On March 25, 2019 PharmaMar (PHM:MSE) reported that its Phase II trial of lurbinectedin as a single agent for the treatment of relapsed small cell lung cancer (SCLC) has achieved its primary endpoint, by both investigator review and IRC (Independent Review Committee) (Press release, PharmaMar, MAR 25, 2019, View Source [SID1234534599]).

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The primary endpoint of this trial was to measure the Overall Response Rate (ORR), with other secondary endpoints such as Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS) and safety.

This multicenter, single arm, phase II clinical trial, involving 105 patients from 38 centers in nine different countries in Europe and the US, assessed the safety and efficacy of lurbinectedin in patients with relapsed SCLC.

The results will be submitted for presentation at a major medical meeting.

Around 15% to 20% of lung cancers are small cell, and it is one of the cancer types with the worst prognosis. The treatment of relapsed SCLC has not changed substantially in more than two decades. The last FDA approved new chemical entity in second line small cell lung cancer was topotecan, in 1996.

In the lurbinectedin clinical program, the SCLC indication is currently PharmaMar’s first priority. PharmaMar completed the recruitment in July 2018 of its Phase III ATLANTIS study for the treatment of relapsed SCLC. The Company is awaiting results.

Lurbinectedin was designated an Orphan Drug by the FDA in August 2018, and a positive opinion for Orphan Drug Designation by EMA was received in January 2019 for the treatment of SCLC.

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On March 25, 2019 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, AmpliPhi Biosciences, MAR 25, 2019, View Source [SID1234534598]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial results release.

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"I am pleased with the strong progress AmpliPhi achieved in 2018, capped off by the announcement of the pending merger with C3J at the beginning of 2019," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "Leading up to the closing of the merger, which is expected in May 2019, we remain on track to initiate a clinical trial of AB-SA01 for the treatment of S. aureus bacteremia later in 2019. The increasing prevalence of antibiotic-resistant infections has become a global public health crisis, and we believe precisely targeted bacteriophage therapeutics, with their novel mechanism of action, could be an important therapeutic option where currently-available antibiotic treatments have become ineffective."

Recent Business Highlights

In January 2019, AmpliPhi and C3J Therapeutics, Inc., a private clinical stage biotechnology company focused on the development of novel synthetically engineered bacteriophage products, announced they had entered into a definitive agreement under which a wholly owned subsidiary of AmpliPhi will merge with C3J in an all-stock transaction, subject to shareholder approval. Certain existing C3J shareholders have agreed to purchase $10.0 million of common stock of the combined company immediately following the closing of the merger, subject to customary conditions. The financing will help fund further development of the combined company’s preclinical and clinical programs, and is expected to close immediately following the completion of the merger. Management expects the merger will close in May 2019.
Presented clinical case data from the expanded access program at the ID Week 2018 Conference in October 2018. Thirteen patients with serious and life-threatening S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney. Eighty-three percent (10 out of 12) patients in the modified intent-to-treat (mITT) population achieved treatment success at the end of therapy as reported by treating physicians. Bacteriophage treatment was well tolerated, with no adverse events attributable to the therapy.
Completed treatment of 21 patients at 7 hospitals with serious or life-threatening infections not responding to antibiotics with AmpliPhi’s bacteriophage product candidates, AB-SA01 and AB-PA01. Following administration of 1,000+ doses, a treatment success rate of 84% was observed at the end of therapy, and treatment was generally well tolerated.
Completed an underwritten public offering in October 2018 generating net proceeds of $5.8 million.
Fourth Quarter and Full Year Ended December 31, 2018 Financial Results

Research and development (R&D) expenses for the fourth quarter of 2018 were $1.4 million compared to $1.1 million for the fourth quarter of 2017. The increase of $0.3 million was primarily attributable to an increase in clinical costs and related professional services.
R&D expenses for the year ended December 31, 2018 were $4.9 million compared to $2.9 million for the year ended December 31, 2017. The increase in 2018 was impacted by a $1.2 million tax incentive payment received in 2018 from the Australian tax authority, compared to a $2.0 million tax incentive payment from the Australian tax authority received in 2017. Excluding any benefit from tax incentive payments, R&D expenses were $6.1 million and $4.9 million, respectively. The increase of $1.2 million in 2018 was primarily related to an increase in clinical activities and related professional and consulting expenses.
General and administrative (G&A) expenses were $1.5 million for the fourth quarter of 2018 compared to $1.3 million for the fourth quarter of 2017. The increase of $0.2 million was primarily due to higher legal and professional fees in the fourth quarter of 2018.
G&A expenses for the year ended December 31, 2018 were $5.7 million compared to $7.6 million for the year ended December 31, 2017. The $1.9 million decrease was primarily attributable to a decrease in severance costs, legal and professional fees and lower non-cash charges in 2018.
Operating expenses in the fourth quarter of 2018 included a non-cash charge of $1.9 million for the impairment of intangible assets for the excess of book value over the computed fair value of those assets as of December 31, 2018. The impaired assets were recorded in connection with acquisitions of a predecessor company in 2011.
Net cash used in operating activities for the year ended December 31, 2018 was $9.4 million, as compared to $9.2 million for the year ended December 31, 2017.
Cash and cash equivalents as of December 31, 2018 totaled $8.2 million.
As of March 8, 2019, there were approximately 32.3 million shares of common stock outstanding.
The audit opinion included in the company’s Annual Report on Form 10-K for the year ended December 31, 2018 contains a going concern explanatory paragraph.

