On November 16, 2021 Tempus, a leader in artificial intelligence and precision medicine, reported that it will incorporate data from both the Memorial Sloan Kettering Cancer Center (MSK) OncoKB database and National Comprehensive Cancer Network (NCCN)’s Clinical Practice Guidelines in Oncology (NCCN Guidelines) into its clinical reports (Press release, Tempus, NOV 16, 2021, View Source [SID1234595716]). Tempus is collaborating with two of the world’s largest clinical decision-support resources to support the genomic foundational science and clinical applications of its xT assay.

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Tempus reports will reflect therapy choices based on molecular profile and corresponding NCCN Guidelines recommendations and information from the OncoKB database, therefore making it easier for physicians to optimize treatment plans for their patients. Tempus is also the largest genomic sequencing company to incorporate the OncoKB database, which recently received partial recognition by the Food & Drug Administration (FDA) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.

"We are combining and curating two of the most robust oncology resources in the world and delivering them to physicians through the lens of their patients’ specific molecular and clinical profiles," said Kimberly Blackwell, MD, Chief Medical Officer at Tempus. "This initiative is a step towards making our diagnostics even smarter and making personalized care achievable for every patient facing cancer."

The OncoKB database features detailed information regarding specific alterations in 682 cancer genes, curated from various sources, including FDA drug labels, medical professional group guidelines, medical and scientific literature, and clinical trial eligibility criteria. The FDA recognized a portion of the OncoKB database as a source of valid scientific evidence and mapped the selection of cancer mutations to FDA Level 2 (clinical significance) and FDA Level 3 (potential clinical significance).

"OncoKB channels the clinical and scientific expertise of MSK physician-scientists into a structured database that provides information about the biologic and therapeutic implications of cancer-specific alterations," said Debyani Chakravarty, PhD, Lead Scientist, OncoKB and Assistant Attending, Department of Pathology at MSK.

The NCCN Guidelines are a comprehensive, continuously-updated set of guidelines detailing the sequential management decisions and interventions that currently apply to 97 percent of cancers affecting patients in the United States. Specific NCCN Guidelines have also been developed for cancer screening and prevention, therapeutic management, supportive care issues, and specific populations. The NCCN Guidelines are intended to assist all individuals who impact decision-making in cancer care including physicians, nurses, pharmacists, payers, patients and their families, and many others.

"This collaboration with Tempus will help us share the frequently-updated, evidence and expert consensus-based recommendations in the NCCN Guidelines more seamlessly with healthcare providers," said Robert W. Carlson, MD, Chief Executive Officer, NCCN. "We are happy to be working with this precision medicine technology company to place important cancer decision support tools at the point-of-care, ultimately benefiting patients."

On November 16, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Evercore ISI 4th Annual HealthCONx Conference 2021 on Wednesday, December 1, 2021 at 10:30 a.m. ET (Press release, PerkinElmer, NOV 16, 2021, https://ir.perkinelmer.com/news-releases/news-release-details/perkinelmer-present-evercore-isi-healthconx-conference-2021 [SID1234595678]).

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Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update on the Company and its strategic priorities. To register, click here.

A live audio webcast will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentation will be posted on the PerkinElmer website after the event and will be available for 90 days following.

On November 16, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that BofA Securities and Morgan Stanley, as representatives of the several underwriters, notified Evotec of the underwriters’ exercise of their option to purchase up to 3,000,000 additional ADSs, representing 1,500,000 ordinary shares at the offering price of $ 21.75 per ADS (Press release, Evotec, NOV 16, 2021, View Source [SID1234595685]).

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An additional 2,995,000 American Depositary Shares ("ADSs"), representing 15% of the initial offering of 20,000,000 new ADS, have finally been registered in the commercial register on 15 November. Each ADS represents half of one ordinary share of Evotec. Upon exercise of the Greenshoe option, the free float amounts to approximately 68.4% of all outstanding Evotec shares.

In total, gross proceeds of the transaction amount to $ 500 million comprising the first offering of 20,000,000 ADSs ($ 435 million) and, the exercised option of 2,995,000 additional ADSs ($ 65 million), before deducting underwriting commissions and estimated offering expenses payable by Evotec. The proceeds from the issuance of the new shares are intended to be used to fund and in particular expand the ongoing business operations

Evotec’s ordinary shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or Jurisdiction.

