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Tessa Therapeutics Announces Collaboration with Merck Investigating the Combination of KEYTRUDA® (pembrolizumab) and Virus-Specific T Cell Therapy Targeting Human Papillomavirus in Cervical Cancer

On April 15, 2019 Tessa Therapeutics, a clinical-stage immunotherapy company focused on autologous and off-the-shelf, allogeneic therapies targeting solid tumors, reported that it has entered into an agreement with Merck (known as MSD outside the US and Canada), through a subsidiary, to evaluate Tessa’s armored human papillomavirus-specific T cell (HPVST) therapy, or TT12, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with recurrent or metastatic HPV 16 and 18-positive cervical cancer (Press release, Tessa Therapeutics, APR 15, 2019, View Source [SID1234535137]).

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Under the agreement, Tessa will conduct a multi-center Phase 1b/2 trial to evaluate the safety and efficacy of the combination. The trial is planned for initiation in the United States, Singapore and South Korea. "We are very excited to work with Merck to evaluate the potential of KEYTRUDA in combination with Tessa’s VST therapy for cervical cancer," said Mr. Andrew Khoo, Tessa Therapeutics CEO and Co-Founder. "Cervical cancer is a major cause of death in women, especially in some of the most vulnerable parts of the world. Furthermore, the current prognosis and treatment options for patients with metastatic cervical cancer are poor. We look forward to developing this novel combination further, which has the potential to bring more effective treatment options for such patients." Tessa’s TT12 is an autologous cell therapy product composed of HPVSTs that have been trained to target HPV 16/18 antigens and genetically modified with a decoy TGF-β receptor to overcome the suppressive tumor microenvironment. The safety and optimal dose selection of armored HPVSTs in combination with another anti-PD-1 antibody is currently being evaluated in a separate, ongoing investigator-sponsored Phase 1 trial in the United States, in patients with relapsed HPV-associated cancers. Preliminary results from this trial show that armored HPVSTs and its combination with anti-PD-1 are well-tolerated, have minimal toxicities and early signs of efficacy. Dr. Ivan D. Horak, M.D., Tessa Therapeutics President of Research and Development said, "Tessa’s TT12 Phase 1 study has shown encouraging results, supporting the effectiveness of armoured HPVSTs in targeting HPV-positive tumors and the addition of anti-PD-1 may remove potential immune inhibition that can hamper the tumor-killing activity of the HPVSTs. Bringing this therapy into a Phase 1b/2 trial and the expansion of clinical sites into Asia reflect our desire to bring novel therapies to more cancer patients globally, as well as our belief in the therapy’s potential to improve the clinical outcomes of patients with advanced stages of HPV-positive tumors." KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA. About Cervical Cancer and Armored HPVST Immunotherapy According to the World Health Organization, cervical cancer is the fourth most common cancer in women worldwide and second most common in less developed regions. Cervical cancer is caused by sexually acquired infection with certain types of human papillomavirus (HPV), with two HPV types (16 and 18) accounting for 70% of cervical cancers and pre-cancerous cervical lesions. Various studies have reported poor outcome of patients with metastatic cervical cancer. Currently, the median survival time for metastatic cervical cancer is only 8 to 13 months[1] and the 5-year survival rate is 16.5% compared to 91.5% for localized cervical cancer[2]. Contrary to patients with early-stage cervical cancer and locally advanced cervical cancer who have access to conventional treatments including surgery, chemotherapy, or radiotherapy, patients with metastatic cervical cancer have no standard treatment because of its heterogeneous manifestations. T cells are a critical part of the body’s immune system that play a central role in fighting virus infections and cancers. Virus-Specific T cells (VSTs), in particular, have the ability to recognize and kill infected cells while activating other parts of immune system for a coordinated response. HPVSTs are produced by collecting patient’s blood and selectively expanding T cells which recognize HPV 16/18 antigens. To increase durability in the tumor microenvironment, the HPVSTs are armored by modifying the cells to express a decoy TGF-β receptor. The armored HPVSTs are expanded before undergoing strict quality control prior to infusion back into the patient.

NuVasive Announces Conference Call And Webcast Of First Quarter 2019 Results

On April 15, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported the Company will release its first quarter 2019 earnings results on Wednesday, May 1, 2019 after the close of the market (Press release, NuVasive, APR 15, 2019, View Source [SID1234535135]).

NuVasive will hold a conference call on Wednesday, May 1, 2019, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its financial performance for the first quarter 2019. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through May 31, 2019. In addition, a telephone replay of the call will be available until May 8, 2019. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13689332.

Aptorum Group Limited Reports 2018 Fiscal Year Financial Results and Business Update

On April 15, 2019 Aptorum Group Ltd. (NASDAQ: APM), a preclinical stage pharmaceutical company developing and commercializing a broad portfolio of projects under development of therapeutic and diagnostic technologies to tackle unmet medical needs, reported its financial results for the fiscal year ended December 31, 2018 (Press release, Aptorum, APR 15, 2019, View Source [SID1234535133]).

