On March 15, 2018 – Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT),
a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition,
development and commercialization of novel treatments for patients with solid tumor cancers, reported its financial results and recent corporate highlights for the fourth quarter and full year ended December 31, 2017 (Press release, Checkpoint Therapeutics, MAR 15, 2018, http://www.checkpointtx.com/press-releases/checkpoint-therapeutics-reports-fourth-quarter-and-full-year-2017-financial-results-and-recent-corporate-highlights/ [SID1234525088]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "Checkpoint achieved
significant financial and pipeline-related milestones in 2017. Most notably, our common stock
began trading on The NASDAQ Capital Market in June 2017, and in October, we announced the
dosing of the first patient in our Phase 1 trial of our anti-PD-L1 antibody, CK-301. In addition, the
FDA granted Orphan Drug Designation to our third-generation EGFR inhibitor, CK-101, for the
treatment of EGFR mutation-positive non-small cell lung cancer. As we enter 2018, we believe
we are well-positioned to generate initial efficacy data from our clinical trials in support of our
planned registration studies to commence in 2019."

Financial Results:
• Cash Position: As of December 31, 2017, Checkpoint’s cash and cash equivalents totaled
$19.2 million, compared to $35.1 million at December 31, 2016, a decrease of $15.9
million. On a non-GAAP basis, pro-forma cash and cash equivalents as of December 31,
2017 (excluding first quarter 2018 operations) totaled approximately $40.1 million, after
giving effect to $20.9 million of net proceeds from an underwritten public offering during
March 2018.
• R&D Expenses: Research and development expenses for the year ended December 31,
2017 were $19.1 million, compared to $20.3 million for the year ended December 31,
2016, a decrease of $1.2 million.
• G&A Expenses: General and administrative expenses for the year ended December 31,
2017 were $5.4 million, compared to $4.5 million for the year ended December 31, 2016,
an increase of $0.9 million.
• Net Loss: Net loss attributable to common stock holders for the year ended December
31, 2017 was $22.7 million, or $1.00 per share, compared to a net loss of $22.5 million,
or $1.04 per share, for the year ended December 31, 2016.

2017 and Recent Corporate Highlights:

• In February 2017, the U.S. Patent and Trademark Office issued a composition of matter
patent for CK‐101, an oral, third‐generation epidermal growth factor receptor ("EGFR")
inhibitor in development for the treatment of EGFR mutation‐positive non‐small cell lung
cancer ("NSCLC").
• In June 2017, Checkpoint’s common stock began trading on The NASDAQ Capital Market
under the ticker symbol "CKPT."
• In September 2017, Checkpoint announced that the U. S. Food and Drug Administration
granted Orphan Drug Designation to CK-101 for the treatment of EGFR mutation-positive
NSCLC.
• In October 2017, Checkpoint announced the dosing of the first patient in a Phase 1 clinical
trial evaluating the safety and tolerability of CK-301, an anti-PD-L1 antibody, in checkpoint
therapy-naïve patients with selected recurrent or metastatic cancers.
• In March 2018, Checkpoint completed an underwritten public offering that raised net
proceeds of $20.9 million.

On March 15, 2018 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported that promising preclinical data with BerGenBio’s lead AXL inhibitor bemcentinib (formerly BGB324) will be featured at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on 14-18 April in Chicago, USA (Press release, BerGenBio, MAR 15, 2018, View Source [SID1234525083]).

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The data highlight bemcentinib’s potential to reverse tumour immune suppression and enhance immune checkpoint inhibitor efficacy. These data continue to support the clinical rationale for combining bemcentinib with immune checkpoint inhibitors to improve cancer treatment. BerGenBio is currently conducting three Phase II clinical trials evaluating bemcentinib in combination with the immune checkpoint inhibitor, KEYTRUDA.

Abstract ID#: 6026

Poster presentation: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM, McCormick Place South, Exhibit Hall A, Poster Section 32

The abstract is now available online.

