On November 16, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported that it has entered into a Regional Licensing Agreement (The Agreement) with Adlai Nortye (Adlai), a biopharmaceutical company focused on discovering and developing important new treatments for cancer and metabolic diseases (Press release, Oncolytics Biotech, NOV 16, 2017, View Source [SID1234522120]). Under the terms of The Agreement, Adlai will have exclusive development and commercialization rights to REOLYSIN in China, Hong Kong, Macau, Singapore, South Korea and Taiwan.

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"Adlai Nortye has a top-tier clinical, regulatory and commercial team with global experience, that will be able to gain significant regional exposure for REOLYSIN upon potential approval, following our phase 3 study in HR+/HER2- metastatic breast cancer," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "China is the fastest growing pharmaceutical market in the world, and we are delighted to be able to unlock value for Oncolytics and our shareholders through this regional partnership. We’re very happy this was able to happen as expediently as it did following our end-of-phase two meeting with the FDA. On the back of that meeting we also have escalated our efforts to find a suitable global or larger regional partner, in regions such as Europe or Japan, and look forward to providing updates on our progress in the first half of 2018."

"With its impressive clinical data coupled with its unique and novel mechanism, REOLYSIN will be an instrumental component in furthering the development of our oncology pipeline," said Carsten Lu, CEO of Adlai Nortye. "It immediately makes Adlai Nortye a late stage biotechnology company and REOLYSIN itself becomes our lead product. Given its potential in multiple oncological indications and its ability to be used in combination with multiple chemotherapies and immunotherapies, REOLYSIN will help to broaden future therapies made available by Adlai Nortye and advance us towards commercialization."

Terms of The Agreement
Oncolytics will receive an upfront licensing fee and milestone payments to support the phase 3 registration study in metastatic breast cancer (mBC) of USD $21.2 million, and is eligible to receive up to an additional USD $65.4 million upon achievement of clinical, regulatory and commercialization milestones. Oncolytics is also eligible to receive double digit royalty payments associated with the commercialization of REOLYSIN for all indications, subject to regulatory approval. Included in the USD $21.2 million:

Upfront payments of USD $5.3 million

Two milestone payments totalling USD $8 million made up of two common share purchase warrants:

One common share purchase warrant of USD $2 million whereby, upon exercise, Adlai may purchase Oncolytics’ common shares priced at a 120% premium of the five-day weighted average closing price immediately preceding the exercise date. Oncolytics has the right to call this warrant when the first patient is enrolled in the phase 3 mBC study or six months after execution of The Agreement, whichever is later.

One common share purchase warrant of USD $6 million whereby, upon exercise, Adlai may purchase Oncolytics’ common shares priced at a 120% premium of the five-day weighted average closing price immediately preceding the exercise date. Oncolytics has the right to call this warrant upon the enrollment of the 50th patient in the phase 3 mBC study.

USD $7.9 million based on certain regulatory advancements.
Oncolytics recently had a favorable End-of-Phase 2 Meeting with the United States Food and Drug Administration that outlined a single, 400-patient phase 3 study focused on HR+/HER2- patients. The Company expects to have formal guidance back from the European Medicines Agency (EMA) before the end of the year and to begin enrolling patients in its phase 3 study in mid-2018.

Adlai Nortye will be responsible for all clinical, regulatory and commercialization activities in its territories. Oncolytics maintains exclusive rights outside of these territories and will be responsible for all development outside of these territories.

Webcast and Conference Call
Oncolytics management will host a conference call for Analysts and Institutional Investors regarding this announcement tomorrow, November 17, 2017 at 8:30 am ET. The live call may be accessed by dialing (888) 231-8191 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their region. A replay of this call will be available approximately two hours after the call is ended at 855-859-2056 using the replay code 8987978 and will be available for three months.

A live audio webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for a full year.

On November 16, 2017 Celgene Corporation (NASDAQ:CELG) and bluebird bio, Inc. (NASDAQ:BLUE) reported that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA) (Press release, Celgene, NOV 16, 2017, View Source [SID1234522111]).

BTD designation and PRIME eligibility for bb2121 were based on preliminary clinical data from the ongoing phase 1 study CRB-401. Updated data from CRB-401 is scheduled to be presented at the 59th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Atlanta during an oral presentation on Dec. 11.

"Receiving Breakthrough Therapy Designation and PRIME eligibility for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment," said Jay Backstrom, M.D., Chief Medical Officer and Head of Global Regulatory Affairs for Celgene. "We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma."

"Despite recent advances, multiple myeloma remains an incurable disease, and heavily pretreated patients have limited therapeutic options," said David Davidson, M.D., Chief Medical Officer for bluebird bio. "Early data suggest that treatment with bb2121 has the potential to induce durable responses in this patient population. It is encouraging for both the FDA and EMA to identify bb2121 as a candidate for accelerated development as we continue our work with Celgene to bring this therapy to patients in need of new options."

