On October 15, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that in conjunction with the two Proffered Papers Sessions (oral presentations) highlighting data from ongoing clinical trials of sitravatinib, the Company will conduct an investor conference call during the 2018 Annual Meeting of the European Society for Medical Oncology in Munich, Germany, on October 22nd at 2:00 p.m. CEST/8:00 a.m. EDT/5:00 a.m. PDT (Press release, Mirati, OCT 15, 2018, View Source [SID1234529931]).

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The Proffered Papers (Oral Presentations) Details:

Title: Sitravatinib demonstrates activity in patients with novel genetic alterations that inactivate CBL
Presentation Topic: Proffered paper session – Developmental therapeutics (ID 170)
Location: Hall B3 – Room 22, ICM München, Munich, Germany
Lecture Date and Time: October 21, 2018, at 11:00 a.m. – 11:12 a.m. CEST
Presentation Number: 408O
Presenter: Lyudmila Bazhenova, M.D.

The data being presented in this oral presentation will feature data from the ongoing Phase 1b trial of sitravatinib monotherapy in patients with certain genetic alterations.

Title: Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy
Presentation Topic: Proffered paper session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ID 159)
Location: Hall A2 – Room 18, ICM München, Munich, Germany
Lecture Date and Time: October 22, 2018, at 12:06 p.m. – 12:18 p.m. CEST
Presentation Number: 1129O
Presenter: Ticiana A. Leal, M.D.

The data being presented in this oral presentation comprise updated clinical data from the ongoing Phase 2 trial of sitravatinib in combination with OPDIVO (nivolumab) for the treatment of non-small cell lung cancer (NSCLC) patients who have progressed on prior immune checkpoint inhibitor therapy.

Investor Call and Webcast Information
In conjunction with the oral presentations, Mirati will host a live conference call and webcast, led by Dr. Charles Baum, on Monday, October 22, 2018, at 2:00 p.m. CEST/8:00 a.m. EDT/5:00 a.m. PDT. The live call can be accessed by dialing (866) 324-3683 (toll free) or (509) 844-0959 (international) and then using passcode 3890724. A telephone replay will be made available by dialing (855) 859-2056 (toll free) or (404) 537-3406 (international) using conference replay ID 3890724.

The call will also be webcast live through the "Investors" section of the Mirati corporate website at View Source A replay of the webcast will be available on the Mirati website shortly after the conclusion of the event.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL kinase. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations

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.

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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."

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.

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"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

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."

On October 15, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that preliminary results of pilot studies in China in which patients received T-cell receptor affinity enhancing specific T-cell therapy ("TAEST") showed encouraging positive clinical signals in terms of efficacy and safety (Press release, Athenex, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371574 [SID1234529935]).

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The pilot studies are being conducted in China by Xiangxue Life Sciences ("XLifeSc"), a wholly-owned subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147). In July 2018, XLifeSc and Athenex entered into an agreement to establish a new joint venture named Axis Therapeutics Limited, which owns the global rights to the TAEST technology, excluding China (XLifeSc retains the mainland China rights), and in this territory Axis Therapeutics is leading the research, development and commercialization efforts of T-cell receptor-engineered T cells (TCR-T, including the TAEST technology), a form of cancer immunotherapy.

The pilot studies are focused on the testing of TAEST technology generated T-cells, with enhanced binding affinity, against the antigen NY-ESO-1 and is HLA-A*02:01 restricted. Preliminary results of TAEST technology generated T-cell therapy studied in nine end-stage cancer patients who failed all standard treatments showed the following: In the first three patients, dose escalation in one patient and full dose in two patients were tested. All three patients showed an acceptable safety profile. Two of the patients showed stable disease with survival of 6 and 10 months, respectively. One patient with lung cancer showed a small tumor reduction, and a reduction in pain and softening of the subcutaneous metastasis following treatment. Lymphodepletion was added to the protocol in patients 4 through 9. Treatment was well tolerated with fever (n=5), chills (n=4), weakness (n=4), and mild skin rash (n=3) observed. Two patients (one breast cancer, one synovial sarcoma) had more than 40% reduction in tumor size, as measured by CT scans. The patient with breast cancer also had healing of two skin metastatic ulcers. Two other patients (one liver cancer patient with retroperitoneal recurrence after resection, one with thyroid cancer) showed stable disease. Both of these patients showed significant tumor necrosis shortly after the treatment, resulting in the formation of cavitation in the middle of the tumors. Clinically, there was also symptomatic relief of local pain reported during the period of radiologic evidence of increased tumor necrosis. The remaining two patients with lung cancer had stable disease for more than 60 days after treatment. This study also observed the expected cytokine response, detection of TCR-expression on T-cells, and persistence of the introduced TCR-gene in all patients during therapy.

An abstract with more detailed data will be submitted for presentation at an international scientific meeting.

Dr. Yi Li, Chief Scientific Officer of Axis Therapeutics and XLifeSc, stated, "We believe our TAEST technology has four distinct advantages: first, our engineered TCR has an improved binding affinity; second, our engineered TCR has excellent expression level on the engineered T-cells; third, we have demonstrated in this pilot study that our engineered TCR genes persisted in these patients; and finally, we have developed other HLA subtypes and we will be able to treat more patients with different HLA subtypes in the near future."

Dr. Johnson Lau, Vice Chairman and CEO of Axis Therapeutics and Chairman and CEO of Athenex, said, "We are excited by the positive clinical signal observed in this group of patients. The safety profile is within expectations and within acceptable limits of cancer therapy. The observation of clinical signal in these patients, with tumor reduction of more than 40% in two patients and significant tumor necrosis after treatment in two others, indicates that this approach showed anti-tumor activity even in late stage cancer patients. We have also followed the circulating level of the engineered T-cells and inserted gene expression and so far, their persistence in the patients’ circulation suggested that this approach can have the desired effect of having a consistent anti-tumor immune response for at least a moderate amount of time. More work will be done soon to define the best treatment protocol to advance this program. We are very grateful to Perceptive Advisors for their support and confidence in our team which made this joint venture possible."

Mr. YongHui Wang, Chairman of Axis Therapeutics and Chairman and CEO of Xiangxue Pharmaceutical, stated, "We are very impressed by the scientific and management skills that Athenex team contributes to this joint venture. We are excited to see these encouraging preliminary clinical data. We have full confidence in our collaboration and strongly believe that we will make a meaningful contribution to the arsenal of cancer treatment options for patients worldwide."

Axis Therapeutics is also announcing the line-up of the management team, with Mr. YongHui Wang as the Chairman of the Board, Dr. Johnson Lau as Vice-Chairman and CEO, Dr. Yi Li as Chief Scientific Officer, Dr. WingKai Chan as Chief Medical Officer, and Ms. Jacqueline Li as the Chief Financial Officer.