On November 30, 2020 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00am ET on Monday, December 7, 2020 to discuss updated findings from the first-in-human trial of IMGN632, an antibody-drug conjugate targeting CD123, in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) to be presented in an oral session at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 5, 2020 (Press release, ImmunoGen, NOV 30, 2020, View Source [SID1234571996]). During the call, Dr. Naveen Pemmaraju, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, will summarize the data presented during the oral session and management will provide an update on the pathway to FDA approval for IMGN632 in BPDCN as well as recent progress in the acute myeloid leukemia (AML) program.

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CONFERENCE CALL INFORMATION

To access the live call by phone, dial (877) 621-5803; the conference ID is 1795760. The call, along with associated slides, may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On November 30, 2020 Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, reported that Gerri Henwood, the Company’s President and Chief Executive Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held virtually December 1-3, 2020 (Press release, Baudax Bio, NOV 30, 2020, View Source [SID1234572279]). The company will conduct institutional investor meetings on December 2, 2020; meetings may be requested through Piper Sandler.

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A pre-recorded fireside chat with Ms. Henwood is now available on the Piper Sandler conference site and on the "Events" page within the Investors section of the Baudax Bio website at View Source The recording will be available for a period of 30 days following the event.

On November 30, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST) (Press release, Deciphera Pharmaceuticals, NOV 30, 2020, View Source [SID1234571945]). QINLOCK, the Company’s switch-control tyrosine kinase inhibitor, is currently approved in the U.S., Canada, and Australia for patients with fourth-line GIST.

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"We are pleased to announce the completion of target enrollment for our Phase 3 INTRIGUE study in patients with second-line GIST," said Matthew L. Sherman, MD, Executive Vice President and Chief Medical Officer of Deciphera Pharmaceuticals. "This marks an important step forward to potentially bringing QINLOCK to an early-stage GIST population and establishing QINLOCK as the best-in-class treatment for this disease. We look forward to announcing top-line results for this study in the second half of 2021. I am grateful to the patients and their families, investigators, and our employees who have helped us reach this milestone."

The INTRIGUE Phase 3 clinical study is a randomized, global, multicenter, open-label study to evaluate the efficacy and safety of QINLOCK compared to sunitinib in patients with GIST previously treated with imatinib. This study was designed to support regulatory approvals in second-line GIST patients in the United States, Europe, and other major markets. Approximately 426 patients were randomized 1:1 to either QINLOCK 150 mg once daily or sunitinib 50 mg once daily for four weeks followed by two weeks without sunitinib. The primary efficacy endpoint is median progression-free survival (mPFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR) and Overall Survival (OS). The study is being conducted at 122 investigational sites in 22 countries.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST.

QINLOCK is approved by the U.S. FDA for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib. It is also approved by Health Canada for the treatment of adult patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib and by the Australian Therapeutic Goods Administration for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.

About GIST

Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in the United States and a similar incidence rate in European and other countries. Most cases of GIST are driven by a spectrum of mutations. The most common primary mutations are in KIT kinase, representing approximately 80% of cases, or in PDGFRA kinase, representing approximately 6% of cases. Current therapies are unable to inhibit the full spectrum of primary and secondary mutations, which drives resistance and disease progression. Estimates for 5-year survival range from 48% to 90%, depending on the stage of the disease at diagnosis.

On November 30, 2020 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that it has commenced an underwritten public offering of $60,000,000 of shares of its common stock (Press release, Cogent Biosciences, NOV 30, 2020, View Source [SID1234571978]). In addition, Cogent Biosciences has granted the underwriters a 30-day option to purchase up to an additional $9,000,000 of shares of its common stock. All of the shares of common stock to be sold in the underwritten public offering are being offered by Cogent Biosciences.

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Cogent Biosciences intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to PLX9486 and other product candidates, as well as for working capital and general corporate purposes.

Jefferies and Piper Sandler & Co. are acting as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital and Ladenburg Thalmann are also acting as co-managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (SEC) and became effective on May 1, 2019.

A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering have been filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering can be made only by means of a prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected].

On November 30, 2020 Kiromic BioPharma ("the Company") (NASDAQ: KRBP), a pre-clinical stage biotechnology company using its proprietary DIAMOND artificial intelligence ("A.I.") platform to improve drug discovery and development with a therapeutic focus on immune-oncology, reported its financial results for the third quarter ended September 30, 2020, and provided an update on its corporate developments (Press release, Kiromic, NOV 30, 2020, View Source [SID1234571997]).

