On October 5, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that a safety signal has emerged in Phase 2 studies of TAK-994, an investigational oral orexin agonist (Press release, Takeda, OCT 5, 2021, View Source [SID1234590852]). As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase 2 studies early. This allows for the timely interpretation of the benefit /risk profile of TAK-994 and to determine next steps for the program.

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"Ensuring the safety of patients participating in clinical studies is of the utmost importance as we strive to develop transformative medicines. We are grateful to all of the patients, physicians and site staff who participated in these important clinical trials," said Sarah Sheikh, Head Neuroscience Therapeutic Area Unit at Takeda. "Takeda is committed to bringing innovative, safe and effective treatments to patients with narcolepsy. We are working to quickly assess the totality of available data to inform the further development of TAK-994."

Takeda is committed to advancing its multi-asset orexin franchise including the oral orexin agonist TAK-861, which is currently in Phase 1 development.

Takeda’s Commitment to Neuroscience

Takeda Neuroscience is driven by the unmet need of patients with neurologic and psychiatric diseases. Our mission is to bring innovative and potentially disease-modifying medicines to these individuals. Our dedication extends beyond our marketed products and research efforts. We are committed to raising awareness for these conditions, building strategic partnerships with both industry and advocacy, educating patients and physicians, and broadening access to therapies.

On October 5, 2021 Exscientia plc (Nasdaq: EXAI), an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner, reported the closing of its previously-announced upsized initial public offering in the United States of 15,927,500 American Depositary Shares ("ADSs") representing 15,927,500 ordinary shares, including 2,077,500 ADSs sold pursuant to the full exercise of the underwriters’ previously granted option to purchase additional ADSs (Press release, Exscientia, OCT 5, 2021, View Source [SID1234590851]). All ADSs sold in the offering were offered by Exscientia at a public offering price of $22.00 per ADS. The total gross proceeds to Exscientia from the offering were approximately $350.4 million, prior to deducting underwriting discounts and commissions and estimated offering expenses payable by Exscientia. The offering was upsized from the number of shares offered at launch and priced at the top of the price range indicated at launch.

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The Company also closed the concurrent sale of an additional 7,272,727 ADSs at a price of $22.00 per ADS, for gross proceeds of $160.0 million, prior to deducting underwriting discounts and commissions payable by Exscientia, in concurrent private placements to SVF II Excel (DE) LLC, or Softbank, and the Bill & Melinda Gates Foundation.

Goldman Sachs & Co. LLC, Morgan Stanley & Co. LLC, BofA Securities and Barclays Capital Inc. acted as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on September 30, 2021. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from any of the joint book-running managers for the offering: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected]; Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or email: [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 1-888-603-5847 or by email at [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of the Regulation (EU) 2017/1129 and has not been reviewed by any competent authority in any member state in the European Economic Area or the United Kingdom.

In any member state of the European Economic Area (the "EEA") this announcement and any offering are only addressed to and directed at persons who are "qualified investors" ("Qualified Investors") within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129). In the United Kingdom, this announcement and any offering are only addressed to and directed at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation (Regulation (EU) 2017/1129 as if forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (ii) high net worth entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as "relevant persons").

This announcement must not be acted on or relied on (i) in the United Kingdom, by persons who are not relevant persons, and (ii) in any member state of the EEA, by persons who are not Qualified Investors. Any investment or investment activity to which this announcement relates is available only to and will only be engaged with (i) in the United Kingdom, relevant persons

On October 5, 2021 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of the LuViva Advanced Cervical Scan, based on its patented biophotonic technology, reported that its Chinese partner, Shandong Yaohua Medical Instrument Corporation (SMI), had received ethics board approval and placed LuViva devices at two of the three participating hospitals for clinical trials aimed at achieving Chinese FDA approval (Press release, Guided Therapeutics, OCT 5, 2021, View Source [SID1234590850]). The clinical study is expected to start next month, include approximately 400 patients and be completed this year or early next year. Participating hospitals include Fudan University Hospital, Qilu Hospital of Shandong University and Peking University People’s Hospital. The physicians testing LuViva at these institutions represent the leadership of the Chinese obstetrics and gynecology community and include Professor Dr. Wei Lihui of Peking University and Dr. Kong Beihua of Qilu Hospital. Dr. Wei is former National Chairwoman of the Chinese Society of Obstetrics and Gynecology and Dr. Kong is currently the vice chairman of the Chinese Society of Obstetrics and Gynecology.

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SMI also placed orders for additional LuViva devices and paid $100,000 to GTHP as part of an existing purchase order that totals $530,000, $252,000 of which has been paid thus far in 2021. The remaining $278,000 is due over the next five months. GTHP holds another purchase order from SMI for $2.5 million, $620,000 due upon SMI filing the clinical study results with Chinese FDA and $1,880,000 due upon approval by Chinese FDA. A recently signed distribution agreement then calls for minimum orders of $72 Million over the first four years post Chinese FDA approval.

