On June 21, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported the closing of its previously announced underwritten public offering of common stock, including the exercise in full by the underwriters of their option to purchase an additional 885,000 shares at the public offering price of $17.00 per share (Press release, Kura Oncology, JUN 21, 2019, View Source [SID1234537209]). The exercise of the option to purchase additional shares brought the total number of shares of common stock sold by Kura to 6,785,000 shares and increased the amount of gross proceeds raised in the offering, before underwriting discounts and estimated expenses of the offering payable by Kura, to approximately $115.3 million.

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SVB Leerink and Cowen acted as joint book-running managers for the offering. Wedbush PacGrow and Oppenheimer & Co. acted as co-lead managers, and H.C. Wainwright & Co. acted as co-manager for the offering.

The securities described above were offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura with the Securities and Exchange Commission (the "SEC") and that was declared effective on November 21, 2018. A final prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC and are available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected], or Cowen and Company, LLC c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 592-5973, or by email at [email protected].

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.

On June 21, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is reported the grant of a new patent (number 2014368420) entitled "Combined Preparations for the Treatment of Cancer" by the Australian Patent Office (Press release, Immutep, JUN 21, 2019, View Source [SID1234537208]).

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This Australian patent follows the recent grant of the corresponding European patent (announced 23 May 2019) and protects Immutep’s intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a chemotherapy agent. The chemotherapy agent is either a platinum-based anti-neoplastic agent, such as oxaliplatin or carboplatin, or a topoisomerase I inhibitor, such as topotecan.

The new patent again highlights the broad potential of efti as an immunostimulant and provides patent protection in Australia for a range of novel and highly relevant chemo-immunotherapies featuring efti that may be pursued in the future.

The patent expiry date is 19 December 2034.

On June 21, 2019 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing novel drug candidates in indications of high unmet medical need, reported financial results for the first quarter ended March 31, 2019 (Press release, Applied Therapeutics, JUN 21, 2019, View Source [SID1234537207]).

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"Since the launch of Applied Therapeutics just three years ago, we have built a robust pipeline of novel drug candidates with the potential to deliver a meaningful impact in multiple disease areas of high unmet medical need," said Shoshana Shendelman, PhD, President and Chief Executive Officer of Applied Therapeutics. "With the recent completion of our initial public offering, we have strengthened our cash position, extending our runway and providing additional resources to accelerate our clinical development plan. This includes our lead asset, AT-001, which is on track to enter a pivotal Phase 2/3 clinical trial in diabetic cardiomyopathy (DbCM) later this year and advance AT-007 into Phase 1/2 study into adults with Galactosemia this month."

Recent Highlights

·Received FDA Orphan Drug Designation for AT-007 in Galactosemia. In May 2019, we received orphan drug designation for AT-007 in Galactosemia. The designation allows Applied Therapeutics to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; exemption from FDA application fees for Galactosemia; and tax credits for qualified clinical trials.

·Presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the American Diabetes Association (ADA) 79th Annual Scientific Sessions in San Francisco. In June 2019, we presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the ADA Annual Scientific Sessions. The data, presented as part of the Late Breaking session, demonstrated that AT-001 was well tolerated at all dose levels, and target engagement was confirmed by potent aldose reductase (AR) inhibition as evidenced by significant reductions in sorbitol, a pharmacodynamic biomarker of AR activity. AT-001 also improved selectivity and affinity for AR and resulted in potent AR inhibition.

·Presented Phase 1/2 Data Highlighting Safety and Proof of Biological Activity for AT-001 in DbCM at The European Society for Cardiology (ESC) 6th World Congress in Athens, Greece. In May 2019, we presented two posters at ESC, the first of which was presented in the Late Breaking session and highlighted key data from a recently completed Phase 1/2 study in approximately 120 type 2 diabetic patients demonstrating the safety and proof of biological activity for AT-001 in DbCM. Supporting preclinical data from an animal model of DbCM was also presented, demonstrating that AT-001 prevents or reduces cardiac damage in a relevant disease model.

· Completed Initial Public Offering. In May 2019, we completed our IPO, generating approximately $34.0 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

·Announced Appointment of Mark Vignola, PhD, as Chief Financial Officer. In April 2019, we announced the appointment of Mark Vignola, PhD, as Chief Financial Officer. Dr. Vignola served most recently as Head of Corporate Development & Investor Relations at Intercept Pharmaceuticals.

