Category Archives: Cf

SOUTH SAN FRANCISCO, July 13, 2020 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, today announced that it has dosed the first patients in its Phase 1b clinical trial of the arginase inhibitor CB-280 in adult patients with cystic fibrosis (CF) and chronic airway infection. The study will evaluate the safety and optimal dose range of CB-280 when added onto existing therapies for CF patients, including CFTR modulators.

We remain committed to advancing our arginase inhibitor clinical development program to fully explore the potential of this new class of therapeutics in a variety of conditions, said Susan Molineaux, PhD, president and chief executive officer of Calithera. Based on preclinical data and the unique pathology of this disease, we believe that CB-280s mechanism of action represents an opportunity to further improve upon the current standard-of-care for CF patients, for whom there remains great unmet need despite recent therapeutic advancements.

Research in CF patients has demonstrated that increased arginase activity correlates directly with worsened lung function, and reduced expiratory nitric oxide (NO) levels. Pre-clinical studies conducted by Calithera and collaborators have shown that arginase inhibition increases systemic arginine levels, decreases airway bacterial colonies, and improves lung function in CF mouse models of infection. Inhibiting arginase may reduce infection and improve lung function in people with CF. Chronic poly-microbial infection remains a major area of unmet need in CF.

The Phase 1b randomized, double blind, placebo-controlled, dose escalation trial will evaluate multiple ascending doses of CB-280 compared to placebo in 32 adult CF patients to determine a safe dose range for CB-280, dosed orally twice daily for 14 days. The study follows the completion of a Phase 1 trial that evaluated the safety, tolerability and pharmacokinetic profile of CB-280 in healthy volunteers, which was conducted under a United States Food and Drug Administration Investigational New Drug (IND) application.

In October 2017, Calithera entered into a global collaboration agreement with Incyte, focused on research, development and commercialization of a first-in-class arginase inhibitor in hematology and oncology. As part of this agreement, Calithera retained the rights to develop additional arginase inhibitors in specific non-oncology indications, including CF. The molecule being evaluated in these clinical trials, CB-280, is wholly owned by Calithera.

About Calithera

Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially block tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit http://www.calithera.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of the arginase inhibitor CB-280 in adult patients with cystic fibrosis, the overall advancement of CB-280 in the Phase 1b clinical trial , the unmet need in the treatment of patients despite recent therapeutic advancements, Calitheras global collaboration with Incyte, and Calitheras plans to continue development of CB-280. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, and other periodic filings with the Securities and Exchange Commission at http://www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

SOURCE:Calithera Biosciences, Inc.

CONTACTS:

Investor RelationsJennifer McNealeyCalitherair@Calithera.com650-870-1071

MediaMichele ParisiSam Brown, Inc.micheleparisi@sambrown.com925-864-5028

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Calithera Biosciences Initiates Phase 1b Trial of Arginase Inhibitor CB-280 for the Treatment of Cystic Fibrosis - GlobeNewswire

A letter from local resident Beth Vanstone, the mother of Cystic Fibrosispatient and warrior, Madi Vanstone:

When Madi was diagnosed with Cystic Fibrosis at eightmonths old it felt like our world had just crumbled around us.

Gone were out thoughts of raising our two little girls and looking forward to what ever lay ahead of them. Careers, families travel, growing old and living happy were shadowed by keeping Madi alive . Cystic Fibrosis stole those dreams from us and replaced them with countless hospital admissions, physio multiple times a day, bags full of medications and a very scary and tumultuous future.

As parents will do, we took the challenge put to us and did everything we could to provide Madi with the best life we could. We made fabulous memories and packed in lots of fun each day when she was well enough. While we focused on raising our girls we also jumped into fundraising for CF and research hoping against hope that one day there would be a cure and a future for our little girl.

Well after 11 years, as Madi's health was declining rapidly, we were given hope in the form of two little blue pills. Kalydeco the first gene modulator was here and it was going to save our daughter. Well, it wasn't quite as easy as that, there was our very public two year battle for drug funding, but that's another story. Fast forward sevenyears and Madi's life and our lives have been transformed. Two pills a day have taken Madi who was slowly drowning daily in her Cystic Fibrosis, to a healthy and happy young woman who is looking forward to a beautiful and bright future. These two little blue pills taken twice a day correct the defect in the gene that causes Cystic Fibrosis. Tested today while on her medication she tests NEGATIVE for the disease.

