On June 7, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the appointment of Yaping Shou MD, PhD, as Chief Medical Officer. Dr. Shou joins Trillium from Takeda Pharmaceuticals (Press release, Trillium Therapeutics, JUN 7, 2018, View Source [SID1234527238]).

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"Yaping’s broad clinical drug development experience in oncology and her demonstrated commitment to translational research makes her a strong addition to Trillium’s senior management team," said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. "Her arrival is particularly opportune, since we have recently refined and narrowed the focus of our two ongoing TTI-621 trials, based on preliminary clinical proof of concept data, and are on the cusp of dosing our first patient in our TTI-622 trial. We look forward to Yaping’s leadership as we continue to advance our SIRPaFc programs."

Dr. Shou has more than 18 years of industry experience spanning clinical development and translational medicine, with a strong focus in oncology. She most recently served as Executive Medical Director at Takeda Pharmaceuticals, where she also held several other clinical leadership positions over the past seven years. Prior to joining Takeda, Dr. Shou held several clinical oncology positions at Novartis Pharmaceuticals and GlaxoSmithKline. She has contributed to the approval of several targeted therapies for oncology over the years, including lapatinib, pazopanib, nilotinib, sonidegib, and ixazomib. She received her MD degree from Zhejiang University School of Medicine, and her PhD degree from Drexel University College of Medicine and the University of Pennsylvania. Dr. Shou also conducted postdoctoral studies in the Genetics Branch at the National Cancer Institute.

"I am excited to be joining Trillium at this important time in the company’s evolution," said Dr. Shou. "I believe we have the potential to build a CD47 franchise in immuno-oncology that could meaningfully benefit patients."

On June 7, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported the recent initiation of a Phase 1b study of ADU-214 (JNJ-64041757) in combination with nivolumab for the treatment of advanced lung cancer
(Press release, Aduro Biotech, JUN 7, 2018, View Source;p=RssLanding&cat=news&id=2353774 [SID1234527224]). ADU-214 is an immunotherapy based on Aduro’s live, attenuated double-deleted Listeria (LADD) technology platform in development for the treatment of advanced or metastatic non-small cell lung cancer. Janssen Biotech, Inc. (Janssen), Aduro’s license partner for ADU-214, is conducting the global trial.

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"Based on single agent data from a Phase 1 dose-escalation study in patients with advanced-stage relapsed or refractory non-small cell lung presented at the 2017 International Association for the Study of Lung Cancer’s World Conference, Janssen made the decision to advance ADU-214 in combination with an anti-PD-1 checkpoint inhibitor," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "The initial data demonstrated that five out of nine patients treated with single agent ADU-214 achieved a best response of stable disease, with one patient having received 25 cycles of treatment at the time of data cut off."

Isaacs continued, "The clinical data was supported by biomarker data demonstrating innate immune activation with transient cytokine increases in all patients, as well as induction of mesothelin-specific T cell immunity in a subset of patients, and we are pleased with Janssen’s progress for this program."

The Phase 1b, multi-center study is designed to evaluate the safety and efficacy of ADU-214 in combination with nivolumab, Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor that Janssen secured through a 2016 clinical collaboration. The trial is enrolling patients with mesothelin-positive, relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung (see www.clinicaltrials.gov, identifier NCT03371381).

In October 2014, Aduro entered into an agreement with Janssen, granting an exclusive, worldwide license to ADU-214 and other product candidates engineered for the treatment of lung cancer and certain other cancers based on Aduro’s LADD immunotherapy platform. Under the agreement facilitated by Johnson & Johnson Innovation LLC, Aduro received a $30 million up-front payment and a $21 million milestone payment upon completion of various development activities, and is eligible to receive future development, regulatory and commercialization milestone payments up to a potential total of $766 million. In addition, Aduro is eligible to receive royalties at a rate ranging from high single-digits to low teens on worldwide net sales upon successful launch and commercialization.

On June 7, 2018 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, reported the appointment of Gilmore O’Neill, M.B., M.M.Sc. as its chief medical officer. Dr. O’Neill will lead all clinical development, medical affairs, pharmacovigilance, and regulatory affairs (Press release, Sarepta Therapeutics, JUN 7, 2018, View Source [SID1234527243]).

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Dr. O’Neill joins Sarepta from Biogen, where he held leadership roles of increasing responsibility over a 15-year period in research and development, most recently as senior vice president responsible for all late-stage clinical development. During his tenure, Dr. O’Neill oversaw development programs for Alzheimer’s disease, movement disorders, acute neurology, multiple sclerosis, pain, neuromuscular disease, gene and cell therapy, and rare diseases. He played a leadership role in seeking, receiving and maintaining global marketing approvals for Tecfidera, Zinbryta, Plegridy and Spinraza.

"I feel extremely fortunate to welcome Dr. O’Neill to Sarepta and to our executive team as we advance our 21 pipeline programs and build ourselves into one of the most meaningful precision genetic medicine companies in the world," said Doug Ingram, Sarepta’s president and chief executive officer. "Gilmore is uniquely positioned to successfully lead our development strategy. He has deep expertise in neurobiology, genetic medicine and clinical development, having driven some of biotech’s most successful clinical programs. And his proven leadership ability and passion for our mission of changing lives through genetic medicine will be essential as we advance toward our goals with a sense of urgency, creativity and purpose."

