On October 8, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will report financial results for the third quarter 2021 after market close on Thursday, November 4, 2021 (Press release, Guardant Health, OCT 8, 2021, View Source [SID1234591024]). Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time .

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Live audio of the webcast will be available on the "Investors" section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

On October 8, 2021 Compass Therapeutics, Inc. (OTC:CMPX) and ABL Bio (KOSDAQ: 298380) reported that clinical trial data for CTX-009 (ABL001/ES104), a dual anti-angiogenic bispecific antibody targeting DLL4 and VEGF-A, at an oral plenary session during the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) (Abstract Number: 4749; Session Title: Plenary Session 2: New Drugs on the Horizon I) (Press release, Compass Therapeutics, OCT 8, 2021, View Source [SID1234591025]).

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The first in human Phase 1 single agent dose escalation and expansion study evaluated CTX-009 across nine dose levels. The study enrolled 45 heavily pre-treated patients with cancers primarily of colorectal and gastric origin. CTX-009 was well tolerated across all doses evaluated, with no dose-limiting toxicities reported. The most frequent treatment related adverse event was hypertension, observed in 17 patients of the 45 patients enrolled. Among those, 7 patients reported Grade 3 hypertension and the rest had Grade 1 or Grade 2 (16%). Only 4 mild cases of pulmonary hypertension were reported that were all reversible, and CTX-009 demonstrated significant clinical activity as a stand-alone therapy. The majority (87%) of the patients enrolled in the study had ECOG performance status of 1; 42% (n=19) were patients with gastric cancer and 40% (n=18) were patients with colorectal cancer with a median of three prior lines of systemic anticancer therapies. Importantly, 62% of the patients enrolled were previously treated with anti-VEGF antibodies containing regimens. There were 4 partial responses (including three partial responses confirmed by RECIST 1.1 and one partial response which was unconfirmed) and 20 stable diseases among 39 evaluable patients. The confirmed overall response rate (ORR) across all dose levels tested (0.3 – 17.5mg/kg) was 8%, not including 1 unconfirmed partial response, and the disease control rate (DCR) across all dose levels was 62%. The ORR at the recommended phase 2 doses (RP2D) of 10.0-12.5 mg/kg was 19% (n=3/16) not including one unconfirmed partial response, and the DCR at the RP2D was 69% (n=11/16).

"This is a significant clinical result because current approved anti-angiogenic drugs have little efficacy as a monotherapy. Furthermore, 94% of the colorectal patients and 58% of the gastric patients in this study were previously treated with Avastin (bevacizumab) or Cyramza (ramucirumab), respectively; the response rate is almost three times that seen for current 3rd and 4th line therapies in patients with colorectal and gastric cancers." said Jeeyun Lee, MD, a Professor at the Samsung Medical Center, Seoul, South Korea and the principal investigator of the study.

"The responses to CTX-009 as a monotherapy in this refractory patient population combined with the excellent tolerability profile suggests that CTX-009 can become an important drug for a broad range of solid tumors" said Thomas Schuetz, MD, PhD, CEO and scientific Founder of Compass Therapeutics. "We look forward to developing CTX-009 in the United States and other geographies and to unlocking its full potential". Compass Therapeutics of Boston, Massachusetts holds the global rights to CTX-009 with the exception of S. Korea (rights held by Handok) and China (rights were out-licensed to Elpiscience Biopharma).

"We are pleased to present the clinical data of CTX-009 (ABL001) for the first time at a prominent international conference," said Sang Hoon Lee, PhD, CEO of ABL Bio. "CTX-009 has demonstrated its potential to benefit cancer patients, especially those that have been unable to experience improvements with standard treatments. We expect to further validate the therapeutic value of CTX-009 as it progresses through clinical trials in the U.S., China and South Korea."

"We are happy to see the next frontier of anti-angiogenic therapies, CTX-009 (ES104) showing promising anti-tumor activity in a Phase 1 study as monotherapy," said Steve Chin, MD, CMO of Elpiscience Biopharma, "We look forward to initiating the clinical trials in China to explore its therapeutic potential in the heavily pre-treated digestive tract cancer patients."

About CTX-009

CTX-009 (ABL001/ES104) is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of CTX-009 suggests that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. CTX-009 has completed a Phase 1 monotherapy dose escalation and expansion study. Phase 1b and Phase 2 combination studies are ongoing.

On October 8, 2021 Pacific Cancer Care and Deep Lens reported that they are collaborating to optimize clinical trial matching and accelerate enrollment at the Monterey-based practice through the use of Deep Lens’ artificial-intelligence (AI) based solutions and other services (Press release, Pacific Cancer Care, OCT 8, 2021, View Source [SID1234591026]). Pacific Cancer Care is the largest hematology and oncology practice on the California Central Coast. Deep Lens is a digital healthcare company that helps community oncology practices improve and expand clinical research programs through the use of their proprietary AI solution, VIPER. This partnership will expand Pacific Cancer Care’s existing clinical trial offering to patients by more accurately and effectively identifying eligible patients for trials, improving communications between patient care teams and bringing more trials to the practice.

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"Clinicals trials are not only critical to the advancement of new therapeutic options for cancer, but they present a unique opportunity for patients to access novel treatments well in advance of their commercialization, some of which may help positively impact the state of their disease," said Zach Koontz, M.D., oncologist at Pacific Cancer Care. "We are excited to partner with Deep Lens to broaden our clinical research program through an increased number of trials that we can offer onsite and by expediting the time we can get patients into these trials. We have a very busy practice and we look forward to leveraging other Deep Lens services to help alleviate some of the administrative tasks associated with clinical trial recruitment, so that our staff can focus more exclusively on patient care."

It is estimated that more than 15,000 oncology clinical trials are actively recruiting patients; however, fewer than 1 in 30 patients participate in a clinical trial. Limited trial site resources make it time-consuming to identify eligible patients, especially as trial protocols increase in complexity. VIPER supports care teams by automating the identification of potentially eligible patients at the time of diagnosis and easily matching them to relevant trials.

"Pacific Cancer Care already has an extremely comprehensive clinical research program – they’ve been the first site to offer access to certain therapies via clinical trials and they place great importance on the role that clinical research plays in the overall acceleration of our knowledge and treatment of cancer," said Simon Arkell, president and co-founder at Deep Lens. "We are thrilled to align with such a prominent, reputable practice that is just as passionate as Deep Lens about innovation and the potential of precision therapies for the treatment of cancer. We look forward to helping this practice better serve the Central Coast oncology community."

Deep Lens’ VIPER will pre-screen all patients from Pacific Cancer Care’s EMR (OncoEMR) and integrate molecular data feeds from Caris Life Sciences, Foundation Medicine and Guardant Health as well as all pathology feeds to automatically identify qualified patients for clinical trials. Deep Lens pre-screening and clinical trial matching solution is provided at no cost to oncology practices.

Deep Lens is working with a significant number of community oncology practices representing every region in the U.S. It is estimated that approximately 85 percent of cancer patients are diagnosed and treated at local, community-based oncology practices. Deep Lens is committed to expanding important oncology research by making trials more accessible to a larger and more diverse population within these local community settings.

On October 8, 2021 bluebird bio, Inc. (NASDAQ: BLUE) reported the filing by 2seventy bio of an updated Form 10 Registration Statement with the U.S. Securities and Exchange Commission (SEC) (Press release, 2seventy bio, OCT 8, 2021, View Source [SID1234594668]). This Form 10 reflects bluebird bio’s plans for a tax-free spin-off of its oncology programs and portfolio into 2seventy bio as a publicly traded company. The spin-off is on track to be completed by early November 2021. bluebird bio also announced the appointment of Najoh Tita-Reid and Sarah Glickman to the bluebird bio board of directors. Upon effectiveness of the Form 10, Ms. Glickman will also be a member of the board of directors of 2seventy bio and will step down from the bluebird bio board of directors upon completion of the spin-off.

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"As we approach separation, we have been strategic and diligent in setting up each business for success," said Nick Leschly, chief bluebird and expected chief kairos officer, 2seventy bio. "The first part of this year was largely directed toward focusing and shaping our internal operations and continuing to advance the transformative gene and cell therapy products that sit on both sides of the current business. Rounding out those necessary pillars for success is financial strength and leadership, and we’re extremely pleased to share today further detail on the balance sheet that each company is expected to launch with, as well as key members of each board of directors. This is another step forward and we remain on track to launch bluebird bio and 2seventy bio by early November with the right pieces in place to drive both entities toward delivering for patients with meaningful, value-creating milestones."

Upon separation, bluebird bio plans to distribute 100% of the outstanding shares of 2seventy bio common stock to bluebird’s shareholders in a 3:1 ratio. For every three shares of bluebird bio stock, current shareholders will receive one share of 2seventy bio stock.

The company anticipates that its cash, cash equivalents and marketable securities balance at separation will be approximately $1.0B, inclusive of proceeds from the recent sale of the company’s manufacturing facility in North Carolina and its private placement equity financing. bluebird bio expects to fund 2seventy bio with approximately $480M in cash upon separation, with the balance to be retained by bluebird bio. Together with existing and emerging sources of revenue and other anticipated cash inflows, which includes the potential sale of priority review vouchers that would be issued with anticipated U.S. regulatory approvals of BLAs for bluebird’s therapies in beta-thalassemia and cerebral adrenoleukodystrophy, the Company expects its cash, cash equivalents and marketable securities balance will be sufficient to fund operations for bluebird bio and 2seventy bio into 2023 under current business plans.

The company also announced the appointment of two new board members.

Najoh Tita-Reid was appointed to the bluebird bio board of directors. Najoh Tita-Reid is Chief Marketing Officer for Logitech, a global manufacturer of computer peripherals, software and services with headquarters in Switzerland and California. In her role, Ms. Tita-Reid is leading the transformation of the global marketing function and spearheading a strategic, digital-first and data-driven consumer and customer omnichannel experience. A multi-faceted executive with global marketing expertise, she has a record of strategic and operational ingenuity and transformation across complex organizations. Prior to her role at Logitech, Ms. Tita-Reid was Global Chief Marketing Officer and Executive Board Member for Hero-AG, a family-run healthy food company, and held leadership positions at Bayer PLC and Merck & Co, Inc. Ms. Tita-Reid spent 19 years at Procter & Gamble where she managed several multi-billion-dollar brands. She also led African American Marketing for P&G, the world’s largest advertiser, and created breakthrough marketing strategies, including "My Black is Beautiful," which stands as a template for multi-cultural campaigns across industry today. Ms. Tita-Reid graduated with a Bachelor of Arts from Spelman College and holds an MBA from Fuqua School of Business at Duke University.

"As we approach separation, we are in a strong financial and operational position and poised to unlock value both for our patients and our shareholders," said Andrew Obenshain, president, severe genetic diseases and expected chief executive officer, bluebird bio, post separation. "We are pleased to welcome Najoh to bluebird bio’s board of directors and look forward to benefiting from her expertise in multi-brand strategy and execution as we enter the next chapter for bluebird bio, focused on the commercialization of three transformational gene therapies for severe genetic diseases."

Sarah Glickman was also appointed to the bluebird bio board of directors and is expected to join the 2seventy bio board of directors as Audit Committee Chair upon separation. Ms. Glickman is the Chief Financial Officer for Criteo, a global technology company headquartered in Paris, France and listed on Nasdaq. She jointly leads Criteo’s strategy to drive profitable long-term growth and shareholder value through transformational change, including M&A. Key responsibilities include leading all aspects of financial planning and reporting, investor relations, treasury, tax, controllership and internal controls. She is also responsible for global IT, procurement and real estate. Prior to Criteo, she was the acting Chief Financial Officer and Chief Transformation Officer of XPO Logistics in Greenwich, CT. Prior to XPO, she was the Chief Financial Officer for the Novartis Business Services division of Novartis AG, a global pharmaceutical company. Ms. Glickman spent ten years at Honeywell, Inc. and before held finance roles at Bristol-Myers Squibb and PricewaterhouseCoopers. She is a Certified Public Accountant (US) and Fellow Chartered Accountant (UK) and graduated with a Bachelor of Arts in Economics and History, with honors, from the University of York in England.

"We’re excited that Sarah will join the board of 2seventy bio in this crucial launch phase," said Nick Leschly. "Her financial leadership experience at several successful companies will be a tremendous asset as we focus on shoring up our balance sheet and setting up 2seventy bio with a healthy foundation to enable the continued advancement of our cell therapy platform."

On October 8, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that its collaboration with Bristol Myers Squibb (NYSE: BMY) has been expanded to include a new cell type, triggering a payment of $ 9.0 m to Evotec (Press release, Evotec, OCT 8, 2021, View Source;announcements/press-releases/p/evotec-expands-neuroscience-collaboration-with-bristol-myers-squibb-to-include-novel-cell-type-6100 [SID1234591011]).

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The collaboration was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of the patients’ symptoms and there is tremendous unmet medical need for therapeutic options that slow down or reverse disease progression. The collaboration pursues an innovative approach to the discovery and development of novel medicines by leveraging Evotec’s iPSC platform using patient-derived disease models, which is one of the largest and most sophisticated platforms in the industry.

Since 2016, the companies have expanded the collaboration several times. The latest expansion will enable the companies to investigate the root causes of many neurodegenerative diseases in a cell type specific fashion using cells directly derived from patients. In addition, molecular disease signatures will be used to define detailed molecular disease phenotypes using Evotec’s leading panomics platform, EVOpanOmics & EVOpanHunter.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are delighted that our important collaboration with Bristol Myers Squibb will now investigate and target mechanisms driving neurodegeneration more comprehensively through the addition of a new cell type. Through our human iPSC-based approach we believe we have the potential to improve clinical outcomes of neurodegeneration programmes. iPSC technology enables us to directly work on human neurons to explore new drug candidates in the pre-clinical setting."