Kalydeco was the first of a new generation of gene modulators and sadly only effective in a very small percentage of patients. The fourth generation and by far the best of the modulators is here, Trikafta is saving lives around the world every day. Patients at the end stage of their disease are coming out of their hospital beds and living again, going back to work, looking forward to exciting futures they thought they would never see! Sadly Canada has made some very deadly changes to regulations that pharmaceutical companies must comply with. These changes are literally killing patients and they prevent lifesaving drugs from being submitted to Canada.

CF families are begging for Canadians to stand with them as they respond to these changes, so they will not have to watch their children die as the drug that will save them sits outside our borders. We have made a VERY simple form for you to complete and stand with us to let government know Canadians deserve better. I urge you to please take the two minutes to complete and urge your friends and family to complete as well. We are hoping to get 4,400 submissions, one for each CF patient in Canada. Letters for Lives will save lives.

Please consider writing a letter to thePatented Medicine Price Review Board, using the following template here.

Thank you,

Beth Vanstone, Beeton

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LETTER: Mother of local CF Warrior Madi Vanstone requesting help from the community in fight for access to orphan drugs - BradfordToday

When the current owners of CF Ranch were looking to buy land to raise cattle, a powerful underground irrigation system sealed the deal on a northeast Texas ranch with great bones but in need of work. During the past three years, Parker Flannery has used a heavy rotational grazing technique he picked up ranching for nearly a decade in Australia to transform an estimated 1,600 to 1,700 grazing acres into lush terrain thats not only beneficial to cows but also sustainability.

Icon Global just listed his property for a cool $6.495 million.

About half an hour from charming Paris, Texas, the 2,105-acre CF Ranch offers miles of pristine Red River frontage with sandy beaches. The self-sustaining ranch is ideal for both beginners and professional ranchersand with two homes, a turnkey opportunity for a city dweller looking for a family getaway within 1.5 hours of Dallas.

Amenities include three spring-fed private lakes, each which are set within descending elevations, ensuring free flow and year-round enjoyment of bass fishing. Duck, hogs, and deer roam the ranch for prime hunting. And ranch facilities include pens, laneways, fencing, barns, a roping arena, shops, and hay barns.

Conventionally, 2,000-acre ranches have four pastures. At CF Ranch, more than 800 cows rotate through 15 different Bermuda-grass pastures, which the animals love because it means better food.

Once you rotate them enough, theyre broke and easy to manage, Flannery says. By putting them in a small area, we can kind of force them to that and not just the really good stuff, but they have to eat some of the junk too. And that way over time, by eating everything, it controls the junk and the good stuff. And the good stuff naturally will take over.

Rotational grazing is designed to improve soil health, grass quality, nutrient availability, and water-holding capacity. Additionally, it has eliminated the use of herbicide on the property, says Flannery, who also breeds polo-prospect horses at the ranch.

The ranch is crowned with woodsthe primary purpose for them is for fighting erosion, but the cows benefit from it too. Many ranchers free their cows in open pastures, but the key, Flannery says, is to provide shaded areas in each field. It makes the cows feel better, which makes the production better, and its more profitable for the farm.

A highlight of the property is 10 miles of underground pipe that flows on-demand to pivots and stock water troughs throughout, complementing a series of wells and other natural creeks ponds and water throughout the ranchinsulating it from drought. In Texas, theyre really rare, Flannery says. Floods come and go in three days but droughts can last years.

The soil and the water, he adds, is what makes the land rare. You wont get that anywhere else. Its just unreal.

Theres a huge disconnect between the city and the land, and theres not really a reason for it, Flannery says. People just seem sort of intimidated about getting into agriculture, but we need fresh blood, and its gotta happen.

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Home on the Range: CF Ranch Along the Red River - D Magazine

By CHARLES ODUM The Associated Press

ATLANTA - Ronald Acuna Jr. isn't letting the coronavirus pandemic silence his love of baseball.

The empty seats at the Atlanta Braves' newly renamed Truist Park have left Acuna with more space to yell encouragement, sing and joke during workouts. Sometimes he teases or encourages his buddy, second baseman Ozzie Albies.

Acuna's constant chatter means there will be cheering at Braves games, even without the fans.

"You can hear his voice," Albies said. "It's so clear. ... He's always singing, always loud screaming. He enjoys the game."

Acuna, only 22, is an important lead voice for the Braves in the shortened 60-game season. Outfielder Nick Markakis has opted out and first baseman Freddie Freeman has been absent following a positive test for the coronavirus, taking away two of the team's leaders.

The Braves don't know when Freeman, the four-time All-Star, will return to the team. It seems increasingly unlikely he'll be ready for the July 24 opener at the New York Mets.

