On January 15, 2021 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported the closing on January 14, 2021, of its $10 million registered direct offering consisting of the purchase and sale of 2,221,358 shares of Enveric’s common stock and common stock equivalents, at a purchase price of $4.5018 per share (Press release, Enveric Biosciences, JAN 15, 2021, View Source [SID1234574051]). Also, Enveric has issued to the investors unregistered warrants to acquire 1,666,019 shares of Common Stock at $4.9519 per share, exercisable immediately and terminating five years after the date of issuance.

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The net proceeds to Enveric from the offering after deducting financial advisory fees and other costs and expenses were approximately $9 million. Enveric intends to use the net proceeds from this offering for working capital and general corporate purposes.

Palladium Capital Group, LLC acted as a financial advisor to the issuer.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by Enveric pursuant to a "shelf" registration statement on Form S-3 (File No. 333-233260) previously filed with the Securities and Exchange Commission (the "SEC") on August 14, 2019, and declared effective by the SEC on November 19, 2019. The offering of the securities (other than the warrants and the shares of common stock underlying the warrants) was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus can be obtained on the SEC’s website at View Source

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Enveric has agreed to register the shares of common stock issuable upon exercise of the warrants for resale pursuant to a customary registration rights agreement.

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 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 January 15, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing new treatment options for cancer patients in indications with the greatest medical need, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, reported the presentation of data from its Phase 1b/2 study in KRAS-mutated metastatic colorectal cancer (mCRC) as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI), and provided an additional data update from its mCRC clinical program and initial findings from its Expanded Access Program (Press release, Cardiff Oncology, JAN 15, 2021, View Source [SID1234574050]).

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Enrollment of patients in the Phase 1b segment of the Phase 1b/2 KRAS-mutated mCRC trial is complete and the recommended Phase 2 dose (RP2D) of onvansertib has been confirmed at 15 mg/m2. The Phase 2 segment of the trial is open to full enrollment of approximately 26 patients across 6 trial sites: USC Norris Comprehensive Cancer Center, Mayo Clinic Cancer Centers (Arizona, Rochester, Jacksonville), Kansas University Medical Center and CARTI Cancer Center.

"The Phase 1b data show that a significant percentage of patients had tumor shrinkage, achieved clinical benefit and, importantly, that the response appears durable with two-thirds of the patients having been on treatment for at least six months," said Daniel H. Ahn, D.O., lead investigator and medical oncologist, Mayo Clinic Cancer Center, Arizona. "This highlights the promise of onvansertib plus standard-of-care as an effective second-line treatment for patients with KRAS-mutated mCRC. We look forward to building on these promising data during the Phase 2 portion of the trial."

Initial findings from Cardiff Oncology’s EAP for onvansertib in KRAS-mutated mCRC are similar to results from the Phase 1b trial. In the EAP, 6 (66%) of the first 9 patients treated have shown tumor shrinkage and remain on treatment to-date with durable responses lasting an average of 6 months. Additionally, 5 different KRAS mutation subtypes are represented (G12A, G12C, G12V, G13D, A146T) and all patients had received prior treatment with FOLFIRI. Importantly, decreases in the KRAS mutational burden after the first cycle of treatment have been predictive of subsequent tumor shrinkage.

"We are pleased with the continued advancement of our KRAS-mutated mCRC clinical study and are excited to initiate enrollment in the Phase 2 segment of this trial," said Dr. Mark Erlander, chief executive officer of Cardiff Oncology. "Additionally, our EAP is being very well received by clinicians and patients who would otherwise not have access to onvansertib because they don’t meet the strict eligibility criteria for our trial. We are encouraged by the initial observations and, in particular, the duration of response we are seeing, which is consistent with the data from our clinical trial. Of note, the key difference in the patients enrolled in our EAP is that several had received and progressed on prior FOLFIRI-based treatment and with the addition of onvansertib we are seeing tumor shrinkage and durable stable disease."