Breakthrough Therapy Designation is intended to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

PRIME is a program launched by the EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier. The program focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA. To be accepted for PRIME, a medicine must show its potential to benefit patients with unmet medical needs based on early clinical data.

On November 16, 2017 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare diseases, reported the successful completion of a $27 million Series B financing (Press release, X4 Pharmaceuticals, NOV 16, 2017, View Source [SID1234522108]). Proceeds from the financing will be used to advance X4’s two lead drug candidates in clinical efficacy studies in immuno-oncology and a pivotal study in WHIM syndrome, a rare primary immunodeficiency disease. X4’s novel therapeutics are directed against the CXCR4 pathway to correct the trafficking of key immune cells that regulate healthy immune surveillance throughout the body.

"We are incredibly pleased to have the support of Cormorant Asset Management and additional new and existing investors to support our mission of bringing innovative treatments to patients with cancer and rare diseases," said Paula Ragan, PhD, President and CEO of X4. "We are now in a strong position to advance our lead candidate in WHIM syndrome into a pivotal study in 2018 and to advance our proof of concept studies in oncology. This financing recognizes the progress we have made as well as the important milestones that lie ahead in 2018."

"Having been an investor in the earliest stages of X4, we have witnessed the strong progress the company has made and the impact these treatments are having for patients," said Bihua Chen, CEO and Portfolio Manager, Cormorant Asset Management. "X4 has built a differentiated approach rooted in strong science and clear regulatory pathways. We are pleased to support X4’s continuing work in developing and commercializing innovative therapies for primary immunodeficiencies and cancer."

In the two years since X4 launched in 2015, the company has rapidly entered clinical studies with lead programs for two different diseases: as an immuno-oncology agent for solid tumors and as a treatment for the rare disease WHIM syndrome. The company’s oral, small molecule drug candidates inhibit the binding of chemokine CXCL12 to C-X-C receptor type 4 (CXCR4), a receptor-ligand pair that plays an essential role in normal immune surveillance. X4P-001-IO has demonstrated encouraging results in Phase 1/2 testing in refractory clear cell renal cell carcinoma, as well as in melanoma where results support activation of the immune system. In addition, X4P-001-RD has demonstrated initial proof-of-concept in the Phase 2 portion of an on-going Phase 2/3 study in patients with WHIM syndrome.

About Renal Cell Carcinoma

Kidney cancer is among the ten most common cancers in both men and women with more than 60,000 new diagnoses each year in the United States.1 Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer, and advanced ccRCC accounts for approximately 20% of the patient population. Therapies for advanced ccRCC include immunotherapies, mammalian target of rapamycin (mTOR) kinase inhibitors, and angiogenesis inhibitors, such as vascular endothelial growth factor (VEGF) inhibitors.2 There continue to be unmet medical needs with advanced ccRCC because durable responses remain a serious clinical challenge for patients with advanced disease.

About WHIM Syndrome

WHIM syndrome is a primary immunodeficiency disease ("PID") caused by genetic mutations in the CXCR4 receptor gene resulting in susceptibility to certain types of infections. WHIM is an abbreviation for the characteristic clinical symptoms of the syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. Within the overall category of primary immunodeficiencies, there are between 15,000 and 100,000 patients in the US that are classified with PID of unknown origin — of which WHIM is one.3,4,5 WHIM syndrome is a rare disorder and the precise prevalence or incidence of patients that have the genetic mutation responsible for WHIM syndrome is unknown. Because patients are highly susceptible to infections, WHIM syndrome is associated with significant morbidity beginning in early childhood and continuing throughout life. Current therapy is limited to treatment of acute infections with antibiotics or prevention through the use of intravenous immunoglobulin or G-CSF. There is no approved therapy for the treatment of WHIM syndrome.

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On November 16, 2017 Innovation Pharmaceuticals Inc. (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported additional perspectives on the planned continued development of Brilacidin-OM for the prevention and treatment of Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients (Press release, Innovation Pharmaceuticals, NOV 16, 2017, View Source [SID1234522105]).

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As previously announced, the Phase 2 randomized, placebo-controlled clinical trial of Brilacidin-OM (see NCT02324335), enrolling a total of 61 patients, recently was completed, with top-line analysis to be reported shortly.

After unblinding, should final study results compare favorably to those observed at interim, in which patients treated with Brilacidin-OM showed a markedly reduced rate of severe OM (WHO Grade ≥3 ) compared to those on placebo, the Company will initiate an aggressive development plan going forward, including: applying to the Food and Drug Administration (FDA) for Breakthrough Therapy Designation and possibly applying for a similar expedited path in Europe; enhancing oral rinse administration with patient-friendly formulation and packaging; and, dedicating internal resources to Phase 3 trial design planning and execution.

