On September 28, 2020, Sorrento Therapeutics, Inc. (the "Company") and Fortis Advisors LLC, in its capacity as representative of the former holders of equity (the "Equityholders’ Representative") of Semnur Pharmaceuticals, Inc. ("Semnur"), reported that it entered into an amendment (the "Amendment") to that certain Exchange and Registration Rights Agreement, dated as of March 18, 2019, by and among the Company and the stockholders and stock option holders of Semnur, as set forth on Schedule A thereto (the "Original Exchange Agreement") (Filing, 8-K, Sorrento Therapeutics, SEP 28, 2020, View Source [SID1234567978]). The Original Exchange Agreement was entered into in connection with the Agreement and Plan of Merger entered into among the Company, Scilex Holding Company ("Scilex Holding"), Sigma Merger Sub, Inc. and the Equityholders’ Representative, as amended by that certain Amendment No. 1 to Agreement and Plan of Merger, dated August 7, 2019 (as amended, the "Merger Agreement"), pursuant to which Merger Sub merged with and into Semnur and Semnur became a wholly-owned subsidiary of the Company (the "Merger").

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Pursuant to the Original Exchange Agreement, if by September 18, 2020, 100% of the outstanding equity of Scilex Holding had not been acquired by a third party and Scilex Holding had not entered into a definitive agreement with respect to, or otherwise consummated a firmly underwritten offering of Scilex Holding capital stock on a major stock exchange that met certain requirements, then the former holders of Semnur capital stock and holders of options to purchase Semnur’s common stock (collectively, the "Semnur Equityholders") could elect to exchange, during the 60-day period commencing on September 18, 2020 (the "Share Exchange"), the shares of Scilex Holding issued to the Semnur Equityholders in the Merger (the "Stock Consideration") for shares of the Company’s common stock with a value of $55.0 million, based on a price per share of its common stock equal to the greater of (a) the 30-day trailing volume weighted average price of one share of its common stock as reported on The Nasdaq Stock Market LLC as of the consummation of the Share Exchange and (b) $5.55 (such greater price, the "Exchange Price").

The Amendment amends the Original Exchange Agreement to, among other things, provide that if the Company receives notice from the Semnur Equityholders that the Semnur Equityholders will proceed with the Share Exchange (an "Exchange Notice"), the Company may, in its sole discretion, elect, within seven days of receipt of an Exchange Notice, to exchange all the Stock Consideration and the rights to receive cash from Scilex Holding held by certain of the Semnur Equityholders under the Merger Agreement for an amount in cash equal to $55.0 million, in lieu of issuing $55.0 million of shares of the Company’s common stock at the Exchange Price.

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment filed herewith as Exhibit 10.1 and the full text of the Original Exchange Agreement that was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 22, 2019, each of which are incorporated by reference herein.

On September 28, 2020 Virogin Biotech reported the completion of its Series C round of financing for a total of $62 million USD on September 20, 2020 (Press release, Virogen, SEP 28, 2020, View Source [SID1234567955]).

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Virogin Biotech is an oncolytic virus company developing next-generation oncolytic virotherapies to enhance the systemic antitumor immunity in patients. The financing round was co-led by CMG-SDIC Capital and CDH Investments, with participation from Lingdao Capital, Panlin Capital, Korea Investment Partners, Guanghua Alumni Capital of Canada and Stream Holdings. The endorsement of new investors reflects continued and growing confidence in Virogins’ ongoing clinical development as well as discovery projects.

The proceeds from this round of financing will be used to continue the clinical development of Virogins’ lead asset – VG161 through to Phase II studies; completion of pre-clinical research and IND-enabling studies for Virogins’ next-generation oHSVs; continued expansion and optimization of research and further development and expansion of the company product pipeline.

"Despite all the challenges in 2020, we are extremely grateful for the strong level of support and dedication from our investors", said Mr. Chris Huang, CEO and co-founder of Virogin. "With these funds, Virogin will continue to be a leader in the oncolytic virotherapy field, while continuing to expand and develop effective drugs for patients. The continued support and belief from our investors allows us to carry forward our lead asset through to Phase II studies, and continue the research work required to take our next-generation virotherapies to the clinic, one step closer to helping cancer patients."

"Oncolytic virotherapy is a valuable investment opportunity in the emerging biotech space", said Hua Yi, Executive Director of CMG-SDIC Capital. "We are confident on its demand in immunotherapy, and, through the continued support of current and future investors, aim to grow the company into a world leader in oncolytic virotherapy."

Dan Liu, the Healthcare Executive Director at CDH Investments Venture and Growth Capital, added: "We have been following immuno-oncology therapeutics, especially innovative approaches that change the tumor microenvironment. Believing in the potential and the importance of oncolytic virotherapy in treating cold tumors, we conducted a global search for OV companies and have identified Virogin as the frontrunner for the competitiveness of its proprietary TTDR viral backbone and Synerlytic platform. We are very excited to work with existing shareholders to help Virogin become a global leader in the field of oncolytic virotherapy."

