On June 11, 2020 Travecta Therapeutics reported it has raised an additional $12 million in financing, closing its Series A round at a total of $27 million (Press release, Travecta Therapeutics, JUN 11, 2020, View Source [SID1234605570]). The fund-raise was led by TKS1, a life science focused venture capital fund formed by the partnership between SPRIM and Tikehau Capital.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The positive traction we are having with our data along with the strength of interest from development and licensing partners has motivated our current investors to contribute an additional $12 million," said Michael Shleifer, CEO of Travecta Therapeutics. "This financing will accelerate our trajectory into the next phase of development, and we’re thankful to our partners for the support."

This funding comes on the heels of Travecta Therapeutics’ mVECTATM platform achieved targeting of a broad range of product candidates across the blood-brain-barrier with proven efficacy against pharmacological targets. "Our mVECTATM platform technology is unlocking key biological targets in neurological diseases that were previously difficult to engage because of the blood-brain barrier," said Dr. Mahmood Ahmed, Chief Scientific Officer.

The proceeds from the Series A financing will be used to support Travecta’s growth and advance the development of TVT-004, Travecta’s lead non-opioid product targeting pain. The company plans to enter clinical trials in 2021. The funding will also support the progression of the company’s earlier stage research programs in neuro-oncology and neuro-inflammation.

Bruno de Pampelonne, Chairman of Tikehau IM said, "Travecta Therapeutics’ mVECTATM platform could revolutionize treatments in a broad range of neurological indications often very difficult to treat. We are thrilled to partner with Travecta’s team in this endeavor"

On June 11, 2020 Invitae reported that New recommendations from a large, multidisciplinary consensus conference published this week in the Journal of Clinical Oncology suggest expanding use of genetic testing to guide treatment for men with prostate cancer, including the use of panel testing and testing patients with early stage disease (Press release, Invitae, JUN 11, 2020, View Source [SID1234561384]). Taken together with research recently presented by Invitae (NYSE: NVTA), a leading genetics company, the publications underscore the utility of increased access to genetic testing for men with prostate cancer across all stages of disease.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

Invitae was among the non-voting sponsors of the conference, which gathered more than 100 experts across a number of specialties with the goal of developing recommendations for how clinicians can use genetic testing to help patients benefit from precision medicine approaches to prostate cancer.

"Inherited prostate cancer is starting to get the attention it deserves, but we have a long way to go to catch up to the research and testing that has been done in other cancers, such as breast cancer," said Sarah Nielsen, M.S., L.C.G.C. a medical affairs liaison now at Invitae who previously participated in the conference. "This framework provides a very thoughtful approach to implementing genetic testing for prostate cancer treatment, screening and family testing. Importantly, the framework recognizes that changes in a number of different genes can increase prostate cancer risk and therefore encourages greater use of panel testing for men with metastatic disease. With new precision therapies linked to specific genetic changes, increased genetic testing can help identify patients who could benefit from these approaches."

Among the consensus conference recommendations:

Larger panels are useful for patients with metastatic disease

Large germline panels and somatic testing were recommended for patients with metastatic prostate cancer. Of the approximately 12-17% of men with metastatic prostate cancer who harbor germline variants, the majority are found in DNA damage repair (DDR) genes such as BRCA1, BRCA2, ATM, CHEK2, PALB2, and the DNA mismatch repair (MMR) genes. Large panels provided information across these and other genes of significance, information which is increasingly informing options for PARP inhibitors, immune checkpoint inhibitors, platinum chemotherapy, and clinical trials.

Genetic information can support early diagnosis and inform disease surveillance

Germline test results are increasingly important for early detection, as men with BRCA2 variants exhibit higher rates of prostate cancer, often with a younger age at diagnosis and more clinically significant disease. Among patients with early-stage disease, emerging data suggest that men with germline BRCA2 mutations and possibly ATM mutations have higher rates of upgrading of prostate biopsies while on active surveillance, suggesting the utility of genetic information in shaping surveillance strategies after diagnosis.

Importance of using genetic information requires novel strategies to increase access to counseling resources

The guidelines recommend broad access to genetic counseling support but shortages of genetic counselors and wait times for traditional genetic counseling workflows will require development of alternate models for timely and responsible delivery of genetic testing for men and their families. The consensus framework provides suggestions for clinicians on how to counsel and provide alternatives to traditional in-person appointments for patients across a number of issues related to testing, including using pretest education materials and the use of telehealth genetic counseling sessions.

"This framework provides an important step in helping clinicians incorporate genetic testing into care for a wide range of prostate cancer patients," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Research has shown that narrow testing criteria will miss men with clinically relevant variants that could inform their care. Providing a framework for more clinicians to expand their use of genetic testing will increase the number of patients who benefit from precision medicine approaches."

Research underscores frequency of clinically important variants that may be missed by narrow testing criteria

In addition, a study presented recently at the American College of Medical Genetics and Genomics online annual meeting that further underscored the frequency of actionable variants expanded testing can help uncover.

The study of 2,252 men who participated in Invitae’s Detect Prostate Cancer program found an overall positive rate of 13% with no statistical differences in rates among stages of disease. Only half of patients with an actionable variant reported a family history suggestive of increased risk. Nearly three-quarters (71%) of positive patients were eligible for management guidelines and/or potentially eligible for approved precision therapies or clinical trials. These data suggest that broader testing criteria and greater access to testing leads to better informed care for patients and their families.

The consensus conference noted the need for additional research into the associations between genetics and prostate cancer in African-American men, who are 1.8 times more likely to be diagnosed with and 2.2 times more likely to die from prostate cancer. Importantly, this study included 16% participation among African-Americans, which is greater participation than previous similar studies, aligning to the consensus conference research priorities.

