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported new positive clinical data from the ongoing Phase 1 expansion study of its novel, autologous, CART-ddBCMA therapy for the treatment of patients with relapsed or refractory multiple myeloma (Press release, Arcellx, JUN 3, 2022, View Source [SID1234615549]). The clinical results are being presented during an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Evaluable for efficacy and safety analysis were 31 patients, based on follow-up of at least one month, following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 million CAR+ T cells, n=6), the second dose level (300 million CAR+T cells, n=6), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 100 million CAR+T cells (n=19). All patients enrolled in the study have poor prognostic factors with 21 of 31 (68%) patients penta-refractory, 12 of 31 (39%) extramedullary disease (EMD), and all 31 patients having had at least three prior treatments.

The interim CART-ddBCMA clinical results (May 3, 2022 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

Of the 31 evaluable patients with median follow-up of 12.1 months
100% overall response rate (ORR) achieved in all patients per International Myeloma Working Group criteria
22 of 31 (71%) evaluable patients achieved complete response (CR) or a stringent complete response (sCR)
29 of 31 (94%) patients achieved > very good partial response (VGPR)
2 of 31 (6%) patients achieved a partial response (PR)
12 of 31 (39%) with extramedullary disease
13 of 16 patients (81%) dosed more than 12 months ago reached CR/sCR; 8 (50%) with EMD; 9 (56%) remain in ongoing response with a median follow up of 17.7 months
Conversions to sCR have occurred as early as 1 month and also at ≥12 months
CART-ddBCMA dosed at RP2D (100 million CAR+T cells) continues to be well-tolerated
Toxicities including CRS and ICANS have been manageable, and all resolved with standard management at both dose levels
No cases of delayed neurotoxicity events or parkinsonian symptoms
No cases of grade 3 (or greater) CRS and only one case (4%) of grade 3 ICANS event with no additional cases from previously reported.
Matthew J. Frigault, M.D., CART-ddBCMA study investigator and Assistant Director of the Cellular Therapy Service at Mass General Cancer Center and Instructor at Harvard Medical School said, "The demand for clinically meaningful and safe CAR-T therapies outweighs what’s currently available to multiple myeloma patients. It is encouraging to see these data continue to demonstrate deep responses and provide a benefit to patients. I look forward to enrolling patients in the Phase 2 pivotal study."

"We’re excited by these long-term results, particularly given the challenging patient demographics, and believe these promising results reflect the potential for our lead program, CART-ddBCMA, to be a best-in-class treatment for patients with multiple myeloma," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "We believe there’s a significant unmet need for cell therapies and we’re committed to providing physicians with a safe and effective treatment option for multiple myeloma patients. We’re honored to have our data presented at ASCO (Free ASCO Whitepaper) by Dr. Frigault and look forward to beginning enrollment in our Phase 2 pivotal study by the end of this year as the next step in the path towards regulatory approval."

The presentation can be accessed on the company’s corporate website here.

Oral Presentation Details:
Title: Phase 1 Study of CART-ddBCMA in Relapsed or Refractory Multiple Myeloma
Speaker: Matthew J. Frigault, M.D., Assistant Director of the Cellular Therapy Service at Mass General Cancer Center, and Instructor at Harvard Medical School
Session Type/Title: Oral Abstract Session/Hematologic Malignancies—Plasma Cell Dyscrasia
Session Date: Sunday, June 5, 2022
Session Time: 8:00 a.m. – 11:00 a.m. CDT
Location: McCormick Place Convention Center, Chicago, Illinois
Abstract Number: 8003

Webcast Event:
Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Sunday, June 5, 2022, at 7:00 p.m. CDT. The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA
CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 1 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

Lilly to Participate in Goldman Sachs Global Healthcare Conference

On June 3, 2022 Eli Lilly and Company (NYSE: LLY) reported that it will attend the Goldman Sachs 43rd Annual Global Healthcare Conference on Tuesday, June 14, 2022 (Press release, Eli Lilly, JUN 3, 2022, View Source [SID1234615502]). Anne White, senior vice president and president, Lilly Neuroscience, and Mark Mintun, senior vice president, research and development – neuroscience and president, Avid Radiopharmaceuticals, will participate in a fireside chat at 1:40 p.m., Eastern time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.