Freeman set career highs with 38 home runs and 121 RBIs last season as Atlanta won its second straight NL East title before falling to St. Louis in the playoffs.

Markakis, 36, made his decision to skip the season after talking on the telephone with Freeman and realizing Freeman was struggling with symptoms, including a fever. Another veteran, right-hander Felix Hernandez, the former Cy Young winner with Seattle, also opted out.

Acuna, Albies and free-agent addition Marcell Ozuna must lead the lineup while Freeman recovers.

Acuna is regarded as one of the top outfielders in the game after he hit .280 with 41 homers and 37 stolen bases in 2019, just missing a rare 40-40 season.

"It's obviously going to be hard not to have Nick around and we don't know what Freddie's status is going to be or how much he's going to be around," Acuna said through a translator. "We just have to keep moving on."

NEW LOOK

The Braves hope Ozuna can return to his peak form of 2017 with Miami, when he hit .312 with 37 homers and 124 RBIs. Ozuna couldn't match that production the last two years with St. Louis.

Ozuna, 29, could split his time between left field and designated hitter. He's expected to hit cleanup. Ozuna's production is crucial to the team's ability to replace Josh Donaldson, who signed with Minnesota.

The other key newcomers, set-up reliever Will Smith and left-handed starter Cole Hamels, may not be ready for the start of the season. Hamels, slowed by a sore left shoulder in spring training, was unable to throw a scheduled side session last week because of triceps tendinitis.

Smith was one of four players to test positive for the coronavirus at the start of summer camp. The others were Freeman, right-hander Touki Toussaint and infielder Pete Kozma. When he returns, Smith could push Mark Melancon for the closer's role.

ROOKIES TO WATCH

If Ozuna is the designated hitter, the outfield could include Acuna, Ender Inciarte and Adam Duvall. Rookies Cristian Pache and Drew Waters could be needed for depth.

Hamels' arm issues and the decision by Hernandez to opt out creates opportunities for such rookies as right-hander Kyle Wright, who could open the season in the rotation.

CORNER COMBO

Austin Riley opened spring in a competition with Johan Camargo to replace Josh Donaldson at third base. Manager Brian Snitker said he's confident Riley, who hit 18 homers as a rookie in 2019, could make a smooth transition if needed at first base while Freeman recovers.

Duvall also can play first base. Other options include Yonder Alonso and Peter O'Brien.

DUVALL'S DETERMINATION

Duvall, who has Type 1 diabetes, is a high-risk candidate for COVID-19. He said he made the decision to play after doing research and talking with his doctors.

Duvall said he needs his teammates to take proper precautions.

"It's a collective thing. Everybody has got to buy in," he said. "It's a pretty tight-knit group here. We've all got each other's back and we're all looking out for each other."

WASHINGTON'S TOE-TAP

Players can't hug or give high-fives, so third-base coach Ron Washington devised a toe-tap with players as a new way to celebrate during the pandemic.

"I just stuck my foot out," Washington said. "Next thing I know we started doing it."

Washington, 68, is at high risk for the virus. He remained with the team even after first-base coach Eric Young Sr. opted out.

To help his health, Washington said he stopped smoking on March 13, when MLB cut off spring training due to the pandemic.

"I trust Major League Baseball and the protocols they have in and I also trust me," he said.

Original post:

Braves' CF Acuna has even bigger role in shortened 2020 season - Sumter Item

The COVASE trial has been funded by LifeArc, a medical research charity, and will be run in partnership with UCL and the Francis Crick Institute. Up to 40patients are expected to be recruited.

During a viral infection, a group of white blood cells called neutrophils release neutrophil extracellular traps (NETs) which are extra-cellular meshes whose primary role is to trap and kill bacteria. Researchers believe the immune system in COVID-19 patients is over-active and an abundance of NETs could be causing excess inflammation (hyperinflammation) and contributing to the onset of pneumonia and severe damage to the lungs.

In the trial, select hospital patients will be given Dornase alfa twice a day for seven days and researchers will examine the drugs effect on inflammation and survival. Historic controls will be derived from an existing database of 120 subjects with COVID-19 who have been admitted to UCLH since the beginning of the outbreak.

Chief Clinical Investigator, UCLH consultant Professor Joanna Porter, said: Hyperinflammation is an overreaction of the bodys immune system, which can cause serious breathing problems and has proven to be one of the most fatal conditions in those with severe COVID-19.

Dornase alfa has an excellent safety profile and has been used for many decades to help break down mucus secretion in the lungs of patients with cystic fibrosis.