"I was inspired to join the Sarepta leadership team by the quality of Sarepta’s pipeline and the sense of urgency within the Company to advance these programs and improve the lives of patients," said Dr. O’Neill. "I’m looking forward to making a fast start, and one of my most pressing priorities will be to meet with and learn from the DMD patient community."

Dr. O’Neill received a Bachelor of Medicine degree from University College Dublin and a Master of Medical Sciences degree from Harvard University. He is the recipient of numerous awards in science and medicine, including the Lefler Fellowship in the Department of Neurobiology at Harvard Medical School. Dr. O’Neill is the author of numerous publications on multiple sclerosis, has served as a neurology peer reviewer for medical literature, and lectures in the United States and globally on advances in neurology and neurological research.

Dr. O’Neill is licensed to practice medicine in the state of Massachusetts. He is a member of the American Academy of Neurology and a board-certified neurologist (ABPN). He is formerly Chief Resident in Neurology at the Massachusetts General Hospital (MGH) and served, until recently, as a Clinical Instructor in Neurology at Harvard Medical School. He has maintained his clinical appointment at the MGH with a sub-specialty interest in neuromuscular diseases and inherited leukodystrophies.

On June 7, 2018 LIDDS AB (publ) reported that it has decided on a direct share issue to Nyenburgh Holding BV, AESCAP 2.0 and BWG Invest, all being international funds that invests in closely selected European biotech- and pharma companies (Press release, Lidds, JUN 7, 2018, View Source [SID1234555913]). The raised capital will facilitate a fast acceleration of LIDDS’ development projects, including the immune-oncology field where NanoZolid based immuno-active compounds have shown very promising preclinical effects.

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The direct issue of 1 180 000 shares will add approx. 21,7 MSEK to LIDDS. Nyenburgh Holding will maintain as the third largest shareholder in LIDDS and contributes with financial strength, an excellent network and expertize within the sector. AESCAP 2.0, based in Amsterdam, is a current shareholder in LIDDS that invests in next generation medicines and builds a selected portfolio of only 20 companies across Europe and the US. BWG Invest is a top ten shareholder in LIDDS and strengthens its shareholding position through this direct share issue.

The share price of 18,38 SEK is based on volume weighted average of the share price with a 5 % discount. The share issue decision is based on the shareholders authorization on LIDDS Annual Meeting on May 16, 2018.

– The directed share issue to Nyenburgh Holding, AESCAP 2.0 and BWG Invest is an important validation of the NanoZolid technology and we are very pleased to attract these funds to increase their ownership in LIDDS. The share issue adds longer term financing of the company, resources to reach key milestones in our development projects and provides additional financial strength to conduct an effective business development process, says Monica Wallter, CEO of LIDDS.

LIDDS total number of shares after the direct issue will be 23 051 188 and the share capital will amount to 1 221 712,964 SEK when the new shares are registered with the Swedish Companies Registration Office, Bolagsverket. The dilution of shares is 5,1 %.

LIDDS will with the raised capital further accelerate the exciting NanoZolid development projects with the aim to build alliances, collaborations and license agreements.

The directed share issue to Nyenburgh Holding, AESCAP 2.0 and BWG Invest is further strengthening LIDDS owner structure and it confirms the international interest for LIDDS and the NanoZolid technology.

On June 7, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported a new prioritization of its product portfolio, as well as financial results and business highlights for the three months ended April 30, 2018 (Press release, Advaxis, JUN 7, 2018, View Source [SID1234527226]).

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The product portfolio review was conducted under the leadership of recently appointed President and CEO Ken Berlin, along with the full Advaxis executive team including recently named Chief Medical Officer Andres Gutierrez, M.D., Ph.D. The process reflects a commitment to allocate capital to programs that meet three criteria: (i) commercially attractive applications for the company’s Lm technology platform, (ii) the opportunity for the Lm platform to meaningfully impact cancer care, and (iii) a rapid and cost-effective route to generate clinical and immunological response data to demonstrate proof of concept. Each portfolio program was reviewed to determine whether Advaxis can create more value by developing the program internally or externally.

Advaxis has decided to reduce internal investment in axalimogene filolisbac (AXAL) and will seek partnership opportunities for AXAL in most human papillomavirus (HPV)-associated cancers, including cervical cancer. If the company is unable to secure a partner within a limited period of time, Advaxis will wind down the ongoing AIM2CERV trial in high-risk locally advanced cervical cancer, and will not conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer, which has not yet been initiated. Advaxis has determined to focus future development efforts for AXAL on HPV-positive head-and-neck cancer through cost-effective clinical studies that are currently being explored.

Data were presented on the ADXS-PSA combination trial with KEYTRUDA on June 2nd at ASCO (Free ASCO Whitepaper) 2018. These data, while early, have proven worthy of further evaluation and the company will continue to follow patients for the next six to nine months in order to determine the path forward.