The Phase 1b data will be featured in a poster, A phase Ib/II study of the polo-like kinase 1 (PLK1) inhibitor, onvansertib, in combination with FOLFIRI and bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal Cancer (mCRC), presented by Dr. Daniel Ahn and streamed virtually at ASCO (Free ASCO Whitepaper)-GI on January 15th from 8:00 am – 6:15 pm ET during the Trials in Progress Poster Session: Colorectal Cancer (Abstract TPS155).

Highlights from the Poster Presentation:

Efficacy:

Of the 12 evaluable patients as of the ASCO (Free ASCO Whitepaper)-GI data cut-off date, 5 (42%) achieved a partial response (PR); 4 patients had a confirmed PR; 1 patient went on to curative surgery; 1 patient with a non-confirmed PR went off study due to an unrelated event prior to their 16-week confirmatory scan
Time to achieving a PR ranges from 2 to 6 months in patients on treatment
8 (67%) showed durable responses of >6 months with a range from 6.1 to 13.7 months
Biomarker Analyses:

10 of 12 patients had a KRAS variant detected by ddPCR at baseline (all had a KRAS mutation detected by NGS)
Clinical responses were observed across different KRAS variants, including the 3 most common in CRC
The greatest decreases in KRAS mutant allelic frequency (MAF) after 1 cycle of treatment were observed in patients achieving a PR (ranging from -78% to -100%), while the 2 patients who progressed showed a more modest reduction in KRAS MAF (-55% and -26%)
Patients with PR and stable disease (SD) tended to have lower on-treatment KRAS MAF than patients with early progressive disease (PD)
Safety:

Onvansertib in combination with FOLFIRI/bevacizumab is safe and well tolerated with only 9% of all adverse events (AEs) being grade 3 or 4
Grade 4 adverse events were attributed to the 5-FU bolus component of the combination regimen, which was eliminated in subsequent cycles of treatment per protocol and institutional guidelines
The only G3/G4 AEs reported in ≥2 patients were neutropenia (n=8), which were managed by dose delay, growth factor therapy and/or discontinuation of the 5-FU bolus; no patients went off trial due to neutropenia
No major or unexpected toxicities were attributed to onvansertib
The poster, A phase Ib/II study of the polo-like kinase 1 (PLK1) inhibitor, onvansertib, in combination with FOLFIRI and bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal Cancer (mCRC), will be available on the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 1b/2 Trial of Onvansertib in KRAS-mutated mCRC

This is a multi-center, open-label Phase 1b/2 trial of onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab) to evaluate the safety and preliminary efficacy of the combination regimen in the second-line treatment of patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second–Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. In addition, eligible patients must have failed treatment with, or be intolerant to, FOLFOX (fluoropyrimidine and oxaliplatin) with or without bevacizumab. The trial is being conducted at six cancer centers across the U.S.: USC Norris Comprehensive Cancer Center, The Mayo Clinic (Arizona, Rochester and Jacksonville), Kansas University Medical Center (KUMC) and CARTI Cancer Center. For more information on the trial, please visit View Source

About the Expanded Access Program (EAP) for Onvansertib in KRAS-mutated mCRC

Sometimes called "compassionate use", expanded access is a potential pathway for a patient with a serious or life-threatening disease to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available. The Cardiff Oncology EAP in KRAS-mutated mCRC is using the same combination treatment regimen (onvansertib 15 mg/m2 + FOLFIRI/bevacizumab) and dosing schedule as the ongoing Phase 1b/2 clinical trial and is intended for patients that have progressed on prior therapy and do not meet the eligibility criteria for enrollment in the clinical trial. Requests for expanded access to onvansertib must be made by a U.S. licensed, treating physician. For more information on the expanded access program, please visit View Source

On January 15, 2021 Five Prime Therapeutics, Inc. (NASDAQ: FPRX) reported clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer (Press release, Five Prime Therapeutics, JAN 15, 2021, View Source [SID1234574049]). Trial results were presented in a late-breaking oral presentation today by UCLA Health’s Zev Wainberg, M.D., at the 2021 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Virtual Annual Symposium (ASCO GI). The ASCO (Free ASCO Whitepaper) GI presentation slides are available on the company’s website.

