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Qihan Biotech Raises Additional USD 67 Million in Series A++ Financing. Funds to Advance Pipeline of Novel Cell and Organ Therapies

On March 29, 2021 Qihan Biotechology a leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, reported that it has raised an additional $67million in Series A++ financing (Press release, Qihan Biotech, MAR 29, 2021, View Source [SID1234584524]). Proceeds from the financing will primarily be used to advance Qihan’s pipeline of novel cell therapies in IND-enabling studies and hypoimmunity projects, and expansion of the company’s GMP manufacturing facilities.

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The financing was backed by new investors including leading biomedical venture capital firm, Lilly Asia Ventures and Matrix Partners China, as well as existing shareholders, Sequoia and CMB International. With these investments, Qihan’s total Series A financing raised to date has exceeded $100 million.

Cell therapy is rapidly becoming an important weapon against cancer and other serious diseases, but technological optimization in cell therapy remains a critical need. Autologous cell therapy can avoid immune rejection to a certain extent, but prohibitive costs put these therapies out of reach for many patients. The allogeneic cell therapy currently available requires patients to take immunosuppressive drugs, often for life, to avoid rejection of cells by the patient’s immune system. A cost-effective solution to these two issues would bring hope to millions of patients and families around the world.

Qihan is using its deep professional knowledge of transplantation immunology to develop that solution. The Company’s research team uses high-throughput multiplexable gene editing technology to develop "immune-privileged" human stem cells, that will not be attacked or rejected. Qihan is focused on developing off-the-shelf, or universal, cell therapy products, which compared to autologous cell therapy products, are more widely targeted and more affordable to patients.

Through its experience with xenotransplantation animal models, Qihan is able to identify and edit the genes in human cells that affect immune rejection to achieve low- to risk-free allogeneic cell therapy. The Company has advanced the editing process, directly editing stem cells, and inducing their proliferation and differentiation to produce high volumes of immune cells. This not only reduces production costs, but improves the efficiency and targeting of gene editing, greatly improving the clinical accessibility of cell therapy products.

The Company’s first cell therapy products for human clinical trials are now in development. Considering the long research period and difficulty of xenotransplantation products, Qihan may commercialize cell therapy products prior to xenotransplantation.

"We are delighted to expand our investor base with support from high caliber investors including Lilly Asia Ventures," said Dr. Luhan Yang, founder and CEO of Qihan Biotech. "The expanded Series A funds will allow us to advance both Qihan’s near-term focus of developing allogeneic cell therapies and our long-term mission of developing xenogeneic organs for clinical application.

"We will also be working toward growing our GMP manufacturing capacity to support rapid development and scale-up of our therapies. We look forward to continuing to expand our pipeline and working toward our vision of a world in which cell and organ therapies are universally available to patients."

HUTCHMED Initiates International Phase I Trials of IDH1/2 Dual Inhibitor in Patients with Advanced Solid Tumors or Hematological Malignancies

On March 29, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it has initiated two international Phase I studies of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase ("IDH") 1 and 2 mutations (Press release, , MAR 29, 2021, View Source [SID1234583625]). One trial is in patients with advanced solid tumors and one trial is in patients with hematological malignancies. Both trials have sites in the US and Europe. The first international patient was dosed on March 25, 2021, following a Phase I trial that was initiated in China in the second half of 2020. This new program is a demonstration of HUTCHMED’s accelerating and expanding global clinical development presence.

These two trials are multi-center studies to evaluate the safety, tolerability pharmacokinetics, pharmacodynamics and preliminary efficacy of HMPL-306. The first trial is in solid tumors (including but not limited to gliomas, chondrosarcomas, or cholangiocarcinomas), while a second trial is in advanced relapsed, refractory or resistant hematological malignancies that harbor IDH1 or IDH2 mutations. The first stage of each study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL-306 to determine the maximum tolerated dose and/or the recommended Phase II dose ("RP2D"). The second stage is a dose expansion phase where patients will receive HMPL-306 to further evaluate the safety, tolerability, and clinical activity at the RP2D. Additional details may be found at clinicaltrials.gov, using identifiers NCT04762602 and NCT04764474, respectively.

The MD Anderson Cancer Center ("MDACC") is the lead institution on both studies. The lead investigator for the hematological malignancies study is Dr. Farhad Ravandi, the Janiece and Stephen A. Lasher Professor of Medicine and Chief of Section of Developmental Therapeutics in the Department of Leukemia at The University of Texas MDACC. The lead investigator for the solid tumor study is Dr. Filip Janku, Associate Professor, Department of Investigational Cancer Therapeutics at The University of Texas MDACC.

A Phase I study of HMPL-306 is underway in China, with the first patient dosed in July 2020. Additional details of that study may be found at clinicaltrials.gov, using identifier NCT04272957.

