On May 15, 2018 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that data from preclinical studies of its HER2-targeted CAR-T cell containing its dual-switch technology will be reviewed in an oral presentation at the 21st Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held in Chicago, Illinois from May 16-19 (Press release, Bellicum Pharmaceuticals, MAY 15, 2018, View Source [SID1234526611]).

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"The potential of our novel dual-switch CAR-T platform to provide in vivo control over adoptive immunotherapies is very exciting," said Bellicum’s President & CEO Rick Fair. "These data suggest the potential to significantly reduce toxicities while prolonging efficacy using molecular switches activated by small molecule agents. We believe this technology may address some of the major challenges with CAR-T therapies, particularly when targeting solid tumors. We look forward to initiating clinical trials in 2019 with two CAR-T cell candidates engineered with dual switches."

Presentation Details:

Title: HER2-Targeted Dual-Switch CAR-T Cells Enable Post-Infusion Control of CAR-T Efficacy and Safety with Small Molecules
Session: 113 Cancer – Targeted Gene & Cell Therapy I
Date/Time:Wednesday, May 16th11:00 a.m. CDT

The presentation will be made available in the Events and Presentations section of the Bellicum website shortly after the presentation.

On May 15, 2018 CohBar, Inc. (NASDAQ: CWBR) ("CohBar" or the "Company"), an innovative biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported its financial results for the first quarter ended March 31, 2018 (Press release, CohBar, MAY 15, 2018, View Source [SID1234526641]).

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"We raised $4.6 million in additional funding since the beginning of the year to further support our pre-clinical and clinical activities," said Simon Allen, CohBar CEO, "and our latest findings regarding CB4211’s novel mechanism of action were accepted for presentation at a major scientific conference next month. Our planned clinical entry will mark significant milestones both for CohBar’s transition to a clinical-stage company, and for the transformation of naturally occurring mitochondrial peptides into a novel class of therapeutics for the potential treatment of a range of age-related diseases."

Recent and First Quarter 2018 Business and Preclinical Development Highlights:

CB4211 Mechanism of Action Findings Accepted for Presentation at Major Scientific Conference in June. The Company will be presenting its findings to date about the molecular mechanisms underlying CB4211’s efficacy in animal models of NASH at a major scientific conference in June 2018. The Company’s ongoing investigation identified CB4211’s interaction with a cell-surface receptor that plays a key role in metabolic regulation.

Completed Private Placement. With the final closing in April 2018, the Company issued and sold a total of $3.9 million of non-convertible unsecured promissory notes, together with warrants to purchase 780,500 shares of the Company’s common stock. Insider participation accounted for more than $500,000 of the financing. An additional $0.7 million was raised from warrant and option exercises during the first quarter.

Investment and Scientific Community Outreach. During the first quarter, CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at the H.C. Wainwright & Co. 2nd Annual NASH Investor Conference, and met with institutional investors and NASH scientific and medical experts at the BIO CEO and Investor Conference, and at the 30th Annual ROTH Conference.

First Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash, cash equivalents and investments of $8,456,656 on March 31, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $2,680,983 in the three months ended March 31, 2018 compared to $1,292,780 in the prior year first quarter. The increase was due primarily to costs related to our clinical and IND-enabling activities, and an increase in stock-based compensation for option grants made during the current year quarter, and for prior grants to consultants that are revalued at each balance sheet date.

G&A Expenses. General and administrative expenses were $913,088 in the three months ended March 31, 2018, compared to $940,089 in the prior year quarter. The decrease in general and administrative expenses were related to lower stock-based compensation costs compared to the prior year first quarter, offset by increases in insurance premiums and directors fees related to the addition of a new Board member announced at the end of 2017.

Net Loss. For the three months ended March 31, 2018, net loss was $3,586,585, or $0.09 per basic and diluted share, compared to a net loss of $2,232,110, or $0.06 per basic and diluted share, for the three months ended March 31, 2017.

CohBar will not be hosting a first quarter 2018 investor conference call. The Company will be conducting an investor teleconference in conjunction with its Annual Shareholder Meeting scheduled for June 19, 2018. Details of the Annual Shareholder Meeting will be announced in early June.

About CohBar’s Lead Program

CohBar’s lead preclinical development program is based on MOTS-c, a mitochondrial-derived peptide (MDP) that was discovered in 2012 by CohBar founder Professor Dr. Pinchas Cohen and his academic collaborators, whose research has shown that MOTS-c plays a significant role in the regulation of metabolism. The Company has developed CB4211, a novel and improved analog of MOTS-c, which has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity.

