On January 8, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, is pleased to inform shareholders of recent articles published in "The Lancet," a leading independent, international journal for medical professionals, detailing data from two, separate clinical studies1,2 of radiotherapy plus ERBITUX (cetuximab) or cisplatin in treating oropharyngeal cancer, a type of Head and Neck Cancer (HNC) (Press release, Innovation Pharmaceuticals, JAN 8, 2019, View Source [SID1234532565]).

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The findings from the large studies are particularly great news for the Company and relevant for development of Brilacidin oral rinse under a U.S. Food and Drug Administration (FDA) Fast Track designation as a new drug candidate for the prevention and treatment of severe Oral Mucositis (OM) in HNC patients receiving chemoradiation.

Cetuximab, an Epidermal Growth Factor Receptor inhibitor, has been hypothesized as a less toxic option to cisplatin, a drug commonly used today in combination with radiotherapy in HNC treatment regimens. While effective, cisplatin is known to have certain toxicities, including frequently causing severe OM, a debilitating and painful side effect characterized by lesions in the mouth’s mucosa that can force suspension of cancer therapy, render a patient unable to eat or drink and increase risk of sepsis, among other complications. There are currently no FDA-approved drugs for the prevention and treatment of OM for patients with solid tumors.

In each study, replacing cisplatin/radiotherapy with cetuximab/radiotherapy delivered inferior results when evaluated for overall survival, progression-free survival, or tumor control and no difference in overall severe toxicity. Although each study should be considered landmark on its own, the harmonized results are most notable in showing that the combination of cisplatin and radiotherapy will remain a standard of care in treating HNC.

"These data indicate that a cisplatin/radiotherapy regimen is likely to continue to be a mainstay in treating HNC, in spite of the drug commonly causing severe OM. A glaring critical void in patient care — and, thus, comprising a tremendous market opportunity for the Company — is in developing a safe and effective treatment that can become part of the standard regimen to prevent severe OM," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We are highly confident that Brilacidin oral rinse could fill that large therapeutic gap in cancer care and give patients preventative relief from a frequently occurring and horrible consequence of chemoradiation."

In the Company’s successfully completed Phase 2 trial, Brilacidin oral rinse significantly reduced the incidence of severe OM (WHO Grade ≥ 3) in HNC patients receiving cisplatin administered 80-100 mg/m2 every 21 days in combination with radiotherapy. In this patient population, incidence of severe OM was reduced to 25.0 percent in the modified Intent-to-Treat population, versus 71.4 percent of placebo patients. In the Per Protocol patient group, incidence of severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.

The Company recently completed an End-of-Phase 2 meeting with the FDA, paving the way for pivotal trials of Brilacidin oral rinse for HNC patients receiving chemoradiation. In Phase 3 trials, Brilacidin will be evaluated in patients receiving aggressive chemotherapy (cisplatin administered 80-100 mg/m2 every 21 days) and in those receiving less aggressive chemotherapy (cisplatin administered 30-40 mg/m2 weekly) as part of the chemoradiation regimen.

In its goal to build a world-class clinical asset across the Brilacidin franchise, with the indication of severe OM a Company priority, Innovation Pharmaceuticals is preparing to seek scientific advice from the European Medicines Agency to round out European Union program requirements for Phase 3 clinical trials.

On January 8, 2019 Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported recent updates to several of its immuno-oncology and rare disease programs and outlined its 2019-2020 corporate objectives (Press release, Moderna Therapeutics, JAN 8, 2019, View Source [SID1234532581]). Moderna has 21 mRNA development candidates in its pipeline, with 11 programs now in clinical development.

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"This year we are focused on making significant advances to our pipeline as we work to bring multiple programs into Phase 2 clinical trials, move programs within our rare disease portfolio toward the clinic and leverage our mRNA platform to create both new development candidates and potential new modalities where we believe there is an opportunity to develop therapies for a broad range of diseases," said Stéphane Bancel, Moderna’s Chief Executive Officer. "I am pleased with the continued progress of our pipeline, our ability to now manufacture mRNA for clinical development at our new site in Norwood and the relentless work of our team. I believe we are better positioned than we have ever been to deliver on the promise of our science to bring forward mRNA medicines that have the potential to improve the lives of patients."

Mr. Bancel will present a company overview and strategy update today at 10:30am PST at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. A live webcast of today’s presentation can be found at investors.modernatx.com.

Detailed program updates:

Intratumoral Immuno-oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

OX40L (mRNA-2416): Based on previously reported clinical observations in two patients with advanced ovarian carcinoma in its Phase 1 study, Moderna has submitted an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) and to the study’s clinical research sites to commence a Phase 2 cohort of mRNA-2416 as a monotherapy in advanced ovarian carcinoma within its current Phase 1 study. Thus far, 28 patients have been dosed in the ongoing Phase 1 trial for mRNA-2416, an open-label, multicenter study of repeated intratumoral injections of mRNA-2416 in patients with advanced relapsed/refractory solid tumor malignancies and lymphomas. Initial data from the Phase 1 study were presented in a poster session at the Annual Meeting of the Society for Immunotherapyof Cancer in November 2018.
OX40L + IL23 + IL36γ (Triplet) (mRNA-2752):Moderna has dosed the first patient in the Phase 1 study of mRNA-2752, an intratumoral injection comprising three mRNAs encoding for OX40L + IL23 + IL36γ for the treatment of advanced or metastatic solid tumor malignancies or lymphoma. The open label, multi-center study is evaluating the safety and tolerability of mRNA-2752 as a single agent and in combination either with AstraZeneca’s durvalumab or tremelimumab, and will assess anti-tumor activity, protein expression in tumors and pharmacokinetics, and exploratory endpoints that include assessment of immunological response.
Cancer Vaccines: These programs focus on stimulating a patient’s immune system to tumor-related antigens to enable the immune system to elicit a more effective antitumor response.

Personalized Cancer Vaccine (PCV) (mRNA-4157): Moderna and Merck areplanning a randomized Phase 2 study comparing PCV and KEYTRUDA against KEYTRUDA alone. To date, interim Phase 1 PCV study data from 24 patients showed no dose limiting toxicities up to 0.39 mg (the third of four dose levels). Interim Phase 1 immunogenicity data have also been collected in certain patients dosed with mRNA-4157 as a monotherapy, and potential antigen-specific T cell responses have been detected. The Phase 1 study continues in the dose-escalation phase of the protocol.
KRAS vaccine (mRNA-5671): Merck will lead an open-label, multi-center, dose-escalation and dose-expansion Phase 1 study to evaluate the safety and tolerability of mRNA-5671 administered as an intramuscular injection both as a monotherapy and in combination with KEYTRUDA. KRAS is a frequently mutated oncogene in epithelial cancers, primarily in non-small cell lung, colorectal and pancreatic cancers. The IND for a KRAS vaccine was originally submitted by Moderna and included an mRNA for the membrane protein STimulator of INterferon Gene (STING) to help promote antitumor activity. That IND was transferred to Merck which now will move the program forward under the same IND with KRAS as the sole mRNA. Merck may choose to include STING mRNA in later clinical development of the KRAS vaccine.
Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

Methylmalonic Acidemia (MMA) (mRNA-3704): An IND application has been submitted to the FDA for mRNA-3704, Moderna’s development candidate for MMA. If approved, this will be Moderna’s first rare disease program to advance into clinical trials. The Company plans to conduct an open-label, multi-center, dose escalation Phase 1/2 study of multiple ascending doses of mRNA-3704 in pediatric patients with isolated MMA due to MUT enzyme deficiency. The objectives of the study are to evaluate safety and tolerability. mRNA-3704 has received Rare Pediatric Disease Designation by the FDA and Orphan Drug Designation by both the FDA and the European Medicines Agency.
Propionic Acidemia (PA) (mRNA-3927): mRNA-3927 was granted Orphan Drug Designation by the FDA in December 2018 and Rare Pediatric Disease Designation by the FDA in January 2019. PA is a rare, life-threatening, inherited metabolic disorder due to a defect in the mitochondrial enzyme propionyl-CoA carboxylase, or PCC. It primarily affects the pediatric population and there is no approved therapy. Moderna is continuing to advance mRNA-3927 in pre-clinical studies. Moderna also continues to enroll patients in a global natural history study of MMA and PA (MaP Study) designed to identify and correlate clinical and biomarker endpoints for these disorders. This is a global, multi-center, non-interventional study for patients with confirmed diagnosis of MMA due to methylmalonyl-CoA mutase (MUT) deficiency or PA.
More than 760 subjects have been dosed with a therapeutic or vaccine candidate developed with Moderna’s mRNA technology.

Information about each program in Moderna’s pipeline, including those discussed in this press release, can be found on our investor relations page of our website www.modernatx.com.

Corporate Objectives:

Moderna shared its corporate objectives for 2019 – 2020, which include:

1. Generate human proof-of-concept data for multiple medicines
2. Execute on current development pipeline
3. Create new development candidates in existing modalities
4. Invent new modalities

Corporate Updates:

Continued growth across organization:Moderna ended 2018 with approximately 735 full time employees. The Company ended 2017 with 535 employees.

Continued strong cash position: We expect our cash, cash equivalents, and investments in marketable securities as of December 31, 2018 to be approximately $1.7 billion (unaudited), as compared to $902 million (audited) as of December 31, 2017. The year over year increase includes approximately $564 million (unaudited) in net proceeds from our initial public offering completed in December 2018, approximately $661 million in net proceeds from our preferred stock issuances in 2018, and a $13 million (unaudited) premium associated with the 2018 amended and restated personalized cancer vaccines agreement with Merck & Co.

