On September 10, 2020 CMAB Biopharma (Suzhou) Inc. ("CMAB"), and Laekna Therapeutics Shanghai Co., Ltd. ("Laekna Therapeutics"), reported a strategic collaboration agreement in Suzhou BioBAY for speedup of Immune Checkpoint Inhibitor (ICI) drug candidate to the clinical trial and future commercialization (Press release, CMAB Biopharma, SEP 10, 2020, View Source [SID1234564977]).

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Signing Ceremony of Strategic Colaboration Between laekna Therapeutics and CMAB Biopharma
According to the agreement, CMAB will provide a full spectrum of CMC services based on the recognized global quality standards for Laekna Therapeutics’ anti-PD-L1 antibody (LAE005). Services to be provided by CMAB include technology transfer, process development, GMP clinical drug substance and drug product manufacturing to support IND filing in China and in the US. These services will facilitate the global development and future commercialization of LAE005.

Laekna Therapeutics is a biotechnology innovation company focusing on the research and development of new generation of small molecules for target therapy and antibodies in the field of oncology and liver diseases. In February 2020, Laekna Therapeutics obtained the exclusive global development and commercialization rights for LAE005 from the Novartis group, Switzerland. At present, LAE005 has completed phase I clinical trials which confirmed the tolerability, safety and preliminary anti-cancer efficacy in different solid tumors, including triple negative breast cancer.

Laekna Therapeutics is applying for the permission of clinical trials for LAE005 both in China and in the US. "We are looking forward to the results of clinical efficacy and safety of LAE005. In the recent years, cancer therapy has entered a brand new era of immuno-oncology. The combination of anti-PD-L1 antibody and AKT inhibitor, such as LAE005 plus Afuresertib, is one of the most innovative therapies among many different combination therapies. Afuresertib is an AKT inhibitor of Laekna Therapeutics that is currently undergoing phase II global clinical trials in both China and the United States, which has great potential for the treatment of different cancers. Laekna Therapeutics is committed to bringing more safe, precise and personalized treatments to cancer patients globally, especially in China," said Dr. Chris Lu, founder and CEO of Laekna Therapeutics, "We are pleased to work closely with CMAB to provide process development and production of clinical trial drugs for anti-PD-L1 candidate. The excellent technology, experience and service of CMAB assure us that they can support Laekna’s clinical and commercial needs for our innovative pipeline and that our joint efforts will surely accelerate the benefits to cancer patients worldwide."

Located in Suzhou Biotech Industrial Park (BioBAY), CMAB is currently the fastest growing pure-play biopharmaceutical CDMO company in China. It is committed to using disruptive technologies to meet its customer’s needs as quickly as possible. Dr. Yongzhong Wang, CEO of CMAB, said: "Since our establishment in 2017, CMAB has successfully helped many partners gain valuable milestones in the new drug development and has also successfully completed the production of cGMP batches for several different clinical candidates being developed by leading biopharmaceutical enterprises. Since 2019, CMAB has continuously hired high-quality talent at home and abroad. At present, CMAB has nearly 260 employees, forming a stable and experienced team. As a respectable enterprise in the industry, Laekna Therapeutics has built up an experienced Sino-US operational team in a few years, and successfully and efficiently introduced a number of clinically validated new product candidates. We are very happy to establish a strategic cooperation with Laekna Therapeutics. The CMAB team will make every effort to realize the global development and commercialization of LAE005, the first biopharmaceutical project of Laekna Therapeutics."

On September 10, 2020 Codiak BioSciences, a company developing therapies based on tiny bubbles secreted by cells, reported that it is lining up an IPO as it prepares for the first tests of its technology in humans later this year (Press release, Codiak Biosciences, SEP 10, 2020, View Source [SID1234564997]).

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In paperwork filed with securities regulators late Wednesday, Codiak set a preliminary $100 million goal for its stock market debut. The Cambridge, MA-based biotech has applied for a Nasdaq listing under the stock symbol "CDAK."

