On May 7, 2021 photonamic GmbH & Co. KG (Head office: Pinneberg, Germany; CEO: Ulrich Kosciessa, Ph.D.) ("photonamic"), a subsidiary of SBI Holdings, Inc. (Head office: Minato-ku, Tokyo; Representative Director, President and CEO: Yoshitaka Kitao) the leader in the pharmaceutical development, translation and global commercialization of 5-aminolevulinic acid ("5-ALA") (*) reported that its Canadian subsidiary SBI ALApharma Canada Inc. (Head office: Toronto, Canada; CEO & CTO, Dr. Ralph DaCosta) ("SBI Canada") has enrolled the first patient in its Pivotal Phase 3 randomized controlled trial (RCT) evaluating the safety and efficacy of PD G 506 A (5-ALA HCl) in margin assessment during breast conserving surgery (ClinicalTrials.gov Identifier: NCT04815083) (Press release, photonamic, MAY 7, 2021, View Source;co-kg-germany-enrolls-first-patient-in-pivotal-phase-3-clinical-trial-of-pd-g-506-a-5-ala-hcl-and-eagle-fluorescence-imaging-system-for-breast-conserving-surgery-301286333.html [SID1234579501]). This important milestone occurs on the heal of the company’s FDA IND clearance for the RCT on April 23, 2021. The multicenter trial involves 20 clinical centers in the United States and Canada and will use SBI Canada’s proprietary intraoperative handheld Eagle Fluorescence Imaging SystemTM to visualize PD G 506 A-induced protoporphyrin IX (PpIX) fluorescence.

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SBI Canada was established in 2019 as part of photonamic’s strategic acquisition of the oncology business from MolecuLight Inc. (Toronto, Canada). Data from an earlier Phase 2 clinical study at Princess Margaret Cancer Center demonstrated that PD G 506 A-induced PpIX fluorescence (known to be selective for cancerous tissues) can be visualized in surgical specimens and within the surgical cavity in real-time using the compact fully handheld camera of the Eagle Fluorescence Imaging SystemTM.

"We are pleased having accomplished this milestone in our development for breast cancer surgery program" explains Ulrich Kosciessa, photonamic GmbH & Co. KG’s CEO. "It is an important step on our pathway to utilize the capabilities of 5-ALA as a precursor of PpIX and its tumor selectivity together with innovative technologies to help improve the lives of cancer patients around the world. With our proprietary handheld Eagle imaging device technology of our subsidiary SBI Canada, surgeons will now be able to investigate the surgical cavity following conventional lumpectomy allowing them to identify residual disease as part of this Phase 3 trial in breast cancer surgery". "This will allow us to further develop our technology to one day benefit breast cancer patients in a manner similar to our current 5-ALA based product currently FDA approved for neurosurgery. This product similarly helps neurosurgeons around the world to perform fluorescence-guided glioblastoma surgery."

"We are delighted at achieving both FDA IND clearance and the first patient enrolled in our Pivotal Phase 3 trial within days of each other", says Dr. Ralph DaCosta, SBI Canada’s CEO & CTO. "These achievements are important markers of progress in our on-going program to investigate 5-ALA and our novel Eagle imaging technology to improve intraoperative margin assessment and fluorescence-guided surgery. Our initial focus is on breast cancer surgery, but this work lays the foundation for other cancers where real-time visualization of carcinoma during surgery is a clinical priority". "Despite the on-going COVID pandemic, our outstanding SBI Canada team, together with the support from the SBI group of companies have managed to bring us to this critical stage in clinical translation in breast cancer surgery", says DaCosta.

(*) 5-aminolevulinic acid ("5-ALA") is an endogenous amino acid derivative produced in mitochondria. Apart from its natural role as an important natural substance metabolized to heme and cytochromes serving the energy production in the mitochondrial membranes, 5-ALA is known to metabolize into the (pink/red) fluorescent compound protoporphyrin IX (PpIX) in cancer cells. This fluorescence can be detected with the appropriate instrumentation. In addition, PpIX, is a well-known photosensitizer used in photodynamic therapy of cancers.

On May 7, 2021 Daewoong Pharmaceutical(CEO Sengho Jeon) reported its management performance (based on consolidation) in Q1 of 2021 (Press release, Daewoong Pharmaceutical, MAY 7, 2021, View Source [SID1234579500]). Its sales and operating profit were 269.6 billion and 26.6 billion KRW. It rose 4.7 percent and 305 percent yoy, respectively. Operating profit surpassed 20 billion won in eight years as ETC and OTC drugs maintained solid sales plus upfront from Fexuprazan to China and decreased legal cost as ITC lawsuits were settled.