This communication and the information contained herein is made solely for information purposes only and does not constitute or form part of a prospectus or any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any securities of Evotec, in any jurisdiction. Neither this communication, nor any part of it, nor the fact of its distribution, shall form the basis of, or be relied on in connection with, any contractual commitment or investment decision in relation to the securities of Evotec, in any jurisdiction, nor does it constitute a recommendation regarding any such securities.

The placement of the securities mentioned in this communication was directed only at persons in member states of the European Economic Area (the "EEA") who are "Qualified Investors" within the meaning of the Prospectus Regulation EU 2017/1129 ("Prospectus Regulation") ("Qualified Investors"). Any person in the EEA who acquires the securities in any offer (an "Investor") or to whom any offer of the securities is made will be deemed to have represented and agreed that it is a Qualified Investor.

In the United Kingdom, this communication is only directed at persons who are "qualified investors" within the meaning of Article 2 of the Prospectus Regulation as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 who are also (i) investment professionals falling within Article 19(5) of the UK Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any investment or investment activity to which this communication relates is available only to Relevant Persons in the United Kingdom and will only be engaged with such persons. Any person in the United Kingdom who is not a Relevant Person should not act or rely on this communication or any of its contents.

On November 16, 2021 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, reported that the results from a Phase 1 trial evaluating multiple ascending doses and the food effect of LYT-100 (deupirfenidone) were published in the journal Clinical Pharmacology in Drug Development (Press release, PureTech Health, NOV 16, 2021, View Source [SID1234595701]). Topline results from this Phase 1 study were previously announced in November 2020 and demonstrated that LYT-100 was well-tolerated in healthy volunteers under both fed and fasting conditions.

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LYT-100 is PureTech’s wholly-owned therapeutic candidate that is being advanced for the potential treatment of conditions involving inflammation and fibrosis and disorders of lymphatic flow. It is currently being evaluated in two Phase 2 trials in patients with Long COVID respiratory complications and breast cancer-related, upper limb secondary lymphedema. Enrollment in the Long COVID respiratory trial is expected to be completed by the end of 2021, with topline results anticipated in the first half of 2022. Topline results from the breast cancer-related, upper limb secondary lymphedema trial are anticipated in 2022.

"The data set from the completed Phase 1 MAD study, including a favorable safety and tolerability profile, reaffirms our belief that LYT-100 has the potential to be an attractive therapeutic option across a range of conditions. There are substantial shortcomings with the current standards of care for patients living with fibrotic lung disease, and we believe that the anti-fibrotic and anti-inflammatory properties along with the favorable tolerability profile demonstrated with LYT-100 to date could address this issue," said Michael Chen, Ph.D., Head of Innovation at PureTech Health. "We’re encouraged by these results and look forward to the upcoming clinical readouts as we advance LYT-100 in multiple indications."

LYT-100 is a selectively deuterated form of pirfenidone that retains the pharmacologic properties of the parent compound but is expected to be metabolized at an attenuated rate. GI-related tolerability issues have historically been associated with pirfenidone and have limited its usage in patients at the therapeutic dose approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF). Despite a noted dose-efficacy response in clinical trials in patients with IPF, higher doses of pirfenidone have not been adequately explored due to limitations in tolerability. PureTech is currently exploring the pharmacokinetic (PK) and tolerability profile of LYT-100 across a range of doses in order to determine whether LYT-100 can achieve higher levels of systemic exposure than the currently FDA-approved dose of pirfenidone.

Multiple ascending dose and food effect study results

The Phase 1 multiple ascending dose and food effect study was a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK profile and food effect of LYT-100 in healthy volunteers in both fed and fasting states. Plasma concentrations of LYT-100 and its metabolites were measured to determine PK parameters.

Part 1 assessed multiple ascending doses of LYT-100 administered in doses of 100 mg, 250 mg, 500 mg, 750 mg and 1000 mg BID over five days without dose titration. Part 2 assessed the effect of fed versus fasting conditions on the PK profile of LYT-100 following a single 500 mg dose. No dose limiting toxicities were noted, and a maximum tolerated dose was not determined.

