On September 27, 2019 Three Upstate Medical University professors reported that it will present work at the world’s second-largest cancer conference starting this weekend in Spain (Press release, SUNY Upstate, SEP 27, 2019, View Source [SID1234551517]).

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Jeffrey Ross, MD, Jeffrey Bogart, MD, and Gennady Bratslavsky, MD, will attend the annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, Sept. 27 to Oct. 1 in Barcelona, Spain. About 30,000 cancer specialists gather at ESMO (Free ESMO Whitepaper) each fall. It is an opportunity for oncology experts from around the world to share their latest research and findings.

"Many breakthroughs in anti-cancer drug trials are now being presented at the ESMO (Free ESMO Whitepaper) meeting," said Ross, an assistant professor of pathology at Upstate and medical director of Foundation Medicine in Cambridge, Massachusetts. Ross, who has attended ESMO (Free ESMO Whitepaper) many times over the years, said he is involved in eight Upstate projects that will be either presented or addressed at ESMO (Free ESMO Whitepaper). His recent research into a particularly deadly type of cancer called Carcinoma of Unknown Primary (CUP) site, will be presented by a colleague at this year’s Congress and is being highlighted by the organization as a significant study.

CUP affects about one in 15 patients with cancer. CUP patients are diagnosed when the cancer has already spread and no primary tumor can be located. Only one in 10 CUP patients survive for one year.

Ross is first author on the study, which showed that about one in three patients with CUP may be a candidate for targeted treatment or immunotherapy based on DNA changes in the tumor. Ross said a colleague will present the study and he will be available to answer questions. This paper is a follow-up to one that was published in 2015, Ross said.

"That paper allowed pharma to initiate a $100 million clinical trial to enroll patients for treatment based on the genomic findings of their cancer," he said.

Bogart, interim director of the Upstate Cancer Center, will present on "interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on the experimental thoracic radiotherapy (TRT) arms of CALGB 30610 (Alliance.)" And Bratslavsky, chair of Upstate’s urology department, will present on malignant pheochromocytoma and malignant paraganglioma.

Bogart said his research is based on a 10-year study of more than 700 patients throughout the country – including many treated at Upstate. The study involved varying radiation treatment plans for patients with small cell lung cancer.

"The trial is completed and we will have to follow up with these patients over the next several years," Bogart said. "The final question is one we don’t have the answer to yet and that is the best way to give radiation, which will have a big impact for how patients are treated in the future."

Bogart and Ross said Upstate’s involvement at an international conference like ESMO (Free ESMO Whitepaper) helps to further establish Upstate as a leader in cancer research.

"It’s exciting for Upstate Cancer Center to be a significant source of new information for cancer patients and to be on the cutting edge of this kind of cancer genomics research," Ross said. "It’s hopefully going to make the breadth of cancer work done at Upstate more well known. We’re doing more than just treating cancer patients. We’re doing basic and clinical research trying to help patients not just in Syracuse but everywhere."

On September 27, 2019, Rigel Pharmaceuticals, Inc., a Delaware corporation (the "Company") reported that it entered into a Credit and Security Agreement, dated as of September 27, 2019 (the "Closing Date") by and among the Company, the lenders party thereto from time to time and MidCap Financial Trust, as administrative agent and collateral agent ("Agent") (the "Term Loan Credit Agreement"), which provides for a $60 million term loan facility (Filing, 8-K, Rigel, SEP 27, 2019, View Source [SID1234552181]). The Term Loan Credit Agreement provides for (i) on the Closing Date, $10.0 million aggregate principal amount of term loans, (ii) at the Company’s option, until December 31, 2020, an additional $10.0 million term loan facility, (iii) at the Company’s option, until March 31, 2021, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions ("Tranche Three") and (iv) at the Company’s option, until March 31, 2022, an additional $20.0 million term loan facility subject to the satisfaction of certain conditions ("Tranche 4") (collectively, the "Term Loans"). The Company used the proceeds of the Term Loans for general corporate purposes

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The obligations under the Term Loan Credit Agreement are secured by a perfected security interest in all of the Company’s assets except for intellectual property and certain other customary excluded property pursuant to the terms of the Term Loan Credit Agreement.

