On October 19, 2020 Cytocom, Inc. (Cytocom), a leading biopharmaceutical company in the area of immune-modulation, and Cleveland BioLabs, Inc., (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, reported that they have entered into a definitive merger agreement to combine their businesses in an all-stock transaction (Press release, Cleveland BioLabs, OCT 19, 2020, View Source [SID1234568641]). Cytocom shareholders will have a majority position in the newly combined entity, which the parties anticipate will continue to be listed on the Nasdaq, and the initial Board of Directors for the combined company will consist of four members selected by Cytocom and three members selected by Cleveland BioLabs. The Boards of Directors of both companies have approved the combination.

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Each party to the proposed merger believes that the combined company will create near-term commercial opportunities in numerous areas of significant unmet medical needs including acute radiation injury, oncology, infectious disease, inflammation and autoimmune-mediated conditions, with multiple commercial, regulatory and clinical milestones expected over the next 12 to 18 months. Operating as "Cytocom, Inc." and under the leadership of Cytocom’s experienced management team, the combined company will be positioned for consistent growth.

Overview

Michael K. Handley, President and Chief Executive Officer of Cytocom, stated, "Our merger with Cleveland BioLabs and its subsequent immune-focused platform will be a transformative growth opportunity for Cytocom and Cleveland BioLabs shareholders. We believe that the combination of these highly complementary late-stage pipelines will strengthen our position and advance our efforts to unlock the potential of immune-modulating agents in the treatment of serious medical conditions. Further, this merger will enhance our ability to become a recognized leader in immune-modulating treatments and builds on the momentum created by our recent acquisition of ImQuest Life Sciences. We plan to utilize the combined platform to further drive value with additional clinical and commercial products and continue to seek strategic partnerships and acquisitions."

Dr. Andrei Gudkov, Chief Scientific Officer of Cleveland BioLabs, said: "This is an exciting day for Cleveland BioLabs and a great opportunity for our stockholders. The merger with Cytocom will allow us to add the strength of our science and bright perspectives associated with Entolimod development in cancer treatment and radiation defense arenas with a string of immunomodulators developed by Cytocom to form a powerful blend of conceptually and scientifically aligned products. We believe that the merger with Cytocom is the ideal way to unlock the value of our technology platform and our lead drug candidate, Entolimod, and I look forward to seeing this exciting new therapy advance through the clinic."

Conditions

The proposed transaction is subject to customary closing conditions, including approval by the stockholders of Cleveland Biolabs, the shares of the combined company being approved for listing on Nasdaq and a registration statement under the Securities Act becoming effective. Cytocom and Cleveland Biolabs expect the transaction to close during the first quarter of 2021.

Conference Call

Cytocom will host a conference call and live audio webcast at 8:00 a.m. EDT on October 28th to discuss the merger and provide a strategic vision for the combined company. To access the conference call supported with slides, please dial 646-558-8656 with the meeting ID: 841 7826 2704 and passcode: 281020. The conference call can also be accessed at https://cleartrustonline.com/cytocom. Approximately two hours following the live event, a webcast replay of the conference call will be available on Cytocom’s website for approximately 30 days.

On October 19, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported it has entered into an exclusive license agreement with Voronoi, Inc., an innovative drug discovery company dedicated to advancing novel therapeutics. ORIC secured exclusive rights worldwide excluding the People’s Republic of China, Hong Kong, Macau and Taiwan (the ORIC Territory) for the development and commercialization of ORIC-114, a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency against exon 20 insertion mutations (Press release, ORIC Pharmaceuticals, OCT 19, 2020, View Source [SID1234568640]). ORIC expects to initiate a global Phase 1/2 tumor-agnostic trial in genetically defined cancers during the second half of 2021.

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"ORIC-114 is well aligned with our mission of overcoming cancer resistance by leveraging our expertise in precision oncology and key tumor dependencies, and it puts us in position for three INDs or equivalents next year," said Jacob Chacko, M.D., president and chief executive officer of ORIC. "ORIC-114 fits with our team’s success in developing therapies for tumor-agnostic mutations, including in patients with brain metastases, and will leverage our team’s prior experience in the pioneering development of entrectinib for genetically defined cancers. We believe Voronoi’s highly selective and brain penetrant inhibitors targeting exon 20 insertion mutations may address an area of significant unmet medical need for which no FDA-approved therapies exist today."

