On January 6, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into an exclusive license agreement with Gaelan Medical Trade LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia (omeprazole magnesium, amoxicillin and rifabutin)1, an H. pylori therapy, in the United Arab Emirates (UAE) (Press release, RedHill Biopharma, JAN 6, 2022, View Source [SID1234598388]).

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Under the terms of the agreement, RedHill will receive an upfront payment of $2 million and is eligible for additional milestone payments as well as tiered royalties up to mid-teens on net sales of Talicia in the UAE. Gaelan Medical will receive the exclusive rights to commercialize Talicia in the UAE, as well as a right of first refusal to commercialize Talicia in the Gulf Cooperation Council region (Saudi Arabia, Kuwait, Qatar, Bahrain and Oman) for a pre-determined period.

"We are delighted to partner with Gaelen Medical to help bring Talicia to H. pylori patients in the UAE and potentially other territories in the region," said Dror Ben-Asher, RedHill’s CEO. "This partnership is particularly important given that H. pylori, a major public health concern, impacts up to 84% of the population in the region2 and is one of the strongest risk factors for gastric cancer, leading to a recent regional clinical consensus meeting calling for eradication therapy to be offered to all individuals infected with H. pylori3. We are seeing rapid growth of Talicia in the U.S. in light of the alarming failure rates of clarithromycin-based therapies and growing physician awareness of the need for highly effective first-line H. pylori therapy. We continue to explore with potential partners the expansion of Talicia’s reach into additional ex-U.S. territories."

"H. pylori can cause extensive damage if not properly eradicated first-time and there is considerable need for a therapy like Talicia in the UAE, where 41% of the population4 is affected and have limited options for treatment," said Ghassan Aboud, Chairman of GAG. "Talicia would become the first approved combination product in the UAE specifically designed to treat H. pylori, and we are excited to be partnering with RedHill and at the prospect of realizing Talicia’s potential to help patients with H. pylori infection in the UAE and potentially other territories in the region."

About Talicia
Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.

Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill’s pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent5 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm6.

Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

About H. pylori
H. pylori is a bacterial infection that affects approximately 35%7 of the U.S. population, with an estimated two million patients treated annually8. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer9 and a major risk factor for peptic ulcer disease10 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma11. More than 27,000 Americans are diagnosed with gastric cancer annually12. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies13.

On January 6, 2022 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported continued advancement of the company’s ongoing clinical trial, KN-8701, to include patients with NRAS-mutant melanoma and planned 2022 milestones for its product candidates, including KIN-2787, an orally available small molecule pan-RAF inhibitor being developed for the treatment of patients with lung cancer, melanoma, and other solid tumors (Press release, Kinnate Biopharma, JAN 6, 2022, View Source [SID1234598387]). The company also updated its cash position as of December 31, 2021.

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"We have built a solid clinical foundation in 2021 with initial data from our ongoing first-in-human trial of KIN-2787 expected in the third quarter of 2022 and are pleased to announce that we will be expanding the trial to include patients with NRAS-mutant melanoma both in monotherapy and in combination with binimetinib," said Nima Farzan, Chief Executive Officer of Kinnate. "We are leveraging the power of the Kinnate Discovery Engine to potentially improve outcomes of cancer patients and overcome the limitations of current targeted therapies. Our goal is to generate one IND filing a year and in 2022 we expect Phase 1 initiation for our second program, KIN-3248, a Fibroblast Growth Factor Receptor inhibitor candidate, in the first half of the year subject to IND clearance by the FDA."

NRAS-mutant melanoma is an adjacent population to RAF-driven solid tumors where signaling is highly CRAF-dependent. Approved BRAF inhibitors that target BRAF Class I alterations are not effective in NRAS-mutant melanoma. Currently there is no approved targeted therapy approved for this population. The company’s preclinical data supports development of KIN-2787 in combination with binimetinib in NRAS-mutant melanoma. In vitro data indicates meaningful and synergistic combination benefit of KIN-2787 with binimetinib in NRAS-mutant melanoma cells. In in vivo xenograft models of NRAS-mutant melanoma, treatment with KIN-2787 in combination with binimetinib was well tolerated and resulted in significant tumor growth inhibition, including tumor regressions at clinically relevant twice-daily (BID) doses of KIN-2787 and binimetinib, respectively. The addition of NRAS-mutant melanoma patients meaningfully expands the potential market opportunity for KIN-2787 as the NRAS-mutant melanoma population represents approximately 25% of advanced and metastatic melanoma patients and is largely discrete from those melanoma patients with BRAF Class I, II or III alteration-driven disease.