Similar mucus secretions, along with cellular debris from NETs, have been seen in patients with COVID-19, so we are hopeful this drug can have a similar positive effect reducing inflammation and enabling patients to be discharged from hospital earlier than they would have been without the treatment.

This trial is based on research by Dr Venizelos Papayannopoulos at the Crick. His lab has already identified specific damage-associated molecular patterns (DAMPs) in NETs that are responsible for excess inflammation during infection. The trial aims at clearing these DAMPs using Dornase. Therefore, the Crick lab will be monitoring the effect of the treatment on the presence of these DAMPs and the impact on inflammation in patients on the trial.

Dr Papayannopoulos said: Weve spent years studying how the immune system interacts with microbes to protect against infection but also, what happens when these responses are deregulate to promote disease.

The challenge at hand is to use this information in order to tackle excess inflammation in the lungs of patients with COVID-19. We hope to reduce the amount of time people spend in hospital and the number of patients who require intensive care.

Dornase alfa has been approved since 1994 for the treatment of cystic fibrosis (CF), an inherited condition that causes mucus to build up in the lungs. The drug is delivered directly to the lungs as patients breathe in a mist created by a nebuliser. In CF patients it has been shown to reduce NETs and inflammation, reduce the risk of developing a respiratory tract infection, and improve pulmonary function.

The drug can be self-administered at home and so if shown to be effective in hospital, could also benefit people with COVID-19 who have mild disease and are self-isolating, or those who have been discharged from hospital to continue their recovery at home.

This study is being supported by a grant from the medical research charity LifeArc, as part of its activities to address the need for new therapies for Covid-19. LifeArc has made 10m available to repurpose existing medicines or those in the late stage of development as this approach offers one of the fastest routes to develop new treatments that could tackle the virus and its impact.

The Dornase alfa will be administered using the PARI eFlowRapid electronic nebuliser, kindly donated by Pari.

Support for the COVASE study design and protocol was provided by the statistical analysis specialists, Exploristics, and by drug discovery and development consultancy, Target 2 Treatment.

Read more:

Cystic fibrosis drug tested to fight inflammation in COVID-19 - University College London Hospitals

BRAVE Combat Federation, the fastest-growing mixed martial arts organisation in the world, has struck a broadcasting deal with WIN Sports, one of the leading sports networks in Colombia.

The partnership aims to expand BRAVE CF Latin America, where it is already seen as one of the giants of the sporting world.

The organisation, founded by Supreme Council for Youth and Sports first deputy chairman and Bahrain Olympic Committee president Shaikh Khalid bin Hamad Al Khalifa, has constantly invested in Latin America, with four shows in Brazil and two in Colombia. After BRAVE CF 26 beat UFC Abu Dhabi with Khabib Nurmagomedov last year in the Colombian households ratings, WIN Sports and BRAVE CF made a long-term deal official.

According to the deal, WIN Sports will broadcast BRAVE CF fights every Saturday in their prime time, proving that the Bahraini organisation has truly become the only global MMA promotion.

Among the Colombian stars expected to feature are Eduardo Mora and Dumar Roa. The latter shocked the MMA world last November by knocking out former BRAVE CF lightweight world champion Abdul Kareem Al Selwady at BRAVE CF 29 in Bahrain.

I cant wait for my people in Colombia to witness BRAVE CF events. They will fall in love with the sport. I want to represent my country at the highest level and thats what BRAVE CF provided me, said Roa.

Roas victory has been seen as the beginning of a revolution for MMA in Colombia, with BRAVE CF and its partner Latin Fighter Championship at the head of transforming the sporting scene in yet another region.

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Other Sports: BRAVE CF partners with WIN Sports - Gulf Digital News

Top mixed martial arts promoter BRAVE Combat Federation and Fight Globe have announced a new partnership for the international content distribution of BRAVE CFs MMA events.

The Bahrain-based MMA promotion is considered one of the fastest-growing sports promotions in the world and has hosted 34 events globally in a little over three years.

We are thrilled to represent BRAVE CF and look forward to working with their team, said Fight Globe CEO Sabine Kesseler.

BRAVE CF is one of the reasons why we are in the MMA business. It guarantees top-notch fight and superb production. It is very impressive what they have accomplished in such a short time.

BRAVE CF president Mohammed Shahid added, As the only truly global MMA promotion, we are pleased to add the largest distributor of fight content worldwide to our BRAVE family. We are confident that Fight Globe will accelerate our effort of introducing fans around the world to our vision and content as the fastest growing MMA promotion in the world.

