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F-star Appoints Dr Eliot Forster as Chief Executive Officer

On October 15, 2018 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel bispecific antibodies that target the immune system to fight cancer, reported the appointment of Dr Eliot Forster as Chief Executive Officer. Dr Forster succeeds former CEO Dr John Haurum (Press release, f-star, OCT 15, 2018, View Source [SID1234529916]).

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Eliot brings more than 25 years of extensive leadership experience in clinical-stage biopharmaceutical companies. Most recently, he served as CEO of Immunocore where he successfully steered the company’s strategy in immuno-oncology (IO), raising a $320M Series A and establishing clinical collaborations with global pharmaceutical companies including AstraZeneca, GSK and Roche. Prior to Immunocore, Eliot held senior leadership positions at Pfizer (including Head of EU Development & Operations) and GSK. During his pharma tenure, he played a critical role in the clinical development of Celebrex (celecoxib) and Relpax (eletriptan).

"Over recent years, IO has transformed the oncology treatment paradigm, offering significantly better options to patients. The co-administration of immunotherapies is expected to be the next cornerstone in cancer treatments. I believe that F-star’s first-in-class molecules bring together in a single form, the full power of IO and combinations. We anticipate this synergistic benefit will deliver more targeted, potent and safer treatment options for cancer patients," said Eliot Forster MBA, PhD, CEO of F-star. "I am honoured and excited to be joining the F-star team, to lead the Company through its next phase of development and bring life-changing medicines to patients sooner."

F-star’s Modular Antibody Technology is leading a paradigm shift in IO, with the potential to leapfrog current combination approaches. The platform, based on superior and clinically-relevant novel biology, introduces an additional antigen-binding site in the Fc region of an antibody that allows for a ‘plug-and-play’ insertion into any monoclonal antibody. The resulting novel, bivalent binding bispecific antibodies (mAb2 TM) preserve the simplicity and manufacturability of the IgG format at the same time as creating extensive bispecific treatment opportunities. F-star’s pipeline targets patients who have either limited or partial response to existing IO treatment regimens and aims to stimulate the immune response through a tumour-directed activation while reducing systemic toxicity. FS118, F-star’s lead Phase I candidate, is partnered with Merck KGaA and the Company is rapidly moving the next wave of its proprietary bispecific IO products towards clinical development.

"We are delighted to welcome Eliot as F-star’s new CEO. His proven track record in leading and developing biotech IO companies will be essential in driving F-star forward to deliver the next wave of immunotherapies for cancer patients," said Nessan Bermingham PhD, Executive Chair of F-star. "The Board is grateful to John for the pivotal role he has played in leading the Company in developing and executing a transformative strategy, positioning F-star for long-term success."

During his leadership as CEO, John led the transformation of F-star from a drug discovery platform into a successful, clinical-stage IO company. Under his leadership, F-star launched new innovative cancer drug development capabilities and established a substantial pipeline of candidates with the potential to benefit patients, especially those who are not well served by existing cancer therapies.

"It has been rewarding to lead F-star through a period of significant growth, to become a recognised leader in the bispecific space. Our approach has been validated through a series of strategic collaborations with leading pharmaceutical and biotechnology partnerships in IO with AbbVie and Merck KGaA, and in central nervous system disorders with Denali Therapeutics. We have established a pipeline with two candidates entering the clinic and generated circa $250M in funding and investment," said John Haurum MD, PhD, former CEO of F-star. "I am pleased to hand over the reins to Eliot, who is highly experienced and well positioned to lead F-star and its extraordinary staff, pipeline and partnerships, as it continues to discover and develop transformative IO therapeutics for patients in need."

OncoSec Initiates KEYNOTE-890, a Phase 2 Clinical Trial of TAVO in Combination with Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Late-Stage Triple Negative Breast Cancer

On October 15, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that it has initiated KEYNOTE-890, a Phase 2 clinical trial for the treatment of late-stage triple negative breast cancer (TNBC) with TAVO (intratumoral plasma encoded IL-12, or tavokinogene telseplasmid, plus electroporation) in combination with Merck’s KEYTRUDA (pembrolizumab) (Press release, OncoSec Medical, OCT 15, 2018, View Source [SID1234529915]). The initiation of KEYNOTE-890 marks the second Phase 2 trial for OncoSec involving a combination of TAVO and KEYTRUDA. The first, PISCES/KEYNOTE-695, is a global, multicenter Phase 2 trial of TAVO in combination with KEYTRUDA for metastatic melanoma.

"Metastatic triple negative breast cancer represents an extreme unmet medical need, where pre-treated patients rarely achieve objective responses with PD-1/PD-L1 checkpoint treatments," said Dr. Pamela Munster, Professor of Medicine and Program Leader of Experimental Therapeutics at University of California San Francisco (UCSF). "The marked synergy of TAVO and checkpoint inhibition shown in previous clinical observations strongly suggests that IL-12 may prime the tumor microenvironment for PD-1/PD-L1 checkpoint treatments. This represents a highly promising therapeutic approach for TNBC."

KEYNOTE-890 is a multicenter Phase 2 open-label trial of TAVO in combination with KEYTRUDA in patients with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least one prior line of approved systemic chemotherapy or immunotherapy.

