Enthusiasm on Liquid Biopsies Drives Guardant IPO to $1.59B Valuation

Guardant Health went on the Nasdaq yesterday under the symbol GH. Shares climbed almost 70 percent on the first day of trading, selling 12.5 million shares at $19 per share in the initial public offering (IPO). It closed up 69.47 percent at $32.20 per share.

Guardant was founded in 2012 in Redwood City, Calif. The company offers liquid biopsy tests that provide genomic data for advanced cancers, which helps match the correct cancer treatments. One of its primary products is Guardant360 for advanced solid tumor cancers.

Liquid biopsies, as compared to a solid tissue biopsy, are tests performed on blood to look for cancer cells or DNA from a tumor circulating in the blood. They are also used to detect other diseases. The key difference between a liquid biopsy and a traditional clinical blood test is the focus on identifying cells or DNA from whatever illness is being tested for. Traditional lab tests do this as well, but generally not by trying to identify and sort so much information. In some cases, the liquid biopsy is conducted as a broad screening test utilizing next-generation sequencing.

It’s an increasingly competitive area for biopharma. Another Redwood City, Calif.-based company, Karius, developed a liquid biopsy test that can diagnose infectious disease in July. A year ago, Verily Life Sciences, one of Google/Alphabet’s companies, invested in Freenome,which is working on a liquid biopsy diagnostic platform to detect the cell-free DNA of cancer. Another company, Apostle, is developing a bioinformatics diagnostics liquid biopsy platform in cancer. In early January 2016, Illumina launched GRAIL Bio to develop a liquid biopsy cancer test.

According to Crunchbase, Guardant had already raised $550 million prior to the IPO. With the success of yesterday’s offering, the company is now valued at around $1.59 billion.

MarketWatch writes, “The startup sets its total market opportunity at more than $35 billion in the U.S. That includes a market Guardant is already in—using liquid biopsies in late-stage cancers (an about $6 billion opportunity, by the company’s estimates)—plus two that it is working toward, the cancer recurrence detection market (about $15 billion) and early cancer risk detection (about $18 billion).”

The Guardant360 tests cost about $6,800 and takes seven days. That is both cheaper and faster than a traditional tissue biopsy. The company’s goal is to develop tests for early cancer detection. The company is working on that. The data collected using Guardant360 and other products is being used to develop its next-generation assays, such as Lunar-1 for cancer recurrence and Lunar-2 for early cancer detection. MarketWatch notes, “Lunar-2 is geared toward individuals who don’t have symptoms but do have a higher risk of cancer due to genetics, smoking, health conditions and other factors.”

Guardant’s co-founder and chief executive officer, Helmy Eltoukhy, told MarketWatch in January that with additional data, “the better we are at decoding signals in the blood.” But collecting enough takes time and there’s usually plenty of “static” in blood—which is filled with a broad assortment of enzymes, proteins and other molecules—that has to be sorted out as well. Eltoukhy believes that an early cancer detection is “certainly” possible within years, rather than decades.

But there are currently concerns about the reliability of liquid assays. Researchers at Johns Hopkins evaluated Guardant360 with another company’s test, Personal Genome Diagnostics’PlasmaSELECT, and found “very low congruence” between the two. They published their work in June in the journal JAMA Oncology.

They conclude, “These data cannot determine which test is more accurate but suggest that reported gene alterations will not be the same across different platforms, raising the specter that patients could potentially receive different treatments depending on the cfDNA platform. Insufficient genetic profiling congruence could jeopardize the clinical benefit of personalized medicine.”

At the moment, at least, investors are thrilled with the products Guardant is currently offering and are optimistic about its future.

https://www.biospace.com/article/investor-enthusiasm-about-liquid-biopsies-drives-guardant-health-ipo-to-1-59-billion-valuation/

Evotec and Sanofi Join to Further Cutting-Edge Therapeutic Drug Discovery

Yesterday, Evotec AG (EVT) announced that Sanofi will be participating in an organized Public Private Partnership (PPP) that involves the initiation of brand newly formed BRIDGE, or LAB031, which was created to further the discovery of therapeutic drugs in multiple areas.

Evotec Execute is described on the company’s website as representing “Evotec‘s core discovery and development alliance businesses built on a systematic, unbiased and comprehensive innovation infrastructure. In this segment, the Company serves its partners intellectual property with its innovative drug discovery and development integrated tools and expertise. Evotec has evolved into one of the global leaders in providing complete drug discovery and development solutions on a stand-alone basis or through holistic, fully integrated solutions. In EVT Execute, these services are provided on a typical fee-for-service basis or through a variety of commercial structures including research fees, milestones and/or royalties. Evotec never takes development risks within such alliances.”

“EVT Execute offers the life sciences industry a variety of ways to access drug discovery innovation in a time efficient manner, through variable cost models but still with the highest standards of scientific execution,” additions Dr. Mario Polywka, Coo of Evotec. “Partners can access our drug discovery platform on a stand-alone or integrated project basis and have the confidence that through creative deal making and high-quality alliance and project management, their programmes are in safe hands.”

Throughout the course of the next three years, Sanofi will make funds available to utilize Evotec’s drug discovery and industrial screening platforms. Sanofi will additionally make known milestone criteria from which to determine and confirm development on each individual project. The BRIDGE LAB031 will give Evotec connections to academic institutions all over the globe, entering into research collaborations and initial-stage discoveries with groundbreaking information on subjects of disease where there is largely unmet medical demand.

