On September 10, 2020 University of California at Los Angeles reported that Despite the success of checkpoint inhibitors that remove the blockade that cancer cells impose on the immune system, the drugs only work in some patients (Press release, University of California at Los Angeles, SEP 10, 2020, View Source [SID1234565053]). A research team led by scientists at the University of California, Los Angeles figured that understanding how responders’ immune cells act differently from those of nonresponders could point to new ways to enhance the efficacy of immuno-oncology therapies.

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In a new study published in Cancer Cell, the UCLA team pinpointed two main drivers that help the immune system attack cancer in response to I-O treatment: T-cell infiltration of tumors and interferon-gamma signaling.

The researchers analyzed tumor biopsies from melanoma patients treated with Bristol Myers Squibb’s PD-1 inhibitor Opdivo, either on its own or in tandem with the company’s anti-CTLA-4 drug Yervoy, in the CheckMate-038 trial. They compared genomic data from the tumors collected before and during treatment in both patients who had a clinical response and those who didn’t respond.

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As previous researchers had reported, the UCLA scientists found that high levels of CD8 T cells traveling to tumors were associated with the clinical response to the checkpoint inhibitors.

So, they examined the expression of cancer cell-killing cytokines as a result of tumor antigen-specific T-cell activation. The team discovered that cytokine expression followed the pattern of interferon-gamma, which was found at high levels in biopsies of patients who had responded well to checkpoint inhibitors.

Further analysis of genes that are related to interferon-gamma exposure revealed that the main difference separating patients who had responded and those who resisted I-O therapy was an increase in antigen-presenting machinery.

"The cancer is blocking how the immune system attacks cancer cells by the immune checkpoints," Antoni Ribas, M.D., Ph.D., the study’s senior author, explained in a statement. "And whenever we’ve released them, then there’s an increased immune activation that depends on the strength of the T cells to produce [interferon gamma], resulting in the activation of over 600 genes that amplify the antitumor immune response."

RELATED: New insights into cancer cell escape mechanisms could boost immuno-oncology treatments

Numerous research efforts have focused on identifying methods to boost the efficacy of immuno-oncology treatments. These include combining the targeting of immune checkpoints. For example, Roche recently demonstrated that combining its PD-L1 blocker Tecentriq with experimental anti-TIGIT antibody tiragolumab shrank non-small lung cancer better than Tecentriq alone.

Researchers in China recently found that inhibiting AKT with Merck’s MK-2206 boosted T-cell infiltration in glioblastoma in mice. They argued that combining the drug with an anti-PD-1 medicine could improve the anti-tumor effect.

The UCLA-led team’s findings provide hope that combination therapies that "increase interferon signaling inside tumors to jump-start an anti-tumor immune response when it is not already pre-existing" may dial up the efficacy of immune checkpoint inhibitors so that they can help more patients, the scientists wrote in the study.

On September 10, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States, reported its financial results for the six months ended June 30, 2020 (Press release, Anpac Bio, SEP 10, 2020, View Source [SID1234564926]).

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Financial Highlights for the First Six Months of 2020

Total revenues were RMB4.1 million (US$0.6 million) for the first six months of 2020, an increase of 3.4% from RMB3.9 million for the first six months of 2019.
Gross margin was 45.3% for the first six months of 2020, an increase of 3.9 percentage points from 41.4% for the first six months of 2019.
The average selling price ("ASP") of CDA-based tests increased by RMB228, or 114% from the first six months of 2019 to the same period of 2020 primarily due to higher pricing for new contracts and a more favorable distributor mix.
Net loss was RMB56.1 million (US$7.9 million) for the first six months of 2020, compared to net loss of RMB34.9 million for the first six months of 2019. The net loss for the first six months of 2020 was due in part to one-time charges and expenses of RMB19.4 million related to the Company’s initial public offering ("IPO") and non-cash share-based compensation of RMB17.5 million.
Debt has been dropped significantly (a decrease of approximately 84%) compared to the end of last year (December 31, 2019).
Business Highlights for the First Six Months of 2020