"We are thrilled to be partnering with ORIC to further develop our potential best-in-class EGFR/HER2 exon 20 inhibitor program," said Daekwon Kim, chief executive officer of Voronoi. "With ORIC’s focus on developing targeted cancer therapies and their team’s prior experience in leading efforts for multiple global regulatory approvals for mutant NSCLC and tumor-agnostic indications, ORIC is an ideal partner to further the development of this program."

Under the terms of the agreement, in exchange for an exclusive license to develop and commercialize Voronoi’s EGFR and HER2 exon 20 inhibitor program in the ORIC Territory, ORIC paid to Voronoi a one-time payment comprising $5 million in cash and $8 million in shares of ORIC common stock. The number of shares issued to Voronoi was based on a price of $28.24 per share, representing a premium of 25% to the 30-day trailing volume-weighted average trading price of ORIC’s common stock. In addition, ORIC will pay Voronoi success-based payments of up to $111 million in development and regulatory milestones and up to $225 million in sales milestones with respect to the first licensed product. If ORIC pursues a second licensed product, ORIC would pay Voronoi up to an additional $272 million in success-based milestones. ORIC will also pay tiered mid-single-digit to low double-digit royalties based on annual net sales in the ORIC Territory. ORIC will be responsible for development activities and expenses in the ORIC Territory.

Webcast and Conference Call

ORIC will host a webcast and conference call today, October 19th, at 4:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID: 8129902. Please join the conference call at least 15 minutes early to register. A live webcast will be available in the Investors section of the company’s website at www.oricpharma.com. The webcast will be archived for 60 days following the presentation.

About ORIC-114 and Exon 20 Insertion Mutations in EGFR and HER2

The ErbB receptor tyrosine kinase family is involved in key cellular functions, including cell growth and survival. Epidermal growth factor receptor (EGFR, or ErbB1) and human epidermal growth factor receptor 2 (HER2, or ErbB2) exon 20 insertion mutations are observed across multiple solid tumors, including NSCLC, breast, gastrointestinal, bladder and other cancers. EGFR exon 20 insertion mutations are observed in approximately 2% of all patients with NSCLC and have a worse prognosis than patients with NSCLC driven by other EGFR mutations. HER2 exon 20 insertion mutations are observed in approximately 1.5% of all patients with NSCLC. Approximately one-third of patients with exon 20 insertion mutations may develop brain metastases, which contributes to poor prognosis.

On October 19, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported details of its plans to report third quarter 2020 financial results on October 30, 2020 (Press release, Ligand, OCT 19, 2020, View Source [SID1234568639]). Ligand’s CEO John Higgins, President and COO Matt Foehr, and Executive Vice President and CFO Matt Korenberg will host the conference call .

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Third Quarter 2020 Earnings Conference Call

What:

Ligand conference call to discuss financial results and provide general business updates

Date:

Friday, October 30, 2020

Time:

8:30 a.m. Eastern time (5:30 a.m. Pacific time)

Conference Call:

Dial (833) 325-0071 within the U.S.

Dial (720) 405-1612 outside the U.S.

Conference ID is 9279386

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On October 19, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported details of its plans to report third quarter 2020 financial results on October 30, 2020 (Press release, Ligand, OCT 19, 2020, View Source [SID1234568638]). Ligand’s CEO John Higgins, President and COO Matt Foehr, and Executive Vice President and CFO Matt Korenberg will host the conference call.

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Third Quarter 2020 Earnings Conference Call

What:

Ligand conference call to discuss financial results and provide general business updates

Date:

Friday, October 30, 2020

Time:

8:30 a.m. Eastern time (5:30 a.m. Pacific time)

Conference Call:

Dial (833) 325-0071 within the U.S.

Dial (720) 405-1612 outside the U.S.

