On March 28, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it will share further data on the savolitinib development programs in lung cancer at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Georgia, USA, March 31 to April 3, 2019 (Press release, Hutchison China MediTech, MAR 28, 2019, http://www.chi-med.com/pres-on-savo-at-aacr19/ [SID1234534753]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Preliminary efficacy and safety results will be presented from the China Phase II study of savolitinib monotherapy in non-small cell lung cancer ("NSCLC") patients with MET Exon 14 skipping mutations who have failed prior systemic therapy, or are unable to receive chemotherapy (abstract #CT031, clinicaltrials.gov identifier NCT02897479).

In addition, several abstracts will be presented from the TATTON Phase Ib/II trial of savolitinib in combination with Tagrisso (osimertinib) in patients with epidermal growth factor receptor ("EGFR") mutation-positive NSCLC and MET-amplification who have progressed following treatment with an EGFR tyrosine kinase inhibitor ("EGFR-TKI") (clinicaltrials.gov identifier NCT02143466). One presentation will focus on patients who had progressed on a first- or second-generation EGFR-TKI and had not previously received a third-generation EGFR-TKI (abstract #CT032). Another presentation will focus on patients whose disease further progressed despite prior treatment with a third-generation EGFR-TKI (abstract #CT033). These presentations are complemented by a poster presentation on detection methods for identifying MET-driven EGFR-TKI resistance in the TATTON trial (abstract #4897/20).

TATTON preliminary results were presented at the World Conference on Lung Cancer (WCLC) in Yokohama, Japan, in October 2017.[1] The TATTON trial supports SAVANNAH, an ongoing Phase II clinical trial exploring the combination of savolitinib and Tagrisso to overcome MET-driven EGFR-TKI resistance following treatment with Tagrisso (clinicaltrials.gov identifier NCT03778229).

Further details of the presentations are as follows:

Session: Can the Challenge of NSCLC Resistance Be MET or Will We Not MEK It?
Session Type: Clinical Trials Plenary Session
Session # & Link: CTPL02
Date & Time: Sunday, March 31: 3:00 PM-5:15 PM
Location: Marcus Auditorium, Building A, Georgia World Congress Center
1st Presentation Title: Preliminary efficacy and safety results of savolitinib treating patients with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations
Lead Author: Shun Lu, Professor at Shanghai Chest Hospital, Jiao Tong University
Abstract # & Link: CT031 – abstract available after 3:00 PM EST on Friday, March 29, 2019
Time: 3:05 PM-3:30 PM
2nd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior first/second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Helena A. Yu, Medical Oncologist at Memorial Sloan Kettering Cancer Center
Abstract # & Link: CT032 – abstract only available at time of presentation
Time: 3:40 PM-3:55 PM
3rd Presentation Title: TATTON Phase Ib expansion cohort: Osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-amplified NSCLC after progression on prior third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
Lead Author: Lecia V. Sequist, Associate Professor of Medicine at Harvard Medical School and the Director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital
Abstract # & Link: CT033 – abstract only available at time of presentation
Time: 3:55 PM-4:15 PM

Session: Novel Strategies for Biomarker Identification and Use in Cancer 3
Poster Title: Detection of MET-mediated EGFR tyrosine kinase inhibitor (TKI) resistance in advanced non-small cell lung cancer (NSCLC): biomarker analysis of the TATTON study
Lead Author: Ryan J. Hartmaier, AstraZeneca
Abstract # & Link: 4897 / 20 – abstract now available
Date & Time: April 3, 2019, 8:00 AM – 12:00 PM
Location: Section 19, Building B, Georgia World Congress Center

About Savolitinib
Savolitinib is a potential first-in-class inhibitor of c-MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective c-MET inhibitors. In clinical studies to date, involving over 900 patients, savolitinib has shown promising signs of clinical efficacy in patients with c-MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in partnership with AstraZeneca in Phase Ib/II studies, in multiple solid tumor indications, both as a monotherapy and in combinations.

On March 28, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported financial results and provided a corporate update for the full year ended December 31, 2018, and recent activities (Press release, Unum Therapeutics, MAR 28, 2019, View Sourcenews-releases/news-release-details/unum-therapeutics-reports-fourth-quarter-and-full-year-2018" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-reports-fourth-quarter-and-full-year-2018" rel="nofollow">View Source [SID1234534736]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2018 was an important year for Unum as we brought the company public and continued to innovate in cell therapy with the advancement of our ACTR platform and the development of our new BOXR platform," said Chuck Wilson, President and CEO of Unum. "We have demonstrated proof of concept with the ACTR approach and see a clear path to further evaluating differentiated, potentially best-in-class product candidates designed to address continued patient needs. We are building out our solid tumor pipeline and have initiated our first solid tumor clinical trial, ATTCK-34-01, and selected BOXR1030 as our first product candidate from the BOXR platform. In 2019, we look forward to reporting data from all of our ongoing trials that will help determine next steps for our efforts in non-Hodgkin lymphoma, multiple myeloma, and solid tumors."