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"Kiromic BioPharma achieved important scientific and operational milestones during the quarter that have us well positioned for growth as we focus on being the leader in A.I.-enabled immune-oncology drug development," said Dr. Maurizio Chiriva-Internati, CEO and President of Kiromic BioPharma. "We are thankful to our employees and collaborators who have maintained this high level of execution in the middle of the hard challenges posed by the COVID-19 pandemic. Through their efforts, as of today nothing has come to our attention causing us to believe that we are not poised to file our two INDs for Epithelial Ovarian Cancer during 4Q-2020. The first IND will be our chimeric PD1 for ovarian cancer, and the second IND will be our isoform mesothelin in ovarian cancer."

Subsequent to the quarter end, on October 20, 2020, we completed a successful IPO, raising gross proceeds of $15,000,000, significantly strengthening the Company’s balance sheet to support the continued development of our promising pipeline of targeted cancer therapies. Our approach and goal is to defeat cancer by developing immunotherapies that rely on improving target discovery and validation. With better targets, we believe our therapies will be more effective than the current crop of immunotherapies using older targets.

Corporate and Scientific Highlights

Intellectual Property Application Filing – Kiromic BioPharma ("The Company") filed a United States provisional patent application on July 6, 2020, entitled "Mesothelin Isoform Binding Molecules and Uses Thereof," that discloses engineered gamma-delta T cells containing mesothelin isoform-directed molecules. This provisional application is expected to expire on July 7, 2021, and the Company plans to file at least an international PCT patent application claiming priority to the provisional application before it expires. The Company plans to build at least one patent family directed to engineered allogeneic effector cells, in support of its development of off-the-shelf allogeneic immunotherapy treatments to patients with indications of Isoform Mesothelin Epithelial Ovarian Cancer, and Isoform Mesothelin Malignant Pleural Mesothelioma.
External Validation of Targets – The Company completed external validation of Isoform Mesothelin targets including mesothelioma, ovarian cancer, and pancreatic cancer during the 3 months ended September 30, 2020.
Clean Rooms and Vivarium Facility Construction Completion – The Company completed construction of an $820,000 leasehold improvement located at the Houston, TX based offices. The asset contains a current Good Lab Practices ("cGLP") Vivarium Facility, and current Good Manufacturing Practices ("cGMP") Clean Rooms for clinical manufacturing. The cGLP Vivarium is currently being used to perform key in vivo non-clinical research to support the Company’s clinical initiatives through an Initial New Drug ("IND") filing with the FDA. The cGMP suite consists of 5 clean rooms which will be used to manufacture the Company’s off-the-shelf allogeneic therapies during clinical trials. Management plans to commence clinical trials only if IND applications are approved by the FDA.
Q3 2020 Financial Highlights

Cash Position: Cash and cash equivalents were $469,300 as of September 30, 2020, compared to $1,929,100 as of December 31, 2019. The decrease was primarily due to cash outflows of $3,557,200 and $1,013,100 attributable to operating activities and investing activities, respectively. The offsetting cash inflows of $3,110,500 was attributed to financing activities related to the Company’s Series B Preferred Stock issuance along with proceeds net of repayments from the Paycheck Protection Program loan.

R&D Expenses: Research and development expenses were $1,225,700 for the quarter ended September 30, 2020, compared to $272,100 for the quarter ended September 30, 2019. The increase was primarily attributable to augmented headcount, increased square footage to our Houston, TX leased facilities, and in-vitro experimentation costs.

G&A Expenses: General and administrative expenses were $1,190,000 for the quarter ended September 30, 2020, compared to $607,400 for the quarter ended September 30, 2019. This increase was primarily due to personnel expenses.

Net Loss: Net loss was $2,415,700 for the quarter ended September 30, 2020, compared to a net loss of $886,900 for the quarter ended September 30, 2019.

Dr. Chiriva-Internati continued, "Developing live-cell therapies by leveraging artificial intelligence is central to transforming the cost and efficiency of the immune-oncology field and improving the potential for off-the-shelf therapies for cancer patients. We believe our approach will help us design more efficient pre-clinical validation studies and more targeted clinical trials, thereby accelerating our drug candidates’ time to approval and eventually to market. DIAMOND is central to our process in achieving this outcome rapidly and with reduced costs," concluded Dr. Chiriva-Internati.