HMPL-306 is HUTCHMED’s ninth innovative oncology drug candidate that it has discovered that has entered clinical development and the sixth to enter global clinical development. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, HMPL-306 could potentially provide therapeutic benefits in cancer patients harboring either IDH mutation, and may address acquired resistance to IDH inhibition through isoform switching.

About IDH and Malignancies

IDHs are critical metabolic enzymes that help to break down nutrients and generate energy for cells. When mutated, IDH creates a molecule that alters the cell’s genetic programming and prevents cells from maturing, 2-hydroxyglutarate ("2-HG"). Reduction in 2-HG levels can be used as a marker of target engagement by an IDH inhibitor. IDH1 or IDH2 mutations are common genetic alterations in various types of blood and solid tumors, including acute myeloid leukemia ("AML") with approximately 20% of patients having mutant IDH genes, myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), low-grade glioma and intrahepatic cholangiocarcinoma ("IHCC"). Mutant IDH isoform switching, either from cytoplasmic mutant IDH1 to mitochondrial mutant IDH2, or vice versa, is a mechanism of acquired resistance to IDH inhibition in AML and cholangiocarcinoma.1,2,3 Currently, the U.S. Food and Drug Administration (FDA) has approved one drug for IDH1 mutation and one drug for IDH2 mutation, but no dual inhibitor targeting both IDH1 and IDH2 mutants has been approved.

In the US, it is estimated that there were approximately 20,000 new cases of AML in 2020 and the five-year relative survival rate is 28.7%.4

IDH mutations are present in a number of solid tumors, including malignant glioma and IHCC. In the US, the annual incidence of malignant glioma is estimated to be 20,000, 50-70% of which are glioblastoma.5,6 Approximately 60-80% of Grade 2 or 3 glioma and secondary glioblastoma harbor IDH mutations.7 IHCC accounts for 10-20% of primary liver cancer, which was estimated to be diagnosed in 42,810 US patients in 2020.8,9 Approximately 20-30% of IHCC harbors IDH mutations.10

Kinnate Biopharma Inc. Reports Full Year 2020 Financial Results

On March 29, 2021 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 financial results for the full year ended December 31, 2020 (Press release, Kinnate Biopharma, MAR 29, 2021, View Source [SID1234579513]).

"Since completing our IPO last year, we entered 2021 well-funded to advance the development of our lead targeted therapy RAF and FGFR programs towards the clinic," said Nima Farzan, Chief Executive Officer of Kinnate Biopharma. "We are pleased to be on track with our stated goals of filing an investigational new drug application for KIN-2787, our RAF inhibitor candidate, in the first half of 2021 and initiating a Phase 1 clinical trial later in the year. Additionally, our FGFR inhibitor KIN-3248 candidate is progressing towards an IND filing and Phase I clinical trial in the first half of 2022. We believe our Kinnate drug discovery engine has the ability to identify product candidates with the potential to overcome the limitations of current targeted oncology therapeutics."

Recent Business Highlights and Corporate Update:

In December 2020, completed a successful initial public offering, raising $276.0 million in aggregate gross proceeds (before deducting underwriting discounts and commissions and estimated offering expenses) and listed on The Nasdaq Global Select Market.
Remain on track for an Investigational New Drug (IND) filing for KIN-2787 in the first half of 2021 following encouraging pre-IND feedback from the U.S. Food and Drug Administration (FDA). KIN-2787, our most advanced product candidate, is a RAF inhibitor we are developing for the treatment of patients with lung cancer, melanoma and other solid tumors. Unlike currently available treatments that target only Class I BRAF kinase mutations, we have designed KIN-2787 to target Class II and Class III BRAF mutations, where it would be a first-line targeted therapy, in addition to covering Class I BRAF mutations.
In our KIN003 program we have selected KIN-3248 as our lead FGFR inhibitor candidate for the treatment of patients with intrahepatic cholangiocarcinoma and urothelial carcinoma. Our FGFR candidates are designed to address clinically observed genomic alterations in FGFR2 and FGFR3 that drive resistance to current therapies. We anticipate filing an IND for KIN-3248 with the FDA in the first half of 2022.
Our RAF and FGFR candidates have demonstrated proof of concept in preclinical models and, subject to our planned IND submissions taking effect, we anticipate initiating a Phase 1 clinical trial for KIN-2787 in 2021 and an additional Phase 1 clinical trial for KIN-3248 in the first half of 2022.
Continued to advance a number of other small molecule research programs, including a CDK12 inhibitor in our KIN004 program to target the treatment of ovarian carcinoma, triple-negative breast cancer and metastatic castration-resistant prostate cancer.
Expanded organization with 31 full-time employees at December 31, 2020, of which 24 were engaged in research and development activities.
Full-Year 2020 Financial Results

Full year net loss for 2020 was $35.8 million, compared to $12.0 million in 2019.
Full year research and development expenses for 2020 were $29.2 million, compared to $9.0 million in 2019.
Full year general and administrative expenses for 2020 increased to $6.8 million, compared to $3.1 million in 2019.
As of December 31, 2020, the total of cash and cash equivalents and short-term investments was $396.9 million.