Financial Results

·Cash and cash equivalents totaled $14.7 million as of March 31, 2019, compared with $18.7 million at December 31, 2018. Subsequent to the close of the quarter, we completed an initial public offering resulting in net proceeds of approximately $34.0 million.

·Research and development expenses for the three months ended March 31, 2019 were $6.9 million, compared to $1.5 million for the three months ended March 31, 2018. The increase of approximately $5.4 million was primarily related to the progressing of our clinical trials through development, including an increase in clinical and pre-clinical expenses of $4.1 million and drug manufacturing and formulation expenses of $0.7 million, and personnel expenses of $0.7 million due to the hiring of research and development personnel, including the Chief Medical Officer in August 2018.

·General and administrative expenses were $1.9 million for the three months ended March 31, 2019, compared to $0.4 million for the three months ended March 31, 2018. The increase of approximately $1.4 million was primarily related to professional fees of $0.7 million due to increased legal and consulting fees, personnel expenses of $0.4 million due to the hiring of other personnel, including the interim Chief Financial Officer and the Controller, and other expenses of $0.3 million, primarily due to public relations efforts, travel expenses and rent.

·Net loss for the first quarter of 2019 was $8.7 million, or $1.58 per basic and diluted common share, compared to a net loss of $2.3 million, or $.43 per basic and diluted common share, for the first quarter of 2018.

On June 20, 2019 Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage cellular immunotherapy company, reported preliminary results of a multi-center pilot study designed for evaluating the safety and efficacy of Gracell’s patented FasT CAR-19 (GC007F) investigational cell gene therapy (Press release, Gracell Biotechnologies, JUN 20, 2019, View Source [SID1234539455]). The customized treatment which genetically modifies patient’s T-cells to express CD19-specific chimeric antigen receptor (CAR), showed a clinically meaningful and positive result in the treatment of B-cell acute lymphoblastic leukemia (B-ALL). The results of the study were announced during the CAR-TCR Summit Asia, held June 18-20, 2019 in Shanghai.

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B-ALL is a sub-type of ALL, a cancer of the lymphoid line of blood cells. For a vast number of patients, B-ALL can be treated by chemotherapy and stem cell transplant. However, for the many patients who develop relapsed or refractory (r/r) B-ALL, significant complications in treatment remain. With characteristically low life expectancy, r/r B-ALL is one of the most devastating forms of malignancies. Anti-CD19 CAR-T products have been developed specifically for these late-stage patients.

Currently approved anti-CD19 CAR-T bioprocessing takes on average two weeks to manufacture and seven days to pass quality test. With Gracell’s FasT CAR solution, preparation time can be cut to 24 hours, significantly reducing production cost and waiting time. In addition, FasT CAR can be administered vein-to-vein (time from when cells are extracted to when they are infused back into the patient) within seven days after leukapheresis, providing substantial meaning and significant benefitto physicians and patients.

With a manufacturing success rate of 19/19 (100%) without patient loss, FasT CAR-19 cells are considered much more potent and durable in comparison to currently available alternatives. With these advantages, FasT CAR-19 is highly cost-effective and has considerable potential to establish a new standard in CAR-T treatment for r/r B-ALL.

The multi-center investigational study enrolled 19 adolescent and adult patients aged from 14 to 70 years, who suffered from relapsed or refractory B-ALL and had failed to respond to multiple prior lines of therapy. As of June 12, all patients received a single infusion of FasT CAR-19 following lymphodepleting chemotherapy. FasT CAR-19 was administered at three dose levels from low to high, equivalent to 1/30-1/10 of the standard CAR-T therapy dose, respectively.

