On November 8, 2021 Doloromics has reported the appointment of Dr. Chris Flores as their new President and Chief Research and Development Officer (Press release, Lifescience Newswire, NOV 8, 2021, View Source [SID1234594729]). In this role, Dr. Flores will be responsible for leading the Doloromics portfolio of drug discovery and development programs, two of which are scheduled to launch in early 2022, while building relationships with strategic partners and collaborators in support of these efforts.

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"After an extensive and diverse experience in the Pharmaceutical and Consumer sectors of Johnson & Johnson, I’m both thrilled and privileged to commit the full measure of my expertise and passion in executing the core mission of Doloromics, to eradicate pain in patients who remain tragically underserved by current standards of care." — Chris Flores, PhD.

Dr. Flores will complement the Doloromics leadership team after a successful, 19-year career at Johnson & Johnson, where he held several executive positions, including Vice President of Neuroscience, La Jolla R&D Site Head, Pain Franchise Strategy Leader, Head of Pain Discovery and Global External Innovation Head of Discovery Sciences within Janssen Research & Development as well as Head of Emerging Science and Innovation Strategy for J&J Consumer Companies.

On November 8, 2021 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to elicit a potent and durable immune response in the tumor microenvironment, reported that company leadership will participate in two upcoming virtual investor conferences in November (Press release, Bicara Therapeutics, NOV 8, 2021, View Source [SID1234594746]):

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Stifel 2021 Virtual Healthcare Conference
Format: Live presentation
Date: Monday, November 15, 2021
Time: 10:40 – 11:10 a.m. ET

Piper Sandler 33rd Annual Virtual Healthcare Conference
Format: On-demand presentation
Date: Monday, November 22, 2021
Time: 10:00 a.m. ET

On November 8, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter of 2021 and recent corporate updates (Press release, Mirati, NOV 8, 2021, View Source [SID1234594794]).

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"Mirati is aggressively focused on executing its strategy to deliver targeted cancer medicines to patients, and is well positioned for sustained growth from our differentiated research and development capabilities," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "Our recent positive clinical updates for adagrasib reinforce a best-in-class profile, including topline results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study in patients with KRASG12C-mutated lung cancer, where we expect to launch in the U.S. next year, as well as encouraging results in KRASG12C-mutated colorectal and pancreatic cancers, which were presented at recent medical congresses. We are also pleased to advance the development of adagrasib in earlier lines of therapy, including in first-line non-small cell lung cancer. The rest of our novel pipeline continues to progress rapidly, which includes sitravatinib, MRTX1719, our MTA-cooperative PRMT5 inhibitor, as well as our mutant KRAS programs beyond KRASG12C, including MRTX1133, our KRASG12D inhibitor, and our SOS1 program."

