On October 5, 2021 I-Mab (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel or highly differentiated biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter "ABL"), a South Korean biotech specializing in bispecific antibody technology, reported that data from the preclinical studies of TJ-CD4B/ABL111 and TJ-L14B/ABL503, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021), taking place November 12 – 14, 2021 (Press release, I-Mab Biopharma, OCT 5, 2021, View Source [SID1234590876]).

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Developed in collaboration with ABL, TJ-CD4B/ABL111 and TJ-L14B/ABL503 are part of I-Mab’s highly differentiated bispecific antibody pipeline that target the 4-1BB co-stimulatory molecule on T-cells and mount an anti-tumor response. Both target a highly specific epitope on 4-1BB, which results in localized action and reduced systemic toxicity.

TJ-CD4B/ABL111 engages the Claudin18.2 (CLDB18.2) tumor antigen mainly on gastric and pancreatic cancers to produce localized T-cell activation at the cancer site. It has demonstrated a strong affinity to CLDN18.2-positive cancer cells even at low levels of CLDN18.2 and has potential application in a wide range of cancers. TJ-CD4B/ABL111 is currently undergoing phase 1 trials in the U.S. (NCT04900818) and soon will be in China, in patients with advanced solid tumors, including gastric cancers.

TJ-L14B/ABL503 is a novel bi-specific antibody targeting both PD-L1 and 4-1BB. It engages the PD-L1 molecule on cancer cells and exerts a strong anti-tumor activity through localized activation of T-cells and it is designed to overcome the limited efficacy of anti-PD-L1 therapies and anti-4-1BB-related toxicity. TJ-L14B/ABL503 is currently undergoing a phase 1 clinical trial in the U.S. (NCT04762641) in patients with locally advanced or metastatic solid tumors.

Details of the poster discussion session are as follows:

Abstract Number: 702

Title: TJ-CD4B (ABL111), a Claudin18.2-targeted 4-1BB tumor engager induces potent tumor-dependent immune response without dose-limiting toxicity in preclinical studies

Poster Session: Poster hall, 12-14th November 2021, 7.00 am-5.00 pm

Presenter: Dr. Wenqing Jiang, I-Mab

Abstract Number: 892

Title: ABL503 (TJ-L14B), PD-L1x4-1BB bispecific antibody induces superior anti-tumor activity by PD-L1-dependent 4-1BB activation with the increase of 4-1BB+CD8+ T cells in tumor microenvironment

Poster Session: Poster Hall, 12-14th November 2021, 7.00am-5.00pm

Presenter: Dr. Gihoon You, ABL Bio

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About TJ-CD4B/ABL111

TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement while silent elsewhere. TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. TJ-CD4B is being developed under collaboration between I-Mab and ABL.

About TJ-L14B/ABL503

Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s "Grabody-T" bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.

On October 5, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that new data from the ongoing Phase I/II GLORIA trial in brain cancer will be presented by Dr. Frank Giordano, the principal investigator of the study, in an oral presentation at the Society for Neuro-Oncology Annual Meeting (Press release, NOXXON, OCT 5, 2021, View Source [SID1234590853]). The meeting will take place in Boston, Massachusetts, US from November 18 – 21, 2021.

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Details of the oral presentation are as follows:

Title: CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial (NCT04121455)
Session Title: Abstract Session: Clinical Trials I
Session Date: Friday, November 19, 2021
Presentation Time: 05:00 – 05:05 p.m. EST / 11:00 – 11:05 p.m. CET
Presenter: Dr. Frank Giordano, Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn, Germany

The embargo for abstracts published in the 2021 abstract supplement to the SNO official journal Neuro-Oncology will lift at 07:00 a.m.EST on Thursday, November 11, 2021 and the abstract will be made available at: View Source

To register to the event, please click here.

A copy of the presentation will be available on NOXXON’s website shortly after the event.

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.