On May 15, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2018 (Press release, Cel-Sci, MAY 15, 2018, View Source [SID1234526658]).The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study has been fully enrolled since September 2016. All 928 patients are being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database. All that remains to be done in this pivotal Phase 3 study is to continue to track patient survival until the 298 deaths have occurred and it can be determined if the primary endpoint has been met.
Closing arguments in the arbitration against the former clinical research organization (CRO) for the Phase 3 trial concluded on April 25, 2018. The parties are now awaiting a decision from the arbitrator.
The U.S. Patent and Trademark Office allowed a patent for CEL-SCI’s LEAPS technology for methods of inducing immune responses.
"We expect two significant and material outcomes in the near term. In the very near term we are awaiting a decision from the arbitrator in our case against our former CRO. The read out of the Phase 3 study is expected to take longer than the decision by the arbitrator, however, based on overall survival data available in the scientific literature for the study’s patient population and the fact that the last patient was enrolled in the study over 1.5 years ago, we believe that the end of the Phase 3 trial is approaching as well," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "Separately, we continue to advance our LEAPS technology through preclinical studies in preparation for human clinical studies. The current work with the Rheumatoid Arthritis vaccine is funded by a $1.5 million grant from the National Institutes of Health."

During the six months ended March 31, 2018, CEL-SCI’s cash increased by approximately $0.7 million. Significant components of this increase include net proceeds from the sale of CEL-SCI’s common stock of approximately $7.1 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $6.4 million.

CEL-SCI reported an operating loss of ($4,205,745) for the quarter ended March 31, 2018 versus an operating loss of ($7,906,557) for the quarter ended March 31, 2017. The operating loss was ($9,117,175) for the six months ended March 31, 2018 versus an operating loss of ($12,844,565) for the six months ended March 31, 2017.

The research and development expenses decreased by approximately $4.8 million compared to the six months ended March 31, 2017. The majority of CEL-SCI’s research and development expense relates to its on-going Phase 3 clinical trial. Clinical trial costs tend to be higher during the enrollment phase of the study and because the study is fully enrolled, the expenses incurred over the last six months have decreased. The general and administrative expenses increased by approximately $1.3 million compared to the six months ended March 31, 2017. This increase is primarily due to an increase of approximately $1.0 million in equity based compensation related to the Company’s shareholder approved 2014 Incentive Stock Bonus Plan, and a net increase of approximately $0.3 million in other general and administrative expenses primarily for accounting fees and public relations services.

On May 15, 2018 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the first quarter 2018 (Press release, BerGenBio, MAY 15, 2018, View Source [SID1234526612]). A presentation of the results by the Company’s management will take place today at 10.00 am CET in Oslo – details below.

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Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased with the progress made during Q1 2018. Patient recruitment into our global Phase II clinical proof-of-concept trials with bemcentinib is progressing well and we expect to deliver interim read-outs across all studies during 2018. Presentation of these results will be at major clinical congresses, including the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June. Coinciding with ASCO (Free ASCO Whitepaper), we will host a satellite event that will allow us to meet with our stakeholders and provide insights from KOLs and clinical experts on our selective AXL inhibitor bemcentinib as a potential cornerstone of cancer combination therapy. We believe that we will be able to demonstrate the significant potential of bemcentinib in cancer therapy by making tumour cells visible to the immune system and more susceptible to treatment with chemotherapy, targeted therapy and immuno-oncology drugs."

Highlights – First Quarter 2018

Good progress advancing bemcentinib’s proof-of-concept clinical development

First efficacy endpoint met in Phase II trial of bemcentinib/TARCEVA (erlotinib) combination in advanced lung cancer (NSCLC) patients
Recruitment completed in first stage of Phase II trial of bemcentinib in combination with KEYTRUDA in advanced breast cancer (TBNC) patients
Bemcentinib shown to be well tolerated in all patients enrolled across three combination trials with KEYTRUDA – data presented at ASCO (Free ASCO Whitepaper)-SITC 2018
Single agent therapy with bemcentinib led to increased immune activity in relapsed / refractory leukaemia (AML & MDS) patients – data presented at ASCO (Free ASCO Whitepaper)-SITC 2018
Post period

Private placement raising gross NOK 187.5 million from international institutional investors including from the USA, specialising in the biotechnology sector
Recruitment completed in the first stage of Phase II trial of bemcentinib in combination with KEYTRUDA in NSCLC patients
Preclinical data highlighting bemcentinib’s potential to reverse tumour immune suppression and enhance immune checkpoint inhibitor efficacy, presented at AACR (Free AACR Whitepaper) annual meeting
Publications describe the role of AXL signalling in, and potential therapeutic effect of selective AXL inhibition to counteract the progression of aggressive fibrosis in lung and liver diseases

Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place at 10.00 am CET at:
Felix Konferansesenter, Bryggetorget 3, 0125 Oslo
The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/ Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and the presentation will be available at www.bergenbio.com in the section: Investors/ Financial Reports from 7:00 am CET the same day.