Recent Highlights

Continuing Dose Escalation in ATTCK-20-03 Phase I Trial: At the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, Unum presented preliminary results from the first two dose levels of its ongoing Phase 1 study of ACTR707 in combination with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma (r/r NHL). These data demonstrated that three of the six patients treated at Dose Level 1 (25 MM ACTR+ T cells) and one of three patients treated at Dose Level 2 (40 MM ACTR+ T cells) achieved a complete response. Enrollment and dose-limiting toxicity (DLT) assessments at Dose Level 3 (55 MM ACTR+ T cells) have since been completed, and enrollment at Dose Level 4 (80 MM ACTR+ T cells) has initiated. Through the first three cohorts, no DLTs and no severe adverse events of cytokine release syndrome (CRS) or neurologic events have been observed. Following completion of the dose escalation phase of the trial, Unum plans to initiate a cohort expansion at the preliminary recommended Phase 2 dose of ACTR707 in the second half of 2019.

Completed Enrollment of ATTCK-20-2 Phase I Trial: Following the decision in 2018 to prioritize ACTR707 for future development in r/r NHL, Unum has completed enrollment in the ATTCK-20-2 study, a Phase I clinical trial evaluating safety and anti-lymphoma activity of ACTR087 in combination with rituximab in patients with r/r NHL. Unum plans to report data on all enrolled patients from ATTCK-20-2 at the end of 2019. These data will inform other ACTR programs, specifically ATTCK-17-01, a Phase I trial of ACTR087 in combination with SEA-BCMA.

Continuing Dose Escalation with ATTCK-17-01 Phase I Trial: At the 2018 ASH (Free ASH Whitepaper) Annual Meeting in December, Unum presented data from the initial cohorts of the ongoing Phase 1 ATTCK-17-01 study, testing ACTR087 in combination with SEA-BCMA (an investigational monoclonal antibody targeting B cell maturation antigen, or BCMA) in patients with relapsed/refractory multiple myeloma (r/r MM). In the first three cohorts, no DLTs and no severe adverse events of CRS or neurologic events were observed. Having cleared cohorts with very low levels of SEA-BCMA antibody administered, dose escalation is continuing now at doses of SEA-BCMA that may be expected to have pharmacological activity based upon preclinical studies. Enrollment at Dose Level 4 (30 MM ACTR+ T cells and 2.0 mg/kg SEA-BCMA) is ongoing. In subsequent dose cohorts, the dose of both ACTR087 and SEA-BCMA will be explored. Unum expects to continue to enroll and dose patients through the dose escalation phase of the trial and to report data from multiple dose cohorts in the second half of 2019.

Initiated ATTCK-34-01 Phase I Trial in Solid Tumors: Unum announced that it has initiated ATTCK-34-01, a Phase 1, multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers. This is Unum’s first ACTR T cell study in solid tumors. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further development. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence, and trastuzumab pharmacokinetics. Unum plans to report initial clinical data from the ongoing dose escalation at the end of 2019.

Initiated Preclinical Development of the First Product Candidate from the BOXR Platform: In November 2018, Unum announced its new Bolt-On Chimeric Receptor technology platform (BOXR), which improves T cell functionality by countering immunosuppression in solid tumor cancers. Unum presented preclinical data at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting demonstrating the ability to significantly improve the activity of both ACTR- and CAR-targeted engineered T cells in immunosuppressive solid tumors. Unum has subsequently nominated BOXR1030 as the first product candidate from this platform and has initiated IND-enabling preclinical studies and plans to present additional information regarding BOXR1030 in the second half of 2019. BOXR1030 consists of a T cell co-expressing a glypican-3 (GPC3)-directed CAR and an undisclosed metabolism-enhancing bolt-on transgene. GPC3 is a well-known oncofetal antigen selectively expressed in a variety of tumor types including certain liver and lung cancers.
Fourth Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the fourth quarter ended December 31, 2018 was $3.8 million, compared to $2.1 million in the same period of 2017. The increase reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs attributed to the ATTCK-17-01 study.

R&D Expenses: Research and development expenses were $10.8 million for the fourth quarter ended December 31, 2018, compared to $7.6 million for the same period of 2017. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs to support these activities.

G&A Expenses: General and administrative expenses for the fourth quarter ended December 31, 2018, were $2.0 million, compared to $1.4 million for the same period of 2017. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.

Net Loss: Net loss attributable to common stockholders was $8.6 million, or $0.29 per share, for the fourth quarter ended December 31, 2018, and $6.7 million, or $0.66 per share, for the same period of 2017.

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2018, Unum had cash, cash equivalents, and marketable securities of $78.6 million. Total cash burn for 2018, net of IPO related costs, was $36.3 million. Today, Unum updated its cash runway and now anticipates that its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into early 2021.
Investor Call and Webcast Information

Unum will host a live conference call and webcast today, March 28, 2019, at 8:00 a.m. ET, to discuss these financial results and company updates. To access the call, please dial 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 8169027. A webcast will be available at View Source at least 10 minutes before the event begins. The archived webcast will be available at the same location approximately two hours after the event and will be archived for 90 days.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"…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."

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.