On November 1, 2021 Inhibrx, Inc. (Nasdaq: INBX), a biotechnology company with four clinical programs in development and an emerging pre-clinical pipeline, reported that the Company will be presenting at the Connective Tissue Oncology Society, or CTOS, 2021 Virtual Annual Meeting taking place November 10-13, 2021 (Press release, Inhibrx, NOV 1, 2021, View Source [SID1234594051]).

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CTOS Virtual Presentation Details:

Title: Safety and Efficacy of the Tetravalent Death Receptor 5 Agonist INBRX-109 in Patients with Conventional Chondrosarcoma: Update from the Phase 1 Expansion Cohort
Lead Author: Vivek Subbiah, MD
Abstract: 1082377, (P 018)
Oral Presentation on Thursday, November 11th at 1:29 p.m. – 1:36 p.m. Eastern Time

Title: Tetravalent Death Receptor 5 Agonist INBRX-109 in Ewing Sarcoma: Planned Phase 1 Cohort Expansion Guided by Preclinical Data
Lead Author: Emily Rowell, PhD
Abstract: 1818985, (P 090)
Poster Presentation on Thursday, November 11th at 2:30 p.m. – 3:15 p.m. Eastern Time

Additionally, the Company will be presenting at the following upcoming virtual investor conferences:

The Credit Suisse 30th Annual Healthcare Conference; Tuesday, November 9th at 3:30 p.m. Eastern Time;
The Stifel 2021 Healthcare Conference; Tuesday, November 16th at 10:00 a.m. Eastern Time;
The Jefferies London Healthcare Conference; November 16th–19th; Pre-recorded for conference attendees and available post-conference on Inhibrx’s website;
The Evercore ISI 4th Annual HealthCONx Conference; Wednesday, December 1st at 3:30 p.m. Eastern Time; and
The JMP Securities Hematology and Oncology Summit; Tuesday, December 7th at 2:00 p.m. Eastern Time.
The scientific posters and presentation will be accessible through a link on the investors section of Inhibrx’s website at View Source The investor conference presentations will be webcast live and will also be accessible through the same link. The webcasts will be available for at least 60 days following the event.

On November 1, 2021 Akeso, Inc. (the Company, 9926.HK) announces that AK112 (PD-1/VEGF bi-specific antibody), the novel immuno-oncology drug independently developed by the Company, reported that obtained approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People’s Republic of China to initiate a phase II clinical trial for monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy of resectable non-small cell lung cancer (NSCLC) (Press release, Akeso Biopharma, NOV 1, 2021, View Source [SID1234594050]).

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This is an open and multi-center phase II randomized clinical trial aiming to evaluate whether pre-operative AK112 monotherapy or combined chemotherapy neoadjuvant/adjuvant therapy can improve the surgical pathological remission rate for patients with resectable NSCLC.

Lung cancer is one of the cancers with the highest morbidity and mortality in the world, of which about 85% are NSCLC, and about 30% of patients belong to resectable early and midstage NSCLC when they are first diagnosed. Certain clinical trials have shown that neoadjuvant immunotherapy can play an important role in the comprehensive treatment of early stage NSCLC, with controllable adverse reactions and less surgery delay.

Currently, the consensus on NSCLC neoadjuvant immunotherapy is: patients with resectable phase IB-IIIA NSCLC may consider neoadjuvant immunotherapy combined with platinumcontaining dual-agent chemotherapy or neoadjuvant immune monotherapy before surgery. The efficacy of immunotherapy combined with chemotherapy is better than chemotherapy with controllable safety, but the improvement of pathological remission rate is limited.

Immune checkpoint inhibitors plus anti-angiogenic drugs have been synergistically observed in multiple tumor types, PD-1/VEGF bi-specific antibody combined with chemotherapy is therefore expected to obtain better clinical benefits.

AK112 has shown good safety and tolerability in early clinical trials on various types of lung cancers including NSCLC and small cell lung cancer (SCLC), and has also shown excellent anti-tumor effects.

AK112 is the world’s leading drug which entered phase III clinical trial among the same type of drugs. AK112 is another first-in-class bi-specific antibody drug developed by the Company to enter advanced clinical stage after the first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104) entered the review stage.

In addition, the registrational phase III clinical trial of AK112 for the treatment of NSCLC after treatment failure by epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI) has been initiated; the phase III clinical trial of AK112 for the first-line treatment of driver-gene negative PD-L1 positive NSCLC and the phase III clinical trial of AK112 for the first-line treatment of extensive stage SCLC are about to be initiated.

INFORMATION ABOUT AK112 (PD-1/VEGF BI-SPECIFIC ANTIBODY)

AK112 is a first-in-class and the first to enter clinical trial PD-1/VEGF bi-specific antibody independently developed by the Company. Engineered with our unique Tetrabody technology, AK112 blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors. PD-1 antibody in combination with VEGF blocking agents have shown robust efficacy in various tumor types (including renal cell carcinoma, non-small cell lung cancer and hepatocellular carcinoma). In the view of the co-expression of VEGF and PD-1 in the tumor micro environment, AK112, as a single agent to block these two targets, may block these two pathways more effectively and enhance the anti-tumor activity, as compared to combination therapy.