Key 2021 Highlights

In collaboration with Guardant Health, announced initial findings from a BRAF kinase alteration genomic landscape and real-world clinical outcomes study with preliminary analyses suggesting that the prevalence of Class II and III alterations across patients with advanced and metastatic solid tumors is higher than previously understood. Among the nearly 6,000 patients who were identified as having BRAF alteration-positive cancers, approximately 55% were found to be harboring Class II and III alterations in over 25 common adult solid tumors, including Non-Small Cell Lung Cancer, Melanoma, Colorectal Cancer, Prostate Cancer and Breast Cancer.

Announced the first patient dosed in a Phase 1 trial evaluating KIN-2787 and detailed the two-part Phase 1 trial design for KN-8701 (NCT04913285), a first-in-human, multicenter, non-randomized, open-label, Phase 1 trial of KIN-2787 in adult patients with BRAF-mutant advanced and metastatic solid tumors.

Presented data at major medical meetings including:

details of the two-part Phase 1 trial design for KN-8701 at the AACR (Free AACR Whitepaper)-NCI-EORTC 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);
preclinical data on the KIN-3248 program at the JCA-AACR Precision Cancer Medicine International Conference; and
preclinical data from the KIN-2787 program at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Closed a $35 Million Series A financing to establish a Chinese joint venture, Kinnjiu Biopharma Inc. ("Kinnjiu"), led by OrbiMed Asia Partners, with participation from OrbiMed Private Investments and Foresite Capital. Kinnjiu has an exclusive license to develop and commercialize Kinnate’s currently most advanced kinase inhibitor candidates in Greater China.

Expanded the organization to 61 full-time employees as of December 31, 2021, of which 46 were engaged in research and development activities, and announced key appointments to the Board of Directors and executive team.

Announced the addition of Kinnate to the NASDAQ Biotechnology Index and the Russell 2000 Index.

Key Upcoming 2022 Milestone Targets

KIN-2787 Program

Initial monotherapy data from the ongoing KN-8701 Phase 1 trial expected in the third quarter of 2022.
Initiation of the combination portion of KN-8701 to study KIN-2787 with binimetinib in NRAS-mutant melanoma expected in the first half of 2022 with initial data expected by year end 2022.
Initiation of a Phase 1 trial in Greater China by Kinnjiu expected in mid-2022.
KIN-3248 Program

Initiation of a Phase 1 trial expected in the first half of 2022 subject to Investigational New Drug ("IND") clearance by the U.S. Food and Drug Administration ("FDA").
Early Discovery Pipeline

Goal to generate one IND filing a year from the Kinnate Discovery Engine.
Announcement of the next pipeline target expected in the second half of 2022.
Financial

Updated cash, cash equivalents and investments as of December 31, 2021 of approximately $324.9 million (exclusive of Kinnjiu’s cash), which is expected to fund current operations, including initiation of multiple registrational studies, into the second half of 2023.

On January 6, 2022 Sanofi and Exscientia reported a groundbreaking research collaboration and license agreement to develop up to 15 novel small molecule candidates across oncology and immunology, leveraging Exscientia’s end-to-end AI-driven platform utilizing actual patient samples (Press release, Exscientia, JAN 6, 2022, View Source [SID1234598385]). The companies have been working together since 2016 and in 2019, Sanofi in-licensed Exscientia’s novel bispecific small molecule candidate capable of targeting two distinct targets in inflammation and immunology.

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"We look forward to deepening our work with Exscientia, a leader in leveraging AI to modernize all aspects of drug discovery and development," said Frank Nestle, Global Head of Research and Chief Scientific Officer, Sanofi. "Sanofi’s collaboration with Exscientia aims to transform how we discover and develop new small molecule medicines for cancer and immune-mediated diseases. Application of sophisticated AI and machine learning methods will not only shorten drug discovery timelines, but will also help to design higher quality and better targeted medicines for patients."

Exscientia and Sanofi will collaborate to identify and select target projects, leveraging Exscientia’s personalised medicine platform. The platform enables a "patient-first" approach through integrating primary human tissue samples into early target and drug discovery research. By doing so, Exscientia scientists can integrate patient, disease, and clinically relevant data into decisions on potential new medicine candidates earlier in the drug creation process. In addition to target discovery, Exscientia will lead small molecule drug design and lead optimization activities up to development candidate nomination, with Sanofi assuming responsibility for preclinical and clinical development, manufacturing and commercialization.

