On May 28, 2019 Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, reported that it has obtained approval from Health Canada to conduct Phase 2 clinical trials evaluating AVID100, a novel anti-EGFR antibody drug conjugate (ADC), in EGFR-overexpressing squamous cell carcinoma of the head and neck (SCCHN), squamous non-small cell lung cancer (sqNSCLC) and triple negative breast cancer (TNBC) (Press release, Forbius, MAY 28, 2019, View Source [SID1234536623]).

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AVID100-01 (NCT03094169) is a Phase 2, open label, multicenter study to evaluate the safety and efficacy of AVID100 in up to 100 SCCHN, sqNSCLC and TNBC patients with confirmed EGFR-overexpression. The trial is currently enrolling patients at centers in the U.S. and will be expanding to additional clinical sites in Canada.

Preclinical data demonstrated AVID100 to be highly potent and selectively cytotoxic against EGFR-expressing cancer cells while sparing normal keratinocytes. A Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin confirmed that AVID100 was well tolerated and established an RP2D of 220 mg/m2 (~6 mg/kg), which is expected to be in the therapeutically active range and is one of the highest RP2Ds reported for ADCs with maytansinoid payload.

Approximately 20–25% of patients with SCCHN, sqNSCLC and TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for these indications with confirmed EGFR-overexpression.

About AVID100 and the AVID100-01 Trial
AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

AVID100-01 (NCT03094169) is an open-label, multicenter, dose-expansion study to evaluate the efficacy, safety and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+) and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).

On May 28, 2019 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development of female-specific oncology products, reported that its lead investigational drug, lasofoxifene, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) (Press release, Sermonix Pharmaceuticals, MAY 28, 2019, View Source [SID1234536622]). Sermonix is currently engaged in a Phase 2 clinical study of lasofoxifene in estrogen receptor-positive (ER+) metastatic breast cancer.

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Fast Track designation allows companies to "get important new drugs to the patient earlier," according to the FDA. It is designed to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The Fast Track designation will allow Sermonix more frequent interactions with the FDA during Phase 2 and for the potential to obtain breakthrough designation and priority review of a New Drug Application.

"Lasofoxifene’s Fast Track designation highlights the significant unmet medical needs of women who have estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation," said Sermonix Chief Executive Officer Dr. David Portman. "Fast Track will allow us to more quickly complete our development program and, if successful, make lasofoxifene available to patients sooner."

Sermonix’s open-label, randomized, multi-center Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study will assess the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation. ESR1 mutations are commonly found in women with ER+ metastatic breast cancer progressing after prior endocrine treatment and confer poorer prognosis. A liquid biopsy test will be utilized to identify women for inclusion in the ELAINE study.

"We are very encouraged to receive Fast Track designation, a recognition of lasofoxifene’s potential promise as a precision medicine for women with ER+ metastatic breast cancer," said Sermonix Chairman Dr. Anthony Wild.

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized SERM, lasofoxifene, if approved, could play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.

On May 28, 2019 Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN), a leading biotechnology company developing novel products for life science markets, reported its financial results for the first quarter ending March 31, 2019 (Press release, Evogene LTD, MAY 28, 2019, View Source [SID1234536620]).

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Ofer Haviv, Evogene’s President and CEO, stated: "In 2019 we have completed the transition, as planned, to our new corporate structure consisting of Evogene, the company, as a technology hub for multiple divisions and subsidiaries in different life-science markets, each with an exclusive access to the CPB platform, our core technology, for its specific field. We currently apply the CPB platform in three general life-science markets: agriculture, human health and life-science based industrial applications."

"Looking forward, we expect Evogene’s value will stem from the activities and the derived value of its divisions and subsidiaries. When substantial milestones in their product development pipeline are achieved, or strategic collaboration agreements are announced, these should be reflected in the valuations of our divisions’ and subsidiaries’ and subsequently in Evogene’s as well, as a major shareholder. Moreover, since one of the tasks of our subsidiaries is to secure external financial resources in addition to the potential revenue they will generate through collaborations, third-party investments could provide color on our subsidiaries’ valuation as well."

"A key motivation in the establishment of our subsidiaries is to enable increased management focus and a more efficient path to product development and an important parameter in their success is the quality of their leadership. Most of our CEO’s have been with Evogene for several years, previously filling the position of general manager of our internal divisions that were the basis of our subsidiaries’ activities. I am confident that under these subsidiaries’ current leadership, each company is paving its independent path to success."