Pipeline Updates

The U.S. Food and Drug Administration (FDA) will review the Company’s New Drug Application (NDA) for adagrasib for the treatment of patients with previously treated KRASG12C-mutated non-small cell lung cancer (NSCLC) who have received prior systemic therapy under the Real-Time Oncology Review (RTOR) pilot program. The RTOR status follows the previously announced U.S. FDA Breakthrough Therapy Designation for adagrasib in the same indication. The Company expects to complete the adagrasib NDA submission to the FDA by the end of 2021.
Preliminary results from the Phase 1b cohort of the KRYSTAL-1 study evaluating adagrasib plus pembrolizumab1 in 8 patients with KRASG12C-mutated first-line NSCLC support moving forward with a 400 mg BID dose of adagrasib with full dose pembrolizumab, which will be evaluated in the ongoing Phase 2 KRYSTAL-7 study. The Phase 1b data showed adagrasib 400mg BID plus pembrolizumab had a manageable tolerability profile, with no observed Grade 4 or Grade 5 adverse events or treatment-related discontinuations. Of the 7 patients evaluable for a response as of October 21, 2021, 4 had a confirmed RECIST-defined partial response and 1 additional patient, who is still on study, experienced 49% tumor regression in the first scan, which allowed for tumor resection prior to achieving a RECIST-defined confirmed response. The disease control rate was 100%, with all 7 patients exhibiting tumor regression ranging from 37% to 92%. With a median follow up of 9.9 months, 5 of the 7 patients remained on treatment, as of the data cutoff date, and had been on treatment for 8 to 11 months.
Announced positive topline results from the potentially registration-enabling cohort of the Phase 2 KRYSTAL-1 study evaluating adagrasib in patients with advanced NSCLC harboring the KRASG12C mutation following prior systemic therapy, as well as updated findings from the Phase 1/1b KRYSTAL-1 study evaluating adagrasib in all enrolled patients with KRASG12C-mutated advanced NSCLC. The topline results were presented at a virtual Investor Event held during the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) congress. The Company plans to submit detailed results for presentation at a medical congress prior to the potential U.S. launch of adagrasib in 2022. (View Release)
Announced a non-exclusive clinical trial collaboration agreement with Sanofi to evaluate adagrasib with Sanofi’s investigational SHP2 inhibitor SAR442720, also known as RMC-4630, in patients with previously-treated NSCLC and KRASG12C mutations. (View Release)
Presented clinical research on adagrasib and sitravatinib at the 2021 ESMO (Free ESMO Whitepaper) Congress, including:
Data from a cohort of the Phase 1/2 KRYSTAL-1 study evaluating adagrasib as a monotherapy or in combination with cetuximab (ERBITUX)2 in patients with KRASG12C -mutated colorectal cancer (CRC). (View Release) The Company has an actively enrolling global registrational Phase 3 clinical trial, KRYSTAL-10, comparing adagrasib plus cetuximab to standard of care chemotherapy in second-line KRASG12C-mutated CRC.
Exploratory results from the Phase 2 MRTX-500 study evaluating sitravatinib plus nivolumab (OPDIVO)3 in patients with advanced NSCLC who had disease progression following treatment with checkpoint inhibitors. The Company has an actively enrolling global registrational Phase 3 study, SAPPHIRE, evaluating sitravatinib plus nivolumab in second or third line non-squamous NSCLC and plans to provide an update based on an interim analysis of overall survival in the second half of 2022. (View Release)
Presented preclinical and clinical data at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), including:
A summary of the discovery and preclinical characterization of MRTX1133, a mutant-selective KRASG12D inhibitor. This presentation also included preliminary new clinical data from a cohort of the KRYSTAL-1 study evaluating adagrasib in previously-treated patients with KRASG12C-mutated pancreatic cancer, as well as proof-of-concept data in non-clinical models for inhibitors of additional KRAS mutations beyond KRASG12C and KRASG12D.
Preclinical results on MRTX1719, the selected development candidate from the Company’s MTA-cooperative PRMT5 inhibitor program, in MTAP-deleted cancer models. The Company expects to file an Investigational New Drug application for MRTX1719 by the end of 2021.
Corporate Updates

Announced the appointment of David Meek as chief executive officer and board member of the Company, Charles M. Baum, M.D., Ph.D. transitioning to the Company’s president, founder and head of research and development, and continuing in his role as a board member; and other previously announced leadership updates.
Third Quarter 2021 Financial Results