Earlier this year BRAVE CF had postponed BRAVE CF 35 to 37 due to the Covid-19 pandemic. However, Bahrain based MMA pioneer Mohammed The Hawk Shahid made the much-anticipated statement that it will resume its roster announcing several more events for this year starting with BRAVE CF 35 taking place on Monday in Romania.

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Other Sports: BRAVE CF and Fight Globe announce content tie-up - Gulf Digital News

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Complex Fertilizers 2020: Record Overwhelming Hike in Revenues by 2027 | CF Industries Holdings Inc. (US),Yara International ASA (Norway) - Daily...

Whatever Inter Miami CF forward Jerome Kiesewetter chooses to pursue when he's done playing soccer, it's safe to say he will not be joining the PGA Tour.

A few Miami playershit the links at the ESPN Wide World of Sports Complex on Friday, and midfielder Lee Nguyen took the liberty of filming Kiesewetter while he attempted to tee off, posting the results on Instagram. The swing would make Charles Barkley proud, as Kiesewetter missed the ball entirely, driving the club into the ground and snapping it in two. Watch it below.

I might have to start a humor thread involving Inter Miami if this keeps up.

Here's Jerome Kiesewetter with quite possibly the most astonishing golf swing that you may ever see.

(: @LeeNguyen24)#InterMiamiCF #MLSisBack #MLS pic.twitter.com/zV0VO6gmzj

The reaction from teammate Juan Agudelo says it all. The good news for Kiesewetter is that he should have plenty of time to practice in Orlando. For the sake of the poor golf clubs, we'll hope the form improves.

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The golf swing that broke the club: Inter Miami CF's Jerome Kiesewetter caught on video - MLSsoccer.com

CLEVELAND, Ohio -- The Indians are making quick work of signing their picks from the June draft.

They signed center fielder Petey Halpin and shortstop Milan Tolentino on Friday. It leaves Auburn right-hander Tanner Burns, the No. 36 selection, as the only unsigned player from their 2020 draft.

Halpin, who was scheduled to attend the University of Texas, signed for $1.525 million. The signing bonus was well above his slot value of $610,800 for a third-round pick. Tolentino was the Tribes fourth-round pick. He was scheduled to attend UCLA and had a slot value of $460,000.

The Indians recently signed No.1 pick Carson Tucker, No. 2 pick Logan Allen and No.5 pick Mason Hickman. Tucker received a $2 million signing bonus, while Allen signed for $1.25 million and Hickman signed for just about his slot value of $343,400.

Halpin, 18, hits left and throws right. He went to Mira Costa High School in Manhattan Beach, Calif. His senior season was canceled after five games because of the coronavirus.

Last year Halpin appeared in MLBs High School All-Star Game at Progressive Field and went on to play well at the Area Code Games later that summer. In MLBs Prospect Development Pipeline League, he went 6-for-6 in stolen bases. He throws well from the outfield and has been clocked at 92 mph on the mound.

Halpin is an extremely athletic left-handed hitting center fielder, said Scott Barnsby, Indians director of amateur scouting. Petey has the speed, the athleticism, along with the arm strength, to stay in center field.

Offensively, its just an advance feel for the barrel. He continues to develop physically, so we feel theres going to be some power there down the road. Hes an extreme competitor, plays with energy and is fearless on the field.

Milan, 18, was the 124th player taken in Junes unique five-round draft. He went to Santa Margarita High School in California. Milan, like Halpin, played in the High School All-Star Game last year at Progressive Field. In his first game of the season, he hit a grand slam before the virus shut down the season.

Jose Tolentino, Milans father, played 15 years professionally. He helped the University of Texas win the College World Series and played one year in the big leagues. He is now a broadcaster for the Angels.

Tolentino bats left and throws right.

Hes the starting shortstop for Team USA this summer, said Barnsby. Hes an impressive all-around player. He has instincts, hes got well above average feel for the game. Hes a left-handed hitter with the ability to recognize pitches and put the bat on the ball.

Defensively, hes a sure-handed defender with an outstanding internal clock. Its a lot of fun watching him out on the field.

The Indians are said to be making progress with Burns, whose slot value is $2.045 million. The Tribes signing bonus pool for the 2020 draft is $7,662,800.

Fanatics has released Cleveland Indians face masks, with sales benefitting two charities. See details and product links below.

New Indians face masks for sale: Heres where you can buy Cleveland Indians-themed face coverings for coronavirus protection, including a single mask ($14.99) and a 3-pack ($24.99). All MLB proceeds donated to charity.

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Cleveland Indians sign CF Petey Halpin and SS Milan Tolentino, their 3rd and 4th round picks in 2020 - cleveland.com