Conference ID is 9279386

Webcast:

Live conference call webcast and replay accessible at www.ligand.com

On October 19, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Welby Inc. reported that they launched a patient support program to promote proper use of Tecentriq, an immune checkpoint inhibitor marketed by Chugai (Press release, Chugai, OCT 19, 2020, View Source [SID1234568637]).. The program is based on "Welby MyKarte ONC," (hereafter, MyKarte ONC), a free personal health record (PHR) service by Welby to support treatment for cancer patients.

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MyKarte ONC is a PHR service to support cancer patients and healthcare professionals. Patients can easily enter and access data on their daily symptoms and treatment status to centrally manage such information. Also, the program provides optimized information according to cancer types and symptoms based on the patient’s record. The PHR service aims at achieving better treatment outcome through these functions which will help patients deepen understanding of the treatment and assist healthcare professionals to see changes in patients’ conditions (including adverse reactions and worsening of symptoms) sooner.

With the use of MyKarte ONC, Chugai started to offer the patient support program as described below, starting from October 2020. The objective of the program is to promote proper use of Tecentriq in patients with breast cancer receiving therapy with Tecentriq. The safety profile of Tecentriq, including development of immune-related adverse events (irAE), is different from that of the conventional chemotherapies. Our key challenge, therefore, is the prevention of severe irAE by early detection and management. MyKarte ONC is a platform-based PHR service that can be used regardless of cancer types and medications. It provides proper information based on an individual patient’s health information recorded by the patient. The service will become available for lung and liver cancers in due course so that more patients can receive proper treatment with Tecentriq utilizing the unique advantage of the PHR service.

1) Self-check functions: Patients on treatment with Tecentriq can self-monitor if they have symptoms related to irAE which requires attention by using self-check functions offered by MyKarte ONC. If severe symptoms (according to PRO-CTCAE*) are recorded, a message will be displayed to urge the patient to contact a medical institution for telephone counseling, etc. In addition, the patient can report his/her conditions to the physician with the severity based on PRO-CTCAE. By performing the self-check on a regular basis, patients can raise their awareness of important adverse reactions and deepen their understanding of the disease.

* Patient-Reported Outcome Common Terminology Criteria for Adverse Events

2) Information service functions: For the patients who have selected "Tecentriq/breast cancer" as a drug they currently use when upon registration for MyKarte ONC, the information page on Tecentriq provided by Chugai will be displayed. The seamless access to the information page via MyKarte ONC will increase convenience in gaining information. Comments are also displayed according to the state of entries, which enables patients to further understand their treatments.

Image (Japanese only)

Reference: Introduction page for patients of "Welby MyKarte ONC" View Source (Japanese only)

"Under CHUGAI DIGITAL VISION 2030, we aim to transform our business by using digital technologies to make Chugai a top innovator in the provision of society-changing healthcare solutions. To achieve this goal, the Value Delivery functions of Chugai consisted of Drug Safety Division, Marketing & Sales Division, and Medical Affairs Division will collaborate to broaden the use of the PHR service," said Satoko Shisai, Chugai’s Vice President, Head of Digital & IT Supervisory Division. "COVID-19 has brought rapid changes in our lifestyle. Similarly, the communication between patients and healthcare professionals will shift to contactless communication, including online clinical practice. Through this PHR service, patients can routinely record their daily status and share necessary information with healthcare professionals even under the situation where face-to-face communication is limited. In addition, it will contribute to realization of patient-centric healthcare by supporting patients to understand their treatments and proactively engage in their own treatment. Chugai will approach various needs in clinical settings by means of digital technologies, and continue to make efforts to realize patient-centric healthcare."

Takeru Hiki, Representative Director of Welby, commented, "Welby launched MyKarte ONC service in February 2020 as a PHR platform to help patients on cancer therapies monitor symptoms to be noted according to their conditions and treatments, as well as access necessary information. It has already been introduced to multiple key partner hospitals for cancer treatment and used by many patients. A range of pharmaceutical companies and their affiliates are participating in MyKarte ONC as a PHR platform to support cancer patients and healthcare professionals, which covers treatments of multiple cancer types. Chugai understood the concept ahead, which resulted in the release of MyKarte ONC to patients with breast cancer as a patient support program. Welby will cooperate with Chugai to further improve MyKarte ONC to popularize PHR among patients."

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