On December 19, 2019 Agilent Technologies Inc. (NYSE: A) reported the following presentation will be webcast for the investor community (Press release, Agilent, DEC 19, 2019, https://www.agilent.com/about/newsroom/presrel/2019/19dec-gp19028.html [SID1234552497]):

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What: 38th Annual J.P. Morgan Healthcare Conference
Where: The Westin St. Francis Hotel, San Francisco, California
When: Tuesday, Jan. 14, 2020 at 2:30 p.m. PT
Who: Mike McMullen, Agilent President and CEO

On December 19, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies1 and cancer vaccines, reported the first patient dosed with AGEN1181, an anti-CTLA-4 antibody, in combination with balstilimab, Agenus’ PD-1 inhibitor (Press release, Agenus, DEC 19, 2019, View Source [SID1234552496]). Agenus began this study as a monotherapy in patients with advanced solid tumors within a Phase 1 dose escalation study (NCT03860272) in April 2019.

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The first patients to be treated with AGEN1181 as a monotherapy as well as the combination trial with PD-1 were dosed by Dr. Steven O’Day, Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer.

"AGEN1181, with its potential for enhanced immune activation and tumor fighting abilities, may bring superior benefit to a broader group of patients compared to first generation anti-CTLA-4 antibodies," said Dr. O’Day. "The pre-clinical data suggest the superiority of this molecule as a monotherapy and in combination with anti-PD-1, like balstilimab. Furthermore, AGEN1181 was designed to bring benefit to a broad population of patients both who respond to first generation molecules and those who do not respond due to a genetic polymorphism. Expanding the important immune priming benefit of CTLA-4 to a broad group of patients would be outstanding. I am thrilled to be working with this compound."

Balstilimab, the company’s proprietary anti-PD-1 antibody, is currently being evaluated as a monotherapy and in combination with zalfrelimab (a first generation CTLA-4) in trials designed to support a planned BLA filing in 2020 for patients with relapsed/refractory cervical cancer.

This expanded trial is another example of Agenus’ ability to rapidly advance its novel pipeline. Next-Gen CTLA-4 is a novel antibody from Agenus’ discovery engine, and with its own PD-1 molecule, Agenus has been able to move this important combination into the clinic with a high sense of urgency.

About AGEN1181
AGEN1181, a novel ‘Fc engineered’ antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete intratumoral regulatory T cells that promote immune evasion. By enhancing binding to a specific Fc receptor, FcγRIIIA, on antigen-presenting cells or natural killer cells, AGEN1181 significantly enhances the therapeutic potential of anti-CTLA-4 therapy leveraging novel mechanisms that are not captured by the first-generation anti-CTLA-4 therapies. AGEN1181’s Fc engineered backbone improves the cross-talk between antigen-presenting cells and T cells, to enable optimal T cell priming, activation and formation of durable memory responses. Moreover, AGEN1181 enhanced binding to FcγRIIIA, significantly increases the potential to deplete intratumoral regulatory T cells, a significant barrier to successful anti-cancer immune responses. Notably, AGEN1181 is engineered to strongly bind both the low affinity and high affinity FcγRIIIA polymorphisms, unlike first generation molecules which weakly bind the low affinity polymorphism. AGEN1181 is designed to expand the benefit to an additional ~40% of patients with the low affinity polymorphism and enhance the benefits of CTLA-4 in all patients.

On December 19, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that it has entered into definitive agreements to sell securities in a private placement with a group of institutional investors and certain members of the Company’s Board of Directors (Press release, Selecta Biosciences, DEC 19, 2019, View Source [SID1234552494]). The lead institutional investors in the private placement were Vivo Capital LLC, Mangrove Partners, EcoR1 Capital LLC, BVF Partners L.P., and Boxer Capital LLC. The transaction is expected to result in gross proceeds to the company of approximately $70 million, before deducting placement agent fees and other offering expenses.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Company plans to use the net proceeds from the financing primarily to fund the ongoing head-to-head Phase 2 COMPARE clinical trial of its lead product candidate, SEL-212, for the treatment of chronic refractory gout, its gene therapy programs, and for general corporate purposes.

Pursuant to the terms of the securities purchase agreement, the Company will issue 45,977,011 units at a price of approximately $1.5225 per unit. Each unit consists of approximately one share of common stock and a warrant to purchase 0.5 of a share of common stock at an exercise price of $1.46. Certain institutional investors have elected to receive pre-funded warrants to purchase common stock in lieu of a portion of their common stock. The closing of the offering is subject to certain conditions and is expected to occur on Monday, December 23, 2019.

Cantor Fitzgerald & Co. served as placement agent for the offering.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. The Company has agreed to file a registration statement covering the resale of the securities acquired by the investors in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On December 19, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported that it will announce results for the fourth quarter of 2019 on Thursday, February 6, 2020 (Press release, Bristol-Myers Squibb, DEC 19, 2019, View Source [SID1234552493]). During a conference call at 8:30 a.m. ET on February 6, 2020, company executives will review financial information and will address inquiries from investors and analysts.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 888-204-4368 or international 786-789-4797, confirmation code: 5605395. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:45 a.m. ET on February 6 through 11:45 a.m. ET on February 20, 2020. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 5605395.

On December 19, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Kadcyla (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy (Press release, Hoffmann-La Roche, DEC 19, 2019, View Source [SID1234552491]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Optimal treatment is vital for every patient with early-stage breast cancer, a setting where cures are possible," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "This approval of Kadcyla will allow many more women with HER2-positive early breast cancer to be given a transformative treatment that may cut the risk of their disease returning or progressing."

The goal of neoadjuvant treatment is to shrink tumours in order to help improve surgical outcomes. Adjuvant treatment aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.1 People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.2

The approval of Kadcyla in Europe is based on results from the phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.001) compared to Herceptin (trastuzumab) as an adjuvant treatment in people with HER2-positive eBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%. The safety profile of Kadcyla was consistent with that observed in previous studies.3

The impact of adjuvant treatment with Kadcyla has already been seen in the US where thousands of women are already being given this treatment following US Food and Drug Administration approval in May.4 Kadcyla in this setting is now approved in 27 countries worldwide and the use of Kadcyla in eBC has been recommended by multiple treatment guidelines, including those from the St Gallen International Breast Cancer Conference, the AGO and the NCCN.5,6,7

About the KATHERINE study8
KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which in this study is defined as the time from randomisation to the time that the patient is free from invasive breast cancer recurrence, or death from any cause. Secondary endpoints include iDFS including second primary non-breast cancer, disease-free survival and overall survival.

About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1.9 Kadcyla is the only ADC approved as a single agent in over 100 countries, including the US and EU, for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane-based chemotherapy, separately or in combination. Kadcyla is also approved in the US for the adjuvant treatment of people with HER2-positive eBC with residual invasive disease after neoadjuvant treatment that included Herceptin and taxane-based chemotherapy. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients.10 Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease.