On August 6, 2018 Harbour BioMed and Glenmark Pharmaceuticals S.A., reported that they have entered into an exclusive license agreement for the Greater China territory to develop, manufacture and commercialize GBR 1302, Glenmark’s bispecific antibody targeting HER2 and CD3 for the treatment of HER2-positive cancers (Press release, Harbour BioMed, AUG 6, 2018, View Source [SID1234528464]).

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Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed said: "We are looking forward to collaborating with Glenmark Pharmaceuticals to develop and commercialize this promising, novel bispecific antibody in Greater China to meet the significant unmet medical needs of Chinese cancer patients. This collaboration is aligned with our strategy to leverage our clinical development expertise by in-licensing highly innovative clinical stage assets. GBR 1302 is complementary to the internal portfolio we are building through our industry leading transgenic mouse platforms for generating innovative antibody-based therapeutics."

"We are very pleased to begin this strategic relationship with Harbour BioMed for the development and commercialization of our bispecific antibody, GBR 1302 in Greater China, where the predominance of certain HER-2 positive cancers presents a significant clinical need," said Glenn Saldanha, Chairman and Managing Director of Glenmark. "GBR1302 is representative of Glenmark’s commitment to the discovery and development of innovative therapeutics for unmet medical need, and the opportunity to work collaboratively with Harbour BioMed on this program, which brings extensive local experience, is very important to Glenmark."

Under the terms of the agreement, Glenmark will receive an upfront payment and is eligible to receive payments for achieving pre-specified development, regulatory and commercialization milestones, as well as tiered royalties on net sales for any approved products from Harbour BioMed. The agreement is potentially worth more than $120 million in addition to royalties for Glenmark. Harbour BioMed will lead the clinical development and commercialization of GBR 1302, with the option to manufacture GBR 1302 for the Greater China market. The companies will collaborate on the generation of clinical data to support the registration of GBR 1302 in HER2-positive indications in their respective territories.

GBR 1302, Glenmark’s lead immuno-oncology candidate, works by stimulating the patient’s immune system against HER2 overexpressing tumor cells. GBR 1302 is currently in a first-in-human study to determine maximum tolerated dose (MTD) in an all-comers population of patients with a variety of HER2-positive cancers. Enrollment for the GBR 1302 clinical study is currently ongoing in the U.S. and Germany.

Kurt Stoeckli, President and Chief Scientific Officer for Glenmark added, "Harbour BioMed represents a company that is dedicated to the same principles as Glenmark in pursuing highly effective, precision-medicine based immunotherapeutics for the benefit of cancer patients and we look forward to working closely with them to advance meaningful treatment options."

About Glenmark’s Oncology Pipeline and Proprietary BEAT Technology
Glenmark’s pipeline currently includes three immuno-oncology candidates being studied in a wide range of tumor types. These include three bispecific monoclonal antibodies (bsAbs). GBR 1302, a HER2xCD3 bsAb, targets HER2 expressing tumors, including those not responsive to standard of care; GBR 1342, a CD38XCD3 bsAb targeting CD38 positive tumors including hematologic malignancies and solid tumors; and GBR 1372, an EGFRxCD3 bsAb targeting EGFR positive tumors including those resistant to standard of care.

BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) is Glenmark’s proprietary technology for the production of bsAbs. With BEAT technology, Glenmark’s scientists have been able to overcome past production obstacles encountered with bsAbs, and can efficiently manufacture these molecules at clinical and commercial scale. Preclinically, BEAT bsAbs demonstrate the potential for more potent activity compared to existing therapeutic antibodies. Additionally, structural similarity to naturally-occurring antibodies may result in a normalized IgG half-life and less immunogenicity. GBR 1302, GBR 1342 and GBR 1372 are based on BEAT technology.

On August 6, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference during August and invited investors to participate by webcast (Press release, Exact Sciences, AUG 6, 2018, View Source [SID1234528468]).

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Canaccord Genuity 38th Annual Growth Conference, Boston
Presentation on Wednesday, Aug. 8, 2018, at 1 p.m. EDT

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On August 6, 2018 Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, and Elasmogen, an SME focused on the development of next generation biologics, reported that they have been awarded a grant from Innovate UK through its Innovation in Health and Life Sciences funding programme (Press release, Elasmogen, AUG 6, 2018, View Source [SID1234637763]).