On March 25, 2019 H3 Biomedicine Inc., a U.S.-based precision medicine research & development subsidiary of Eisai Co., Ltd., reported multiple presentations at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held March 29 through April 3, 2019 at the Georgia World Congress Center in Atlanta, GA (Press release, H3 Biomedicine, MAR 25, 2019, View Source [SID1234534597]).

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Leveraging its integrated data science, human biology and precision chemistry discovery engine, H3 is advancing a pipeline of highly targeted, investigational breakthrough medicines to address critical unmet needs in the treatment of hematologic and solid tumor cancers. The company currently has three precision medicine therapeutic programs in clinical study with several additional research programs advancing toward the development stage.

H3’s presentations at this year’s AACR (Free AACR Whitepaper) Annual Meeting showcase the company’s breadth of expertise in oncology research and the molecular insights enabled by its unique discovery engine.

The schedule for H3’s presentations is as follows (in chronological order):

Oral Presentation/Education Session:

Title:Targeting the spliceosome; perspectives from structural biology

Session:Chemistry to the Clinic: Part 2: Novel Chemical Tools and Leads for Unprecedented Targets

Date and Time: Saturday, March 30, 2019; 10:15 a.m. – 12:15 p.m. EDT

Location: Room A311-312

Presenter: Nicholas Larsen, Ph.D., Director, H3 Biomedicine

Poster Presentations:

Abstract Number: 281

Title: Sensitivity to splicing modulation of BCL2 family genes reveals cancer therapeutic strategies for splicing modulators

Session: Combination Approaches to Novel Therapies

Date and Time: Sunday March 31, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location: Exhibit Hall B; Poster Section 12; Poster Board Number 2

Abstract Number:498

Title: Integrating bulk and spatial profiling technologies for the discovery of RNA and protein biomarkers in muscle invasive bladder cancer

Session: Imaging the Tumor Microenvironment

Date and Time: Sunday, March 31, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location:Exhibit Hall B; Poster Section 20; Poster Board Number 11

Abstract Number: 2467

Title: Heme-CMap: Generation and characterization of ~20K L1000 profiles across 11 hematologic malignant lines

Session: Databases and Computational Tools for Cancer Discovery

Date and Time: Monday April 1, 2019; 1:00 p.m. – 5:00 p.m. EDT

Location: Exhibit Hall B; Poster Section 31; Poster Board Number 7

** In collaboration with the Broad Institute

On March 25, 2019 Advaxis, Inc. (NASDAQ: ADXS) (the Company), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the U.S. Patent and Trademark Office has granted patent number 10,189,885 titled "Non-Hemolytic LLO Fusion Proteins and Methods of Utilizing Same (Press release, Advaxis, MAR 25, 2019, View Source [SID1234534596])." This composition-of-matter patent extends protection for axalimogene filolisbac (AXAL) through March 2028.

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"We are pleased to receive another patent to further expand our robust intellectual property portfolio of more than 400 issued or pending patents worldwide," said Robert G. Petit, Ph.D., Chief Scientific Officer of Advaxis. "The issuance of this patent provides additional intellectual property protection for AXAL, which has demonstrated clinical activity across multiple tumor types."

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. The U.S. Food and Drug Administration (FDA or Agency) has granted AXAL Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer, and a Special Protocol Assessment (SPA) for the Phase 3 AIM2CERV trial evaluating its potential to delay or prevent the recurrence of locally advanced cervical cancer. The FDA has also granted AXAL orphan drug designation in three clinical indications.

Advaxis is in discussions with FDA regarding the partial clinical hold on its Phase 3 AIM2CERV trial and is working to address the questions raised by the Agency surrounding prior AXAL chemistry, manufacturing and controls matters. The FDA did not cite any safety issues related to the trial and all currently enrolled patients are continuing to receive treatment, although no new patients are being enrolled. Advaxis is also in dialogue with FDA to request an amendment to the SPA to include an earlier interim analysis for efficacy.

On March 25, 2019 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of best-in-class anti-CD47 antibody therapies, reported a successful $50 million Series B financing (Press release, Arch Oncology, MAR 25, 2019, View Source [SID1234534595]). The Company plans to use the proceeds from this financing to advance its anti-CD47 antibody AO-176’s ongoing Phase 1 clinical trial in select solid tumors, as well as its pipeline.

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This financing included Arch Oncology’s existing investors, RiverVest Venture Partners, Roche Venture Fund, and 3×5 Partners, and was led by new investor Lightchain (Scottrade Founder and former CEO Rodger Riney’s family office).

"Our investors share our commitment to the exciting work we are doing to develop best-in-class antibodies aimed at improving treatment options for patients with cancer," said Julie M. Cherrington, Ph.D., President and Chief Executive Officer of Arch Oncology. "This financing supports our ongoing Phase 1 clinical trial for AO-176, our highly-differentiated anti-CD47 antibody, as we continue to dose patients. Additionally, these proceeds enable us to advance our discovery-stage pipeline. With the backing of our investors and the hard work of our experienced team, we look forward to developing new cancer treatment options for patients."

"Over the past year, the Arch Oncology team under Julie’s leadership has successfully executed on plans to advance AO-176 from the laboratory, through IND submission, and into the clinic," said John McKearn, Ph.D., Managing Director, RiverVest Venture Partners and Chairman of the Board of Arch Oncology. "We believe AO-176 has a best-in-class profile among agents in the anti-CD47 space and we are excited to see the progress advancing the pipeline."