On May 27, 2020 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported interim safety, tolerability and efficacy data from the ongoing expansion portion of the Phase 1 study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, in patients with ovarian cancer and non-small cell lung (NSCLC) adenocarcinoma (Press release, Mersana Therapeutics, MAY 27, 2020, View Source [SID1234558524]). The Company will host a conference call and webcast today, Wednesday, May 27, 2020, at 8:00 a.m. ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data. These data will also be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program on Friday, May 29, 2020 starting at 8:00 a.m. ET.

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"These data demonstrate not only that XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, can deliver confirmed complete responses, partial responses and durable stable disease in platinum-resistant ovarian cancer, but also that these responses can deepen over time in a patient population with poor prognosis and limited treatment options," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "XMT-1536 continues to demonstrate that it is generally well tolerated, without the dose-limiting toxicities of other ADC platforms such as severe neutropenia, neuropathy and ocular toxicity. These are encouraging signals as we look forward to reporting more mature data in the second half of the year and continuing to advance XMT-1536 for both platinum-resistant ovarian cancer and NSCLC adenocarcinoma patients."

The expansion portion of the Phase 1 study is enrolling patients with platinum-resistant ovarian cancer, fallopian tube or primary peritoneal cancer who have received up to three lines of prior therapy and in some cases four lines of prior therapy regardless of platinum status as well as patients with NSCLC adenocarcinoma who had received prior treatment with platinum-based therapy and immunotherapy or targeted agents. With a data cutoff of May 1, 2020 these data include 34 patients total, 27 with ovarian cancer and seven with NSCLC adenocarcinoma. Patients with ovarian cancer had a median of three prior lines of treatment (range 1-5), and patients with NSCLC adenocarcinoma had a median of two lines of therapy (range 1-3). Fifteen of the patients were dosed at 36 mg/m2, and 19 patients were dosed at 43 mg/m2 every four weeks. Key findings include:

·Safety profile consistent with previously reported dose escalation data and no new safety signals observed.
oThe most frequently (≥20%) reported treatment-related adverse events (TRAEs) were Grade 1-2 fatigue, nausea, vomiting, pyrexia, decreased appetite, diarrhea and fever and transient AST elevation without associated changes in bilirubin or cases of Hy’s law.
oThere were no reported cases of severe neutropenia, peripheral neuropathy or ocular toxicity.

·Promising antitumor activity observed in platinum-resistant ovarian cancer.
oOf the 20 patients that were evaluable for response, 2/20 (10%) achieved confirmed complete responses (CRs) and 5/20 (25%) achieved confirmed partial responses (PRs) for an objective response rate (ORR) of 35%. Additionally, 1/20 (5%) patients achieved an unconfirmed partial response for which a confirmatory scan was pending at the time of the data cutoff, and 8/20 (40%) patients achieved stable disease (SD); the disease control rate (DCR) was 16/20 (80%).
o The majority of responders had prior treatment with bevacizumab, PARP inhibitors, or both. Both patients with confirmed complete responses had prior treatment with bevacizumab and PARP inhibitors.

·Data continue to support a NaPi2b biomarker-based patient selection strategy.
oAn emerging biomarker-response relationship continues to be observed. For consistency, these data were bifurcated using the same expression level as used in the dose escalation portion of the study. More data are needed to define the patient selection strategy.
§Among those patients with higher NaPi2b expression, two (2/14) patients achieved a CR, and two (2/14) achieved a PR.
§Two (2/2) patients with NaPi2b expression not yet determined at the time of data cutoff achieved confirmed PRs.
§One (1/4) patient with lower NaPi2b expression (H-score of 90) achieved a confirmed PR.
§The Company expects to define the patient selection strategy based on the total data set from patients treated with XMT-1536.

Response – Ovarian Cancer N=20* All Higher
NaPi2b o Lower
NaPi2b oo NaPi2b
Not Yet
Determined
N 20 14 4 2
CR 2 (10%) 2 (14%) 0 (0%) 0 (0%)
PR 5 (25%) 2 (14%) 1 (25%) 2 (100%)
uPR** 1 (5%) 1 (7%) 0 (0%) 0 (0%)
SD 8 (40%) 7 (50%) 1 (25%) 0 (0%)
PD 4 (20%) 2 (14%) 2 (50%) 0 (0%)

*7 patients not evaluable: 1 withdrew consent (Lower NaPi2b Expression); 1 with unrelated SAE leading to discontinuation and death (Lower NaPi2b Expression); 5 have not yet received a scan

**uPR=1 patient with unconfirmed PR; confirmatory scan pending at the time of data cut

O Higher NaPi2b Expression: defined in dose escalation as at / above lowest H-score at which response observed (≥110)

OO Lower NaPi2b Expression: defined in dose escalation as below the lowest H-score at which response observed (<110)

·More data are needed to assess antitumor activity of XMT-1536 in NSCLC adenocarcinoma patients.
oAt the time of data cutoff, four out of seven NSCLC adenocarcinoma patients were evaluable for response, and 2/4 (50%) patients had achieved SD as best response.

Conference Call Details

Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 7785868. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.

On May 27, 2020 Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA (eravacycline for injection) to treat serious and life-threatening infections, reported that it has entered into an amendment to the Agreement and Plan of Merger, dated March 15, 2020, to which the Company is a party with AcelRx Pharmaceuticals, Inc. ("AcelRx") and its merger subsidiary (the "Merger Agreement"), to increase the consideration payable to Tetraphase shareholders (Press release, Tetraphase, MAY 27, 2020, View Source [SID1234558540]).

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Under the amended Merger Agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, (1) $0.2434 in cash and 0.7217 of a share of AcelRx common stock, representing approximately $1.43 in upfront per share value, based on the closing price of AcelRx’s common stock as of the close of trading on May 26, 2020, in each case subject to downward adjustment in the event that the Company’s closing net cash is less than $5.0 million, and (2) one contingent value right ("CVR"), which would entitle the holders to receive potential aggregate payments of up to $14.5 million in cash upon the achievement of certain future XERAVA net sales milestones starting in 2021. Under the terms of the Merger Agreement prior to the amendment, upon the consummation of the transaction, Tetraphase stockholders were entitled to receive for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, subject to downward adjustment in the event that the Company’s closing net cash is less than $5.0 million, and one CVR, which would have entitled the holders to receive potential aggregate payments of up to $12.5 million in cash or AcelRx stock, at AcelRx’s option upon the achievement of future XERAVA net sales milestones starting in 2021.

AcelRx proposed the amendment to the Merger Agreement in response to a proposal from Melinta Therapeutics, Inc. ("Melinta"), on May 21, 2020, to acquire Tetraphase for $27.0 million in cash (or $1.21 per share of Tetraphase common stock), plus an additional $12.5 million in cash potentially payable under CVRs upon the achievement of certain future XERAVA net sales milestones starting in 2021.

The boards of directors of Tetraphase and AcelRx have each approved the amendment to the Merger Agreement. Tetraphase’s board of directors has determined that as a result of the amendment to the Merger Agreement with AcelRx, Melinta’s proposal is not superior and recommends the Merger Agreement, as amended by the amendment, to its stockholders.

Based on the closing price of AcelRx stock on May 26, 2020, the total upfront consideration to be received by Tetraphase equityholders is valued at approximately $31.9 million, with approximately $16.5 million of this amount allocated to the Company’s outstanding common stock warrants. In the merger, Tetraphase stockholders would also be entitled to receive, for each share of Tetraphase common stock, one non-tradeable CVR, the holders of which will be entitled to receive potential payments of up to an additional $14.5 million in cash in the aggregate upon the achievement of net sales of XERAVA in the United States, payable as follows: (i) $2.5 million upon annual net sales of $20.0 million during 2021, (ii) $4.5 million upon annual net sales of $35.0 million during any year ending on or before December 31, 2024 and (iii) $7.5 million upon annual net sales of $55.0 million during any year ending on or before December 31, 2024.

Tetraphase continues to plan to hold its special meeting of stockholders to approve the pending transaction on June 8, 2020. The transaction is expected to close in June 2020, subject to specified closing conditions, including Tetraphase having a minimum amount of net cash as of the closing and approval by Tetraphase stockholders. Upon the closing of the transaction, Tetraphase will become a privately held company and shares of Tetraphase’s common stock will no longer be listed on any public market. Subject to certain limited exceptions, the CVRs will be non-transferable.

Janney Montgomery Scott LLC is acting as financial advisor to Tetraphase and Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor.