"We are delighted that SMI has been able to recruit influential thought leaders to work with our products", said Gene Cartwright, CEO of Guided Therapeutics. "These recent developments auger well for the commercial viability of LuViva in China, the world’s most populous nation and second fastest growing medical device market".

According to the World Health Organization, cervical cancer is one of the most frequent cancers in women in the world and in China it is the second most common cancer among women. China has a population of approximately 560 million women above 15 years of age, who are at risk of developing cervical cancer. Current estimates indicate approximately 100,000 new cases of cervical cancer are diagnosed each year and 30,000 deaths occur annually due to cervical cancer in China. It is believed mortality due to cervical cancer has been increasing in China. In response, China has increased efforts to screen more women, especially in rural areas where the laboratory infrastructure for traditional screening tests is lagging. Because LuViva does not require a laboratory infrastructure and produces an immediate result at the point of care, it is well suited to screening women for cervical cancer in these environments.

On October 5, 2021 GNS Healthcare (GNS), an artificial intelligence company creating in silico patients that simulate drug treatment at the individual patient level, reported a multi-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to leverage longitudinal multi-modal prostate cancer patient data and world class prostate cancer expertise with GNS’ Gemini in silico Prostate Cancer patient (Press release, Memorial Sloan-Kettering Cancer Center, OCT 5, 2021, View Source [SID1234590849]). The collaboration is one of four which MSK is undertaking through its new MSK Innovation Hub, a program that blends health tech innovators and MSK experts with the goal to speed the development of innovative products and businesses that have the potential to make a meaningful impact in the lives of people with cancer.

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This collaboration will address key questions for prostate cancer patients, including identifying subtypes of aggressive disease and discovering novel drug targets and drivers of patient response to an increasing array of therapeutics. These insights will enable the design of highly sophisticated clinical trials and generate evidence of comparative effectiveness between drugs and simulate treatment sequencing.

The work will build on the existing Gemini – The in silico Patient for Prostate Cancer developed in partnership with Tempus. Fueled by rich clinico-genomic data, specifically whole exome sequencing, RNAseq, patient treatment history, current treatments and associated lines of therapy and mortality, Gemini has already recapitulated known prognostic markers of overall survival and replicated the landmark Prostate Cancer Phase 3 LATITUDE Trial. Novel potential drivers of survival for metastatic castrate sensitive and castrate resistant prostate cancer patients have been discovered through Gemini’s hypothesis-free approach and will be validated and further understood through the collaboration with MSK.

"Collaborating with the MSK Innovation Hub will help to accelerate the discovery and development of new, more targeted and effective treatments for prostate cancer patients," said GNS CEO and Co-Founder, Colin Hill. "Simulating these in silico patient models allows us to understand what treatments work for which patients and why, improving clinical trial design and generating real-world evidence that maximizes the impact of drugs for patients. This has been a long road, but we are now at the point of being able to deliver true personalized treatments that work."

"The results generated from GNS’ transformative AI approach are compelling and I believe this ongoing collaboration will provide novel insights into prostate cancer that will directly improve patient care," said Howard I. Scher, MD, MSK medical oncologist and Head of the Biomarker Development Program.

MSK has institutional financial interests related to GNS associated with this collaboration.

On October 5, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation (ORACLE) study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of its Guardant Reveal liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types (Press release, Guardant Health, OCT 5, 2021, View Source [SID1234590848]).

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"For oncologists managing patients with early-stage cancer, there is a need for additional tools to help make informed decisions regarding risk for recurrence and benefit of adjuvant therapies, and avoid under- or over-treatment," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "This study is exciting because it will evaluate the first blood-only minimal residual disease (MRD) assay in additional tumor types, and set the stage to identify opportunities for this technology to improve patient care."

The study will analyze circulating tumor (ctDNA) status from blood samples of patients with early-stage cancer, using the Guardant Reveal test after the end of treatment, and during routine follow-up. Participants will be followed until distant recurrence, or up to five years. The ORACLE study adds to currently underway clinical studies (COBRA, ACT-3, PEGASUS) evaluating the performance of the Guardant Reveal blood test in patients with early-stage cancer.

"Initiating this study adds to the growing body of evidence that will support the expansion of the Guardant Reveal blood test from its first indication of early-stage colorectal cancer to multiple cancer types. We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers," said Helmy Eltoukhy, Guardant Health Co-CEO. "The ORACLE study exemplifies our commitment to further demonstrating the utility of our blood tests to improve long-term clinical outcomes."

The Guardant Reveal test is the first blood-only liquid biopsy test that detects residual and recurrent disease from a simple blood draw. The test detects ctDNA in blood after surgery, to identify patients with residual disease who may benefit most from adjuvant therapy, and to detect recurrence months earlier than current standard-of-care methods.1-6 The commercially available test achieves high sensitivity (91%)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The first indication of the test is colorectal cancer, with additional cancer types to follow.

More details about the ORACLE study can be found at NCT05059444.