The research of Codiak focuses on exosomes, extracellular vesicles that carry proteins, genetic material, and other substances in and out of cells. Exosomes function as a messenger system between cells, transporting molecules that alter the function of a recipient cell, Codiak says in its filing. Because these vesicles evolved with humans naturally, they don’t trigger an immune response. Exosomes can also be engineered for selective targeting of particular cells, and they can carry an array of payloads.

Codiak produces its therapies by engineering exosomes to carry drug molecules, either on the surface or the inside of the vesicle. The company says that its proprietary technology, called engEx, can produce therapeutic exosomes at scale and according to pharmaceutical standards.

The lead Codiak program, exoSTING, is being developed as a treatment for solid tumors. This Codiak exosome is engineered to carry molecules inside the vesicle that are intended to elicit an anti-tumor immune response by hitting the stimulator of interferon genes (STING) pathway of the innate immune system. Other attempts to drug this pathway have run into problems delivering the therapy to a cell while also avoiding toxic effects to healthy cells, Codiak says in its filing. The company says its exosome drug could overcome those limitations.

The cancers that Codiak aims to treat with exoSTING include metastatic head and neck squamous cell cancer, triple-negative breast cancer, cutaneous squamous cell carcinoma, and anaplastic thyroid carcinoma. If a Phase 1/2 clinical trial begins later this year as expected, the company says preliminary data could become available by the middle of 2021.

The next program in Codiak’s pipeline is exoIL-12, an exosome that’s engineered with the cytokine interleukin 12 (IL-12) on the surface of the vesicle. Other companies are also pursuing therapies that incorporate IL-12. Codiak notes IL-12 has elicited an anti-tumor immune response in its preclinical research and the clinical studies of others. But the company adds that experimental IL-12 therapies have been hampered by the unwanted spread of the therapy’s effects throughout the body, particularly the liver. Codiak says its exosome-delivered IL-12 drug could avoid such problems.

Codiak is developing exoIL-12 to treat solid tumors for which the IL-12 pathway has been established. These cancers include melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma, and triple-negative breast cancer. The initial focus for this drug is early-stage cutaneous T cell lymphoma. A Phase 1 study is planned to start later this year; preliminary data are expected by the end of 2020. Additional data, including efficacy results, could become available by the middle of next year.

Other companies developing exosome therapies include Aruna Bio, AstraZeneca (NYSE: AZN), Evox Therapeutics, and PureTech Health. Startups are also getting into the mix. Harvard University spinout Vesigen emerged in July with $28.5 million in Series A financing to fund the development of its extracellular vesicle-based therapies.

The Wednesday IPO filing is Codiak’s second attempt to join the public markets. The company initially filed to go public in April 2019 but withdrew those plans three months later. Codiak’s timeline for the start of clinical trials is unchanged from last year. But Codiak can now make its case to investors with some additional validation. In June, Codiak inked a two-year research deal with Sarepta Therapeutics (NASDAQ: SRPT), which agreed to pay its new partner $72.5 million in upfront and near-term milestone payments. Sarepta is interested in exploring Codiak’s exosome technology as a way to deliver genetic medicines for muscular disorders without triggering an immune response.

The Sarepta deal is Codiak’s second partnership with a larger biopharmaceutical company. Early last year, the company began an alliance with Jazz Pharmaceuticals (NASDAQ: JAZZ), which paid $56 million up front in a deal spanning five cancer therapies.

Codiak launched in 2015 with financial backing from an investor group that included Flagship Pioneering (known then as Flagship Ventures), Arch Venture Partners, and Fidelity Management & Research. Those firms are Codiak’s largest stockholders, owning 28.3 percent, 18.9 percent, and 14.1 percent of the company respectively, according to the filing.

Codiak reported that its cash holdings as of June 30 totaled $50.9 million. The company says it will use the IPO proceeds to fund clinical tests of its two lead exosome drug candidates, and to finance further development of programs in earlier stages of development.

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.