Advaxis has also decided to increase internal investment in the ADXS-NEO and ADXS-HOT programs, both of which target neoantigens, a potentially transformational, next-generation approach to treating cancer.

Both the ADXS-NEO and the ADXS-HOT programs aim to instruct T cells to selectively attack neoantigens and, in the case of ADXS-HOT, against other tumor-associated antigens, with the goal of controlling tumor growth and prolonging life. Advaxis’ proprietary Lm platform uniquely positions the company in the development of advanced T cell therapeutics compared with other approaches. This belief is based on, among other things, data derived from more than 530 patients treated with AXAL and other product candidates, showing a manageable safety profile, induction of immune responses and clinical activity.

Clinical Hold Update

In March 2018 the company received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for its Phase 1/2 combination study of AXAL with durvalumab for the treatment of patients with advanced, recurrent or refractory HPV-associated cervical cancer and HPV-associated head-and-neck cancer was placed on clinical hold due to the death of a trial subject that involved pulmonary toxicity occurring after nine months of therapy.

As announced at the time, Advaxis began working closely with the site investigator, its partner AstraZeneca and the FDA to review this event in detail and to resolve this clinical hold. Several external experts from prominent institutions were also consulted in the process.

Advaxis plans to submit a response to the FDA shortly, and expects to receive a response from the Agency within 30 days after the submission.

Management Commentary

"Everything we are striving to accomplish depends on focus and optimal allocation of resources, and is designed to maximize shareholder value. We are dedicating more resources to the HOT program because these assets scored very high when we conducted our portfolio review," said Mr. Berlin. "This program, along with our NEO program which is partnered with Amgen, hold great potential in the exciting and fast-developing field of neoantigens and have application across multiple tumor types in high-value indications. Therefore, it is important for us to allocate increased resources to realize the potential of these programs and to allow for more rapid advancement in this competitive field."

"Our new approach is based on a simple reality: While we are fortunate to have a robust product pipeline, we cannot continue to pursue all programs with our current level of resources. We continue to believe in HPV as a target, and are evaluating cost-effective studies for AXAL in head-and-neck cancer. We hope to secure a partner to continue the development of AXAL in cervical cancer," he added.

"In addition, we are pleased to have completed the buildout of our executive leadership team with yesterday’s announcement that Molly Henderson has joined Advaxis as Executive Vice President and Chief Financial Officer," he continued. "Coupled with the addition of Executive Vice President and Chief Medical Officer Dr. Andres Gutierrez, we now have the team in place to drive the company forward."

Corporate Restructuring and Impact on Operating Expenses

As part of the change in strategic direction, Advaxis will implement a reduction in force, effective today, to align staffing levels with development priorities. The workforce reduction involves the elimination of approximately 24% of the company’s workforce. Advaxis will take a one-time charge in the fiscal third quarter related to this restructuring of approximately $905,000. The elimination of these positions in conjunction with reductions in clinical expenditures will significantly lower operating expenses, allowing the company to focus on priority programs.

Reflecting the product portfolio prioritization and workforce reduction, Advaxis expects that its annual cash burn will be approximately $50 million, down 38% from its prior annual cash burn of approximately $80 million.

Financial Highlights for Second Quarter Fiscal Year 2018

The net loss for the second quarter ended April 30, 2018 was $13.4 million or $0.27 per share based on 49.9 million shares outstanding. This compares with a net loss for the second quarter of fiscal year 2017 of $20.5 million or $0.51 per share based on 40.3 million shares outstanding.

Research and development expenses for the second quarter of fiscal year 2018 were $10.8 million, compared with $16.3 million for the second quarter of fiscal year 2017. The decrease is primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies supporting the MAA, which was filed in February 2018.

General and administrative expenses for the second quarter of fiscal year 2018 were $4.5 million, compared with $7.8 million for the second quarter of fiscal year 2017. The decrease was largely attributable to the elimination of non-cash stock-based compensation paid to consultants.

Balance Sheet Highlights

As of April 30, 2018, the company had $58.8 million in cash, restricted cash, cash equivalents and short-term investment securities on its balance sheet. The company has completed a thorough analysis of operating expenses and its research and development programs. As a result, the company has announced a workforce reduction effective June 7, 2018, and is in the process of making further cost-reduction decisions regarding select ongoing clinical trials. Based upon these actions, the company believes its cash position as of today is sufficient to fund operations for at least one year.

Conference Call and Webcast Information

Advaxis’ senior management will host a conference call to review the content of this news release and answer questions. The conference call and live audio webcast will begin today at 11:00 a.m. Eastern time.

To access the conference call please dial (domestic) (844) 348-6133 or (631) 485-4564 (international) and refer to conference ID 8975538. A live and archived audio webcast of the call will be available on the Company’s website at ir.advaxis.com/events-presentations .

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning two hours after the conference call ends. To access the recording, dial (855) 859-2056 or (404) 537-3406 and provide the operator with the conference ID: 8975538. In addition, the audio webcast will be archived on the Company’s website for a period of time at ir.advaxis.com/events-presentations.