The full consensus statement can be found in the Journal of Clinical of Oncology.

On June 11, 2020, Mustang Bio, Inc. ("Mustang" or the "Company") reported that it has entered into an underwriting agreement (the "Underwriting Agreement") with Cantor Fitzgerald & Co., as representative of the underwriters named therein (each, an "Underwriter" and collectively with Cantor Fitzgerald & Co., the "Underwriters") (Filing, 8-K, Mustang Bio, JUN 11, 2020, View Source [SID1234561090]). Pursuant to the Underwriting Agreement, the Company agreed to sell to the Underwriters, in a firm commitment underwritten public offering, 10,769,231 shares (the "Firm Shares") of the Company’s common stock, $0.0001 par value per share ("Common Stock"), at a price to the public of $3.25 per share, less underwriting discounts and commissions. In addition, pursuant to the Underwriting Agreement, the Company has granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 1,615,384 shares of Common Stock (the "Additional Shares," together with the Firm Shares, the "Shares"). The transactions contemplated by the Underwriting Agreement are expected to close on June 15, 2020, subject to the satisfaction of customary closing conditions. A copy of the Underwriting Agreement is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering. Oppenheimer & Co. Inc. is acting as lead manager for the offering.

The gross proceeds to the Company are expected to be approximately $35 million, assuming no exercise of the option to purchase Additional Shares and excluding underwriting discounts and commissions and other offering-related expenses.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended (the "Securities Act"), other obligations of the parties and termination provisions.

The offering is being made pursuant to the Company’s effective "shelf" registration statements on Form S-3 (File Nos. 333-226175 and 333-233350) (the "Registration Statements") filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on July 27, 2018 and September 30, 2019, respectively, as supplemented by a preliminary prospectus supplement filed with the SEC on June 10, 2020 and a final prospectus supplement filed with the SEC on June 12, 2020, pursuant to Rule 424(b) under the Securities Act.

Alston & Bird LLP, counsel to the Company, delivered an opinion as to the validity of the Shares, a copy of which is attached hereto as Exhibit 5.1 and is incorporated by reference herein.

This Current Report on Form 8-K is being filed to incorporate the Underwriting Agreement and opinion by reference into such Registration Statements. The foregoing summary description of the offering and the documentation related thereto, including without limitation, the Underwriting Agreement, does not purport to be complete and is qualified in its entirety by reference to such Exhibits.

The Underwriting Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Underwriting Agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the Underwriting Agreement and should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company or any of its subsidiaries or affiliates. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Underwriting Agreement, and this subsequent information may or may not be fully reflected in the Company’s public disclosures.

On June 11, 2020 University of Helsinki reported that 1,5 million euros funding supports a new investigator-initiated breast cancer clinical trial in Finland that takes on MYC (Press release, University of Helsinki, JUN 11, 2020, View Source [SID1234561087]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A Finnish Jane and Aatos Erkko Foundation awarded 1,5 million euros to support a VeMA clinical breast cancer study scheduled to start in HUS Comprehensive Cancer Center already this year. The clinical trial is among the first in the world having a biologic rationale rooted to MYC oncoprotein’s apoptosis promoting function.

The award is for a long-term translational collaboration project between breast cancer researchers at the University of Helsinki and clinicians in Helsinki University Hospital.

VeMA is an early phase investigator-initiated clinical trial in metastatic breast cancer setting, which tests the safety of a new combination treatment regimen that includes two targeted therapy agents combined with an immunotherapy agent anti-PD-L1. The study is expected to find the right dosage for further studies and biomarkers to guide patient selection with improved precision and to monitor treatment responses.

"We are truly excited to start VeMA in HUS, since the biologic rationale for the study comes from a research laboratory working next door. VeMA study is a beautiful example of translational research, that is a process where scientific discoveries made with cancer cells and animal models in a research laboratory serve as grounds for a clinical concept that will be tested in patients in the hospital," says the Principal clinical Investigator, Director and Chief Oncologist Johanna Mattson from HUS Comprehensive Cancer Center.

The study Co-Investigator, Research Director Juha Klefström from the University of Helsinki says that VeMA has been totally handcrafted as a local collaboration between the Medical Faculty and HUS Comprehensive Cancer Center.

"MYC oncoprotein drives abnormal pattern of cell proliferation in about half of the breast cancer cases. However, at the same time, MYC renders cells vulnerable to apoptotic cell death. The key question that has for a long time inspired our work is: can we somehow exploit this inherent apoptotic vulnerability of MYC expressing cancer cells in design of new therapies that would selectively kill cancer cell but leave normal cell unharmed? Now we are about to test this concept for the first time to help women suffering from breast cancer," he says.

Most clinical cancer trials are designed and funded by pharmaceutical industry. In the investigator-initiated trials, the researchers are allowed to design the trial by themselves but the main challenge is to find funding from public sources to support the study.

Thanks to the support of the Jane and Aatos Erkko Foundation, the VeMA study can now be launched as planned. Pharma has contributed to the study by donating the three drugs needed for the study for free.

On June 11, 2020 Simcere Pharma of Nanjing reported that it has filed with the Hong Kong Exchange for an IPO that is rumored to seek $500 million (Press release, Jiangsu Simcere Pharmaceutical Company, JUN 11, 2020, View Source [SID1234561028]). Previously, Simcere was listed in the US, but it was taken private in 2013 for $500 million by management and Hony Capital. The company is an active dealmaker, using partnerships and in-house R&D to build a portfolio of nearly 50 novel candidates in development. In 2019, the company’s ten generic products produced a profit of $140 million on $708 million in revenue.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!