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ArcherDX announces collaboration with University College London to Investigate the Novel Use of Cell-Free Tumor DNA to Detect Disease Recurrence in Lung Cancer Patients

On March 28, 2019 ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, reported that it has entered into a research collaboration with the University College London (UCL) and the Francis Crick Institute to use ArcherDX’s proprietary Anchored Multiplex PCR (AMP) technology to detect evidence of disease recurrence in lung cancer patients from cell-free circulating tumor DNA (ctDNA) as part of the Cancer Research UK funded UCL-sponsored TRACERx study (TRAcking lung CancEr evolution through treatment (Rx))[1] (Press release, ArcherDX, MAR 28, 2019, View Source [SID1234534735]).

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"…This collaboration with ArcherDX will help towards achieving our goal of a more personalised approach to developing cancer treatments."
Professor Charles Swanton, M.D., Ph.D., lead researcher for the TRACERx study
Preliminary findings from the TRACERx clinical study were published in Nature and the New England Journal of Medicine in 2017. In the publication, UCL and the TRACERx investigators demonstrated that a patient-specific approach to circulating tumor DNA (ctDNA) profiling could be used to characterize Minimal Residual Disease (MRD) in patients who have undergone potentially curative surgery for lung cancer. Early detection of changes in ctDNA burden after the initiation of curative therapy has been associated in clinical literature with poor disease free survival. In collaboration with ArcherDX, the UCL and TRACERx investigators aim to expand upon these initial findings by developing patient- specific assays based on anchored multiplex-PCR (AMP) technology to detect low-volume MRD at high levels of sensitivity and characterize the phylogenetic and neoantigen landscape of relapsing NSCLC.

"As we expand upon and progress our research, exploring lung cancer in an unprecedented level of detail, this collaboration with ArcherDX will help towards achieving our goal of a more personalised approach to developing cancer treatments," said Professor Charles Swanton, M.D., Ph.D., lead researcher for the TRACERx study.

"We are thrilled to be working with Professor Charles Swanton and UCL," said Josh Stahl, executive vice president and chief scientific officer of ArcherDX. "This collaboration aligns closely with ArcherDX’s mission to expand access and adoption of personalized medicine in oncology. We’ve spent the last five years developing and continually evolving our technology for complex and groundbreaking applications like those being studied in the TRACERx study. We are especially pleased to be a part of this study as it has the potential to fundamentally transform patient care in early stage lung cancer."

Coherus BioSciences Management to Present at H.C. Wainwright & Co. Global Life Sciences Conference

On March 28, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will present at the H.C. Wainwright & Co.Global Life Sciences Conference in London on Tuesday, April 9, 2019 at 12:10 p.m. GMT (Press release, Coherus Biosciences, MAR 28, 2019, http://investors.coherus.com/news-releases/news-release-details/coherus-biosciences-management-present-hc-wainwright-co-global [SID1234534734]).

The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source

Precision BioSciences Announces Pricing of Initial Public Offering

On March 28, 2019 Precision BioSciences (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported the pricing of its initial public offering of 7,900,000 shares of common stock at a public offering price of $16.00 per share, for total gross proceeds of $126.4 million, before deducting underwriting discounts and commissions and expenses payable by Precision (Press release, Precision Biosciences, MAR 28, 2019, View Source [SID1234534733]). In addition, Precision has granted the underwriters a 30-day option to purchase up to 1,185,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Precision. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "DTIL" on Thursday, March 28, 2019. The offering is expected to close on April 1, 2019, subject to customary closing conditions.

J.P. Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays are acting as joint book-running managers for the offering.

A registration statement relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on March 27, 2019. This offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to this offering may be obtained by contacting: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone: (866) 803-9204 or email: [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone: (866) 471-2526, facsimile: (212) 902-9316, or email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone: (877) 547-6340 or email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone: (800) 603-5847.

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 under the securities laws of any such state or jurisdiction.

Molecular Templates Announces Initiation of Phase II Monotherapy Study of MT-3724 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients

On March 28, 2019 Molecular Templates, Inc., (Nasdaq: MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported the initiation of a single-agent Phase II study of MT-3724, a CD20-targeted ETB, in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients (Press release, Molecular Templates, MAR 28, 2019, View Source [SID1234534732]). This multicenter study will enroll up to 100 patients, in a staged manner, who have received at least two standard of care treatment regimens for DLBCL. As a monotherapy study in heavily pretreated patients, this study has the potential to be pivotal.

"We have been highly encouraged by the responses observed in the Phase I/Ib study of MT-3724 in heavily pretreated DLBCL patients," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "This Phase II study largely replicates the Phase Ib expansion cohort, but with more clinical sites for enrollment, an independent data safety monitoring board, and independent central review for efficacy. Given the high level of unmet need in advanced DLBCL, we hope that this study will confirm that MT-3724 provides a meaningful benefit for this difficult to treat patient population."

The Phase II study will initially enroll patients at sites in the United States, Canada and Europe. MT-3724 will be given as 50 mcg/kg intravenous (IV) infusions, with a maximal per dose limit of 6,000 mcg. The primary outcome measure is tumor response, while secondary objectives include safety and other efficacy measures. The Phase II dose of 50 mcg/kg was selected based on safety data, tumor responses observed at dose levels as low as 5 and 20 mcg/kg, and pharmacodynamic effects of CD20+ B-cell clearance observed at various doses in the Phase I/Ib study. The Phase II study will exclude patients with high levels of serum rituximab, given CD20 binding competition of rituximab with MT-3724.