Certara Announces Closing of Public Offering of Common Stock

On March 29, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported the closing of its underwritten public offering of 11,500,000 shares of its common stock by certain existing stockholders at a public offering price of $25.00 per share (Press release, Certara, MAR 29, 2021, View Source [SID1234577953]). The closing includes 1,500,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock. Neither Certara nor its management team sold any shares or received any proceeds from the sale of shares in the offering by the selling stockholders.

The offering was made through an underwriting group led by Jefferies, Morgan Stanley and BofA Securities, who acted as lead joint book-running managers, and Credit Suisse and Barclays, who acted as joint book-running managers.

A registration statement on Form S-1, including a prospectus, relating to these securities was declared effective by the Securities and Exchange Commission. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Copies of the prospectus may be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 547-6340 or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or by email at [email protected]; or BofA Securities, Inc., NC1-004-03-43, Attention: Prospectus Department, 200 North College Street, 3rd Floor, Charlotte, NC 29255, by telephone at (800) 294-1322 or by email at [email protected].

Fortis Therapeutics Closes $40 Million Series A Financing to Advance Novel Anti-CD46 Therapeutic to Treat Late-Stage Prostate Cancer and Multiple Myeloma

On March 29, 2021 Fortis Therapeutics, Inc., an immuno-oncology biotech developing FOR46, a novel antibody drug conjugate (ADC) against CD46, reported the close of a $40 million Series A financing (Press release, Fortis Therapeutics, MAR 29, 2021, View Source [SID1234577777]). Participating in this financing are existing investors, Avalon Ventures, Bregua Corporation, Lilly Asia Ventures, Osage University Partners, and Vivo Capital, as well as new investors, the Myeloma Investment Fund, the venture philanthropy fund of the Multiple Myeloma Research Foundation (MMRF), and Fulcrum 2020, LLC, which shares a portion of its profits with the Prostate Cancer Foundation (PCF) to fund future research. The proceeds of the financing will be used to advance FOR46 in clinical trials for the treatment of relapsed or refractory multiple myeloma and metastatic castration-resistant prostate cancer (mCRPC).

"Our existing investors and new investors, the Myeloma Investment Fund and Fulcrum 2020, see the promise of FOR46 ADC therapy that could help patients where other treatments have failed," said Jay Lichter, Ph.D., President and CEO of Fortis. "Our preliminary clinical data is very exciting, and we are actively advancing our clinical studies in prostate cancer and multiple myeloma and pursuing additional indications."

"PCF is pleased that the 2017 funding to UCSF for their research on CD46 has been leveraged by Fortis for a meaningful Series A financing," said Howard R. Soule, PhD, Executive Vice President and Chief Science officer of PCF. "We are hopeful that CD46 treatment strategies will become a therapeutic option for patients with advanced prostate cancer." In 2017, PCF funded translational research of CD46 that supported clinical advancement of FOR46 through a PCF Challenge Award, which provides $1 million for innovative research with the highest potential for accelerating new and improved treatments for advanced prostate cancer.

In addition, the MMRF supported early development of FOR46 through an immune translational research grant to Fortis Founder Bin Liu at UCSF. The results of that research, published in The Journal of Clinical Investigation in 2016, identified CD46 as a promising target for treatment of multiple myeloma.

For the clinical study in relapsed or refractory multiple myeloma, Fortis has completed single patient cohorts and dose finding and is now enrolling patients in an expansion cohort for treatment with 2.4 mg/kg or FOR46 (ClinicalTrials.gov Identifier: NCT03650491). For the clinical study in mCRPC, Fortis has completed patient enrollment in the dose escalation cohorts (up to 3.0 kg/mg) and is beginning enrollment in dose expansion cohorts in mCRPC and additional indications (ClinicalTrials.gov Identifier: NCT03575819).

About FOR46

FOR46 binds a specific conformational epitope of CD46, a novel immune modulatory receptor. CD46 is highly expressed in multiple tumor types, is part of the tumor’s immune defense shield, and appears to be specific to tumor cells. FOR46 was identified through an antibody selection process that uses living tumor cells residing in their tissue microenvironment, thereby preserving the natural range of surface antigens present on the cells. To create FOR46, the fully human antibody was conjugated to a potent payload using a proven chemistry platform with well-characterized in vivo properties. Early in vitro studies of FOR46 demonstrated its potential to kill tumor cells with no effect on normal cells. Fortis Therapeutics exclusively licensed rights to the antibody in 2016 and maintains a strong intellectual property position.