On March 28, 2018 Arcus Biosciences (NYSE: RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that five abstracts have been accepted for poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting to be held April 14-18, 2018 in Chicago, Illinois. The presentations at AACR (Free AACR Whitepaper) cover three of our clinical and preclinical product candidates including our dual adenosine receptor antagonist, AB928; our PD-1 antibody, AB122; and our small molecule CD73 inhibitor, AB680 (Press release, Arcus Biosciences, MAR 15, 2018, View Source [SID1234525079]).

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Data to be presented include:

AB928:
Title: Pharmacokinetic-Pharmacodynamic relationship for AB928, a dual antagonist of the A2aR and A2bR adenosine receptors – abstract #3769

Title: Combining adenosine receptor inhibition with AB928 and chemotherapy results in greater immune activation and tumor control – abstract #5556

AB122:
Title: Preclinical characterization of GLS-010 (AB122), a fully human clinical-stage anti-PD-1 antibody – abstract #4561

AB680:
Title: CD73 inhibitors (CD73i) reverse the AMP/adenosine-mediated impairment of immune effector cell activation by Immune Checkpoint Inhibitors (ICI) – abstract #710

Title: Discovery and characterization of AB680, a potent and selective small-molecule CD73 inhibitor for cancer immunotherapy – abstract #4886

Additional information – including presentation schedule and full abstracts – can be found at www.aacr.org.

On March 15, 2018 Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies, a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that new data on two of its pipeline programs will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, to be held April 14-18 at McCormick Place North/South in Chicago, Illinois (Press release, Molecular Templates, MAR 15, 2018, View Source [SID1234524813]).

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Molecular Templates has utilized the ability of its Engineered Toxin Bodies (ETBs) to route to the endoplasmic reticulum and cytoplasm to deliver cytomegalovirus (CMV) foreign antigen for presentation in the context of MHC class I molecules on tumor cells. This Antigen Seeding Technology (AST) allows for the targeted delivery, intracellular processing, and surface MHC-I presentation of CMV antigen and subsequent destruction of tumors via a CMV-specific T lymphocyte response.

Preclinical data on the company’s PD-L1 targeted ETB incorporating AST will be presented at the AACR (Free AACR Whitepaper) meeting. This molecule has been engineered to both destroy PD-L1-expressing tumor cells via ribosomal destruction and to deliver the immunodominant HLA:A02 restricted cytomegalovirus (CMV) protein-pp65 for MHC-I presentation on these cells. The dual mechanisms of action against the PD-L1 target allow for a more potent and complete destruction of tumor cells. Molecular Templates expects this program to enter the clinic in the first half of 2019.

"We are excited by this wholly novel approach to immuno-oncology," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "Antigen seeding is a way to target an immense, activated T-cell repertoire to the tumor without having to overcome T-cell exhaustion or stimulate antigen presentation from APCs. We are looking forward moving to this approach into the clinic."

Date: Monday, April 16
Time: 1:00pm – 5:00pm Central Time
Session: PO.IMO2.11 – Therapeutic Antibodies, Including Engineered Antibodies 2
Location: Section 34
Poster Title: Antigen Seeding Technology by Engineered Toxin Bodies Provides a Targeted Immuno-Oncology Approach for Treatment of Cancers
Authors: Brigitte Brieschke, Sangeetha Rajagopalan, Garrett L. Robinson, Erin K. Willert, Hilario J. Ramos

Molecular Templates will also present on its HER2 engineered toxin body program. MT-5111, a HER2-targeted ETB with picomolar potency against HER2 expressing cells, was designed to overcome mechanisms of resistance to current HER2 targeting modalities such as escape from antibody dependent cell-mediated cytotoxicity (ADCC), alterations in signal transduction, epitope masking, and enhanced small molecule efflux. Additionally, MT-5111 was genetically engineered to reduce the anti-drug antibody response and signaling through innate receptors, allowing for repeat dosing.

In vitro and in vivo data will be presented at the AACR (Free AACR Whitepaper) meeting, highlighting the potential for MT-5111 as a novel agent in development for treatment of breast carcinomas and other malignancies overexpressing the HER2 receptor. Molecular Templates intends to file an IND with MT-5111 in 2018.