On November 1, 2021 Compass Therapeutics, Inc. (the "Company"), a clinical stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported that it intends to offer and sell shares of common stock in an underwritten public offering (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594048]). All of the shares of common stock are being offered by the Company. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the aggregate shares of common stock offered in the public offering at the public offering price, less the underwriting discount. In connection with the offering, the Company also announced that its common stock has been approved for listing on the Nasdaq Capital Market under the symbol "CMPX", subject to the pricing of the public offering on the terms proposed.

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The offering is subject to customary closing conditions. The Company intends to use the net proceeds from the public offering, together with its existing cash and cash equivalents, (i) to secure the listing of its common stock on the Nasdaq Capital Market, (ii) for funding of ongoing operations including clinical trials for its existing programs, which may change based on clinical and preclinical results and (iii) for general corporate purposes.

SVB Leerink is serving as the book-running manager for the proposed offering.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-257821) that was declared effective by the Securities and Exchange Commission on July 20, 2021. A preliminary and final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On November 1, 2021 Compass Therapeutics, Inc. (the "Company"), a clinical-stage biopharmaceutical company developing proprietary antibody-based therapeutics to treat cancer, reported that it has priced an underwritten public offering to sell 35,715,000 shares of common stock at a public offering price of $3.50 per share (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594047]). All of the shares of common stock are being offered by the Company. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 5,357,250 shares of common stock at the public offering price, less the underwriting discount. In connection with the offering, the Company also announced that its common stock will begin trading on the Nasdaq Capital Market under the symbol "CMPX" at the opening of trading on November 2, 2021, following its previously announced approval to list its common stock on the Nasdaq Capital Market. The gross proceeds to the Company from the public offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $125.0 million.

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The offering is expected to close on November 4, 2021, subject to customary closing conditions. The Company intends to use the net proceeds from the public offering, together with its existing cash and cash equivalents, for funding of ongoing operations including clinical trials for the programs noted in the preliminary prospectus supplement, which may change based on clinical and preclinical results.

SVB Leerink is acting as book-running manager for the offering. Raymond James & Associates, Inc., Wedbush Securities and H.C. Wainwright & Co. are acting as passive book-running managers and The Benchmark Company and Roth Capital Partners are acting as co-managers for the offering.

The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-257821) that was declared effective by the Securities and Exchange Commission on July 20, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at www.sec.gov. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained, when available, from SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On November 1, 2021 Compass Therapeutics, Inc. (OTC:CMPX) reported an update on the clinical development of CTX-009 (also known as ABL001), a dual anti-angiogenic bispecific antibody targeting DLL4 and VEGF-A (Press release, Compass Therapeutics, NOV 1, 2021, View Source [SID1234594046]).

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A Phase 2a study for CTX-009 in combination with paclitaxel was initiated by Handok Pharmaceuticals, Inc. (KOSDAQ: 002390) in Q1 2021 in patients with BTC and the enrollment in the first part of the study has been completed. The study has been enrolling patients who have unresectable advanced, metastatic, or relapsed BTC’s who have received one or two prior systemic therapies. The Phase 2a design was informed by the CTX-009 Phase 1b study, where CTX-009 in combination with either paclitaxel or irinotecan led to an overall response rate of 23.5% and a clinical benefit rate of 76.5%, including two confirmed and durable partial responses among four patients with advanced cholangiocarcinoma (clinicaltrials.gov Identifier: NCT04492033).

The Phase 2a study utilizes a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the study is three or more partial responses observed in 21 patients. So far, there have been five partial responses observed among the first 17 patients evaluated, which is an overall response rate of 29%, and accordingly, the criteria to advance to the second part of the study has been met. In the second part of the Phase 2a study, 45 additional patients will be enrolled. The preliminary adverse event profile of CTX-009 in this Phase 2a study is consistent with prior studies of CTX-009 with hypertension and neutropenia being the most common events related to CTX-009 and paclitaxel, respectively. Handok initiated the study in Q1 2021 at four leading medical centers in South Korea. Compass plans on submitting an IND for CTX-009 in the United States later this quarter and subject to the IND going into effect with the FDA, plans on initiating a Phase 2 study in the United States in Q2 2022.

"Patients with cholangiocarcinoma have limited treatment options following front line combination chemotherapy. In the Phase 1b and Phase 2a studies, we have seen a total of seven partial responses in 21 total patients evaluated. Impressively, there have been measurable tumor declines in 19 of the 21 advanced patients treated across both studies. We are looking forward to filing our IND in the United States this quarter and pursuing the global development of CTX-009," said Thomas Schuetz, M.D., Ph.D., CEO and scientific founder of Compass. Compass holds the global rights to CTX-009 with the exception of South Korea rights, which are held by Handok, and China rights, which were out-licensed to Elpiscience Biopharma.

About CTX-009

CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Preclinical and early clinical data of CTX-009 suggest that blockade of both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic and non-small cell lung cancer. Partial responses to CTX-009 as a monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. CTX-009 has completed a Phase 1 monotherapy dose escalation and dose expansion study. Phase 1b and Phase 2a combination studies are ongoing.