On November 16, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported its results for the third quarter of 2021 (Press release, BerGenBio, NOV 16, 2021, View Source [SID1234595671]).

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A presentation and live webcast by BerGenBio’s senior management will take place at 10am CET today, please see below for details.

Operational Highlights – third quarter of 2021 (including post-period end)

Martin Olin appointed Chief Executive Officer, bringing 20 years of executive experience in the pharmaceutical and biotechnology industry. Previous roles include CEO of Symphogen
Post-period end, NSCLC data presented at SITC (Free SITC Whitepaper), highlighting bemcentinib’s potential in NSCLC patients harbouring STK11 mutations
AML data presented at EHA (Free EHA Whitepaper) indicate bemcentinib/LDAC combination is efficacious and well tolerated in relapsed elderly AML patients unfit for intensive chemotherapy
COVID-19 data in a late-breaking abstract presentation at ECCMID demonstrate encouraging evidence for the effect of bemcentinib in hospitalised patients receiving steroids ± remdesivir
Financial Highlights – third quarter of 2021

Revenue amounted to NOK 0.0 million (Q3 2020: NOK 0.0 million)
Total operating expenses were NOK 71.4 million (Q3 2020: NOK 68.3 million)
Q3 operating loss of NOK 70.5 million, decreased compared to previous quarters, (Q3 2020: NOK 67.3 million)
A strong cash position of NOK 509.4 million at end of Q3 2021
Martin Olin, Chief Executive Officer of BerGenBio, commented: "It is my great pleasure to provide an update on BerGenBio’s progress over the last quarter, my first since joining the Company as CEO in September 2021. Having completed a strategic review of operations following my appointment, we have reiterated our focus on pursuing a rigorous data driven approach of connecting a consistent scientific rationale, pre-clinical and clinical data to high unmet medical needs will enable us to define the best possible path to registration as well as unlocking significant market potential.

"Our focus will be the clinical development of bemcentinib as a second line treatment in relapsed AML, building on the promising data accumulated so far with the planned initiation of a confirmatory randomized placebo-controlled trial in H2 2022. The clinical development of the NSCLC program continues, and a Phase 1b trial investigating bemcentinib in patients with STK11 mutations in 1L NSCLC is also scheduled to be initiated in H1 2022.

"We will also look to validate our COVID-19 clinical data through a confirmatory randomized placebo-controlled trial supported by a major, multinational collaboration that provides access to a large number of sites across Europe and established infrastructure at significantly reduced cost to BerGenBio. We anticipate this study to commence in H1 2022.

"The Company is well-funded with a strong team in place to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders. I look forward to providing further updates on our progress in due course."

Presentation and Webcast Details

An in-person briefing will take place at 10:00 am CET at: Carnegie AS, Fjordalleen 16, Aker Brygge, 5th Floor, Oslo where BerGenBio’s senior management team will provide an update on the Company followed by a Q&A session.

The presentation will also be webcast live, details below.

The Q3 2021 report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

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.

On November 16, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on November 15, 2021, for FoundationOne CDx Cancer Genomic Profile to be used to identify advanced/recurrent tumor mutation burden-high (TMB-High; ≥10 mutations/megabase (mut/Mb)) solid tumors (Press release, Chugai, NOV 16, 2021, View Source [SID1234595672]). An application for a humanized anti-human PD-1 monoclonal antibody, pembrolizumab (genetical recombination) [Product name: Keytruda] in TMB-High solid tumors that have progressed following prior chemotherapy was submitted by MSD K.K. on March 11, 2021 and is currently under review with the MHLW.

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"The approval may enable physicians to make treatment suggestions based on TMB measurement. TMB is the third tumor-agnostic biomarker following NTRK fusion and high microsatellite instability," said Dr. Osamu Okuda, Chugai’s President and CEO. "We will continue to encourage the proper use of this test to support treatment decision-making, and therefore enable better access to targeted therapies by evaluating many potential gene alterations at one time."

With this approval, FoundationOne CDx Cancer Genomic Profile will help identify patients with TMB-High advanced/recurrent solid tumors.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care, and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information (underlined indicates newly added)

Intended uses or indications

The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesylate
EGFR exon 20 T790M alterations osimertinib mesylate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
BRAF V600E and V600K alterations Malignant melanoma dabrafenib mesylate, trametinib dimethyl sulfoxide, vemurafenib
ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab (genetical recombination)
KRAS/NRAS wild-type Colorectal cancer cetuximab (genetical recombination), panitumumab (genetical recombination)
Microsatellite instability high nivolumab (genetical recombination)
Microsatellite instability high Solid tumors pembrolizumab (genetical recombination)
Tumor mutational burden-high pembrolizumab (genetical recombination)*
NTRK1/2/3 fusion gene entrectinib, larotrectinib sulfate
BRCA1/2 alterations Ovarian cancer olaparib
BRCA1/2 alterations Prostate cancer olaparib
FGFR2 fusion genes Biliary tract cancer pemigatinib
* Application under review and not yet approved for the drug indication as of November, 2021

About FoundationOne CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro companion diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The device is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About tumor mutational burden
Tumor mutational burden (TMB) is a measure of the number of somatic mutations per coding region within a tumor’s genome. Levels are measured by the number of non-inherited mutations occurring per megabase (1 million DNA base pairs) of the tumor genome, and with a status of 10 mutations per megabase or more defined as TMB-High by the FoundationOne CDx Cancer Genomic Profile. More neoantigen is induced in TMB-High tumors, and such tumors may respond better to immune-checkpoint inhibitors. TMB-High tumors are reported to be relatively common in malignant melanoma, non-small cell lung cancer, colorectal cancer, and endometrial cancer1).

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