On August 7, 2018 Teneobio, Inc., a next generation multi-specific antibody therapeutics company, and Poseida Therapeutics, Inc., a San Diego-based clinical-stage company translating best-in-class gene engineering technologies into lifesaving cell therapies, reported a new research collaboration and licensing agreement to develop novel CAR-T therapies using Teneobio’s heavy chain only domain antibodies (UniDabs) (Press release, TeneoBio, AUG 7, 2018, View Source [SID1234558319]).

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Poseida will apply UniDab binders, which demonstrate significant advantages over traditional single chain variable antibody fragment (scFv) binders, to the development of its next generation CAR-T therapies.

The new collaboration follows a commercial license agreement between the companies that was announced in May of 2017. Under the terms of the new agreement, Teneobio will generate multiple UniDab product candidates using its proprietary UniRat transgenic human antibody ‘heavy-chain only’ rodent platform and its state-of-the-art sequence-based discovery engine, TeneoSeek. Poseida will have exclusive global licensing rights for the clinical development and commercialization of specific UniDabs for CAR-T therapies.

Teneobio Inc. will receive an upfront payment and is eligible to receive future research, development and regulatory milestone payments per UniDab candidate, with total potential earnings of over $250 million for CAR-T therapies developed by Poseida. Teneobio would also receive royalties on worldwide net sales of each CAR-T therapy.

"We are delighted to partner with Poseida and to help create the next generation of cell therapies," said Roland Buelow, CEO of Teneobio. "Domain antibodies have been clinically validated as excellent targeting moieties in CAR-T cells. They confer robust in vivo specificity and efficacy. They are smaller in size, have greater humanicity, and superior developability relative to standard scFv’s. The use of UniDabs as binders in CAR-T products is predicted to result in a lack of tonic signaling and lower immunogenicity, thus solving some of the problems of the first-generation, scFv-based CAR-T therapies."

Eric Ostertag, CEO of Poseida, noted, "Teneobio’s UniDab binders are an ideal match for Poseida’s novel and industry-leading CAR-T platform technologies. Poseida has demonstrated that UniDabs can be engineered to serve as binding molecules for our CAR-T therapeutics and oftentimes may function better than other binders for use in CAR-T products."

"We are pleased to expand our existing partnership with Poseida, whose cutting-edge genetic engineering tools combined with our targeting UniDab candidates will enable the development of the next generation of superior CAR-T therapies to treat cancer. We believe that UniDabs provide differentiated advantages from other targeting moieties, and that their utility and reach will extend beyond antibody therapeutics to novel transformational cell therapy treatments," added Omid Vafa, CBO of Teneobio.

On August 7, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on our Probody therapeutic technology platform, reported that it will present at the 2018 Wedbush PacGrow Healthcare Conference. Debanjan Ray, chief financial officer, will present a corporate overview on August 14, 2018, at 9:45 a.m. ET.

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A live audio webcast of the presentation will be available through the Investors and News section of CytomX’s website. An archived replay will be available for 90 days following the event.

On August 7, 2018 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing small molecule drugs that target novel and critical metabolic pathways in tumor and cancer-fighting immune cells, reported its financial results for the second quarter ended June 30, 2018 (Press release, Calithera Biosciences, AUG 7, 2018, View Source [SID1234528513]). As of June 30, 2018, cash, cash equivalents and investments totaled $152.2 million.

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"In the second quarter we continued to execute our clinical development plans for our glutaminase inhibitor and arginase inhibitor programs, while deepening our pipeline with two novel programs entering clinical development," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We have advanced CB-280, a novel arginase inhibitor into development for the treatment of cystic fibrosis and we announced today our next oncometabolism drug candidate, CB-708, an orally bioavailable small molecule CD73 inhibitor."

Second Quarter 2018 and Recent Highlights

Enrolling Two Randomized Phase 2 Combination Trials of CB-839 in Combination for the Treatment of Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind placebo-controlled study of late line patients, is enrolling approximately 66 patients to receive either everolimus and CB-839 or everolimus alone. It is now expected to enroll by the fourth quarter of 2018, or early 2019. CANTATA is a randomized double-blind placebo-controlled trial comparing advanced patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. This trial will enroll approximately 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. The trial opened in 2018 and is expected to take approximately two years to reach the primary endpoint analysis.

