On March 1, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the Company has entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical Co., Ltd. ("AstraZeneca Pharmaceutical" or the "Promoter"), pursuant to which Junshi Biosciences will grant AstraZeneca Pharmaceutical the exclusive promotion right of toripalimab in mainland China for the urothelial carcinoma indications to be approved subsequently for marketing and the exclusive promotion right for all indications approved and to be approved in non-core areas (Press release, Shanghai Junshi Bioscience, MAR 1, 2021, View Source [SID1234575836]). Junshi Biosciences will continue to be responsible for the promotion of other indications approved and to be approved excluding urothelial carcinoma indications in core areas.

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This strong alliance between the two companies will help promote local high-quality innovative drugs to benefit more Chinese patients. Junshi Biosciences and AstraZeneca will continue to explore overseas business collaboration including the emerging markets and actively explore the possibility of expanding the depth and breadth of future collaborations.

"We are delighted to work with AstraZeneca in the commercialization of Toripalimab in China," said Dr. Ning Li, CEO of Junshi Biosciences. "We are confident that by leveraging the extensive networks AstraZeneca has established over the years, and especially by utilizing its ability to promote in the county-level markets, this innovative drug with excellent performance in efficacy and safety will achieve greater success in the Chinese market and will enable more patients to receive timely and effective treatment. Under the guidance of the company’s ‘In China, For Global’ strategy, we also look forward to more in-depth collaborations with AstraZeneca in a wider range of fields in order to provide better and more affordable treatment options to patients in China and all over the world."

About Toripalimab
Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in China. More than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On 17 December 2018, Toripalimab obtained a conditional approval from the the National Medical Products Administration ("NMPA") for the second-line treatment of unresectable or metastatic melanoma. Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. The supplemental NDA of Toripalimab for the second-line treatment of metastatic urothelial carcinoma was accepted by the NMPA in May 2020 and received priority review designations from the NMPA in July 2020. In September 2020, Toripalimab was granted Breakthrough Therapy Designation by the US Food and Drug Administration ("FDA") for the treatment of recurrent/metastatic nasopharyngeal carcinoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA application of Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. Currently, Toripalimab has been granted 1 Breakthrough, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

On March 1, 2021 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that IMV’s executive management team will be participating at the H.C. Wainwright Global Life Sciences Conference which will be held virtually on March 9-10 (Press release, IMV, MAR 1, 2021, View Source [SID1234575835]).

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H.C. Wainwright Global Life Sciences Conference
Presentation availability time: Tuesday, March 9, 2021 at 7:00 AM Eastern Time

A link to this presentation will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website at the above-mentioned time and for approximately 30 days thereafter.

On March 1, 2021 OrbiMed, a leading life sciences investment firm, reported $3.5 billion in commitments for its latest private investment funds, including $1.5 billion for OrbiMed Private Investments VIII, $800 million for OrbiMed Asia Partners IV, and $1.2 billion for OrbiMed Royalty & Credit Opportunities III (Press release, OrbiMed Advisors, MAR 1, 2021, View Source [SID1234575834]). Investors in these new funds include a broad range of medical institutions, university endowments, foundations, pension funds and sovereign wealth funds.

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OrbiMed Private Investments VIII invests primarily in venture capital stage opportunities in North America and Europe, with a focus on biotechnology, medical device, and diagnostics companies. This fund targets investments from $10 million to $100 million across approximately 40 portfolio companies.
OrbiMed Asia Partners IV invests primarily in China and India, from venture capital through growth stage across biotechnology, pharmaceuticals, medical devices, diagnostics, and healthcare services. This fund targets investments from $10 million to $100 million in approximately 20 portfolio companies.
OrbiMed Royalty & Credit Opportunities III invests globally through providing structured credit and royalty monetization financing solutions for healthcare companies and institutions. This fund generally invests from $10 million to $150 million per opportunity.
Where appropriate, OrbiMed invests across multiple funds, bringing potential investment amounts to upwards of $250 million per portfolio company. These new funds bring OrbiMed’s assets under management to approximately $18 billion across public equity, private equity and credit/royalty strategies. These extensive financial resources allow OrbiMed to partner with healthcare companies across their life cycle, solving financing needs from start-up seed capital through to growth equity and non-dilutive debt capital.

OrbiMed is led by its nineteen partners, with a growing team of more than 100 professionals contributing diverse, complementary skills across finance, strategy, and new company formation. OrbiMed combines its substantial financial resources with extensive global team capabilities to partner with exceptional management teams in building the next generation of world-class healthcare companies.

On March 1, 2021 Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported a worldwide in-licensing agreement with Debiopharm, Lausanne, Switzerland, for the development and commercialization of xevinapant (Debio 1143) (Press release, Merck KGaA, MAR 1, 2021, View Source [SID1234575833]). Xevinapant, a potent oral Inhibitor of Apoptosis Proteins (IAP) antagonist, is the only medicine in its class in late-stage clinical development and has the potential to be first in class. Xevinapant is currently being investigated in the Phase III TrilynX study for previously untreated high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), in combination with platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy.

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"As a leading science and technology company, we are constantly evolving our three business sectors to ensure we are best-positioned to create sustainable value. This includes the addition of highly promising technologies, such as the in-licensing of xevinapant. This late-stage asset complements our Healthcare pipeline, which will be one of our key growth drivers in the coming years," said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany.