The Company successfully listed on the NASDAQ stock exchange on January 30, 2020
The San Jose, California US lab received the College of American Pathologists ("CAP") certification. The lab also began to validate a COVID-19 antibody test on a major supplier’s FDA emergency use approved instrument and expects to commercialize the test in the second half of the year.
The Philadelphia, Pennsylvania US lab completed renovations and the 1st phase of instrument installation was finalized.
Two new products were launched, including a proprietary immunology test named ADME (AnPac Defense Medical Examination) and a new cancer test package named APCS (AnPac Pan Cancer Screening) combining CDA technology with ct-DNA methods.
Company continued to receive validation on the efficacy of CDA testing through study follow-ups. As of June 30, 2020, AnPac Bio had contacted over 22,393 tested individuals in China and received substantive feedback regarding health conditions and disease development from 13,488 individuals.
As of June 30, 2020, the Company filed 238 patent applications globally; among these, 128 patents have been granted.
The Company continued to build a cancer risk assessment database, which totaled approximately 180,500 samples as of June 30, 2020, including approximately 137,200 samples from commercial CDA-based tests and approximately 43,300 samples from research studies.
Dr. Chris Yu, AnPac Bio’s Chairman and CEO commented: "We have accomplished a number of critical milestones in the first half of the year, including its successful listing on the NASDAQ Global Markets, the launch of two new products, such as our AnPac Defense Medical Examination immunology test. We have continued to work in obtaining the Class III medical device certification in China and laboratory developed test (LDT) designation in the US. We have improved our financial performance with increased revenue, gross margin and average selling price, and reduced our operating loss, with additional cost-cutting measures to take effect during the second half of the year. The above milestones were achieved despite the outbreak of COVID-19 in the period. Looking ahead, we are optimistic about further revenue growth and gross profit increases, and new test qualification and launches in the second half of the year and in future."

Financial Results for the First Six Months of 2020

Revenue

Total revenues increased by 3.4% to RMB4.1 million (US$ 0.6 million) for the first six months of 2020 from RMB3.9 million for the first six months of 2019, primarily due to an increase in our ASP for the sales of cancer screening and detection tests.

Cost of Revenues

Cost of revenues decreased by 3.5% to RMB2.2 million (US$0.3 million) for the first six months of 2020 from RMB 2.3 million for the first six months of 2019. The decrease was primarily attributable to the Company’s streamlining of various staffing functions and less staff costs following the Chinese government’s stimulus policies in light of the COVID-19 pandemic. The decrease in our cost of revenues was also attributable to a decrease in outsourced testing expenses, as we performed more tests in our own labs.

Gross Profit and Gross Margin

Gross profit increased by 13.1% to RMB1.8 million (US$0.3 million) for the first six months of 2020 from RMB1.6 million for the first six months of 2019. Gross margin was 45.3% for the first six months of 2020, an increase of 3.9 percentage points from 41.4% for the first six months of 2019.

Selling and Marketing Expenses

Selling and marketing expenses decreased by 24.0% to RMB4.7 million (US$0.7 million) for the first six months of 2020 from RMB6.1 million for the first six months of 2019, primarily due to less share-based compensation.

Research and Development Expenses

Research and development expenses increased by 64.4% to RMB7.4 million (US$1.1 million) for the first six months of 2020 from RMB4.5 million for the first six months of 2019, primarily due to increased research activities under one of our research projects.

General and Administrative Expenses

General and administrative expenses increased by significantly to RMB50.7 million (US$7.2 million) for the first six months of 2020 from RMB24.0 million for the first six months of 2019, primarily due to higher professional service fees, which were primarily related to our IPO.

Interest Expenses

Interest expenses decreased by 59.7% to RMB517,000 (US$73,000) for the first six months of 2020 from RMB1,284,000 for the first six months of 2019, primarily due to our repayment of the short-term loans that were incurred prior to our IPO.

Other Income, Net

Net other income increased by significantly to RMB7.3 million (US$1.0 million) for the first six months of 2020 from RMB0.8 million for the first six months of 2019, primarily due to the reversal in fair value of the convertible loans that we borrowed from Zhijun after we repaid these loans.

Net Loss

Net loss was RMB56.1 million (US$7.9 million) for the first six months of 2020, compared to net loss of RMB34.9 million for the first six months of 2019. Basic and diluted loss per share was RMB5.12 (US$0.72) for the first six months of 2020, compared to that of RMB4.03 for the first six months of 2019.

Balance Sheet

As of June 30, 2020, the Company had cash and cash equivalents of RMB10.0 million (US$1.4 million), compared to RMB6.1 million as of December 31, 2019.

Cash Flow

Net cash used in operating activities was RMB53.9 million (US$7.6 million) for the first six months of 2020, compared to RMB22.2 million for the first six months of 2019.