"It is immensely exciting to collaborate with Sanofi with our goal of realizing the full potential of AI to deliver the next generation of cancer and immunology medicines," said Andrew Hopkins, DPhil, CEO and founder of Exscientia. "Our AI-driven platform can be leveraged across drug discovery, translational research and development, with applications ranging from improving the precision medicine and quality of drug candidates to enriching for patient selection in clinical trials. Our expanded collaboration with Sanofi will utilise the breadth of our platform to test AI-designed drug candidates against patient tissue models, potentially providing far better accuracy than conventional approaches such as mouse models. When you consider the change this represents – testing candidates against actual human tissue years before a clinical trial – it’s transformative."

Under the terms of the agreement, Exscientia will receive an upfront cash payment of $100 million from Sanofi and will be eligible to receive future research, translational, clinical development, regulatory and commercial milestone payments of up to approximately $5.2 billion in aggregate, if all milestones for all programs are achieved. In the case that Sanofi commercializes a therapeutic from the collaboration, Exscientia will also be eligible to receive tiered royalties on product sales ranging from high-single-digits to mid-teens and an option for clinical co-investment to increase the royalty rate up to 21% on net sales of co-funded products. The upfront cash payment of $100 million is expected to be reflected in the first quarter 2022 financial results of Exscientia as cash inflows from collaborations and recognized as revenue over the duration of the agreement.

On January 6, 2022 Amgen (NASDAQ: AMGN) and Generate Biomedicines reported a research collaboration agreement to discover and create protein therapeutics for five clinical targets across several therapeutic areas and multiple modalities (Press release, Amgen, JAN 6, 2022, View Source [SID1234598384]). As part of the research collaboration, Amgen will pay $50 million in upfront funding for the initial five programs with a potential transaction value of $1.9 billion plus future royalties, and will have the option to nominate up to five additional programs, at additional cost. For each program, Amgen will pay up to $370 million in future milestones and royalties up to low double digits. Amgen will also participate in a future financing round for Generate. Additional terms were not disclosed.

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"We are now at a scientific hinge point, where computational approaches can advance our knowledge of biology and further drive our ability to design the right molecule for some of the most challenging targets," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We believe Generate Biomedicine’s integrated in silico design and wet lab capabilities combined with Amgen’s strength in protein engineering can accelerate our drug discovery efforts, generating novel protein sequences with optimal therapeutic properties."

Recognizing the unique discovery challenges in multispecific drug discovery, Amgen has invested over the last decade in the marriage of wet lab high throughput automation and dry lab computational biology. Amgen’s generative biology strategy has led to the building of a Digital Biologics Discovery group, to harness the Company’s pioneering strength in biology, automation, and protein engineering. The goal of generative biology at Amgen is to take this experience and expertise in biologics combined with emerging sequence-based drug design technologies to deliver complex multispecific medicines against a variety of difficult-to-treat diseases. Combining Amgen’s biologics drug discovery expertise with the power of Generate Biomedicines Artificial Intelligence (AI) platform provides the opportunity to further facilitate multispecific drug design by shaving time off discovery timelines and generating potential lead molecules that have predictable manufacturability and clinical behavior.

Generate Biomedicines is pioneering the field of generative biology – a revolutionary approach to drug discovery and development that leverages machine learning and AI to program novel protein therapeutics. The company’s machine learning algorithms analyze hundreds of millions of known proteins, looking for statistical patterns linking amino acid sequence, structure and function, and its technology platform has been enhanced by closed-loop learning on tens of thousands of computationally generated and broadly experimental characterized novel proteins over the past three years. Combined with the company’s wet lab research, the platform can rapidly generate antibodies, peptides, enzymes, cell and gene therapies to potentially meet a wide variety of therapeutic needs. This has enabled the company to learn the generalizable rules by which a linear amino acid sequence encodes protein structure and function and design therapeutics for previously intractable targets at an unprecedented speed and scale.

"This agreement is a recognition of the transformative power of our generative biology platform," said Mike Nally, chief executive officer, Generate Biomedicines and CEO-partner, Flagship Pioneering. "We’re proud to partner strategically with Amgen to combine their world-leading expertise in engineering protein-based therapies with our unique machine learning-enabled drug generation platform. With our technology platform, we are able to expand beyond just proteins that are found in nature – creating de novo, purpose-built proteins capable of performing any desired function under timelines that have not been possible through other approaches."

On January 6, 2022 Eli Lilly and Company (NYSE: LLY) reported that it will participate at the 40th Annual J.P. Morgan Virtual Healthcare Conference on Tuesday, Jan. 11, 2022 (Press release, Eli Lilly, JAN 6, 2022, View Source [SID1234598383]). David A. Ricks, Lilly’s chairman and CEO, will participate in a virtual fireside chat at 4:30 p.m. Eastern time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 30 days.