The Term Loans are subject to an origination fee of 0.25% of each funded tranche of Term Loans. The Company will pay the Agent an annual administrative fee of 0.25% of the amount borrowed under the Term Loans, payable annually. The Term Loans may be prepaid in full or in part through September 27, 2020 with payment of a 2.5% prepayment premium, after which they may be prepaid in full or in part through September 27, 2021 with payment of a 1.5% prepayment premium, after which they may be prepaid in full or in part through September 27, 2022 with payment of a 1.0% prepayment premium, after which they may be prepaid in full or in part with no prepayment premium. An additional 2.5% of the amount of Terms Loans advanced by the lenders will be due upon prepayment or repayment of the Term Loans in full.

The interest rate applicable to the Term Loans is LIBOR plus 5.65%, subject to a LIBOR floor of 1.50%. Commencing October 1, 2019, the Company initially will make interest-only payments for 24 months, followed by 36 months of amortization payments. The interest-only period will be extended to 36 months and again to 48 months upon the satisfaction of certain conditions set forth in the Term Loan Credit Agreement. All unpaid principal and accrued interest is due and payable in full no later than September 1, 2024.

The Term Loan Credit Agreement requires that the Company (i) upon both of (x) the draw of Tranche 3 or Tranche 4 and (y) cash falling below 1.25x Term Loans outstanding, maintain U.S. Tavalisse Net Revenue (as defined in the Term Loan Credit Agreement) in amounts set forth in the Term Loan Credit Agreement and (ii) upon the draw of Tranche 3 or Tranche 4, maintain cash and cash equivalents of at least $10.0 million. The Term Loan Credit Agreement also contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions.

Events of default under the Term Loan Credit Agreement include: (i) failure by the Company to timely make payments due under the Term Loan Credit Agreement; (ii) material misrepresentations or misstatements in any representation or warranty by the Company when made; (iii) failure by the Company or its subsidiaries to comply with the covenants under the Term Loan Credit Agreement and other related agreements; (iv) certain defaults under a specified amount of other indebtedness of the Company or its subsidiaries; (v) insolvency or bankruptcy-related events with respect to the Company or any of its subsidiaries; (vi) certain undischarged judgments against the Company or its subsidiaries; (vii) certain ERISA-related events with respect to the Company or its subsidiaries above a specified amount; (viii) certain security interests or liens under the loan documents ceasing to be, or being asserted by the Company not to be, in full force and effect; (ix) the institution of criminal proceedings against the Company; (x) an event of default under the guarantee of the obligations under the Term Loan Credit Agreement; (xi) the prepayment of any subordinated debt other than as specifically permitted by the terms of such subordination; (xii) the occurrence of a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiii) certain adverse actions by the FDA or DEA with respect to certain products or which could be reasonably expected to result in a Material Adverse Change (as defined in the Term Loan Credit Agreement); (xiv) a default or material breach under certain specified material contracts and (xv) any loan document ceasing to be, or any challenge or assertion by the Company that such loan document is not, in full force and effect. If one or more events of default occurs and continues beyond any applicable cure period, the Agent may, with the consent of the lenders holding a majority of the loans and commitments under the facilities, or will, at the request of such lenders, terminate the commitments of the lenders to make further loans and declare all of the obligations of the Company under the Term Loan Credit Agreement to be immediately due and payable.

On September 27, 2019 Amgen (NASDAQ: AMGN) reported new data from the ongoing Phase 1 study evaluating AMG 510 in patients with previously treated KRAS G12C-mutant solid tumors (Press release, Amgen, SEP 27, 2019, View Source [SID1234539862]). The data include the first evidence of anti-tumor activity reported in patients with colorectal cancer (CRC) and appendiceal cancer, as well as previously presented non-small cell lung cancer (NSCLC) findings. AMG 510 continues to be well-tolerated with no dose-limiting toxicities. These data are being presented during a poster discussion at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress.