Net cash used in investing activities was RMB1.2 million (US$0.2 million) for the first six months of 2020, compared to RMB0.4 million for the first six months of 2019.

Net cash provided by financing activities was RMB58.9 million (US$8.3 million) for the first six months of 2020, compared to RMB20.9 million for the first six months of 2019.

Conference Call

The Company’s management will host an earnings conference call at 8:00 am Eastern Time on September 10, 2020 (5:00 am Pacific Time/8:00 pm Beijing Time) to discuss the financial results for the first six months ended June 30, 2020. To attend this earnings conference call, please use the information below for either dial-in access or webcast access. When prompted, please reference "AnPac Bio/ANPC."

Conference Call
Date: September 10, 2020
Time: 8:00 am ET, U.S.
International Toll Free: United States: +1 888-346-8982

Mainland China: +86 400-120-1203

Hong Kong: +852 800-905-945
International: International: +1 412-902-4272
Conference ID: AnPac Bio-Medical Science Co., Ltd.
Please dial in at least 15 minutes before the commencement of the call to ensure timely participation. For those unable to participate, an audio replay of the conference call will be available from approximately one hour after the end of the live call until September 17, 2020. The dial-in for the replay is +1 877-344-7529 within the United States or +1 412-317-0088 internationally. The replay access code is 10147575.

A live webcast of the call will also be available at View Source

On September 10, 2020 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), a drug delivery technology company focused on improving the bio-delivery and bio-distribution of medicines, reported its unaudited interim results for the six months ended 30 June 2020 (Press release, Midatech Pharma, SEP 10, 2020, View Source [SID1234564945]).

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OPERATIONAL HIGHLIGHTS (including post period end)

·In March, an exploratory study was initiated with MTX110 by Columbia University in five patients with DIPG using an alternative convection enhanced delivery system.

·In March, the Company announced a wide-ranging Strategic Review, updated in April to include a Formal Sale Process under the Takeover Code. The Formal Sale Process was subsequently terminated in July.

·In March, the decision was taken to terminate further in-house development of the MTD201 programme with immediate effect although the asset remains available for licensing. All activities connected with MTD201 have been wound down expeditiously and the manufacturing facilities in Bilbao have been closed. Following the termination of in-house development of MTD201, the Company realigned its strategy towards exploiting its Q-Sphera technology more broadly.

·In April, an exploratory study was initiated with MTX110 by the University of Texas, Houston in five patients with recurrent medulloblastoma.

·In June, the Company signed a research collaboration with Dr Reddy’s Laboratories Ltd under which Midatech is deploying its in-house expertise and Q-Sphera drug delivery platform to medicines nominated by Dr Reddy’s.

·In July, the Company signed a collaboration with an unnamed European affiliate of a global pharmaceutical company, to establish the application of the Q-Sphera platform to new modalities in drug delivery.

FINANCIAL HIGHLIGHTS (including post period end)

·Total revenue in H1 2020 was £0.17m (H1 2019: £0.45m). Total revenue represents income from R&D collaborations plus grant revenue.

·Research and development costs increased by 15% to £3.99m (H1 2019: £3.46m) as a result of lower MTX110 development costs, redundancy costs of £0.88m and write-down of Spain assets of £0.55m, offset by a negative share-based payment charge of £0.35m.

·Administrative expenses increased to £2.93m (H1 2019: £2.05m) and included £0.35m one-time costs associated with Spanish Government loans, £0.07m UK redundancy costs and a £0.51m increase in legal and professional fees.

·Impairment of intangible assets of £11.59m (H1 2019: Nil) related to the termination of further in-house development of MTD201 and associated IPRD and goodwill.

·Net cash used in operating activities (after changes in working capital) in H1 2020 was £7.09m, compared with £4.56m in H1 2019.

·In May, in a concurrent Registered Direct Offering in the US and a Placing in the UK, the Company raised £4.26m before expenses through the sale of 15.76m ordinary shares at £0.27 per share and warrants exercisable for 16.55m ordinary shares at £0.34 per share.

·In July, the Company raised an additional £5.75m before expenses in an oversubscribed UK Placing, including a Broker Option, through the sale of 21.3m ordinary shares at £0.27 per share with no warrants.

·The cash balance at 30 June 2020 was £4.33m.

On September 10, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in three virtual investor conferences in September 2020 (Press release, Mustang Bio, SEP 10, 2020, View Source [SID1234564961]). The company will also host virtual one-on-one meetings during the conferences.