On May 15, 2018 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported pipeline updates and operating results for the quarter ended March 31, 2018 (Press release, Eleven Biotherapeutics, MAY 15, 2018, View Source [SID1234526642]).

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"2018 is set to be a transformational year for the company and, already in the first quarter, we have made important progress in advancing our lead program, Vicinium, for high-grade non-muscle invasive bladder cancer, or NMIBC," said Stephen Hurly, president and chief executive officer of Eleven Biotherapeutics. "Our Phase 3 registration trial, the VISTA Trial, investigating Vicinium for patients with high-grade NMIBC, is progressing well and recently completed enrollment. We look forward to presenting three-month data from the trial in an oral presentation at the American Urological Association Annual Meeting on May 21st, a significant catalyst for the company and our Vicinium program. High-grade NMIBC is a disease for which there is a desperate need for new treatment options, and we look forward to further exploring Vicinium as a potential treatment for these patients."

Pipeline Progress and Updates

Eleven Biotherapeutics will present three-month data from its ongoing Phase 3 VISTA Trial, which is evaluating Vicinium for the treatment of patients with high-grade NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG). The data will be presented during a plenary session on Monday, May 21, 2018 at 11:00 a.m. PDT at the American Urological Association Annual Meeting being held in San Francisco. In March 2018, the company announced enrollment completion in the VISTA Trial.
In April 2018, Eleven Biotherapeutics presented preclinical data from its deBouganin program at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. DeBouganin is a potent deimmunized plant-based toxin designed for systemic use in the treatment of cancer and other indications. The data presented suggest that VB6-845d, a next generation ADC that is composed of an anti-EpCAM antibody fragment fused to deBouganin, mediates tumor cell killing by an immunogenic cell death (ICD) pathway. The potential cross-priming effect initiated by VB6-845d-induced ICD suggests that VB6-845d in combination with immune checkpoint inhibitors may enhance their effectiveness in EpCAM-positive epithelial cancers. Additionally, in collaboration with Crescendo Biologics, the company presented data demonstrating that a potent fusion protein comprised of the company’s deBouganin payload and Crescendo’s Humabody is expressible as a soluble protein in E. coli supernatant and capable of potent killing of cancer cell lines.
First Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents were $19.7 million as of March 31, 2018, compared to $20.3 for the same period in 2017.
Revenue: There was no revenue for the quarter ended March 31, 2018, compared to $0.4 million for the same period in 2017. The decrease was due to a reduction in revenue recognized from the company’s license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche).
R&D Expenses: Research and development expenses were $3.3 million for the quarter ended March 31, 2018, compared to $2.9 million for the same period in 2017. The increase was due primarily to increases in clinical costs.
G&A Expenses: General and administrative expenses were $2.0 million for the quarter ended March 31, 2018, compared to $2.2 million for the same period in 2017. The decrease was due primarily to reductions in legal and professional costs.
Net Loss: Net loss was $4.0 million, or $0.11 per share, for the quarter ended March 31, 2018, compared to net loss of $6.1 million, or $0.25 per share, for the same period in 2017. The decrease was due primarily to the change in the fair value of contingent consideration.
Financial Guidance: Following Eleven Biotherapeutics’ $10.0 million financing in March 2018 and receipt of approximately $4.2 million from the exercise of common stock warrants through mid-May, the company maintains it will have capital to fund its current operating plans into early 2019.
Conference Call Information
The company will host a conference call on May 21, 2018 at 5 p.m. ET to review the data being presented at AUA. To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 4453267. The webcast can be accessed in the Investor Relations section of the company’s website at www.elevenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.elevenbio.com for 60 days following the call.

About Vicinium
Vicinium, also known as VB4-845, is Eleven Biotherapeutics’ lead product candidate and is a next-generation antibody-drug conjugate (ADC), developed using the company’s proprietary Targeted Protein Therapeutics platform, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA Trial, designed to support the registration of Vicinium for the treatment of high-grade NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Three-month data from the ongoing trial are planned for presentation at the 2018 American Urological Association Annual Meeting on May 21, 2018, with 12-month data anticipated in mid-2019. Additionally, Eleven Biotherapeutics believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.