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The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive frontline advanced gastric or GEJ cancer. The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States, with 77 patients randomized to the bemarituzumab arm and 78 patients to the placebo arm.

The Phase 2 trial met all three efficacy endpoints and demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoints of overall survival (OS) and overall response rate (ORR). Additional analysis showed a correlation between benefit and the percentage of FGFR2b+ tumor cells, confirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target.

"Systemic chemotherapy is the standard of care for this deadly and aggressive form of gastric cancer. We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival," said Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. "The FIGHT trial results demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a significant reduction in the risk of disease progression and death in gastric cancer patients whose tumors overexpress FGFR2b."

"The Phase 2 FIGHT clinical trial results validate our pioneering work on the role of FGFR2b overexpression in gastric cancer, and we’re excited about the implications of this new scientific understanding for other cancers," said Helen Collins, M.D., Five Prime’s Executive Vice President and Chief Medical Officer. "With these data in hand, we plan to continue to collaborate with regulatory agencies on next steps, initiate a global Phase 3 trial in gastric cancer and begin studying bemarituzumab in other epithelial cancers that overexpress FGFR2b."

The incidence of all grade adverse events was similar in the bemarituzumab and placebo arms of the study (100% vs 98.7%, respectively). Corneal events were reported more frequently in the bemarituzumab arm (67.1% vs 10.4%), with the most common corneal events in the bemarituzumab arm being dry eye (26.3%), keratitis (15.8%) and punctate keratitis (14.5%). Stomatitis (31.6% vs 13.0%) and elevated transaminases (34.2% vs 19.5%) were also more common in the bemarituzumab arm. Grade 3 and higher adverse events (82.9% vs 74.0%), serious adverse events (31.6% vs 36.4%) and deaths (6.6% vs 5.2%) were comparable across arms.

Ocular events are common in therapies targeting FGFR and were also reported in the FIGHT trial. More patients in the FIGHT trial discontinued bemarituzumab compared to placebo due to an adverse event (34.2% vs 5.2%), the majority (21 of 26 patients) due to an ocular event.

The discontinuation of bemarituzumab due to an ocular event decreased the median duration of exposure to bemarituzumab by 3.2 weeks; from 25.3 weeks (n=55, range: 2.0 to 71.7 weeks) to 22.1 weeks (n=21, range: 12.0 to 46.7 weeks).

In designing the Phase 3 trial, the company plans to incorporate findings from the FIGHT trial including baseline eye exams, prophylactic lubricating eye drops and close monitoring for signs and symptoms of corneal toxicity, including dry eye.

Five Prime Webcast /Conference Call Information

Five Prime Therapeutics will host a KOL conference call and live audio webcast following ASCO (Free ASCO Whitepaper) GI on Friday, January 15, 2021 at 4:30pm (EST) / 1:30pm (PST) to review the Phase 2 FIGHT clinical trial results and provide an update on the bemarituzumab program. The presentation will feature members of the Five Prime management team and Zev A. Wainberg, M.D., Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, and an investigator in the trial.

To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209. To access the live webcast please visit View Source

An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

About FGFR2b

The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a splice form of FGFR which can be found in tumors of epithelial origin. Data from the FIGHT trial suggests that approximately 30 percent of patients with non HER2 positive gastroesophageal cancers overexpress FGFR2b.1 Five Prime and Roche Tissue Diagnostics have also found that FGFR2b is overexpressed in numerous other cancers, including squamous non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian, pancreatic and intrahepatic cholangiocarcinoma.

About Bemarituzumab

Bemarituzumab (anti-FGFR2b) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.

Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

About Gastric Cancer and GEJ Cancer

Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 For HER2 negative patients, frontline therapy available today is the same systemic chemotherapy available since the 1990s.3,4

On January 15, 2021 NuCana plc (NASDAQ: NCNA) reported interim data from the ongoing NuTide:302 study at the ASCO (Free ASCO Whitepaper) GI Conference, being held virtually January 15-17, 2021 (Press release, Nucana BioPharmaceuticals, JAN 15, 2021, View Source [SID1234574048]).

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NuTide:302 is a three-part study investigating NUC-3373, NuCana’s targeted thymidylate synthase inhibitor, in heavily pre-treated patients with metastatic colorectal cancer. The study is evaluating NUC-3373’s optimal dose and schedule in combination with agents commonly used to treat patients with colorectal cancer and is assessing safety, pharmacokinetics and anti-cancer activity. NUC-3373 has been designed to overcome the main challenges associated with 5-FU and capecitabine, including cancer-resistance mechanisms which limit efficacy, off-target toxicity and administration burdens.

The ASCO (Free ASCO Whitepaper) GI presentation highlighted data from 37 patients treated in Part I of the study who received NUC-3373 either as monotherapy or in combination with leucovorin. Ten patient case studies highlighted NUC-3373’s ability to stabilize disease and achieve prolonged durations of progression-free survival. Many patients achieved longer progression-free survival on NUC-3373 than they had on their prior line of therapy and five patients experienced tumor shrinkage. These patients included:

A fourth-line patient who achieved a Partial Response with a 40% reduction in tumor volume;

A third-line patient who achieved a 28% reduction in tumor volume after their disease rapidly progressed through all prior fluoropyrimidine-containing regimens.

Among the efficacy-evaluable population, a disease control rate of 62% was achieved.

In addition to these encouraging efficacy signals, the presentation compared the safety profile of NUC-3373 in Part I of the study with historical data for 5-FU and capecitabine in the front-line treatment of patients with colorectal cancer. NUC-3373 was well tolerated with no hand-foot-syndrome or neutropenia as well as lower rates of diarrhea, mucositis and stomatitis.

Dr. Andrew Coveler, Associate Professor at the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center and an investigator in the NuTide:302 study, remarked: "I am encouraged by both the clinical activity and safety of NUC-3373. To observe this anti-cancer activity, including a Partial Response, in such a heavily pre-treated patient population is very promising. In addition, NUC-3373 has been well tolerated and its safety appears favorable when compared to 5-FU and capecitabine. As such, I look forward to advancing NUC-3373’s development in patients with colorectal cancer."

"We are very pleased with these additional data from Part I of the NuTide:302 study," said Hugh S. Griffith, NuCana’s Founder and CEO. "It was particularly encouraging to observe tumor shrinkages, prolonged disease stabilization and a favorable safety profile in a patient population that had received at least two prior fluoropyrimidine-containing regimens. We look forward to continuing Part II of the study in which NUC-3373 is being combined with leucovorin and either oxaliplatin or irinotecan. Our objective is to replace 5-FU and capecitabine with NUC-3373 as the backbone of treatment for patients with colorectal cancer."

Details of the poster presentation are as follows:

Title: A phase Ib study of NUC-3373 in combination with standard therapies in

advanced/metastatic colorectal cancer (NuTide:302)

Session: Colorectal Cancer

Abstract Number: 93

On January 15, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will participate in a Fireside Chat with Andrew D’Silva of B. Riley Securities on Wednesday, January 20, 2021 at 10:30 am ET (Press release, Infinity Pharmaceuticals, JAN 15, 2021, View Source [SID1234574047]).

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B. Riley is limiting the live audience to institutional investors, investor relations, and employees of each presenting company. Private investors will not be given access to the live conference, but a replay will be available on the Events and Presentations page of the Infinity Pharmaceuticals website following the conference.