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The £2M peer reviewed collaborative project entitled ‘A Technology Platform for Next Generation VNAR based Oncology Medicines’, plans to utilise the highly selective, high affinity and yet low molecular weight non-antibody VNAR protein scaffold and build a versatile platform to facilitate the discovery and development of targeted oncology therapeutics.

The VNAR structure allows ready access for protein engineering of multiple formats. These VNAR formats can be optimised, with or without conjugation of a cytotoxic payload, with further conversion to soloMER format, to become a first-in-class or best-in-class targeted therapeutic. The two year project optimises both target binding and selectivity, via the identification of novel epitopes and formats, approaches to linker design and payload attachments, and further builds upon the experimental data supporting the unique attributes of VNARs.

Almac first entered into an agreement with Elasmogen for the treatment of solid tumours in 2015. This new joint research programme broadens the collaborative work by combining Almac Discovery’s expertise in protein engineering and oncology drug discovery with Elasmogen’s expertise in the generation, screening and formatting of VNAR proteins.

Stephen Barr, President & Managing Director, Almac Discovery commented: "We are delighted to have secured this highly sought after funding from Innovate UK to support this novel field of research which is testament to the novelty of the proposed approach and the quality of the underlying technologies involved. It is heartening to be able to continue and also broaden our successful collaboration with Elasmogen so that we may remain at the forefront of oncology discovery and ultimately benefit patients."

"Given the devastating and wide-ranging impact of cancer on the lives of so many people, there is a continual need to bring new innovative therapies into the clinic" said Caroline Barelle, Chief Executive Officer, Elasmogen. "I have no doubt that by combining the oncology expertise of Almac with the advantages of our soloMER platform that we can deliver a new class of drugs to patients".

Innovate UK is the UK’s innovation agency working with people, companies and partner organisations to find and drive science and technology innovations that will grow the UK economy.

Future research of next generation VNAR-based oncology medicines, as a result of this investment, will be co-funded by the UK’s innovation agency, Innovation UK, Elasmogen and Almac Group.

On August 6, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its second quarter and six months ended June 30, 2018 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, AUG 6, 2018, View Source;p=irol-newsArticle&ID=2362261 [SID1234528449]).

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"The dosing of the first patient with lifileucel in Europe for the treatment of metastatic melanoma marked an important milestone for Iovance and our global development plans as we continue our mission to develop TIL therapy as a treatment option for cancer patients. In line with expansion of the TIL platform, we are initiating investigation of TIL therapy in several new indications with high unmet need, as part of our collaboration with MD Anderson," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "We continue to advance our four company-sponsored trials and intend to provide an update regarding our melanoma program later this year."

Recent Achievements

Manufacturing

Initiated manufacturing at Lonza, Netherlands in support of the melanoma and cervical clinical sites in Europe.
Clinical

Enrollment in the global Phase 2 metastatic melanoma study, C-144-01, continues and in June 2018, the company announced that it dosed the first patient with LN-144 (lifileucel) in Europe at a clinical trial site in the United Kingdom.
As part of a collaboration program, Iovance and MD Anderson Cancer Center (MDACC) initiated two new Phase 2 clinical studies. The first, 2017-0672 (NCT03449108), is studying LN-145 manufactured by Iovance using the company’s Gen 2 manufacturing process to treat patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer. The study is active and enrolling patients. The second study is expected to be activated before the end of 2018 and will use TIL manufactured by MDACC.
Iovance has expanded to over 70 clinical sites for its four company-sponsored studies.
Regulatory

As of the end of July 2018, Iovance has activated sites for its two clinical trials being conducted in Europe in five countries including the Netherlands, France, Hungary, Spain and the United Kingdom.
In early May 2018, the company was granted orphan-drug designation from the U.S. Food and Drug Administration (FDA) for autologous tumor infiltrating lymphocytes for the treatment of cervical cancer with a tumor size of greater than 2 cm in diameter.
Research

Iovance entered into a Research Collaboration Agreement with Roswell Park Cancer Institute for a pre-clinical collaboration to explore the potential for TIL therapy in bladder and other cancers.
Second Quarter 2018 Financial Results

Net loss for the second quarter ended June 30, 2018 was $30.7 million, or $0.34 per share, compared to net loss of $23.4 million, or $0.37 per share for the same period ended June 30, 2017.

