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)."

Bristol Myers Squibb to Acquire Turning Point Therapeutics, a Leading Precision Oncology Company

On June 3, 2022 Bristol Myers Squibb (NYSE:BMY) and Turning Point Therapeutics, Inc. (NASDAQ:TPTX) reported a definitive merger agreement under which Bristol Myers Squibb will acquire Turning Point Therapeutics for $76.00 per share (Press release, Turning Point Therapeutics, JUN 3, 2022, View Source [SID1234615500]). The transaction was unanimously approved by both the Bristol Myers Squibb and Turning Point Therapeutics Boards of Directors and is anticipated to close during the third quarter of 2022.

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Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis. Turning Point Therapeutics’ lead asset, repotrectinib, is a next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors. Repotrectinib has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration. In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC.

Bristol Myers Squibb expects repotrectinib to be approved in the U.S. in the second half of 2023 and become a new standard of care for patients with ROS1-positive NSCLC in the first-line setting. The company also plans to continue to explore the potential of Turning Point Therapeutics’ promising pipeline of novel compounds.

"The acquisition of Turning Point Therapeutics further broadens our leading oncology franchise by adding a best-in-class, late-stage precision oncology asset," said Giovanni Caforio, M.D., Board Chair and Chief Executive Officer, Bristol Myers Squibb. "With this transaction, we are continuing our strong track record of strategic business development to further enhance our growth profile."

"Today’s news builds upon our long legacy of pioneering next-generation medicines for patients with cancer," said Samit Hirawat, M.D., Chief Medical Officer, Global Drug Development, Bristol Myers Squibb. "With repotrectinib, we have the opportunity to change the standard of care and address a significant unmet medical need for ROS1-positive non-small cell lung cancer patients."

"Through this transaction, we will be able to harness the full potential of our precision oncology platform to advance the standard of care for cancer patients. Since our founding, we have leveraged our deep scientific expertise to develop a pipeline of promising precision oncology assets," said Athena Countouriotis, M.D., President and Chief Executive Officer, Turning Point Therapeutics. "With Bristol Myers Squibb’s leadership in oncology, strong commercial capabilities and manufacturing footprint, we will be able to further accelerate the pace at which we can bring our novel medicines to benefit people diagnosed with cancer around the world."

Financial Details and 2022 Financial Guidance

The transaction supports Bristol Myers Squibb’s medium- to long-term growth strategy with accretion to non-GAAP earnings per share (EPS) beginning in 2025. The transaction is expected to be up to $0.08 per share dilutive to non-GAAP EPS in 2022 prior to any impact from an acquired in-process research and development charge based on final accounting treatment. The accounting treatment as a business combination or asset acquisition will be determined upon the expected close of the transaction in the third quarter of 2022.

Transaction Terms and Financing

Under the terms of the merger agreement, Bristol Myers Squibb will promptly commence a tender offer to acquire all of the outstanding shares of Turning Point Therapeutics’ common stock at a price of $76.00 per share in an all-cash transaction for a total consideration of $4.1 billion in equity value. Turning Point Therapeutics’ Board of Directors unanimously recommends that Turning Point Therapeutics shareholders tender their shares in the tender offer.

The transaction is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Turning Point Therapeutics’ common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, Bristol Myers Squibb will acquire all remaining shares of Turning Point Therapeutics that are not tendered into the tender offer through a second-step merger at the same price of $76.00 per share.

Bristol Myers Squibb expects to finance the acquisition with cash on hand.

Advisors

Gordon Dyal & Co., LLC is serving as the exclusive financial advisor to Bristol Myers Squibb, and Kirkland & Ellis LLP is serving as legal counsel. Goldman Sachs & Co. LLC is serving as the exclusive financial advisor to Turning Point Therapeutics, and Cooley LLP is serving as legal counsel.

IconOVir Bio to Present at Jefferies Healthcare Conference

On June 3, 2022 IconOVir Bio, Inc. (IconOVir), a preclinical-stage biotechnology company pioneering the next generation of oncolytic virus (OV) therapy to improve the treatment of patients with cancer, reported that Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of IconOVir, will present a corporate overview at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 8:00 a.m. ET (5:00 a.m. PT) in New York, NY (Press release, IconOVir Bio, JUN 3, 2022, View Source [SID1234615496]).

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Precision BioSciences to Provide an Update on its Ongoing Allogeneic CAR T Programs via Hosted Virtual Webcast and Conference Call on Wednesday, June 8, 2022

On June 3, 2022 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will share an update on its allogeneic CAR T programs during a company-hosted webcast and conference call on June 8, 2022 at 8:00 AM ET (Press release, Precision Biosciences, JUN 3, 2022, View Source [SID1234615495]).

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"We look forward to sharing the recent developments on our CAR T programs, including the latest clinical data on our potential first-in-class allogeneic CAR T program, PBCAR0191, in patients who relapsed following CAR T treatment," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "The CAR T relapse setting is a rapidly growing area with dire unmet medical need that is not adequately addressed by current treatment options."

