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In­hi­brx shares rise on PhI tri­al re­sults; Bragli­a's Helsinn en­ters part­ner­ship with Fo­s­un

California biotech Inhibrx released interim results today from a Phase I trial looking at a recombinant fusion protein program, INBRX-101. The study looked at patients with alpha-1 antitrypsin deficiency, or AATD.

The study revealed interim pharmacokinetic data from 21 patients with AATD, all with the ZZ mutation of the SERPINA1 gene, and interim safety data are from 24 patients with AATD. There were no drug-related severe or serious adverse events at doses up to and including 120 mg/kg single dose, and 80mg/kg multi-dose, according to a company release. Adverse events were predominantly mild with a few moderate events.

Draw­ing Shire par­al­lel, Flem­ming Ørn­skov mulls IPO for Gal­der­ma; Rei­s­tone shows re­sults from eczema study with JAK1 block­er

Two years ago, Flemming Ørnskov took up a new challenge as CEO of Galderma with the expectation he would work the magic like he did with Shire — culminating in the rare disease biotech’s $62 billion sale to Takeda — with the pure-play dermatology outfit freshly spun out of Nestlé.

Now that the ship is steady, he’s seemingly setting his sights on an IPO.

In an interview with Bloomberg, Ørnskov said he’s accelerating research spending while recruiting more dermatologists and medical specialists to the company. The strategy, he added, is similar to Shire’s in the sense that he would double down on the science and shift to cutting-edge, high-risk products that can command high prices — even as Galderma continues to bring in revenue through its consumer aesthetic and skin care products such as Cetaphil moisturizers.

Mi­rati teams with Sanofi on PhI/II tri­al for KRAS treat­ment com­bo; Ab­b­Vie los­es in lat­est Hu­mi­ra biosim­i­lar de­vel­op­ment

Mirati and Sanofi on Friday announced their new non-exclusive, clinical collaboration to evaluate combining Mirati’s investigational KRAS G12C inhibitor adagrasib with Sanofi’s investigational SHP2 inhibitor RMC-4630 in an upcoming Phase I/II study.

Sanofi is taking responsibility for sponsoring and operating the study, while sharing oversight and costs with Mirati, according to a Mirati statement. The announcement of the study, which will be in patients with previously-treated NSCLC and KRAS G12C mutations, comes on the heels of Sanofi’s announcement of success yesterday in administering their flu vaccine simultaneously with Moderna’s Covid-19 booster shot.

Schrödinger teams up with MD An­der­son on WEE1 in­hibitor pro­gram; Amid JAK safe­ty con­cerns, Ab­b­Vie touts new da­ta for Rin­voq 

Physics-based discovery outfit Schrödinger and the University of Texas MD Anderson Cancer Center announced today a two-year research collaboration — focused on accelerating and optimizing development of Schrödinger’s investigational WEE1 inhibitor.

The team, made up of Schrödinger employees and researchers with  MD Anderson’s Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platform, will seek to prioritize clinical studies of a WEE1 inhibitor as a single agent in certain cancer indications and in combinations for defined clinical subpopulations, according to a company statement.

Ae­tion to col­lab­o­rate with UK's NICE on RWE; 4D's cys­tic fi­bro­sis gene ther­a­py cleared for clin­i­cal tri­als

New York-based real world evidence, or RWE, firm Aetion is teaming up with the National Institute for Health and Care Excellence in the United Kingdom to analyze data such as hospital records, prescription records and more to study clinical effectiveness and fill gaps in evidence.

As Aetion CEO Carolyn Magill told Endpoints News, the company’s goal is to collect evidence that would be harder to get outside of a controlled setting, such as a clinical trial.

Ex-FDA of­fi­cials ask SCO­TUS to take up J&J talc case; An­no­vis shows da­ta from PhII Parkin­son's tri­al

Eight former FDA officials, including former FDA commissioner Andrew von Eschenbach and multiple deputy commissioners, submitted an amicus brief to the Supreme Court yesterday — asking for the Court to review the Mississippi Supreme Court decision that ruled against J&J earlier this year.

Mississippi’s complaint in 2014 accused the mega-company of violating consumer protection laws by not disclosing ovarian cancer risks to women posed by its baby powder containing talc.

As­traZeneca's En­her­tu gets BTD for breast can­cer; Centes­sa nabs $300M loan

The FDA has granted breakthrough designation to AstraZeneca’s and Daiichi Sankyo’s HER2 ADC Enhertu, the companies jointly announced today.

The BTD is for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

Breakthrough therapy designation was based on data from the DESTINY-Breast03 pivotal trial at #ESMO21 just last month, which showed a 72% reduction compared to Roche’s ADC Kadcyla in the risk of disease progression or death in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

At­las cre­ates sec­ond op­por­tu­ni­ty fund with $300M; BioN­Tech's col­orec­tal can­cer vac­cine starts PhII tri­al

Life science VC Atlas Venture closed its second Opportunity Fund with $300 million. Known as AVOF II, the fund will enable Atlas to continue backing its portfolio companies, according to a company statement.

“We are delighted to receive support from both our longstanding LP base and new investors in AVOF II, for our mission of building and scaling biotech companies that can bring novel medicines to patients,” said Atlas partner David Grayzel in a statement.

Spero strikes $125M roy­al­ty deal for cU­TI drug; French firm launch­es $100M ear­ly biotech fund

French investment firm Advent France Biotechnology (AFB) announced today the first closing of its second fund for a total of $102 million.

Investors and participants in AFB’s fund included the European Investment Fund (EIF) and the Fonds national d’amorçage 2 (the French Seed Fund 2), which is managed on behalf of the French State by Bpifrance. Other participants included corporate venture funds such as Boehringer Ingelheim’s venture fund.

Te­va set­tles with Louisiana for $18M over opi­oid claims; