GRAIL to Present New Data Supporting its Multi-Cancer Early Detection Test at the American Association for Cancer Research (AACR) Annual Meeting II

On June 22, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported that new data for its investigational multi-cancer early detection blood test will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II (Press release, Grail, JUN 22, 2020, View Source [SID1234561339]).

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Today, the majority of deadly cancers go undetected until they have progressed to late stages, when chances of survival are much lower. This is because most deadly cancers do not have guideline-recommended screening tests available.

GRAIL’s multi-cancer early detection technology can detect more than 50 cancers, with a very low false positive rate of less than one percent, through a single blood draw. When a cancer signal is detected, the test also identifies where the cancer is located in the body (the tissue of origin) with high accuracy.

"At GRAIL, we believe that in order to bend the curve on cancer mortality, we need to transition from screening only for individual cancers, to screening individuals for all types of cancers," said Joshua Ofman, MD, MSHS, Chief Medical Officer and External Affairs at GRAIL. "These new data demonstrate our continued commitment to scientific rigor, and further support the use of our multi-cancer early detection test in broad populations."

GRAIL’s multi-cancer early detection test is supported by evidence from its population-scale clinical study program, which is believed to be the largest ever conducted in genomic medicine.

The AACR (Free AACR Whitepaper) presentation details are included below. The slides and recordings will be available on www.grail.com at the conclusion of the meeting.

AACR Presentation Details

Abstract 2308/19
Joerg Bredno, et al. Classifier performance of a cfDNA-based multi-cancer detection test on uncommon cancer types
Session PO.PR02.02 — Clinical Prevention, Early Detection, and Interception 2: June 22, 2020: 9:00AM-6:00PM EDT

Abstract 721/15
Gregory Alexander, et al. Analytical validation of a multi-cancer early detection test with tissue localization using a cell-free DNA-based targeted methylation assay
Session PO.CL11.08 — Circulating Markers 1: June 22, 2020: 9:00AM-6:00PM EDT

Abstract 2114/1
Robert Calef, et al. HPV-driven cancers show distinct methylation signatures in cell-free DNA (cfDNA)
Session PO.BSB01.05 — Multi-omic and Multimodal Discovery: June 22, 2020: 9:00AM-6:00PM EDT

Abstract 139/2
Qinwen Liu, et al. cfDNA methylation profiling distinguishes lineage-specific hematologic malignancies
Session PO.MCB05.01— DNA Methylation: June 22, 2020: 9:00AM-6:00PM EDT

About GRAIL’s Multi-Cancer Early Detection Test

GRAIL’s multi-cancer early detection blood test can detect more than 50 cancers, across all stages, with a very low false positive rate of less than one percent, through a single blood draw. When a cancer signal is detected, the test identifies where in the body the cancer is located with high accuracy, an important step to guiding diagnostic next steps and care.

HiFiBiO Therapeutics Presents Three Novel Immuno-Oncology Programs at 2020 AACR Virtual Annual Meeting II

On June 22, 2020 HiFiBiO Therapeutics reported its three lead pipeline programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II taking place today (Press release, HiFiBiO Therapeutics, JUN 22, 2020, View Source [SID1234561355]). The company is a pioneer of novel antibody drug discovery and development leveraging single-cell analytics to treat cancer, autoimmune and infectious diseases. HiFiBiO invites members of the scientific and medical communities to listen to these poster presentations online at the AACR (Free AACR Whitepaper) meeting website or, after the AACR (Free AACR Whitepaper) meeting has concluded, at the HiFiBiO Therapeutics website.

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"These presentations demonstrate the rapid progress spearheaded by our scientists at HiFiBiO and the development of our pipeline, and we look forward to soon moving our lead programs to IND," said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. "Given our depth of experience in immune modulation and cutting-edge single-cell science and technology, we believe that HiFiBiO is realizing the potential of single-cell analysis to develop novel, high-quality antibody targets into life-changing treatment options for patients."

POSTER PRESENTATION DETAILS:

Title: HFB301001, a novel OX40 agonistic antibody with a unique pharmacological profile and innovative biomarker strategy
Presenters: Andreas Raue, PhD, Project Leader, Senior Director, Head of Drug Intelligent Science (DIS) at HiFiBiO Therapeutics and Robert Petit, PhD, Senior Scientific Advisor
E-Poster: #2285
HFB301001 is being developed as a potential novel treatment option for cancer coupled with a patient stratification biomarker in solid tumor indications.

Title: Discovery and characterization of novel TNFR2 antibodies to modulate T cell activities in immunosuppressive environment
Presenters: Francisco Adrian, PhD, Senior Vice President, Head of Research and Shuo Wei, PhD, Project Leader, Principal Scientist, Disease Biology
E-Poster: #2282
HFB200301 is an anti-TNFR2 monoclonal antibody being developed as a potential first-in-class therapeutic for the treatment of biomarker-selected patients with advanced cancer.

Title: HFB9-2, a novel Galectin-9 neutralizing antibody to reverse immune suppression in the tumor microenvironment
Presenters: Roshan Kumar, PhD, Senior Director, Head of Discovery Biology and US External Innovation and Yun-Yueh Lu, PhD, Project Leader, Principal Scientist, Disease Biology
E-Poster: #6532
HFB2009 program focuses on developing anti-Gal-9 neutralizing antibodies as a potential first-in-class treatment for AML and solid tumors, both as a single agent and a combination therapy.

More information about these and other programs in the HiFiBiO Therapeutics pipeline is available at View Source

Invitae and ArcherDX to create a global leader in comprehensive cancer genetics and precision oncology

On June 22, 2020 Invitae (NYSE: NVTA), a leading genetics company, and ArcherDX, a leading genomics analysis company democratizing precision oncology, reported the companies have entered into a definitive agreement under which Invitae will combine with ArcherDX to create a genetics leader with unrivaled breadth and scale in cancer genetics and precision oncology (Press release, Invitae, JUN 22, 2020, View Source [SID1234561371]).

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The combined company will be poised to transform care for cancer patients, accelerating adoption of genetics through the most comprehensive suite of products and services available. Integrating germline testing, tumor profiling and liquid biopsy technologies and services in a single platform will enable precision approaches from diagnostic testing to therapy optimization and monitoring, expanding access to best-in-class personalized oncology.

"From the beginning, Invitae’s goal has been to aggregate the world’s genetic tests into a single platform in service of our mission to bring comprehensive genetic information into mainstream medicine. Today, we take another major step forward in that effort," said Sean George, Ph.D., co-founder and chief executive officer of Invitae.

"ArcherDX and Invitae share a foundational belief in the power of genomic information to impact care. We are thrilled to unite with Invitae to form the leading hub for precision oncology, diagnostics, therapy optimization and monitoring, with an opportunity to accelerate both patient care and shareholder value," said Jason Myers, Ph.D., chief executive officer and co-founder of ArcherDX. "ArcherDX was founded to democratize precision oncology with best-in-class products that are personal, actionable and available in local care settings. We see STRATAFIDE DX as a significant near-term value driver, currently under development for cancer therapy optimization, while PCM provides an exciting opportunity to transform cancer care through multiple monitoring applications. ArcherDX products, workflow and powerful bioinformatics solutions provide an opportunity to advance precision oncology into regional and community settings and address an estimated $45 billion market opportunity. Together with Invitae, we look forward to expanding our impact beyond oncology, driving significant value through shared expertise to inform healthcare throughout life, globally."

"Integrating all aspects of cancer genetics can transform care for patients and the flexibility that comes from both centralized and decentralized capabilities will uniquely position Invitae to meet the needs of customers worldwide," continued Dr. George. "By joining together, we will unite world-class capabilities in the hands of a talented team with complementary expertise and strong brands in service of a shared goal to improve healthcare for patients."

Accelerating access and adoption of genetics to improve cancer care

Broad adoption of precision oncology has been limited, particularly in regional and community settings where approximately 85 percent of patients receive care.1 Without precision oncology, late-stage cancer patients can suffer from poor prognosis and outcomes, while early-stage patients may receive an inaccurate prognosis that results in unnecessary treatment and delayed detection of recurrence.2,3

Uniting Invitae and ArcherDX will offer comprehensive support for precision oncology.

Invitae has quickly become a leader in diagnostic and hereditary risk testing and has strong relationships with clinicians caring for cancer patients, including cancer genetic counselors, oncologists and imaging centers.
ArcherDX’s platform, with its proprietary Anchored Multiplex PCR (AMP) chemistry at the core, has enabled it to develop industry-leading products and services under investigation to optimize therapy and enable cancer monitoring across liquid and tissue samples.
ArcherDX has developed and commercialized over 325 unique products, including research products and services in use by more than 300 laboratories worldwide and has collaborated with more than 50 biopharmaceutical companies and contract research organizations (CROs), providing services that enable biopharmaceutical companies, including partners such as AstraZeneca, BMS and Bayer, to cost-effectively accelerate drug development.
ArcherDX is also currently developing in-vitro diagnostic (IVD) products, including STRATAFIDE DX, for therapy optimization, an estimated $5 billion market opportunity with U.S. Food and Drug Administration (FDA) submissions planned this year, and the broadly applicable Personalized Cancer Monitoring (PCM) in development for disease recurrence monitoring, therapy optimization including selection, response and modulation. Both STRATAFIDE DX and PCM have received Breakthrough Device designation from the FDA.
Together, the company will be ideally positioned to serve customers across the continuum, from individuals and community clinicians to biopharmaceutical partners, distribution partners, reference laboratories and academic centers. Invitae’s central laboratory provides support for customers who prefer to send out and can benefit from a full suite of services including reporting, clinician consultation and genetic counseling for patients, while ArcherDX’s decentralized model supports geographies and customers where local control of patient reporting is either desired or required.
With both centralized and local testing capabilities, the combined organization will offer breadth and flexibility in serving customers in more than 95 markets. Together, Invitae and ArcherDX will offer robust support for biopharmaceutical companies, from patient identification and screening, to biomarker identification and companion diagnostic development.

Transaction Terms

Under the terms of the agreement, Invitae will acquire ArcherDX for upfront consideration consisting of 30 million shares of Invitae common stock and $325 million in cash, plus up to an additional 27 million shares of Invitae common stock payable in connection with the achievement of certain milestones, for an overall transaction valued at approximately $1.4 billion. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in several months, subject to customary closing conditions including approval by the stockholders of Invitae and ArcherDX.

Financing Activities

In connection with the proposed combination, Invitae has arranged a strategic financing with over $400 million in financing commitments from a premier syndicate of life sciences investors, led by Perceptive Advisors. Invitae has entered into a definitive agreement to sell $275 million in common stock in a private placement at a price of $16.85 per share. The private placement is being supported by key existing investors in Invitae and Archer, including Casdin Capital, Deerfield Management, Driehaus Capital Management, Farallon, PBM Capital, Perceptive Advisors, Redmile Group, Rock Springs Capital, Soleus Capital, and one additional institutional investor. The placement is expected to close concurrently with the proposed combination, subject to the satisfaction of customary closing conditions. Invitae has also entered into a fully committed credit facility for up to $200 million with Perceptive Credit Opportunities Funds, subject to certain customary closing conditions.

Since the filing of its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, Invitae has sold under its ATM facility approximately 2.6 million shares of common stock for aggregate gross proceeds of $46 million at an average price of $17.59 per share.

Invitae’s current expectations regarding its cash at transaction close would be approximately $425 million and its annualized near-term forward cash burn is expected to be approximately $130 million.

Advisors

Perella Weinberg Partners served as lead financial advisor to Invitae in connection with the business combination and Cowen served as co-financial advisor. Cowen served as lead-placement agent to Invitae for the private placement and Perella Weinberg Partners served as co-placement agent; Cowen served as exclusive financial advisor to Invitae in connection with the senior secured term loan facility. Evercore and J.P. Morgan Securities LLC acted as financial advisors to Archer.

Webcast

Management will host a conference call and webcast today at 5:00 a.m. PT / 6:00 a.m. MT / 8:00 a.m. ET to discuss the transaction. The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the reservation number for both is 7097864. Please note, after dialing in, you will be prompted to enter the Conference ID and then the pound "#" sign to enter the call. Following prepared remarks, management will respond to questions from analysts, subject to time limitations.

The live webcast of the call and slide deck may be accessed by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

SinocellTech Closes $181 Million IPO on STAR Board; Triples in Initial Trading

On June 22, 2020 Beijing’s SinocellTech reported that it completed a $181 million IPO on Shanghai’s STAR Board and nearly tripled in price during its initial trading session (Press release, Sinocelltech, JUN 22, 2020, View Source [SID1234561390]). The offering was priced at 25.64 RMB per share and ended its first session at 73.07 RMB, giving SinocellTech a market capitalization of nearly $4.5 billion. Sinocelltech is a biotech company that discovers and develops mAbs, recombinant proteins and vaccine products. The company has 23 products in its pipeline, including 21 novel differentiated drugs and two biosimilars.

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Saniona raises SEK 22 million through sales of shares in Scandion Oncology

On June 22, 2020 Saniona (OMX: SANION), a clinical-stage biotech company focused on rare diseases, reported that it has raised SEK 22 million (USD 2.3 million) through the sale of shares in Scandion Oncology A/S (Spotlight Stock Market: SCOL) (Press release, Saniona, JUN 22, 2020, View Source(OMX%3A%20SANION)%2C,Spotlight%20Stock%20Market%3A%20SCOL).&text=The%20sale%20of%20shares%20brings,in%20Scandion%20Oncology%20below%2015%25. [SID1234561406]).

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Saniona sold 754,577 shares of Scandion Oncology. The sale of shares brings Saniona’s ownership stake in Scandion Oncology below 15%. Proceeds will be used to continue Saniona’s advancement of mid/late-stage clinical trials with Tesomet in two rare eating disorders: hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as to build its U.S.-based leadership team in support of these programs.

"Saniona continues to tighten our focus on building a global, commercial-stage rare disease company, which will require significant capital investment over the next few years" said Rami Levin, CEO of Saniona. "The 2017 spin-out of our oncology assets into Scandion Oncology has resulted in a win-win situation, creating a highly successful cancer start-up in Scandion Oncology, while allowing Saniona to remain strategically focused on rare diseases, and providing funding for our rare disease programs."

Saniona is preparing to initiate two pivotal clinical trials over the next 12 months, one in hypothalamic obesity and the other in Prader Willi Syndrome. This follows the recent release of the positive top line data from its phase 2 trial in Hypothalamic obesity and the positive FDA interactions on Tesomet in Prader Willi Syndrome.