Ended the third quarter with approximately $1.2 billion in cash, cash equivalents, and short-term investments, which includes net proceeds of $63.4 million for the upfront fee from Zai Lab pursuant to the collaboration and license agreement executed during the second quarter.
Research and development expenses for the third quarter of 2021 were $116.1 million, compared to $79.9 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021 were $354.8 million, compared to $216.6 million for the same period in 2020. The increase in research and development expenses is primarily due to an increase in expense associated with the development of adagrasib, an increase in preclinical and early discovery activities, as well as an increase in salaries and other employee-related expense, which includes an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expenses of $15.7 million during the third quarter of 2021, compared to $12.6 million for the same period in 2020, and $46.7 million during the nine months ended September 30, 2021, compared to $35.9 million for the same period in 2020.
General and administrative expenses for the third quarter of 2021 were $35.2 million, compared to $20.2 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021 were $93.1 million, compared to $58.1 million for the same period in 2020. The increase is due to an increase in professional services expense primarily associated with commercial scale up, an increase in salaries and other employee-related expenses, an increase in insurance, rent and other facilities-related costs, and an increase in sponsorship agreements expense. The Company recognized general and administrative-related share-based compensation expenses of $11.2 million in the third quarter of 2021, compared to $9.2 million for the same period in 2020, and $32.9 million during the nine months ended September 30, 2021, compared to $28.2 million for the same period in 2020.
Net loss for the third quarter of 2021 was $80.1 million, or $1.55 per share basic and diluted, compared to a net loss of $87.3 million, or $1.96 per share basic and diluted for the same period in 2020. Net loss for the nine months ended September 30, 2021 was $382.2 million, or $7.45 per share basic and diluted, compared to a net loss of $256.9 million, or $5.87 per share basic and diluted for the same period in 2020.
Conference Call Information

Investors and the general public are invited listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free 313-209-7315 or international +1 877-614-0009, confirmation code: 3962567. Materials related to the call will be available at the same website at the time of the conference call. A replay of the call will be available approximately 2 hours after the event has ended at the same website or by dialing in the U.S. toll free 719-457-0820 or international +1 888-203-1112, confirmation code: 3962567.

On November 8, 2021 Leadingtac Bio, a company in Zhangjiang Science City announced the completion of a Pre-A round of financing led by Yuan Sheng Venture Capital, with additional investment from long-time shareholder ZJ LEADING VC (Press release, Leadingtac Pharmaceutical, NOV 8, 2021, View Source [SID1234640717]). This funding round will be used primarily to advance the company’s first Protein Degrader pipeline for autoimmune disease treatment to the clinical research stage and to develop follow-on programs and pipelines, including oncology and other autoimmune diseases. With the previous angel round, Leadingtac has raised nearly 100 million RMB in cumulative early-stage financing.

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Leadingtac Bio was founded by Dr. Yan Feng in September 2019 in Zhangjiang Science Park. The company’s R&D direction is dedicated to the development of target protein degradation drugs and focuses on disease areas such as autoimmunity and oncology to address unmet clinical needs.

The target protein degradation drug is a bifunctional small molecule compound, a ligand that binds the target protein at one end and E3 ubiquitin ligase at the other. A Linker connects the ligands to form a complex that draws the target protein closer to the E3 ligase and promotes the ubiquitination of the target protein, which is then degraded through the ubiquitin-proteasome pathway to remove the disease-causing target protein. Targeted protein degradation drugs are characterized by high drug-forming ability, overcoming drug resistance, small dosage, low toxicity, and drug resistance. Therefore, this research direction has received close attention from domestic and international pharmaceutical companies and capital markets.

Since its inception, the company has taken the mission of "leading innovation, Thailand’s people", based on the source of innovation in new drug development, looking for new targets, using protein degradation technology to develop new small molecule drugs that are currently not drug-ready targets, to provide maximum therapeutic value for patients. As a result, we have developed a series of lead compounds with fully independent intellectual property rights based on our Nano-SPUD platform for specific protein ubiquitination and degradation drug discovery. The company’s fastest progressing project is the LT001 project for autoimmune diseases. The project has obtained expected results from a series of in vitro and in vivo experiments, such as degradation activity, pharmacokinetics, and efficacy, and has already carried out IND-enabling studies, which are expected to be submitted to IND at the end of 2022 and enter clinical trials in 2023. In addition, Leadingtac is also actively developing several pipeline projects.

Dr. Yan Feng, the founder of Leadingtac Bio, said, "As a significant direction for future drug development, the development of targeted protein degradation drugs (Protein Degrader) has received much attention from academia, the pharmaceutical industry, and the capital market in the past few years. As a newcomer in this field, Leadingtac has developed its R&D technology platform and pipeline within two years of its efforts. One of the pipelines will enter the clinical filing stage soon. In this financing round, Leadingtac was honored to receive the approval and lead investment from Yuan Sheng Venture Capital, and ZJ LEADING VC also decided to continue to invest. We are very grateful to our new and old investors for their recognition and support. This financing round will help to rapidly advance the clinical filing of Leadingtac’s first pipeline and also provide a strong guarantee for developing several subsequent projects, high-end talent team building, and site expansion. I believe that with the help of our investors and the efforts of the team at Leadingtac, we will be able to maximize our potential for new drug development and make greater contributions to the pharmaceutical field!"