On January 8, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that gonadotrophin-releasing hormone (GnRH) receptor antagonist, Gonax received approval for partial changes for the additional dosage and administration of Gonax for the treatment of prostate cancer at 12-week intervals, and obtained manufacturing and marketing authorization for Gonax 240 mg in Japan (Press release, Astellas, JAN 8, 2019, View Source [SID1234534620]).

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Gonax is a GnRH receptor antagonist with a subcutaneously injectable formulation. Astellas acquired exclusive development and commercialization rights of Gonax for the use of prostate cancer treatment in Japan from Ferring Pharmaceuticals in January 2006, and launched Gonax for the indication of prostate cancer in Japan in October 2012.

GnRH is a hormone synthesized and released from the hypothalamus in the brain and is involved in the production of the male hormone testosterone thorough binding to the GnRH receptors in the pituitary gland. Although testosterone is an important hormone that plays a central role in the maintenance of male function, it also stimulates prostate cancer to grow and to spread out and in result, often aggravates symptoms in prostate cancer patients. Gonax competitively inhibits the binding of GnRH to the GnRH receptors and controls the growth of prostate cancer by suppressing the testosterone.

Astellas believes that adding the maintenance dose of Gonax 480 mg at 12-week intervals to the maintenance dose of Gonax 80 mg at 4-week intervals will improve convenience for patients and reduce the burden on patients and further contribute to the treatment of prostate cancer.

Astellas reflected the impact from this approval in its financial forecasts of the current fiscal year ending March 31, 2019.

On January 8, 2019 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the Company will host a business update call on Tuesday, January 15, 2019 (Press release, Advaxis, JAN 8, 2019, View Source [SID1234532566]).

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Advaxis’ senior management will host a conference call to provide a business update and to discuss fiscal year 2018 financial results, which will be released on January 10, 2019. The conference call and live audio webcast will begin at 11:00 a.m. Eastern time on Tuesday, January 15, 2019.

Conference Call & Webcast Information
WHEN: Tuesday, January 15, 2019 at 11:00 a.m. Eastern time
DOMESTIC DIAL-IN: (844) 348-6133
INTERNATIONAL DIAL-IN: (631) 485-4564
CONFERENCE ID: 4862946
WEBCAST: ir.advaxis.com/events-presentations

For those unable to participate in the live conference call or webcast, a digital recording will be available beginning January 15, 2019 two hours after the close of the conference call. To access the recording, please dial (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and provide the operator with the conference ID: 4862946. In addition, an audio webcast will be archived on the Company’s website for a period of time at www.advaxis.com.

On January 8, 2019 Biond Biologics Ltd. ("Biond" or the "Company"), a privately-held Israeli biotechnology company, developing novel immunotherapies for cancer and autoimmune diseases, reported the closing of a $17 million Series B financing (Press release, Biond Biologics, JAN 8, 2019, View Source [SID1234532582]).

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Biond was founded in 2016 by the former scientific team of cCam Biotherapeutics, an immuno-oncology company which was fully acquired by Merck in July 2015. The former cCAM Biotherapeutics team was joined by additional veterans of the Israeli biotech industry, with the aim to build a strong, sustainable and innovative science-driven biotechnology company. The company’s vision and strategy are to bring innovative drugs to patients based on synergistic long-term collaborations with leading global companies in the immunotherapy field.

Biond intends to use the proceeds to move its lead drug candidate, BION-202, into clinical trials and to advance the preclinical development of BION-206 and its proprietary antibody cell-internalization technology.

The financing and due diligence were led by Israel Biotech Fund and Harel Insurance & Finance Group, with participation of Celgene Corporation, (NASDAQ: CELG), the Japanese-Israeli fund, SBI JI Innovation Fund and existing investors.

"We are excited to have such prominent investors as shareholders who are aligned with the company’s vision of delivering breakthrough immune-based solutions to patients with serious diseases," said Dr. Tehila Ben Moshe, Co-Founder and Chief Executive Officer of Biond Biologics. "After two years of intense and creative discovery work, we are ready to advance our first innovative drug candidate into clinical trials."

"We were very impressed by the innovative science discovered at Biond and by the quality and experience of its managerial and scientific team," said Dr. David Sidransky, M.D., Co-Founder and General Partner at Israel Biotech Fund and Biond board member. "Biond’s novel pipeline candidates have the potential of becoming paradigm shifting therapies in immuno-oncology."

"We are happy to support the outstanding management team at Biond and its cutting-edge pipeline and technology," stated at Harel Insurance & Finance. "This investment aligns with the group’s ongoing effort of investing in breakthrough and innovative technologies developed by companies with great growth potential."