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Details of the events are as follows:

H.C. Wainwright 22nd Annual Global Investment Conference: Presentation on Monday, September 14, 2020, at 2:30 p.m. EDT
Cantor Virtual Global Healthcare Conference: Fireside Chat on Wednesday, September 16, 2020, at 2:00 p.m. EDT
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: Fireside Chat on Monday, September 21, 2020, at 3:20 p.m. EDT
Live webcasts of the presentation and fireside chats will be available on the Events page of the Investors Relations section of Mustang’s website: www.mustangbio.com. Archived replays of the webcasts will be available for approximately 30 days following each presentation and fireside chat.

On September 10, 2020 Genelux Corporation, a privately-held biopharmaceutical company, reported that the abstract covering data from the VIRO-15 Phase 2 trial (NCT02759588) has been accepted for an Oral Plenary Session at the 2020 xDigital Global Annual Meeting of the International Gynecologic Cancer Society (IGCS) (Press release, Genelux, SEP 10, 2020, View Source [SID1234564978]). VIRO-15 assessed Olvi-Vec in combination with a platinum-based regimen in platinum-resistant/refractory ovarian cancer (PRROC) patients. These data are being presented on Friday, September 11, 2020.

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"We are encouraged by the Phase 2 data in PRROC patients, which show Olvi-Vec is well tolerated and demonstrated remarkable anti-tumor activity with durable responses in combination with a platinum-based regimen, especially in patients with difficult-to-treat platinum-refractory disease," said Robert Holloway, MD, principal investigator for VIRO-15 and Chair of Genelux’s Clinical Advisory Board on gynecologic cancers. "Translational analyses results point to Olvi-Vec-mediated immune modulation of the tumor microenvironment and long-term therapeutic effect with cytotoxic platinum-based chemotherapy."

Key findings in ­­­27 heavily pre-treated PRROC patients (median 4 prior lines; 48% platinum-resistant, 52% platinum-refractory) who had documented disease progression from their last line of therapy prior to enrollment are as follows (data of patients eligible for evaluation after initiation of chemotherapy):

Median Progression-free Survival (PFS) is 11.0 months (95% CI: 6.7 – 13.0) and PFS-6-month is 77%.
Objective Response Rate (ORR) by RECIST1.1 criteria is 54% [95% CI: 33-74%; 2 (8%) complete response (CR), 11 (46%) partial response (PR)]; median Duration of Response is 7.6 months; and 86% of patients achieved tumor shrinkage.
ORR by CA-125 tumor biomarker is 85% [95% CI: 65-96%; 10 (38%) CR, 12 (46%) PR]; and 96% of patients achieved decrease of CA-125.
There are no differences in PFS & ORR between platinum-resistant & -refractory patients.
Most common adverse events: Grades 1&2 (≥ 20% patients) were pyrexia 59%, nausea 48%, abdominal distension 44%, abdominal pain 44%, chills 37%, fatigue 33% and vomiting 26%; Grade 3 (≥ 2 patients) were abdominal pain 7% and hypophosphatemia 7%; Grade 4 (none).
Performance status was preserved or improved in 93% of patients while on subsequent platinum-based regimen.
Translational analyses data indicate Olvi-Vec engages the immune system and induces favorable immune response (such as large intraepithelial infiltration of CD4+ & CD8+ T cells into tumors) and gene expression changes to the tumor microenvironment to aid clinical reversal of platinum resistance.
"Genelux is excited about the potential of Olvi-Vec-primed immunochemotherapy to generate meaningful clinical responses and improve the quality of life of PRROC patients who currently lack effective treatment options," said Thomas Zindrick, J.D., President and CEO of Genelux. "A registration trial of Olvi-Vec-primed immunochemotherapy is being planned."

Oral Presentation Session Details
Title: Oncolytic Vaccinia (Olvi-Vec) Primed Immunochemotherapy in Heavily Treated Platinum-Resistant/Refractory Ovarian Cancer
Session Information: Plenary III
Date/Time: ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­Friday, September 11, 2020/ 7:25 a.m. Eastern Time/11:25 a.m. Coordinated Universal Time
Presenter: Robert W. Holloway, MD, Medical Director, Gynecologic Oncology, AdventHealth Cancer Institute, Orlando, FL, USA
Additional information can be found at www.igcs.org

About Olvimulogene Nanivacirepvec
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and anti-tumor activity. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Clinical results in over 150 subjects treated in Genelux studies have shown Olvi-Vec is well tolerated with documented clinical benefits.