Company-Hosted Webcast and Conference Call Information

Precision will host a conference call and webcast on Wednesday, June 8, 2022 at 8:00 AM ET to review its ongoing allogeneic CAR T programs. 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 5754683. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source

ALX Oncology Announces Evorpacept Clinical Program Updates

On June 3, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported clinical program updates for its lead program, evorpacept, a next generation CD47 blocker (Press release, ALX Oncology, JUN 3, 2022, View Source [SID1234615494]).

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Introducing ASPEN-07, a Phase 1 Trial of Evorpacept for the Treatment of Patients with Urothelial Carcinoma ("UC")

ALX Oncology will initiate a new clinical study, ASPEN-07, to investigate evorpacept in combination with an antibody-drug conjugate ("ADC"), PADCEV (enfortumab vedotin-ejfv), for the treatment of patients with urothelial carcinoma ("UC") in the fourth quarter of 2022.
Enfortumab vedotin-ejfv is an ADC directed to Nectin-4, a protein located on the surface of cells that is highly expressed in UC.
In April 2022, ALX Oncology successfully completed a pre-IND consultation with the U.S. Food and Drug Administration ("FDA") for a Phase 1 study of evorpacept in combination with enfortumab vedotin-ejfv in patients with previously treated locally advanced or metastatic UC.
The IND application for ASPEN-07 was submitted to the FDA in May 2022.
"We continue to pursue strategies to expand the potential value of evorpacept as a cornerstone therapy for the treatment of patients with cancer," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ASPEN-07 further expands our solid tumor investigations and will be the first combination study of evorpacept with an ADC. The addition of evorpacept is expected to enhance the antibody-dependent cellular phagocytosis mediated by enfortumab vedotin-ejfv to improve efficacy in patients with UC without increasing toxicity. Our currently enrolling randomized Phase 2 studies remain a key priority for us in order to maintain ALX Oncology’s leadership position in solid tumors in the CD47 space."

Update of ASPEN-05, a Phase 1 / 2 Clinical Trial of Evorpacept in Combination with Venetoclax and Azacitidine in Acute Myeloid Leukemia ("AML"), and ASPEN-02, a Phase 1/2 Study of Evorpacept in Combination with Azacitidine in Myelodysplastic Syndrome ("MDS")

The Phase 1 dose escalation portion of ASPEN-05 has successfully completed enrollment with no safety concerns to date up to the highest protocol defined dose level of 60 mg/kg evorpacept once every four weeks. This portion of the study is designed to characterize the initial safety of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy.
Patient enrollment will be paused before proceeding into the Phase 1 dose optimization portion of ASPEN-05 pending completion of the Phase 1 portion of ASPEN-02, a Phase 1/2 study of evorpacept in combination with azacitidine in patients with MDS. Data from ASPEN-02 will be used to inform the optimal dose(s) of evorpacept to be studied in the ASPEN-05 study in combination with venetoclax and azacitidine. Ongoing patients in ASPEN-05 will continue to be treated and followed per protocol.
"The decision to pause ASPEN-05 is based on the desire to leverage upcoming dose optimization data from the ASPEN-02 MDS study to effectively inform dose optimization in ASPEN-05," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "MDS and AML are indications where evorpacept possesses a similar mechanism of action, and this strategy allows us to evaluate evorpacept in a cost-efficient manner in patients with AML while maintaining our focus in our solid tumor programs. We anticipate preliminary dose escalation data from ASPEN-05 to be presented at a scientific conference in 2022, and initial dose optimization data from ASPEN-02 to be presented at a scientific conference in mid-2023."

Update of ASPEN-03 and ASPEN-04, which are two distinct randomized Phase 2 studies for the treatment of patients with advanced head and neck squamous cell carcinoma ("HNSCC")

ALX Oncology continues to advance evorpacept in two randomized Phase 2 studies in patients with HNSCC in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, with or without chemotherapy. Both studies are being conducted in collaboration with Merck, known as MSD outside the United States and Canada. The first study, ASPEN-03, is evaluating the efficacy of evorpacept in combination with pembrolizumab for the first-line ("1L") treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC with a Combined Positive Score ("CPS") ≥ 1. The second study, ASPEN-04, is investigating evorpacept in combination with pembrolizumab and standard chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC (any CPS value).
Patient enrollment for ASPEN-03 and ASPEN-04 continues as planned with results expected to be presented by mid-2024.
Update of ASPEN-06, a Phase 2/3 Study of Evorpacept for the Treatment of Patients with Advanced Gastric or Gastroesophageal Junction ("GEJ") Cancer

ASPEN-06 is a randomized Phase 2 (open-label) / Phase 3 (double-blind), international, multi-center study to evaluate the efficacy of evorpacept and CYRAMZA (ramucirumab) added to trastuzumab and paclitaxel for the treatment of patients with HER-positive gastric/GEJ cancer whose tumors have progressed following treatment with HER2-targeted therapy and chemotherapy. ASPEN-06 is being conducted in collaboration with Eli Lilly and Company.
In March 2022, the first patient was dosed in the Phase 2/3 ASPEN-06 study.
Patient enrollment continues to progress and results from the Phase 2 portion of ASPEN-06 are expected to be presented in 2023.