CAR-T play­er Po­sei­da march­es on with $30.5M Se­ries B; Kymera inks dis­cov­ery deal with GSK

→ In­vestors have in­fused $30.5 mil­lion in Se­ries B cash in­to Po­sei­da Ther­a­peu­tics’ pipeline of au­tol­o­gous T cell and NK cell ther­a­pies. Us­ing its gene en­gi­neer­ing tech, the San Diego com­pa­ny has iden­ti­fied sev­er­al CAR-T and gene ther­a­pies, with the lead pro­gram, P-BC­MA-101 for mul­ti­ple myelo­ma, cur­rent­ly in a Phase I tri­al. The new round of fi­nanc­ing will go to­wards that study, and push Po­sei­da to­ward INDs for two pro­grams in PS­MA CAR-T and al­lo­genic BC­MA CAR-T. Lon­gi­tude Cap­i­tal led the round, flanked by fel­low new in­vestors Vi­vo Cap­i­tal and the Tavi­s­tock Group, and David Hirsch — its man­ag­ing di­rec­tor — will join Po­sei­da’s board of di­rec­tors.

→ Glax­o­SmithK­line is team­ing up with Cam­bridge, MA-based Kymera Ther­a­peu­tics on a dis­cov­ery pact re­lat­ed to pro­tein degra­da­tion, a hot field that’s seen a va­ri­ety of star­tups come along. The 2-year deal cov­ers new small mol­e­cules and E3 lig­as­es – the en­zymes that do trig­ger the degra­da­tion of pro­teins that cause dis­eases.

→ Bay Area Stan­ford spin­out Sur­rozen, which re­cent­ly grabbed a $33M Se­ries A, just ap­point­ed a new CEO and sci­en­tif­ic co-founder. Craig Park­er, the for­mer SVP of cor­po­rate de­vel­op­ment at Jazz Phar­ma­ceu­ti­cals, is com­ing on board as the com­pa­ny’s new chief ex­ec­u­tive. He’s tak­ing the reins from Tim Kutzkey, a man­ag­ing part­ner at The Col­umn Group, who’s in­stead tak­ing up the role of chair­man of the board. The com­pa­ny, found­ed in 2016, is re­search­ing the Wnt path­way and the role it plays in re­gen­er­a­tive med­i­cine. In the same news re­lease, Sur­rozen al­so ap­point­ed a new sci­en­tif­ic co-founder in Hans Clevers, a pro­fes­sor of mol­e­c­u­lar ge­net­ics at the Hubrecht In­sti­tute. “The chal­lenge of pro­duc­ing Wnt has been a great source of frus­tra­tion in the field, im­ped­ing the ad­vance­ment of organoid tech­nol­o­gy and a deep­er dis­sec­tion of Wnt sig­nal­ing,” Clevers said in a state­ment. “Sur­rozen’s abil­i­ty to gen­er­ate po­tent and se­lec­tive Wnt path­way ag­o­nists with drug-like prop­er­ties is a re­al break­through.  I’m thrilled to join an es­teemed group of co-founders as Sur­rozen con­tin­ues its rapid pace of dis­cov­ery and fur­ther in­no­vates with its tech­nol­o­gy plat­forms.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Lian­Bio an­nounces terms for IPO next week; NIH and White House of­fi­cials dis­cuss hy­po­thet­i­cal bio-med re­search agency

LianBio, a biotech that has operations in both the US and China, announced the terms yesterday for its initial public offering.

The biotech plans to raise $325 million by offering 20.3 million shares priced between $15 and $17.

At the midpoint of the proposed range, LianBio could command a fully diluted market value of $1.8 billion, based on a number of expected outstanding shares.

The two year old biotech has focused on in-licensing and commercialization of therapeutics in China, Hong Kong, Taiwan, Macau and other Asian markets. The company currently has nine programs across five therapeutic areas, including oncology, cardiovascular, and inflammatory diseases.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.