Molecular Templates, Inc. Reports Fourth Quarter 2018 Financial Results

On March 28, 2019 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular" or "Molecular Templates"), a clinical-stage oncology company focused on the discovery and development of the company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics for cancer, reported financial results for the fourth quarter of 2018 (Press release, Molecular Templates, MAR 28, 2019, View Source [SID1234534730]). As of December 31, 2018, Molecular’s cash and investments totaled $98 million, and is expected to fund operations into the first half of 2021.

"2018 was a year of important progress for Molecular Templates, marked by new clinical data for MT-3724, advancement of our preclinical pipeline, the CD38 partnership with Takeda, and a successful equity financing," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "In 2019, we are excited to generate more clinical data from multiple Phase II studies with MT-3724, advance MT-5111 and TAK-169 into the clinic, and file an IND for MT-6035, our PD-L1 ETB with antigen seeding. We are also focused on business development activity to generate additional non-dilutive capital."

Company Highlights and Upcoming Milestones

Corporate

Molecular will present new data on its pipeline programs and technology platform in four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, to be held March 29 – Apr 3, 2019 in Atlanta, Georgia. Presentations will feature data on 1) CD38-targeted ETB TAK-169, 2) CD20-targeted ETB MT-3724 in combination with chemotherapy or IMiDs, 3) PD-L1-targeted ETB for direct cell kill approach to PD-L1 expressing cancers, 4) Bispecific ETBs for targeted cancer treatment.
On February 19, 2019, Molecular strengthened its senior management team with the appointment of Roger J. Waltzman, M.D., as Chief Medical Officer. Dr. Waltzman is a board-certified medical oncologist with over 20 years of experience in the pharmaceutical and biotechnology industries, and in medical practice/academia. His career highlights include 9 years in senior drug development roles at Novartis Pharmaceuticals Corporation, including 6 years in positions of increasing responsibility at Novartis Oncology (2007–2013). He played a leading role in the development of highly successful Novartis branded oncology drugs, Glivec (imatinib) and Jakafi (ruxolitinib).
On November 9, 2018, Molecular presented a poster on its PD-L1 ETB with Antigen Seeding Technology (AST) program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington D.C. The poster, titled "Identification and Functional Profiling of PD-L1 Targeted Engineered Toxin Bodies for Antigen Seeding Technology (AST) and Redirection of T cell Response to Tumors" summarized a series of preclinical experiments conducted by Molecular to create PD-L1 targeted ETBs that have antigen seeding properties and to analyze the mechanisms by which they can kill cancer cells.

TAK-169

Takeda and Molecular expect to file an IND and start a Phase I multiple myeloma trial in 2019 for TAK-169 (CD38 targeted ETB).

MT-3724

Molecular recently announced the initiation of a Phase II monotherapy study of MT-3724 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This study has the potential to be pivotal. Molecular expects to provide an update on this study in 2H19, with final data expected in 2020.
Molecular is also conducting a Phase II combination study with MT-3724 and chemotherapy in earlier lines of DLBCL.
Molecular expects to initiate a second Phase II combination study with MT-3724 and Revlimid in earlier lines of DLBCL in 2Q19.
Molecular expects to report an update on both MT-3724 combination studies with MT-3724 in 2H19.

Research

Molecular expects to initiate a Phase I study in cancer patients for MT-5111, its ETB targeting HER2, in 2Q19.
Molecular expects to report an update on this study in 2H19.
Molecular expects to file an IND application for MT-6035, its ETB targeting PD-L1 (with antigen seeding), in 2H19.
Several other ETB candidates are in preclinical development, targeting both solid and hematological cancers.

Takeda Multi-Target Collaboration

Takeda and Molecular are conducting lead optimization for ETBs against two undisclosed targets selected by Takeda under the collaboration. Should Takeda exercise its option to license ETBs for both targets, Molecular would receive $25 million and would be eligible to receive up to $547 million in milestone payments and tiered royalties on sales.
Financial Results

The net loss attributable to common shareholders for the fourth quarter of 2018 was $6.6 million, or $0.18 per basic and diluted share. This compares with a net loss attributable to common shareholders of $6.9 million, or $0.26 per basic and diluted share, for the same period in 2017.

Revenues for the fourth quarter of 2018 were $4.7 million, compared to $0.8 million for the same period in 2017. Revenues for the fourth quarter of 2018 were comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the fourth quarter of 2018 were $7.6 million, compared with $4.7 million for the same period in 2017. Total general and administrative expenses for the fourth quarter of 2018 were $3.9 million, compared with $3.5 million for the same period in 2017.

The net loss attributable to common shareholders for the year ended December 31, 2018 was $30.3 million, or $1.02 per basic and diluted share. This compares with a net loss attributable to common shareholders of $24.1 million, or $2.11 per basic and diluted share, for 2017.

Revenues for the year ended December 31, 2018 were $13.3 million, compared to $3.4 million for 2017. These revenues were mainly comprised of revenues from collaborative research and development agreements with Takeda, and grant revenue from CPRIT. Total research and development expenses for the year ended December 31, 2018 were $30.2 million, compared with $9.5 million for 2017. Total general and administrative expenses for the year ended December 31, 2018 were $14.1 million, compared with $11.8 million for 2017.