Recent Developments:

Corporate Structure:

Establishment of Lavie Bio Ltd., a subsidiary focused on ag-biologicals, aiming to improve food quality, health and sustainability, led by Mr. Ido Dor.
Establishment of Canonic Ltd., a subsidiary focused on developing next generation medical cannabis products, led by Dr. Arnon Heyman, who will participate in this quarterly call. The company’s presentation can be accessed at: View Source
Evofuel was rebranded as Casterra to better reflect its change in business focus from the castor growers for the alternative fuel industry to castor oil for industrial uses. This subsidiary is led by Mr. Assaf Dotan.
Pipeline advancement included:

Biomica announced the initiation of pre-clinical studies in its immuno-oncology program, aiming to augment current cancer therapies by altering patients’ gut microbiome to improve response
AgPlenus:
Herbicide pipeline: a leading molecule family demonstrated in-planta proof of new Mode-of-Action (MoA) and demonstrated activity on a broad panel of important weeds in greenhouse assays.
Insecticide pipeline: computational identification of a new target representing a new MoA in insect pests has been achieved. Efforts are now focused on the computational prediction of molecule families that should inhibit this target.
"I expect the achievements during the coming months will begin to reflect the existing value and potential represented by each of our divisions and subsidiaries, all powered by the CPB platform." – Mr. Haviv concluded

Consolidated financial results for the period ending March 31, 2019:

Cash position: As of March 31, 2019, Evogene had approximately $50 million in cash, short-term bank deposits and marketable securities, representing a net cash usage of approximately $4.5 million during the first quarter of 2019.

Assuming that no external financial resources are secured, such as through collaborations or external fund raising, the Company estimates that its net cash usage in 2019 will be in the range of $16 to $18 million dollars. The Company does not have bank debts.

Revenues primarily consist of research and development payments. These revenues represent R&D cost reimbursement and milestone payments under our various collaboration agreements. The majority of these agreements also provide for royalties or other forms of revenue sharing from successfully developed products.

Gross profit for the first quarter of 2019 was approximately $0.3 million in comparison to approximately $0.1 million for the first quarter of 2018.

R&D expenses for the first quarter of 2019 remained stable at approximately $3.5 million in comparison to the first quarter of 2018. This stability in R&D expenses reflects increased expenses due to advancement in the Company’s activities to later stages of product development, including field trials and pre-clinical studies provided by third parties, which was offset by operating efficiencies achieved with the new corporate structure.

Operating loss for the first quarter of 2019 was approximately $4.7 million in comparison to approximately $4.9 million in the first quarter of 2018.

The net financing income for the first quarter of 2019 was approximately $0.9 million in comparison to net financing expenses of approximately $0.4 million in the first quarter of 2018. This increase in the first quarter is due to translation of Israeli Shekel nominated cash and marketable securities to US Dollars, revaluation of the Company’s marketable securities and interest income on bank deposits.

Loss for the first quarter of 2019 decreased to approximately to $3.8 million in comparison to a loss of $5.4 million during first quarter of 2018.

Conference Call & Webcast Details:

Evogene’s management will host a conference call to discuss the results at 09:00 AM Eastern time, 16:00 Israel time. To access the conference call, please dial 1-888-668-9141 toll free from the United States, or +972-3-918-0609 internationally. Access to the call will also be available via live webcast through the Company’s website at www.evogene.com.

Dr. Arnon Heyman, CEO of Evogene’s cannabis subsidiary, Canonic, will join the conference call to discuss the company’s activity with highlights from Canonic’s presentation, which can be found on Evogene’s website under the investor relations section.

A replay of the conference call will be available approximately three hours following the completion of the call. To access the replay, please dial 1-888-326-9310 toll free from the United States, or +972-3-925-5904 internationally. The replay will be accessible through May 28, 2019, and an archive of the webcast will be available on the Company’s website through June 8, 2019.

On May 28, 2019 Alphamab Oncology, a leading biopharmaceutical company dedicated to global development of innovative biologics for cancer therapy, reported that it has completed a US$60 million Series B financing led by Hudson Bay Capital Management LP and participated by new investors including entrepreneur Adrian Cheng (Press release, Alphamab, MAY 28, 2019, View Source [SID1234536619]). Existing institutional investors including China Venture Capital Fund (CVC), PAG, and Advantech Capital also participated. Proceeds from the financing round will be used for developing the pipeline, commissioning a new R&D and manufacturing site, accelerating the clinical development of clinical stage assets, and preparing for commercial launch of KN035 (Envafolimab).

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Alphamab Oncology is well positioned to develop next-generation multi-functional biologics therapy for cancer treatment based on its extensive expertise in protein engineering and proprietary platforms including Bispecific and Mix-mAb Platforms as well as rich experience in single domain antibodies. The company has also assembled highly experienced management and technical teams with experiences covering the entire R&D process of innovative biologic drugs.