Breast cancer cells that test negative for estrogen receptors (ER-), progesterone receptors (PR-), and HER2 (HER2-) means the cancer is triple negative.1 Approximately 10-20 percent of US breast cancer cases are triple negative breast cancer (TNBC),1 which disproportionately affects younger women as well as African-American women,2 followed by Hispanic women.3

"The initiation of KEYNOTE-890 is an important milestone for OncoSec as it marks a significant expansion of our clinical pipeline as well as our expanding relationship with Merck," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "Our goal is to enroll this study as quickly as possible and provide preliminary topline data in 2019. Currently, overall survival for metastatic TNBC is one to two years from diagnosis, with therapies resulting in short-lived responses and/or significant toxicity. New approaches are desperately needed, and based on prior and ongoing clinical research, we beleive that TAVO in combination with KEYTRUDA has the potential to be effective in treating this disease. Given the severe unmet medical need, it is possible that TAVO for the treatment of TNBC could be granted Fast Track designation, Breakthrough Therapy designation, and be a candidate for accelerated approval."

TNBC remains a poor-prognosis breast cancer subtype,2 with limited treatment options for patients with advanced, recurrent disease. In the recurrent disease setting, chemotherapy remains the standard of care, and median survival is approximately 13 months from the time of disease recurrence.4 Emerging evidence shows immunotherapy options may play an important role in the treatment paradigm for TNBC.5-8 Preliminary data from early-phase studies demonstrated the anti-PD-1 antibody pembrolizumab led to an objective response in 18 to 19 percent of TNBC patients;5-7 and median overall survival was 8.9 months in a pretreated cohort.6 The anti-PD-L1 antibody atezolizumab (MPDL3280A) achieved an objective response in 25 percent of patients in the first-line and 11 percent of patients in the second-line setting.8 There is increasing evidence that tumors need TILs for anti-PD-1/PD-L1 therapies to be most effective.9-12 Data also show TILs promote better responses to chemotherapy and improve clinical outcomes in breast cancer, including TNBC.13-17

SELLAS to Host Conference Call Following Oral Presentation of Phase 2b Results of NeuVax™ + Herceptin® to Prevent Breast Cancer Recurrence at the European Society for Medical Oncology (ESMO) 2018 Annual Meeting

On October 15, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq:SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that it will host a conference call at 8:00 a.m. ET on October 22, 2018, following the oral presentation at the ESMO (Free ESMO Whitepaper) 2018 Annual Meeting of the interim (median follow-up of 18.8 months) and updated and final (median follow-up of 26.1 months) clinical data from its Phase 2b trial of the combination of trastuzumab (Herceptin) +/- nelipepimut-S (NeuVax) targeting HER2 low-expressing breast cancer patient cohorts (Press release, Sellas Life Sciences, OCT 15, 2018, View Source;Herceptin-to-Prevent-Breast-Cancer-Recurrence-at-the-European-Society-for-Medical-Oncology-ESMO-2018-Annual-Meeting/default.aspx [SID1234529914]). Management and invited Key Opinion Leaders, including Dr. Elizabeth Mittendorf, MD, PhD and Dr. George Peoples, MD, FACS, will participate in the conference call.

Conference Call Details for Monday, October 22, 2018 at 8:00 a.m. ET:

To participate in the conference call, please dial (866) 416-7995 (domestic) or +1 (409) 217-8225 (international) and refer to conference ID 5571389. A live webcast of the call can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.sellaslifesciences.com.

An archived webcast recording will be available on the SELLAS website beginning approximately two hours after the call.

Details for the ESMO (Free ESMO Whitepaper) presentation are as follows:

Title: Pre-specified interim analysis of a randomized phase 2b trial of trastuzumab + nelipepimut-S (NeuVax) vs trastuzumab for the prevention of recurrence demonstrates benefit in triple negative (HER2 low-expressing) breast cancer patients
Date and Time: 22 October, 2018; 11:54 am Central European Time (5:54 am ET)
Location: Hall A2 – Room 18; Messe Munich Congress Venue, Munich, Germany

Herceptin is a registered trademark of Genentech, Inc. and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.

About ESMO (Free ESMO Whitepaper)

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) is Europe’s leading non-profit medical oncology organization. ESMO (Free ESMO Whitepaper) is a membership-based society, comprising of 500 expert committee members and 18,000 oncology professionals. ESMO (Free ESMO Whitepaper) organizes a large number of meetings to provide its members and the community with the resources they need and also plays a major role in public policy and European affairs. The ESMO (Free ESMO Whitepaper) 2018 Annual Meeting represents a multi-professional platform for oncology education and exchange, and for immense international visibility for scientific research, and will be held under the tagline "Securing access to optimal cancer care."

LIGAND TO REPORT THIRD QUARTER 2018 RESULTS ON NOVEMBER 8TH

On October 15, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported its third quarter 2018 financial results on November 8, 2018 (Press release, Ligand, OCT 15, 2018, View Source [SID1234529913]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

Third Quarter 2018 Earnings Call

What: Ligand conference call to discuss financial results and provide general business updates

When: Thursday, November 8, 2018

Time: 9:00 a.m. Eastern time (6:00 a.m. Pacific time)

Conference Call: (833) 591-4752 within the U.S.
(720) 405-1612 outside the U.S.
Conference ID – 5777841

Webcast:
Live conference call webcast and replay accessible at www.ligand.com

Loxo Oncology Announces Receipt of Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-292 for the Treatment of RET Fusion-Positive Thyroid Cancer

On October 15, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options (Press release, Loxo Oncology, OCT 15, 2018, View Source [SID1234529908]). This designation supplements the two LOXO-292 Breakthrough Therapy Designations granted in September 2018. The Breakthrough Therapy Designation announced today was also based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial.

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.