On May 27, 2020 Maverick Therapeutics Inc., a private biopharmaceutical company pioneering conditionally active bispecific T cell targeted immunotherapies, reported it will share company and pipeline updates at the Jefferies Virtual Healthcare Conference being held from June 2 to June 4, 2020 (Press release, Maverick Therapeutics, MAY 27, 2020, View Source [SID1234558576]). Chief Executive Officer Jim Scibetta is scheduled to participate in a live presentation on June 3, 2020 at 3:30 p.m. Eastern Time.

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Following the conference, the presentation will be available on the events & presentations section of the Maverick website at: View Source

On May 27, 2020 Medidata, the global leader in creating end-to-end solutions to support the entire clinical trial process, and a Dassault Systèmes company, reported the online publication of four abstracts at the ASCO (Free ASCO Whitepaper) 2020 Annual Meeting, being held virtually May 29 – 31 (Press release, Medidata, MAY 27, 2020, View Source [SID1234558592]).

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Acorn AI, by Medidata, and its partners – Friends of Cancer Research, Guardian Research Network, Donald and Barbara Zucker School of Medicine of Hofstra/Northwell, Memorial Sloan Kettering Cancer Center, New York-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, and New York Medical College – collaborated on research studies that highlight the importance of integrating multiple sources of data to provide insights into clinical oncology.

"Our research findings demonstrate the value of generating new clinical insights by collecting, combining, and analyzing data in innovative ways," said Glen de Vries, co-founder and co-CEO, Medidata. "We are proud to be working with outstanding research partners, who help bring meaningful contributions to the field and hope to millions of patients."

The published abstracts include use cases that combine omic and clinical data, use real-world data and pooled clinical trial data, and that expand on Medidata’s pioneering work in synthetic control arms. The following are a summary of these abstracts:

Exploring the validity of a synthetic control arm (SCA) for augmentation or replacement of a randomized control in difficult-to-study indications – a case study in relapsed or refractory multiple myeloma (R/R MM) (Abstract e20521)
The study demonstrated that the treatment effect based on a synthetic control arm can mimic the treatment effect from a randomized clinical trial in a study involving patients with relapsed or refractory multiple myeloma; this may have significant implications in speeding drug development and reducing patient burden
Evaluating progression free survival in black and white women with triple negative breast cancer in pooled clinical trials from a Synthetic Control Database (SCD) and real-world electronic medical records (EMR) (Abstract e13102)
A representative pool of cross trial triple negative breast cancer patients demonstrated lower progression free survival in Black patients compared to their non-Black counterparts by using a Synthetic Control Database and real-world EMR data, underscoring the necessity of diversity in clinical trials
Assessing the relationship in relapsed-refractory multiple myeloma between response, progression, and survival between pooled clinical trial subjects and a real-world electronic medical record data source (Abstract e20525)
The study revealed that using pooled clinical trial analyses, together with real-world data, can overcome individual trial sample size limitations and biases; this can expand the range of populations and allow a more comprehensive understanding of the complex oncology treatment landscape
Error-free, automated data integration of exosome cargo protein data with extensive clinical data in an ongoing, multi-omic translational research study (Abstract e16743)
The automatic, efficient, and reliable integration of clinical and omic data was demonstrated in a clinical trial for pancreatic ductal adenocarcinoma (PDAC), an aggressive, difficult to treat malignancy; much-needed diagnostic biomarkers for early detection may now be found in a more expedited, less-resource intensive manner
The Acorn AI/Medidata team invites the oncology community to learn more about these studies at the ASCO (Free ASCO Whitepaper) Industry Expert Theater, which are available starting May 29. This is an opportunity to dive deeper into how the company is bringing data, expertise and technology to the frontlines of decision-making in clinical oncology:

Making Precision Medicine a Reality in Clinical Development, Discovery and Beyond with Bryant Fields, Senior Director, Integrated Evidence Commercial Lead, Acorn AI
Clinical Trial Data meets the Real World: Bridging the Experimental and Post-Launch Worlds with Aaron Galaznik, Head, Acorn AI Labs Boston, Real-World Evidence (RWE)
Medidata is a wholly-owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

On May 27, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in fireside chats at the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2020, View Source [SID1234558525]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 3:00 p.m. ET
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 1:20 p.m. ET
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.