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The ETC division revenue grew 11.7 percent yoy(from 162.1 billion won to 181 billion won). Sales of products such as Ursa(prescription drug), Luphere Depot, and Crezet and introduced items such as Crestor, Forxiga, and Lixiana have increased. The OTC division showed stable results(from 26.1 billion KRW to 26.4 billion KRW). Impactamin(vitamin B complex) series and liver function-enhancing drug URSA(non prescription) continued stable sales.

Nabota’s sales reached 15.4 billion won from 15.1 billion won Q1, 2020. Not only did domestic sales increase, but ITC’s agreement on February 19 resolved uncertainties, resulted in surged U.S. sales, marking the historical high performance in March. Turkey and Chile, which recently acquired product licenses, are also planning to launch Nabota in Q3.

HanAll Biopharma, a major subsidiary, recorded 27.8 billion won this year from 22.1 billion won in sales in the same period last year, and its operating profit increased from 3 billion won to 5.4 billion won during the same period. Upfronts for new drug candidates, such as HL036(for dry eyes) and HL161(for autoimmune diseases) contributed to make better performance.

"We have been showing sluggish performance by many non business factors, but our performance defintely begun to improve from Q1. In particular, Nabota’s scalability in U.S. is just opening and it is expected to stand out in Europe, China and other markets." said from an insider. "Foistar Tab and DWRX2003(Niclosamide) for COVID19 treatmenmt and new drugs such as Fexuprazan and Enavogliflozin, are also considered to have great market potential" he said.

Meanwhile, Daewoong Co., a holding company of Daewoong Pharma., also announced its Q1 performance(based on consolidation). Its sales grew 6.2 percent year-on-year to 348.5 billion won and operating profit rose 78.7 percent to 44.3 billion won.

On May 7, 2021 Abingworth reported that it has raised $582 million for its second clinical co-development fund (Press release, Abingworth Venture, MAY 7, 2021, View Source [SID1234579496]). The fund, ACCD 2, equips Abingworth to make triple-digit million investments in late-stage clinical programs.

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London-based Abingworth got into clinical co-development investing in 2009. Initially, Abingworth used money from its venture funds, but by 2016 the strategy had matured to the point that it set up a dedicated $105 million clinical co-development fund. The new, far larger ACCD 2 sets Abingworth up to continue making late-stage bets at a time when table stakes are higher than in the past.

"[The larger fund] really just allows us to participate," Tim Haines, chairman and managing partner at Abingworth, said. "The deal sizes are certainly going up to some degree. And I think we’ll probably be doing more larger deals. We may do some deals by ourselves directly."

Abingworth has previously invested through its co-development portfolio companies Avillion and SFJ Pharmaceuticals. The co-development companies both finance and facilitate clinical trials, taking on all of the clinical and regulatory risk in return for a pre-agreed return if the drug is approved. Going forward, Abingworth may also invest directly.

The sweet spot for investments is in the range of $100 million to $200 million, Haines said, although Abingworth has gone up to $250 million in the past. By investing directly, Abingworth will be able to support companies that have the internal resources to run a program but need capital.

When Abingworth first got into clinical co-development, it primarily worked with pharma companies that had more clinical candidates than their budgets could support given the desire to limit spending to protect earnings per share (EPS). Rather than running EPS-suppressing clinical programs, pharma companies partnered with Abingworth and only paid out if the project was successful, by which time the cost of the deal could be amortized over the sales of the product.

Abingworth still works with pharma companies, but they are no longer the only game in town. "What has changed quite significantly is the interest from biotechs," Haines said. "The motivation there is slightly different. Clearly, most biotechs are not profitable, so the earnings per share issue is less critical. But what we’re able to do is to significantly reduce the dilutive impact if they had to go out and raise the money on the public market."

Haines cited Apellis Pharmaceuticals as an example of why biotechs are interested in the financing option. In 2019, SFJ, in its first partnership with a pre-revenue biotech, provided Apellis with upfront and near-term payments to support development of APL-2 in hematologic indications in return for a chance to receive regulatory approval milestones.

"When we did the deal, it was about an $800 million market cap. Today, [it’s $3.8 billion] based on the data that was generated from the capital that we provided them. So they saved a huge diluted impact," Haines said.

Abingworth has had one exit from ACCD 1 so far and has another four deals that are still in progress. Factoring in investments made from venture funds, Abingworth has done 11 deals, seven of which have completed. One deal failed, but the rest returned capital, generating "very good returns to the funds," Haines said.

Despite the returns available, Abingworth is part of a small number of investors to target the space. Blackstone, which backs SFJ with Abingworth, is active in the sector but the risk—and need for deep expertise to mitigate it—is a potential deterrent to new entrants.

"You need to really be able to assess the likelihood of success of these products, because if we get it wrong, we get nothing, we get no returns at all. So in some respects, it’s kind of a venture-like model where you need to really dig deep into the clinical data [and] likelihood of success," Haines said.