Presented Results of CB-839 in Combination with Capecitabine at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). A Phase 1 Investigator sponsored clinical trial of CB-839 plus capecitabine was presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).1 In patients with late-line colorectal cancer that had progressed on at least one prior fluoropyrimidine-containing regimen, the median PFS was 26 weeks for patients with PIK3CA mutated cancer (n=7) and 16 weeks for patients with PIK3CA wild-type cancer (n=5,p=0.058). The Phase 2 portion of this study in patients with PIK3CA mutant colorectal cancer is ongoing.

Evaluating CB-839 in Combination with Paclitaxel in Triple Negative Breast Cancer (TNBC). A Phase 2 trial evaluating CB-839 with paclitaxel in TNBC patients is ongoing. Four single arm, open label, cohorts of African American and non-African American patients are being treated in both the early and late stage settings. The primary endpoint of this trial is objective response rate and a number of predictive biomarkers are being assessed. Based on our preliminary Phase 2 clinical trial results and recent changes in the competitive landscape of TNBC, we do not plan to pursue further development of CB-839 plus paclitaxel in TNBC at this time.

Enrolling INCB001158 Clinical Trials. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte.

Advanced Arginase Inhibitor CB-280 for the Treatment of Cystic Fibrosis. Arginase has been proposed to be critical in the pathology of cystic fibrosis by impairing production of nitric oxide. CB-280 is an orally administered small molecule inhibitor of arginase. An investigational new drug (IND) application for CB-280 with the U.S. FDA is planned for the first half of 2019.

Selected CD73 Small Molecule Inhibitor to Enter Clinical Development in 2019. The enzyme CD73 is an oncometabolism target that plays a critical role in the process of ATP conversion to adenosine. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned in 2019.

R&D Day Planned on October 5, 2018 in New York City. The meeting will focus on the Company’s research and development programs, including CB-280 and CB-708. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website.

Selected Second Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $152.2 million at June 30, 2018.

Revenue was $17.1 million for the three months ended June 30, 2018, compared with $7.3 million for the same period in the prior year. In the second quarter of 2018, the Company completed the manufacturing services and technology transfer under its collaboration and license agreement with Incyte, which satisfied the performance obligation under ASC 606 and as a result all remaining deferred revenue was recognized.

Research and development expenses were $17.3 million for the three months ended June 30, 2018, compared with $10.1 million for the same period in the prior year. The increase of $7.2 million was due to an increase in the CB-839 program, including for the Phase 2 CANTATA trial which opened in 2018, an increase in the INCB001158 program, including Incyte’s co-funding of development costs, an increase in the CB-280 program, including to support the IND application, as well as investment in early stage research.

General and administrative expenses were $3.5 million for the three months ended June 30, 2018, compared with $2.8 million for the same period in the prior year. The increase of $0.7 million was primarily due to increases in personnel-related costs.

Net loss from operations for the three months ended June 30, 2018 was $3.1 million, or $0.09 per share.

Conference Call Information

Calithera will host an update conference call today, August 7th at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 2057667. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On August 6, 2018 DotBio, a new company focused on the development of novel immuno-oncology drugs based on humanized domain antibodies, reported the company has officially launched and has successfully raised US$2.3 million in seed financing led by the HeungKong Group via Futec Biomedical Investments Limited (Press release, DotBio, AUG 6, 2018, View Source [SID1234646736]). DotBio is an independent biotechnology company that has spun out from Singapore’s Nanyang Technological University (NTU).

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DotBio aims to develop a broad pipeline of drug candidates to address the pressing need for new oncology treatments based on its proprietary DotBody technology. DotBodies are domain therapeutic antibodies which are multi-specific, humanized and highly-stable.

As a result of their small size, domain antibodies benefit from superior tumor penetration and can be used as building blocks for multi-specific antibodies. DotBodies are optimized by a unique proprietary technology that improves antibody stability, reduces aggregation and lowers the risk of immunogenicity – increasing the probability of their success in clinical trials. The higher stability and small size of DotBodies make them highly modular, allowing rapid optimization of pharmacokinetics, multi-valency and multi-specificity.

DotBio was founded by Professor Pär Nordlund, a world leading structural biologist at NTU and Karolinska Institute, who has pioneered strategies to define cancer drug mechanisms, and Dr. Ignacio Asial, who designed and conceptualized the DotBody technology based on his expertise in protein and antibody engineering at NTU’s School of Biological Sciences. Dr. Asial will lead DotBio as Chief Executive Officer and Dr. Kelly Hew will serve as Chief Operating Officer. Professor Nordlund will be scientific advisor to the company.