Recent Business Updates

Successfully completed an initial public offering ("IPO") on the Nasdaq Global Market of 761,419 Class A ordinary shares at a public offering price of $15.8 per shares
Private placement of convertible bonds in April 2018 of $15 million of which $1.5 million was converted into Class A ordinary shares upon IPO in December 2018
Full year 2018 research and development expenses of $3.1 million, increased $0.5 million compared to the period March 1, 2017 to December 31, 2017
"Last year was monumental for Aptorum Group. On the business front, we completed our IPO in the fourth quarter of 2018," said Ian Huen, Founder and Chief Executive Officer of Aptorum Group. "In 2019, we look forward to continued advancement of our projects under development, and expect to advance our first lead project into IND-enabling studies."

2018 Fiscal Year Financial Results Highlights

Aptorum Group reported a net loss of $15.1 million in 2018, as compared to $2.6 million for the period March 1, 2017 through December 31, 2017. The increase in net loss in 2018 was driven by the decrease in gain on investment in marketable securities due to the a one-off investment disposed in last period, increased in general and administration fees due to the increased headcount in the Group to support the business development, and increased in net interest expenses due to the convertible debts issued in 2018.

Research and development expenses were $3.1 million in 2018 as compared to $2.6 million for the period March 1, 2017 through December 31, 2017. The increase in research and development expenses in 2018 was primarily due to the expansion of research and development team to support growing business and projects.

General and administrative fees were $4.9 million in 2018 as compared to $1.5 million for the period March 1, 2017 through December 31, 2017. The increase in general and administrative expenses 2018 was mainly driven by increased headcount in the Group to support the business development.

Legal and professional fees were $1.8 million in 2018 as compared to $1.4 million for the period March 1, 2017 through December 31, 2017. The increase in legal and professional fees was mainly due to the preparation of IPO and business expansion.

Aptorum Group ended the 2018 with $26.1 million in cash and restricted cash as compared to $16.7 million as of December 31, 2017. The increase in cash and restricted cash was mainly the result of the $15 million of convertible bonds issued during the year.

Can-Fite Receives $1,000,000 Payment from CKD for Distribution of Namodenoson in South Korea

On April 15, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has received a $1,000,000 payment from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) of South Korea (Press release, Can-Fite BioPharma, APR 15, 2019, View Source [SID1234535131]). CKD has licensed the distribution rights to Namodenoson in South Korea for the treatment of liver cancer and non-alcoholic steatohepatitis (NASH) in a deal totaling $6,000,000 in upfront and milestone payments, plus a transfer price for delivering finished products to CKD. The current $1,000,000 payment is an upfront payment for the expansion of CKD’s existing agreement with Can-Fite to include the rights to distribute Namodenoson for the treatment of NASH in South Korea.

"As we advance our pipeline of drugs, we are pleased to work with our expanding network of global distribution partners for Namodenoson and Piclidenoson," stated Can-Fite CEO Pnina Fishman.

Zymeworks Opens Phase 2 Clinical Trial for ZW25 in First-Line HER2-Expressing Metastatic Gastroesophageal Cancers

On April 15, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported it has initiated its global multicenter Phase 2 clinical trial evaluating ZW25 in combination with standard of care chemotherapy for the first-line treatment of HER2-positive metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas (Press release, Zymeworks, APR 15, 2019, View Source [SID1234535130]).

"Advancing ZW25 into a Phase 2 clinical trial represents another key milestone for Zymeworks," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "This reaffirms our commitment to execute our ambitious drug development strategy to address unmet need in patients with HER2-expressing cancers across multiple indications and lines of therapy. We anticipate that data from this trial will support initiation of a first-line registrational trial, which could position ZW25 as the new standard of care for HER2-positive metastatic gastric cancer."

In addition to the Phase 2 metastatic gastroesophageal cancer trial, ZW25 continues to be evaluated in multiple expansion cohorts in the ongoing Phase 1 trial as a single agent in gastrointestinal, gynecological, and other HER2-expressing cancers, and in combination with chemotherapy in breast and gastroesophageal cancers.

About the Trial

The Phase 2 trial is a two-part open-label study. The primary objectives of this trial are to confirm the safety, tolerability, and anti-tumor activity of ZW25 in combination with global standard of care regimens for gastroesophageal adenocarcinoma, including platinum and fluoropyrimidine-based regimens.

"While major advances have been made in the treatment of HER2-positive breast cancer, patients with HER2-positive gastroesophageal adenocarcinomas still have limited options," said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. "Based on the encouraging single agent anti-tumor activity we observed in patients with gastroesophageal adenocarcinomas in our Phase 1 study, we believe that ZW25 has the potential to address this need, and we are excited to be starting this first-line trial."

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Orphan Drug Designation to ZW25 for the treatment of both gastric and ovarian cancers.

About the Azymetric Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug-resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.