"Antibody, small molecule, and ADC approaches to HER2 have all shown meaningful benefit in patients with HER2+ cancers but ultimately cease to work in most patients even though HER2 expression persists," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "We believe the unique mechanism of action of our HER2 ETB may circumvent mechanisms of resistance to the other HER2 modalities."

Date: Wednesday, April 18
Time: 8:00am – 12:00pm Central Time
Session: PO.ET01.02 – Antibodies, Fusion Proteins, and Related Biologics
Location: Section 35
Poster Title: Targeted Engineered Toxin Bodies Provide a Novel Mechanism of Action Against HER2 Positive Cancers
Authors: Brigitte Brieschke, Garrett L. Robinson, Sangeetha Rajagopalan, Hilario J. Ramos, Jensing Liu, Jack P. Higgins, Erin K. Willert

On March 16, 2018 Shares of Adaptimmune Ltd. surged late Thursday after the company reported it saw three partial responses in three of the four myxoid/ round cell liposarcoma (MRCLS) patients the company dosed with its NY-ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cells (Press release, BioSpace, MAR 15, 2018, View Source [SID1234524855]).

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The news sent company stock up more than 20 percent to $12.41 per share. Since that spike, shares have fallen back some to $10.74 as of 10:51 a.m.

Those positive results are also good news for GlaxoSmithKline, which licensed the NY-ESO SPEAR T-cell therapy program last fall. The two companies initiated their collaboration in 2014 and last year the pharma giant exercised its option to exclusively license Adaptimmune’s NY-ESO SPEAR T-cell therapy program. The transition has not yet been completed.

MRCLS is a type of liposarcoma that is characterized by the proliferation of adipocyte (fat cell) precursors called lipoblasts that have undergone differentiation arrest. MRCLS represents about 30 to 35 percent of liposarcomas and 5 to 10 percent of all adult soft tissue sarcomas. It is estimated that there are approximately 2000 patients in the United States and Europe with MRCLS each year.

Rafael Amado, Adaptimmune’s chief medical officer, said the company is encouraged by the initial responses in the first patients dosed. He said the news validates the potential for its platform to treat a broad range of tumors, including those known to be unresponsive to current immunotherapy treatments.

"Although MRCLS is a soft tissue sarcoma which commonly expresses NY-ESO, there are fundamental differences in its clinical course, natural history, molecular signature, and responsiveness to standard treatments that make it distinct from synovial sarcoma. As we expect data from our other trials with our wholly owned assets throughout 2018, these results in a second solid tumor strengthen our conviction that our pipeline of unique TCRs will be capable of addressing multiple solid tumors," Amado said in a statement.

So far Adaptimmune has dosed four patients with its treatment. Of the three partial responses the company said two have been confirmed and one has yet to be confirmed. The other patient was classified as having stable disease. Adaptimmune said the doses were well-tolerated. However, the company said it did see cases of cytokine release syndrome (CRS), a systemic inflammatory response that has been a persistent concern in other CAR-T and cell therapy trials. The CRS cases Adaptimmune patients encountered were managed following standard treatment guidelines, the company said.

Two years ago the U.S. Food and Drug Administration placed a partial clinical hold on the NY-ESO SPEAR T-cell study for MRCLS. The hold was lifted after Adaptimmune revised the trial protocol.

In addition to its NY-ESO SPEAR T-cell study, Adaptimmune is using SPEAR T-cells in two clinical trials targeting MAGE-A10, one in non-small cell lung cancer (NSCLC), and a triple tumor study in bladder, melanoma, and head & neck cancers. Both studies are dose escalation trials that evaluate three doses of transduced SPEAR T-cells, administered after a lymphodepleting chemotherapy regimen. In addition to the MAGE-A10 trial, Adaptimmune is also targeting MAGE-A4. The newly manufactured SPEAR T-cell at the Philadelphia site will be used in a multiple tumor study in bladder, melanoma, head & neck, ovarian, non-small cell lung, esophageal, and gastric cancers.