The treatment efficacy was assessed in 16 patients, of which:

16 (100%) achieved complete remission with or without complete blood count recovery (CR/CRi);
14 (87%) achieved undetectable minimal residual disease (uMRD) (< 10-4 detectable leukemic cells in bone marrow);
15 (94%) experienced an ongoing response by June 12. Notably, one adolescent patient achieved CR and uMRD after 28 days of regular follow-up treatment, turned MRD positive at week 12, and converted back to uMRD again at week 20 with the ongoing response status remaining up to June 12.
During the over six month-durable remission period, FasT CAR-19 demonstrated a good level of persistence. In terms of safety, all 19 patients tolerated the single infusion of FasT CAR-19 at different dose levels, with no dose-limiting toxicities observed. The most common safety concerns were cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) where mild to moderate side effects were observed. In comparison to the high dose group, patients administered low to middle dose levels experienced mild adverse events. Across 14 patients in the low to mid doses group, only 2 (14%) Grade 3 CRS and 1 (7%) manageable Grade 3 ICANS were reported; while in the 4 patients of the high dose group, there were 3 (75%) Grade 3 CRS and 2 (50%) Grade 1-2 ICANS.

"We are very excited to see that the patients with relapsed or refractory B-ALL in this study gained substantial clinical benefit from FasT CAR-19," said CEO Dr. William CAO. "Although the potential of FasT CAR technology is yet to be unlocked, the results of this study have enhanced our confidence to move on with dose expansion studies and to apply FasT CAR to products for various indications, including multiple myeloma and non-Hodgkin lymphoma. We are eager to see Gracell’s highly efficacious, but affordable FasT CAR-T therapies benefit patients globally."

About FasT CAR-19

FasT CAR-19, or GC007F, is an investigational CD19-targeted CAR-T cell therapy for adolescent and adult patients with relapsed or refractory B-ALL, as well as aggressive non-Hodgkin lymphoma. Thanks to Gracell’s patented FasT CAR technology, the bioprocessing of GC007F has been significantly reduced to 24 hours with substantially lower cost. The younger and less exhausted T cell phenotype exhibited superior proliferation capabilities, potency, and extensive bone marrow migration making GC007F a potential best-in-class therapy for relapsed or refractory B-ALL.

About ALL

Acute lymphoblastic leukemia, although rare, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50[1]. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide[2]. It is also the most common cause of cancer and death from cancer among children. ALL is typically treated initially with chemotherapy aimed at bringing about remission. This is then followed by further chemotherapy carried out over several years.

On June 20, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Robert Forrester has decided to step down as President and Chief Executive Officer (Press release, Verastem, JUN 20, 2019, View Source [SID1234537274]). Mr. Forrester has agreed to continue serving Verastem Oncology in an advisory capacity.

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Dan Paterson, the Company’s Chief Operating Officer, has been appointed to serve as President and Chief Operating Officer and will assume the leadership of the executive team while the Board of Directors conducts a search to identify a successor. Mr. Paterson will be supported by other members of the senior leadership team, including Chief Financial Officer, Rob Gagnon, whose role is being expanded to include Chief Business Officer.

Mr. Paterson joined Verastem Oncology in 2011 and has served as its Chief Operating Officer since 2014. He brings more than 25 years of experience at healthcare and biotechnology companies, including leadership roles as Chief Business Officer (CBO), Chief Operating Officer (COO) and Chief Executive Officer (CEO), with specific expertise in oncology drug and diagnostic product development, business development and launch planning.

"On behalf of the entire Board, I want to thank Robert for his countless contributions and leadership for the past six years and his unwavering commitment to Verastem Oncology’s patients, employees and shareholders," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "We remain confident in the growth potential of COPIKTRA and we intend to hire a CEO with commercial expertise who will build on the foundation that Robert has established and execute on our ambitious goals for the future."

"With COPIKTRA, the experienced team and the resources we have in place, we are in a strong position to continue executing on our mission to improve outcomes for patients," said Mr. Paterson. "I look forward to working closely with the Company’s Board, executive leadership, and the broader management team to accelerate the COPIKTRA launch and the future expansion of this important medicine into other hematologic malignancy indications."

"It has been a true honor to serve as the CEO of Verastem Oncology over the past six years," said Mr. Forrester. "I am extremely proud of the Verastem Team, the progress we have made, and our many accomplishments aimed at improving the lives of patients diagnosed with cancer, one patient at a time. I have great confidence in Verastem Oncology’s potential and I will work with the entire team to ensure a seamless transition for all of our stakeholders."

The Company is reiterating its previously issued financial guidance for the full year 2019. The Company continues to expect net product revenue from the sales of COPIKTRA to be in the range of $10-12 million, based on product revenue to date, current run rates and near-term expectations.