Jay Chen, Founding Partner of Yuan Sheng Ventures, said, "We are pleased to invest in Leadingtac as the lead investor in this round. As a newcomer in the field of Protein Degrader, Leadingtac Bio has established a more mature technology platform, the first product has also started the filing of IND, and the subsequent product pipeline is various and has great potential for development. As a result, we believe Leadingtac Bio will have great international competitiveness in the future."

Yu Xiaoyong, the founding managing partner of ZJ LEADING VC, said, "We congratulate Leadingtac on the completion of this financing round. As the round angel investor of Leadingtac, we had the honor to work with Dr. Yan Feng two years ago to help Leadingtac plow through the new drug development track of protein degradation. Over the past two years, we have witnessed the continuous growth of Leadingtac’s team and the company together and have gained a deep understanding of the company’s continuous innovation powerhouse, which is why we have sufficient confidence in Leadingtac’s future development, and that is why we continue to invest in this round. We believe that after this round of financing, Leadingtac Bio will continue to achieve good results in the advancement of clinical filing projects, the layout of pipeline projects, and the reinforcement of the team."

On November 8, 2021 Alkermes plc (Nasdaq: ALKS) reported that it received notices of partial termination (the "Notices") in respect of two license agreements with Janssen Pharmaceutica N.V. ("Janssen"), a subsidiary of Johnson & Johnson and, under these agreements, a licensee and recipient of Alkermes’ nanoparticulate formulation technology, known as NanoCrystal technology (Press release, Alkermes, NOV 8, 2021, View Source [SID1234594698]). The terminations impact know-how royalties related to sales of long-acting paliperidone products, such as INVEGA SUSTENNA and INVEGA TRINZA, and other products in the United States. Pursuant to the agreements, the partial termination is to become effective three months from the date of receipt of the Notices. Janssen maintains that it has not utilized, and does not utilize, Alkermes’ NanoCrystal technology licensed under the agreements. Alkermes strongly disagrees with Janssen’s position and will explore all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property.

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"For years, Janssen has highlighted the use of our NanoCrystal technology in its long-acting INVEGA products and has paid us know-how royalties consistent with this fact. We are not aware of any changes that have occurred to these products that would have altered their use of our intellectual property. We will continue our efforts to engage with Janssen to explore if a mutually agreeable resolution can be reached and will consider all options to enforce our contractual and intellectual property rights," said Richard Pops, Chief Executive Officer of Alkermes. "Over the last several years, we have been engineering the business to become less reliant on revenues from partnered products. For the expected growth drivers within our commercial portfolio – LYBALVI, ARISTADA, VIVITROL and VUMERITY – nothing has changed. We are energized by the opportunities in our pipeline and remain focused on advancing the assets that we believe will drive the future growth of the business and value for our shareholders."

"With the exception of VUMERITY, royalty revenue streams have become less core to Alkermes’ growth. We had been planning for a wind down of the Janssen royalty payments in the coming years and, while the potential earlier loss of these royalty streams will adversely impact our cash flow over the next few years, our long-term outlook remains unchanged," stated Iain Brown, Chief Financial Officer of Alkermes. "We do not expect any impact on our 2021 financial results related to these events. As we look ahead to 2022, we will incorporate any necessary changes from these developments when we provide our financial expectations for the year in February. We will continue to focus on driving operational efficiencies and managing expenses across the business, and we believe we are well-positioned to advance our business objectives and drive profitable growth in the business in the long-term."

Conference Call

Alkermes will host a conference call and webcast at 5:00 p.m. ET (10:00 p.m. GMT) on Monday, Nov. 8, 2021. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.