As part of the spin-out agreement with NTU, DotBio will acquire the rights to the domain antibody technology through NTUitive – the university’s innovation and enterprise company – as well as certain assets developed under a previous collaboration agreement between ASLAN Pharmaceuticals (ASLAN) and NTU. NTU and ASLAN will take minority equity stakes in DotBio. Kingsley Leung, representing HeungKong Group, and Carl Firth, Chief Executive Officer of ASLAN, will join the Board of DotBio as non-executive directors.

The funds raised will enable DotBio to generate a number of therapeutic candidates and complete validation studies. In addition to agreed collaborations with NTU and Karolinska Institute, DotBio is establishing partnerships in industry and academia to advance DotBodies in clinical development. DotBio’s current internal pipeline is focused on multi-specific immuno-oncology drugs targeting different checkpoint blockades, positive immune signals and tumor specific processes with several candidates planned to enter preclinical studies during 2018. The broad applicability of the DotBody technology will enable DotBio to consider other therapeutic areas on a case-by-case basis.

Dr Ignacio Asial, Chief Executive Officer, DotBio, commented: "This is an exciting time for us to launch DotBio, the potential of domain antibody technology to change the way we treat cancer is clear. Our focus is on applying the world-leading protein science expertise of our team to revolutionize multi-specific, CAR-T and ADC therapies, positioning DotBio as a leader in next-generation immuno-oncology drugs."

Professor Pär Nordlund, Co-Founder of DotBio, added: "Multi-specific domain antibodies offer a more refined means to activate the antitumor immune response and to minimize adverse effects as compared to standard antibody-based combination therapies. It is our belief that DotBio´s powerful domain antibody technology uniquely positions the company to become a leader in next-generation multi-specific cancer therapies. The DotBody technology can also be applied to many other therapeutic areas and we look forward to opportunities to collaborate with industry partners and academia to realize the enormous potential of our technology."

On August 6, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Limited ("CMS Medical") for the commercialization of Can-Fite’s Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including Hong Kong, Macao and Taiwan) (Press release, Can-Fite BioPharma, AUG 6, 2018, View Source [SID1234528454]).

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Under the terms of the agreement, CMS Medical is making an upfront payment of $2,000,000 to Can-Fite and is required to pay to Can-Fite milestone payments of up to $14,000,000 upon the achievement of certain regulatory milestones and payments of up to $58,500,000 upon the achievement of certain sales milestones. In addition, the agreement provides for double-digit royalty payments on net sales.

CMS Medical is a wholly-owned subsidiary of China Medical System Holdings Limited ("CMS"; SEHK: 867), a specialty pharmaceutical company based in China, focusing on marketing, promotion and sales of prescription drugs and other medicinal products to therapeutic departments in hospitals. CMS builds up its product portfolio for its target markets by asset acquisition, equity investment, licensing and distribution as well as in-house R&D. CMS is listed on the Hong Kong Stock Exchange with a current market capitalization of approximately HK$34 billion as at August 1, 2018.

According to the agreement, CMS will be responsible for the development of Piclidenoson and Namodenoson to obtain regulatory approval in China and shall be further responsible for obtaining and maintaining regulatory approval in China for the indications described above. Can-Fite may, at the option of CMS, supply finished product to CMS.

"We are very excited to enter into this agreement with CMS, with their broad and professional experience in development, registration and marketing of diverse drugs in the Chinese market and believe that they are the right partner for us to penetrate this big market," stated Dr. Sari Fishman, VP Business Development of Can-Fite. "We believe that CMS’s commitment to us is strong validation of our development efforts to date."

Can-Fite is currently enrolling patients for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis and plans to shortly initiate patient enrollment for its Phase III Comfort trial of Piclidenoson for the treatment of psoriasis. The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects. Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach $35B in 2020 and psoriasis is forecast to reach $9B in 2018.

Phase II studies with Namodenoson for the treatment of advanced liver cancer (hepatocellular carcinoma, Child Pugh B) and NAFLD/NASH are currently ongoing. The last patient for the advanced liver cancer trial was enrolled in August 2017, and treatment of remaining patients is still ongoing.