Formal collaboration with pharmaceutical companies that have expressed an interest in partnering Brilacidin-OM may well assist further with expediting the drug candidate’s development timetable. Some of these partnering conversations have matured to the point of potentially structuring mutually beneficial licensing agreements, pending the final Phase 2 study results.

"We very much look forward to taking what could be the final step in Brilacidin’s development for the prevention of OM—top-line results reporting followed by possible advancement into a pivotal Phase 3 trial," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "The OM market comprises a huge unmet medical need. To think we might one day help end the pain of so many patients suffering from OM, better enabling them to get the critical cancer care they need, would be an incredible accomplishment for Innovation Pharmaceuticals’ staff and a proud moment for our shareholders. Furthermore, securing partnerships with Pharma would represent a significant milestone for the Company, further anchoring the rapidly expanding Brilacidin Franchise."

"What’s important to understand about Brilacidin-OM, at this stage of its development, is that it truly represents a potential breakthrough treatment in OM," commented Arthur P. Bertolino, MD PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "A majority of OM treatments currently being evaluated in clinical trials still target reduction in duration of OM symptoms, rather than going after OM prevention—what we’ve established as our primary efficacy outcome in the completed Phase 2 trial. We’ve set for ourselves a high bar, to be sure, but feel confident that if we deliver strong top-line results, Brilacidin-OM will stand apart from any future competition—a potential first-to-market and best-in-class OM treatment."

About Oral Mucositis

Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation. Head and Neck Cancer (HNC) patients—comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source: GLOBOCAN)—are at the greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak and eat (requiring the insertion of a feeding tube) and are more susceptible to infections, with severe cases leading to hospitalization at increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the potential market for OM is expected to exceed $1 billion in the next few years.

On November 16, 2016 TNK Therapeutics, Inc. ("TNK"), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE; "Sorrento"), reported that it has entered into a binding term sheet to acquire Virttu Biologics Limited ("Virttu") (Press release, Sorrento Therapeutics, NOV 16, 2017, View Source [SID1234518745]).

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Virttu, based in Glasgow, Scotland, is a privately-held biopharmaceutical company focused on the development of oncolytic virus therapy for treatment of cancer. Virttu’s lead product candidate Seprehvir (HSV1716) is a Herpes Simplex Virus (HSV)-based oncolytic virus that selectively kills cancer cells and eliciting an anti-tumor immune response in the patient. The oncolytic virus technologies of Virttu have potential for broad therapeutic application across various cancer indications as well as being synergistic with the immunotherapy portfolios of TNK and Sorrento.

Seprehvir has completed Phase I studies in Europe for treatment of solid tumors, including glioma as well as head and neck squamous cell carcinoma (HNSCC), in adult cancer patients. In addition, it is currently being evaluated in a Phase I/IIa study in the UK for treatment of adult patients with mesothelioma using regional (intrapleural) delivery of Seprehvir and in a Phase I study in the US as therapy for non-CNS malignancies in pediatric patients using intravenous (i.v.) infusion of Seprehvir.

The acquisition is contingent upon completion of each parties’ due diligence and other customary closing conditions. In consideration for the acquisition, Virttu equity holders will receive $5 million in stock of Sorrento at closing (expected in the first quarter of 2017) and an additional $20 million in stock of TNK upon its next financing within 12 months after the closing.

"With the acquisition of Virttu, we will add a clinical-stage oncolytic virus therapy to our armamentarium of immunotherapies. The Virttu team has done a tremendous job of advancing Seprehvir into clinical trials for treatment of adult cancer and pediatric malignancies. In addition to the conventional intratumoral injection route that the marketed HSV-based oncolytic virus therapy utilizes, the Seprehvir can be administered via i.v. infusion for treatment of both local and metastatic cancers due to absence of inherent neurotoxicity in contrast to other HSV-based oncolytic viruses." said Dr. Henry Ji, President and CEO of Sorrento. Dr. Ji added, "We look forward to continuing the clinical development of Seprehvir in the US and Europe as monotherapy but also initiate combination trials globally with TNK’s cellular therapies as well as Sorrento’s immuno-oncology mAb products."

"We are excited to join the Sorrento/TNK team and together accelerate the development of Seprehvir. Sorrento’s antibody-centric therapies and TNK’s CAR-T and CAR.NK programs are a perfect match with our oncolytic virus as our preclinical research has shown significant synergy between Seprehvir and CAR-T therapies as well as with immune checkpoint antibodies. Furthermore, our Seprehvec platform technology will allow for the development of next generation oncolytic virus programs, such as expression of Sorrento’s immune checkpoint antibodies at the tumor site or pro-inflammatory cytokines for enhanced tumor killing and immune activation, by incorporating these genes into the Seprehvir genome," stated Dr. Joe Conner, Chief Scientific Officer of Virttu. "The field of oncolytic virus therapies is rapidly gaining attraction as evident by recent marketing approvals and transactions, so we believe that with Virttu becoming part of TNK, we will be well positioned to become a leader in this exciting immunotherapy space."