All adverse events (AEs) that were possibly or probably related to LYT-100 were mild. Of the 40 participants, 37 (92.5%) completed part 1 of the study and eight participants who completed part 1 also completed part 2. The most common AEs across part 1 of the multiple ascending dose cohorts were headache, abdominal distension and nausea. There were no tolerability issues after administration of a single dose of 500 mg given with or without food.

A dose-proportional PK profile was observed with LYT-100 throughout the range of doses studied. As with pirfenidone, LYT-100 exposure was affected by food, with fed conditions resulting in lower drug exposure compared to fasting conditions. The ratio of exposure during fed conditions was approximately 20% to 25% less than exposure during fasting. Fed conditions led to a 26% reduction in Cmax observed with LYT-100, while the Cmax reduction stated in the ESBRIET (pirfenidone) U.S. Prescribing Information is 49%.

The therapeutic dose of pirfenidone approved by the FDA for the treatment of IPF is 801 mg three times a day. LYT-100 is designed to potentially improve upon this regimen. In a previously conducted single-dose crossover study, an 801 mg dose of LYT-100 resulted in greater drug exposure than an 801 mg dose of pirfenidone. In part 1 of the multiple ascending dose study, LYT-100 was well-tolerated at a dose above 801 mg.

Additional Phase 1 studies and future development plans

Given that the maximum tolerated dose for LYT-100 was not determined in the original Phase 1 study, PureTech initiated a second multiple ascending dose study earlier this year to evaluate higher doses of the drug in healthy volunteers. PureTech also initiated additional Phase 1 studies to further evaluate the PK, dosing and tolerability of LYT-100 in healthy volunteers and healthy older adults to inform the clinical development of LYT-100 across multiple indications. Results from these studies are expected in the first quarter of 2022.

About LYT-100

LYT-100 is PureTech’s most advanced therapeutic candidate from within its Wholly Owned Pipeline. A deuterated form of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug, LYT-100 is being advanced for the potential treatment of conditions involving inflammation and fibrosis, including lung disease (e.g., IPF and potentially other PF-ILDs and Long COVID respiratory complications and related sequelae), and disorders of lymphatic flow, such as lymphedema. PureTech is also exploring the potential evaluation of LYT-100 in other inflammatory and fibrotic conditions such as myocardial, kidney and other organ system fibrosis based on clinical data around the use of pirfenidone in these indications.

PureTech completed a Phase 1 multiple ascending dose and food effect study evaluating LYT-100 in healthy volunteers and found it to be well-tolerated at all doses tested. In the fourth quarter of 2020, PureTech initiated a Phase 2 trial evaluating LYT-100 as a potential treatment for Long COVID respiratory complications and related sequalae and a Phase 2a proof-of-concept study evaluating LYT-100 in patients with breast cancer-related, upper limb secondary lymphedema. PureTech has also initiated additional Phase 1 clinical trials to further explore the PK, dosing and tolerability of LYT-100 in healthy volunteers. Results from these trials are expected to provide additional supportive data to inform the clinical development of LYT-100 across multiple indications.

1 Long COVID is a term being used to describe the emerging and persistent complications following the resolution of COVID-19 infection, also known as post-acute COVID-19 syndrome (PACS).

On November 16, 2021 ViewRay, Inc. (Nasdaq: VRAY), maker of the MRIdian, which combines MRI and external-beam radiation therapy to simultaneously image and treat cancer patients, reported the pricing of an underwritten public offering of 12,500,000 shares of common stock at a price to the public of $5.60 per share, for gross proceeds of $70 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by ViewRay (Press release, ViewRay, NOV 16, 2021, View Source [SID1234595717]). All of the shares to be sold in the offering will be offered by ViewRay. In addition, ViewRay has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

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ViewRay intends to use the net proceeds from the offering for general corporate purposes, including working capital, capital expenditures, continued research and development and commercial expenses.

Piper Sandler and Stifel are acting as the joint book-running managers for the offering. Guggenheim Securities is also acting as a book-running manager for the offering. B. Riley Securities and BTIG are acting as co-managers for the offering.

The offering is expected to close on or about November 19, 2021, subject to satisfaction of customary closing conditions.

A registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") and automatically became effective upon filing. This offering is being made solely by means of a prospectus supplement and accompanying prospectus included in the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Alternatively, copies of the final prospectus supplement, when available, and the accompanying prospectus may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.