On September 28, 2020, Ziopharm Oncology, Inc., or the Company, reported that it entered into an amendment to the patent license agreement, or the Amendment, with the National Cancer Institute, or the NCI (Filing, 8-K, Ziopharm, SEP 28, 2020, View Source [SID1234567871]). The Amendment amended the patent license agreement, or the License, between the Company and the NCI, dated May 28, 2019 and amended on January 8, 2020, pursuant to which the Company holds an exclusive, worldwide license to certain intellectual property to develop and commercialize patient-derived (autologous), peripheral blood T-cell therapy products engineered by transposon-mediated gene transfer to express T-cell receptors, or TCRs, reactive to mutated KRAS, TP53 and EGFR.

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Pursuant to the Amendment, the Company expanded the TCR library licensed from the NCI to include additional TCRs reactive to mutated KRAS. The Company’s license to develop and commercialize products based on the additional TCRs are subject to the same limitations and obligations set out in the original License. The Company is required to pay the NCI a cash payment of $411,000 within sixty days of the execution date of the Amendment and is required to make the performance-based payments and benchmark payments in the License for products that include the additional TCRs.

The foregoing description of the material terms of the Amendment does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Amendment, which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2020 and is incorporated by reference herein. Portions of the Amendment may be subject to a confidential treatment request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

On September 28, 2020 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that an Independent Monitoring Committee (IDMC) determined that the randomized, double-blind, placebo-controlled, international multi-center Phase III study JUPITER-02 at the interim analysis had met its pre-specified primary endpoint (Press release, Shanghai Junshi Bioscience, SEP 29, 2020, View Source [SID1234567842]). The results of the study showed that Toripalimab in combination with Gemcitabine/Cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) significantly extended the progression-free survival than the current standard treatment of Gemcitabine/Cisplatin. The Company will submit biologic license application (BLA) to the National Medical Products Administration (the "NMPA") and regulatory authorities in other relevant countries in the near future.

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About NPC
Nasopharyngeal carcinoma (NPC), a subtype of head and neck cancer, is a malignant tumor that occurs in the nasopharynx. According to statistics from the World Health Organization, NPC is widely distributed in Southeast Asia and the incidence in the region accounts for approximately 84.6% of the new cases worldwide. NPC is prone to distant metastasis at diagnosis, while early stage patients tend to relapse after radiation or radio-chemotherapy. Platinum-based therapy is currently standard care for recurrent or metastatic NPC. In addition, there is no standard treatment after failure of the first-line systemic chemotherapy. The 5-year overall survival rate of patients with advanced disease is less than 10%.

ABOUT JUPITER-02 STUDY
The JUPITER-02 Study (NCT03581786) is a randomized, double-blind, placebo-controlled, international multi-center Phase III clinical study to compare the efficacy and safety of Toripalimab versus placebo in combination with Gemcitabine/Cisplatin, as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma. Professor Xu Ruihua from Sun Yat-sen University Cancer Centre is the leading principal investigator. The JUPITER-02 Study enrolled a total of 289 patients. The primary endpoint of the study is progression-free survival (PFS), and the secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

At the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the global study met its primary endpoint of progression free survival (PFS). Compared with the placebo control, Toripalimab in combination with Gemcitabine/Cisplatin significantly prolonged the PFS as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.

About Toripalimab
Toripalimab is a PD-1 monoclonal antibody developed by Junshi Biosciences. Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019. More than 30 clinical studies covering more than ten cancer indications have been conducted in China, the United States and other countries.

In April 2020, the supplemental New Drug Application ("NDA") of Toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma after failure of at least two prior systemic treatments has been accepted by the NMPA. This supplemental NDA is the world’s first NDA of PD-1 blockade therapy for the treatment of nasopharyngeal carcinoma. In May 2020, the supplemental NDA of Toripalimab for the treatment of locally advanced or metastatic urothelial carcinoma after systemic treatment has been accepted by the NMPA. Both supplemental NDAs received priority review status by the NMPA in July 2020.

In March 2020, Toripalimab in combination with axitinib for the treatment of mucosal melanoma was granted the orphan-drug designation by the US FDA. In May and September 2020, Toripalimab also received the orphan-drug designation by the FDA for the treatment of nasopharyngeal carcinoma and soft tissue sarcoma. In September 2020, Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA.

On September 28, 2020 Carmine Therapeutics reported that it has been named by FierceBiotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Carmine Therapeutics, SEP 28, 2020, View Source [SID1234567822]).

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The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment, FierceBiotech Senior Editor Ben Adams said. "This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology," Adams said.

Carmine Therapeutics is pioneering a novel class of therapeutics based on its REGENT technology – an innovative approach which leverages red blood cell extracellular vesicles (RBCEVs). First published in Nature Communications in 2018, an initial focus is non-viral gene therapies.

In June 2020, Carmine Therapeutics signed a research collaboration agreement with Takeda Pharmaceutical Company Limited to discover, develop and commercialize transformative non-viral gene therapies. Carmine Therapeutics will be eligible for over $900M USD in total milestone payments plus tiered royalties.

XQ Lin, Founding CEO of Carmine Therapeutics and Managing Partner of Esco Ventures X, commented, "We are thrilled to be recognized as a Fierce 15 company, an honor that reflects the innovative nature of our RBCEV platform and the dedication of our team. This comes following a year of successes and we are excited to build on this momentum. We believe that our novel approach will have a tremendous impact on transforming patient lives."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 18th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.