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The study enrolled 76 patients with KRAS G12C-mutant solid tumors. Data being presented at ESMO (Free ESMO Whitepaper) include a subset of 55 evaluable patients as of the July 2019 data cutoff, including CRC, appendiceal cancer and NSCLC patients from the Phase 1 study. Of the 55 patients, 29 had CRC. Twelve patients with CRC received the target dose of 960 mg once daily and 10 remain on treatment. One patient in this dose cohort experienced a partial response and 10 had stable disease for a disease control rate of 92%. Thirteen of the evaluable patients with NSCLC received 960 mg, of which seven (54%) achieved a partial response at one or more timepoints and six (46%) achieved stable disease, for a disease control rate of 100%. Data across dosing cohorts also showed tumor responses in two evaluable patients with appendiceal cancer with one partial response and one experiencing stable disease.

"KRAS is the most frequently mutated oncogene in human tumors. Although KRASG12C has been a formidable target for nearly four decades, we can now report responses in patients with non-small cell lung, colorectal and appendiceal cancers," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are encouraged by these early results, particularly since these patients have progressed after receiving a median of four prior therapies, and in some cases as many as 10. The data suggest there are relevant molecular differences between tumor types. We are initiating combination studies to further explore the potential of AMG 510 in lung and colorectal tumors."

Among the 76 patients enrolled across treatment groups, 52 remain on treatment. The majority of treatment-related adverse events (TRAEs) were grade 1 and 2. Only two TRAEs were grade 3 (diarrhea and anemia). There were no grade 4 or higher TRAEs.

"The prognosis for patients with advanced colorectal cancer remains poor," said Marwan G. Fakih, M.D., clinical study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, Calif. "These are heavily pre-treated colorectal cancer patients, with a median progression-free survival of just over two months, so to see patients still on treatment at the target dose after more than three months is very encouraging."

About the Phase 1 Study
The Phase 1, first-in-human, open-label multicenter study enrolled patients with KRAS G12C- mutant solid tumors. Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint is safety, and key secondary endpoints include pharmacokinetics, objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

When evaluating tumor response, a partial response was defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as at least a 30% decrease in the sum of the diameters of target lesions.1 Stable disease was defined as having neither sufficient tumor shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease.

About KRAS
The subject of almost four decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.2,3 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumors.3 A specific mutation known as KRAS G12C is found in approximately 13% of non-small cell lung cancers, three to five percent of colorectal cancers and one to two percent of numerous other solid tumors.4 Approximately 30,000 patients are diagnosed each year in the United States with KRAS G12C-mutant cancers.5 KRASG12C has been considered "undruggable" due to a lack of traditional small molecule binding pockets on the protein. Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumor types.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

For more information, follow us on www.twitter.com/amgenoncology.

On September 27, 2019 Cerus Corporation (Nasdaq: CERS) reported that Kevin D. Green, Cerus’ vice president, finance and chief financial officer will present and provide a corporate update at the 2019 Cantor Global Healthcare Conference in New York City on Wednesday, October 2, 2019 at 3:00 p.m. ET (Press release, Cerus, SEP 27, 2019, View Source [SID1234539847]).

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A live webcast of the presentation will be available on the Investor Relations page of the Cerus web site at View Source A replay of the webcast will be available for approximately two weeks following the completion of the event.

On September 27, 2019 Lannett Company, Inc. (NYSE: LCI) ("Lannett" or the "Company") reported the closing of $86.25 million aggregate principal amount of 4.50% convertible senior notes due 2026 (the "Notes") in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Lannett, SEP 27, 2019, View Source;300926947.html [SID1234539863]). Lannett granted the initial purchaser of the Notes a 30-day option to purchase up to an additional $11.25 million aggregate principal amount of the Notes, which option the initial purchaser exercised in full.

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"We are pleased to have successfully completed our recent convertible note offering that has strengthened our capital structure by replacing variable interest rate debt that matures in November 2020 with a substantially lower fixed interest rate convertible bond that matures in October 2026," said Tim Crew, chief executive officer of Lannett. "Our cash balances, following the pay down of the Term A Loan, will exceed the outstanding remaining balance of our Term A Loan. Moreover, the convertible debt is excluded in the calculation of our leverage ratio covenants. We continue to evaluate options with regard to further improving our capital structure."

This press release is neither an offer to sell nor a solicitation of an offer to buy the Notes or the shares of the Company’s common stock issuable upon conversion of the Notes, nor will there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

The Notes and the shares of the Company’s common stock issuable upon conversion of the Notes have not been and will not be registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.