Research and development expenses were $24.6 million for the second quarter ended June 30, 2018, an increase of $6.0 million compared to $18.6 million for the second quarter ended June 30, 2017. The increase in research and development expenses was primarily attributable to a $2.8 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and dedicated consultants as we expanded our research efforts and clinical development programs. In addition, a $4.5 million increase occurred due to clinical trial costs because of higher patient enrollment and the number of clinical sites in the clinical trial of lifileucel, for the treatment of metastatic melanoma, and the ongoing clinical trials of LN-145 for the treatment of cervical, head and neck and lung cancers. These increases were partially offset by a $1.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $6.8 million for the quarter ended June 30, 2018, an increase of $1.9 million compared to $4.9 million for the second quarter ended June 30, 2017. The increase was primarily attributable to a $1.6 million increase in payroll and related expenses, including stock-based compensation expenses, due to an increase in head count and higher stock prices during the quarter, and a $0.3 million increase in professional service and legal expenses.

Six Months Ended June 30, 2018 Financial Results

Net loss for the six months ended June 30, 2018 was $ 57.2 million, or $0.65 per share, compared to net loss of $44.1 million, or $0.71 per share for the same period ended June 30, 2017.

Research and development expenses were $44.5 million for the six months ended June 30, 2018, an increase of $10.3 million compared to $34.2 million for the same period ended June 30, 2017. The increase in research and development expenses was primarily attributable to a $5.7 million increase in payroll and related expenses, including stock-based compensation expenses, primarily due to a higher number of full time employees and higher stock prices in 2018, and additional outside services contracted to perform research and development activities on our behalf, and a $7.0 million increase in costs related to our clinical trials as we expanded our clinical development programs into additional indications and added clinical trial sites in Europe. These increases were partially offset by a $2.0 million decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.

General and administrative expenses were $13.8 million for the six months ended June 30, 2018, an increase of $3.6 million compared to $10.2 million for the same period ended June 30, 2017. The increase was primarily attributable to a $2.7 million increase in payroll and related expenses, including stock-based compensation expenses, due to a higher number of full time employees and higher stock prices in 2018, and a $0.5 million increase in legal expenses.

At June 30, 2018, the company held $276.1 million in cash, cash equivalents, and short-term investments compared to $297.1 million at March 31, 2018. During the second quarter the company used $24.0 million for operating activities. The company anticipates that the year-end balance of cash, cash equivalents and short-term investments may be between $190 to $210 million.

Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to discuss these second quarter and six months ended June 30, 2018 results and provide a corporate update. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID for the call is 5177499. The live webcast can be accessed under "News & Events" in the "Investors" section of the company’s website at View Source or you may use the link: View Source

A replay of the call will be available from August 6, 2018 at 7:30 p.m. ET to August 13, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The reference access code is 5177499. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source

On August 6, 2018 Unum Therapeutics Inc. (Nasdaq:UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies based on its novel, universal Antibody-Coupled T-cell Receptor (ACTR) technology platform, reported that the company will host a conference call and live audio webcast on Monday, August 13, 2018 at 5:00 p.m. ET to discuss financial results for the second quarter of 2018 (Press release, Unum Therapeutics, AUG 6, 2018, View Sourcenews-releases/news-release-details/unum-therapeutics-host-second-quarter-2018-financial-results" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-second-quarter-2018-financial-results" rel="nofollow">View Source [SID1234528469]). Unum management will also provide an update on the Company’s recent progress and upcoming milestones.

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Participants may access the conference call by dialing 866-300-3411 (domestic) or 636-812-6658 (international) and refer to conference ID number 2367857. To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

A webcast replay will be available at the same location on the Unum Therapeutics website beginning approximately two hours after the event, and will be archived for 90 days.