Sanofi, a “global healthcare leader”, invested 5.5 billion pounds into Research and Development in 2017 alone. They currently have 70 “projects under development” and boast 7 “new molecular entities and vaccines approvals since 2015”. “Life is a health journey, with its ups and downs, and its challenges. These can be big or small, lifelong or temporary. Everyone, from children to elderly people, face health challenges and needs, wherever they are. We at Sanofi, are there beside people in need, as a health journey partner. Many patients are depending on us. We aim to protect, enable and support people facing health challenges, so they can live life to its full potential,” states its website.

In June of this year, Evotec established the partnership with Sanofi while furthering its effect on the infectious disease sector.  By signing a three-month-old deal with Sanofi, Evotec integrated its anti-infectives unit, which included much of Sanofi’s extensive infection disease research portfolio.

“This BRIDGE announced today is another strategic expansion of Evotec’s relationship with Sanofi. Supporting academic initiatives globally through BRIDGEs is designed to enable Evotec to validate translational ideas more efficiently,” quoted Dr. Werner Lanthaler, Chief Executive Officer of Evotec.

Shiv Krishnan, Head of Technology Platforms, Global Business Development & Licensing, at Sanofi stated that “we are pleased to expand our relationship with Evotec and establish LAB031. Sanofi is focused on identifying the best resources available in order to translate academic innovation into clinical assets.”

BRIDGE LAB031’s name is meant to nod to the section of the Garonne in which Toulouse, France has been a fruitful birthplace for Sanofi and Evotec’s collaborations.

https://www.biospace.com/article/evotec-and-sanofi-join-to-further-cutting-edge-therapeutic-drug-discovery/

Pacific Biosciences checks show Sequels placements decline, says Piper Jaffray

Piper Jaffray analyst William Quirk says channel checks found 10 Sequels placed in Q3, which suggests Pacific Biosciences had a sequential decline in placements, consistent with management comments. The analyst found 15 placements in his Q2 checks. Quirk trimmed his Q3 instrument expectations from 27 Sequels to 20 and his instrument revenue forecast by $2.2M to $6.4M. Despite being encouraged with the company’s continued progress on the 8M chip, he remains Neutral on the shares ahead of the earnings release.

https://thefly.com/landingPageNews.php?id=2800133

Bluebird Bio announces EMA acceptance of MAA for LentiGlobin gene therapy

Bluebird Bio announced that the European Medicines Agency accepted the company’s marketing authorization application, or MAA, for its investigational LentiGlobin gene therapy for the treatment of adolescents and adults with transfusion-dependent beta-thalassemia, or TDT, and a non-beta0/beta0 genotype. LentiGlobin was previously granted an accelerated assessment by the Committee for Medicinal Products for Human Use, or CHMP, of the EMA in July 2018, potentially reducing the EMA’s active review time of the MAA from 210 days to 150 days.

https://thefly.com/landingPageNews.php?id=2800137

MiMedx kept cheaper products out of offerings to VA hospitals, WSJ reports

MiMedx Group, a major supplier to government-run hospitals, has said its products help heal wounded service members and veterans, however the company limited the range of products it offered to federal buyers forcing the government to purchase more costly products than it needed for common treatments, the Wall Street Journal reports, citing former employees and company product lists. The company, which manufactures skin grafts and injectable products from placental tissues, has faced headwinds this year including restating financial results since 2012, ousting founder and former CEO Parker Petit and facing investigations into its practices by the Justice Department, the Department of Veterans Affairs and the Securities and Exchange Commission.

https://thefly.com/landingPageNews.php?id=2800175

Calithera Biosciences announces trials to evaluate Pfizer’s Ibrance with CB-839

Calithera Biosciences (CALA) announced two new clinical trial collaborations to evaluate Pfizer’s (PFE) palbociclib, also known as Ibrance, and the investigational dual-mechanism poly, or ADP-ribose, polymerase, or PARP, inhibitor talazoparib, each in combination with Calithera’s glutaminase inhibitor CB-839. As part of the collaboration, Pfizer will provide palbociclib and talazoparib, as well as financial support. Preclinical data suggest that CB-839, which is designed to starve tumor cells of the key nutrient glutamine, synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. The combination of CB-839 with CDK4/6 inhibitors has demonstrated synergistic activity in a number of preclinical cancer models, including colorectal cancer, or CRC, non-small cell lung carcinoma, or NSCLC, triple negative breast cancer, or TNBC and ER+ breast cancer. Based on these data, Calithera will initiate a Phase 1/2 clinical trial of the combination of CB-839 plus palbociclib in patients with KRAS mutated CRC and patients with KRAS mutated NSCLC in Q1 of 2019. CB-839 also synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation. The combination of CB-839 with PARP inhibitors has demonstrated synergistic activity in a number of preclinical cancer models, including renal cell carcinoma, TNBC, CRC, NSCLC, ovarian cancer and prostate cancer. Based on these data, Calithera will initiate a Phase 1/2 clinical trial of the combination of CB-839 plus talazoparib in patients with RCC, and TNBC in Q1 of 2019.

https://thefly.com/landingPageNews.php?id=2800211

PetIQ price target raised to $50 from $28 at Oppenheimer

Oppenheimer analyst Brian Nagel reiterated an Outperform rating on PetIQ and raised his price target to $50 from $28. In a research note to investors, Nagel says PetIQ’s “unique” business model continues to take shape well and the market is still meaningfully under-appreciating the company’s longer-term sales and profit potential. He also contends that the acquisition of VIP Petcare not only affords the chain a new, higher margin revenue stream, but also serves to meaningfully strengthen its core distribution business.

https://thefly.com/landingPageNews.php?id=2800219