"By bringing our expertise and heritage in head and neck cancer to the development of xevinapant, we have the opportunity to explore an important new treatment option in an area of high unmet need where other approaches, including immunotherapy, have seen limited success. The promising long-term efficacy of xevinapant in the Phase II trial suggests that antagonism of IAP has the potential to be a transformative approach in this cancer," said Peter Guenter, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. "Looking forward, we will continue to pursue opportunities to augment the in-house innovations in our oncology portfolio with new solutions for patients with cancer."

Under the terms of the licensing agreement, Merck KGaA, Darmstadt, Germany, gains exclusive rights to develop and commercialize xevinapant worldwide, including in the U.S. Merck KGaA, Darmstadt, Germany, will co-fund with Debiopharm the ongoing Phase III registrational TrilynX study, a global double-blind, placebo-controlled, 700-patient randomized clinical trial to evaluate the efficacy and safety of xevinapant vs. placebo when added to definitive chemoradiotherapy (CRT) in cisplatin-eligible patients with high-risk LA SCCHN. Merck KGaA, Darmstadt, Germany, also will initiate a second global Phase III study to evaluate xevinapant in patients with LA SCCHN who are unable to tolerate high-dose cisplatin in combination with radiotherapy. The agreement also includes development rights for preclinical follow-on compounds to xevinapant. Debiopharm will receive €188 million in upfront payments and up to €710 million in regulatory and commercial milestones, as well as royalty payments. The parties anticipate the closing of the transaction in early Q2 2021.

"The data for xevinapant to date show its potential to enhance the standard of care in this curative setting for head and neck cancer, addressing a significant unmet medical need for patients with this disease," said Bertrand Ducrey, Chief Executive Officer of Debiopharm. "Our partner is exceptionally qualified to advance xevinapant, given their extensive knowledge in head and neck cancer and their commercial oncology capabilities around the world."

"Locally advanced head and neck cancer is uniquely debilitating, often impairing the ability to swallow, speak and breathe. With the current standard treatments, at least half of patients will relapse, typically within the first two years. Based on the efficacy seen in the Phase II study, in which adding xevinapant to CRT cut the risk of death by half, this investigational medicine has the potential to offer a much-needed new standard of care," said Prof. Jean Bourhis, Department Head of Radio-Oncology at the University Hospital of Lausanne and lead investigator of the Phase III TrilynX study.

Previously reported results from the randomized, double-blind Phase II study showed the addition of xevinapant to standard-of-care CRT provided a statistically significant 21% point improvement in locoregional control rate at 18 months, the primary endpoint, vs. placebo and CRT in patients with high-risk LA SCCHN (54% [95% CI: 39 to 69] vs. 33% [95% CI: 20 to 48]; odds ratio 2.69 [95% CI: 1.13 to 6.42]; p=0.026). A significant progression-free survival (PFS) benefit was also observed vs. the control arm after a two-year follow-up period (HR=0.37, 95% CI: 0.18 to 0.76; p=0.0069).1 At three years of follow-up, xevinapant plus CRT showed a statistically significant 51% reduction in the risk of death versus placebo plus CRT (HR=0.49, 95% CI: 0.26 to 0.92; p=0.0261). About two-thirds of patients in the xevinapant arm were alive at three years, compared with 51% in the control arm. Statistically significant improvements in PFS and duration of response were also sustained at three years.2 Xevinapant showed a predictable and manageable safety profile without substantial additional toxicity to standard CRT.1,2 Primary results of the study were published in The Lancet Oncology, and the three-year follow-up data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020.

In February 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to xevinapant for treatment of patients with previously untreated LA SCCHN, in combination with current standard of care, platinum-based chemotherapy and standard fractionation intensity-modulated radiotherapy, based on the Phase II results.

About Head and Neck Cancer
Worldwide, head and neck cancer accounts for more than 650,000 cases and 330,000 deaths annually, making it the 6th most common cancer type.3 LA SCCHN is a highly debilitating disease that can lead to impaired breathing, swallowing, and speech as it progresses.4 Despite standard-of-care CRT, at least 40% to 60% of patients with LA SCCHN develop locoregional or distant relapses, which are usually detected within the first two years of treatment, underscoring the need to identify new therapeutic approaches.5

About Xevinapant
Xevinapant (Debio 1143) is a potentially first-in-class potent oral antagonist of IAPs (Inhibitor of Apoptosis Proteins). In preclinical studies, xevinapant restores sensitivity to apoptosis in cancer cells, thereby depriving them of one of their major resistance mechanisms. As the most clinically advanced IAP antagonist, xevinapant has established proof of efficacy in combination with chemoradiotherapy (CRT) in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), with a clinically significant and sustained clinical benefit compared with CRT alone.

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On March 1, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that it will participate in the following investor conferences in the month of March, with presentations led by the Company’s President and Chief Exeutive Officer, Rodney Varner (Press release, Genprex, MAR 1, 2021, View Source [SID1234575832]).

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Sachs 14th Annual European Life Sciences CEO Forum (Virtual)

Date: March 10-12, 2021

Time: On demand, starting at 10 a.m. Central European Time (CET) on Wednesday, March 10

Registration Link: http://bit.ly/3pRX0FG

33rd Annual Roth Conference (Virtual)

Date: March 15-17, 2021

Time: On demand, starting at 9 a.m. Eastern Standard Time (EST) on Monday, March 15

Registration Link: http://bit.ly/3srur3N

The Company invites investors to join the webcast presentations, and Mr. Varner will be available for one-on-one meetings with investors throughout the conferences. The presentations will be available for replay on the Company’s website (www.genprex.com) for a period of time following the conferences.