News of ACCD 2 comes months after Abingworth raised a $465 million venture fund.

On May 7, 2021 Mirati Therapeutics reported that investors waiting to hear the latest in the KRAS inhibitor story were disappointed Thursday evening, as the biotech reported that a few key clinical developments have slipped to 2022 (Press release, Mirati, MAY 7, 2021, View Source [SID1234579495]).

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Hot on Amgen’s heels in the race to bring a KRAS-inhibiting cancer drug to market, Mirati said Thursday that most of its clinical programs for adagrasib are on track, including solo studies in non-small cell lung cancer and two colorectal cancer studies.

However, Mirati had been expecting additional data this year from a phase 1/2 study of adagrasib, which targets G12C mutations, combined with Novartis’ experimental SHP-2 inhibitor. That’s now been pushed to the first quarter of 2022.

Mirati will hold off on launching a clinical trial of MRTX1133, a second KRAS inhibitor that targets G12D mutations, until next year. The candidate was previously expected to be a traditional oral or IV formulation, but Mirati has pivoted to a long-acting formulation that will require fewer infusions.

RELATED: Amgen’s up-and-coming KRAS inhibitor gets a name: Lumakras

The company’s shares dipped more than 10% around noon as investors reacted to the so-so news.

"While these delays may be poorly received by some investors, we believe that there remain several significant data readouts this year that could drive additional upside," SVB Leerink said in a note.

The delay could stem from the FDA’s decision to impose a post-marketing trial requirement on Amgen—Mirati’s chief rival in the KRAS arena, SVB Leerink said. In late April, the agency asked Amgen to study a lower dose of Lumakras, the KRAS inhibitor previously known as sotorasib. This could signal that the FDA has concerns about the safety of these emerging treatments.

Mirati told investors during the earnings call that the FDA has not requested a similar study for its KRAS program. And the company is already conducting several clinical trials examining different doses, which were kicked off without prodding from the agency, SVB Leerink said.

Amgen, too, had a trial in the hopper studying a lower dose, putting them in a good position to respond to the FDA’s request.

RELATED: Mirati’s KRAS drug shrinks 45% of NSCLC tumors, putting it in Amgen’s slipstream on race to FDA

Amgen will likely be the first company to reach the KRAS market as Lumakras is set for an August decision from the FDA on its first indication in non-small cell lung cancer.

But Mirati is close behind, with an expected FDA filing for adagrasib’s first new drug application in the second half of this year in the same indication.

"Mirati continues to advance an innovative pipeline of drug candidates," said Mirati President and CEO Charles Baum in a statement. "The company expects to file IND applications for two potentially first-in-class therapies—our KRAS G12D inhibitor, MRTX1133, in 2022, and a synthetic lethal MTA cooperative PRMT5 inhibitor, in the first half of 2022."

On May 7, 2021 Leidos Holdings, Inc. (NYSE: LDOS) ("Leidos"), a FORTUNE 500 science and technology leader, reported the completed acquisition of Gibbs & Cox, Inc. ("Gibbs & Cox") for approximately $380 million in cash (Press release, Leidos, MAY 7, 2021, View Source;Cox/default.aspx [SID1234579493]). The transaction was previously announced on Feb. 23, 2021. Gibbs & Cox will operate as a wholly owned subsidiary and will be combined with Leidos’ maritime systems division.

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Gibbs & Cox-designed DDG-51 Arleigh Burke-class destroyer

Headquartered in Arlington, Virginia, Gibbs & Cox is the largest independent ship design firm focused on naval architecture and marine engineering. The company’s world class naval architects, designers, engineers and program managers develop innovative vessel designs and naval capabilities. The acquisition positions Leidos to provide a broad set of engineering solutions to the US Navy and to an expanding set of foreign Navies.

"We are delighted to welcome the Gibbs & Cox team to the Leidos family," said Leidos Chairman and CEO Roger Krone. "Gibbs & Cox is widely regarded for developing the most talented and experienced naval designers in the world. We look forward to this new era of innovation while combining the best of both companies."

"We are excited to join Leidos, whose employee culture and history of innovation strongly mirror our own legendary 91-year history", said Gibbs & Cox President and Chief Executive Chris Deegan. "Gibbs & Cox will remain the nation’s largest independent provider of maritime services. The combination of our world-class naval architecture, design and engineering services with Leidos’ speed, security and scale will significantly enhance our combined offerings in the fast growing maritime undersea, autonomous and cyber security segments. We look forward to mapping a new Gibbs & Cox with Leidos for the next 90 years."

Advisors

Citigroup Global Markets Inc. served as exclusive financial advisor and Holland & Knight LLP served as legal advisor to Leidos. Houlihan Lokey served as exclusive financial advisor and Greenburg Traurig, LLP served as legal advisor to Gibbs & Cox in connection with this transaction.