The new round comes on the heel of its strong US$130 million Series A financing in November 2018 – one of the largest in China’s biotechnology industry in recent years. Since then, Alphamab Oncology has advanced several drug candidates in its pipeline and formed new partnerships for its leading assets:

KN035 (Envafolimab), the world’s leading subcutaneous injection of PD-L1 antibody, entered phase II and phase III clinical trials for multiple indications.
KN046, the world’s first PD-L1/CTLA-4 bispecific antibody, has undergone phase I clinical trials in Australia and China which has demonstrated promising early clinical results, and is undergoing phase II clinical trials for multiple indications in China. Additionally, Alphamab Oncology reached a partnership with HEC Research Institute and TOT Biopharm to develop innovative combination therapies involving KN046.
KN026, an anti-HER2 bispecific antibody, is starting phase II clinical trial in China.
Immunomodulator KN019 is undergoing phase II clinical trial in China.
"Since the founding of the company, we have been working hard to break new grounds. We have been focusing on the development of key platforms and proprietary innovative drug candidates, and consistently executing our long-term strategy, focusing on global development for innovative biological dugs. We are striving to transform cancer into a controllable and treatable disease and to improve quality of life of cancer patients," said Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology. "We are very grateful to these prestigious investors for their enthusiasm and confidence in Alphamab Oncology. We look forward to working with our stakeholders to accelerate the new generation of multi-functional biological therapeutics, and to fulfill our vision to be globally competitive."

Sander Gerber, Chief Executive Officer and Chief Investment Officer of Hudson Bay Capital Management LP, added, "We are pleased to support Alphamab Oncology in its mission of creating effective, high quality and affordable biotherapeutics for cancer treatment. Hudson Bay’s investment in Alphamab Oncology underscores our confidence in the company’s ability to be a next-generation leader in the development and commercialization of innovative biological oncology drugs globally. We look forward to helping Alphamab Oncology advance its strong product pipeline to drive significant value for the business over time."

Mr. Shaojing Ma, Managing Director of China Venture Capital Fund (CVC) commented: "Alphamab Oncology leads the new-generation innovative biopharmaceutical industry in China. As a Series A shareholder, China Venture Capital Fund is excited to witness that, within one year, the Company has achieved rapid progress in R&D and clinical development, and various data has proven the tremendous growth potential of its products; with a more robust product pipeline, the Company has demonstrated its capability to maintain world-leading R&D of innovative drugs. Therefore, we are also actively participating in this Series B funding. We expect that after entering the capital market in the future, Alphamab Oncology will gain more opportunities for international development and stands out as an excellent representative of innovative Chinese biopharmaceutical companies to the world."

Adrian Cheng commented: "Technological innovation can be a powerful tool in improving the human condition. I believe that advances in biotechnology and pharmaceuticals will be crucial in changing our lives for the better, and I am delighted to see China taking its place at the forefront of medical innovation. Alphamab Oncology boasts world-class capabilities in ground-breaking research and development and they’re very strong in team execution. We are pleased to be a contributor to Alphamab Oncology’s growth as it becomes the world’s leading research and development company for tumor-targeted drugs."

On May 28, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that it has been awarded Chinese Patent No. ZL201080019566.9 entitled, DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS (Press release, Biocept, MAY 28, 2019, View Source [SID1234536618]). The issued patent covers methods and devices for the capture of rare cells of interest, including CTCs that are shed into the blood stream by solid tumors where an antibody, or mixture of antibodies, and a microchannel are used for cell capture, detection, and analysis. The patent encompasses the use of any biological sample type of interest and is the 33rd patent issued to Biocept that is core to its liquid biopsy technology and commercial testing platforms.

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"The granting of this patent further expands Biocept’s international footprint for capturing and analyzing rare cells from biological fluids, such as blood, bone marrow, cerebral spinal fluid (CSF), and tissue, to assess the status of patients with cancer," said Lyle Arnold, Ph.D., Chief Scientific Officer at Biocept. "This technology interfaces well with Biocept’s other patented liquid biopsy technologies that include a blood collect tube and circulating tumor DNA (ctDNA) analysis, which are intended to aid physicians in the treatment of their patients with cancer."

"Obtaining this new patent provides additional intellectual property coverage for the unique and novel features of our Target Selector platform, featuring our antibody cocktail and microchannel capture technologies for CTCs and other rare cells of interest," said Michael Nall, Biocept’s President and CEO. "We believe that the issuance of additional patents around the world leverages our investment in our cutting-edge liquid biopsy technologies and expands the opportunity for Biocept to generate revenue in territories outside the U.S."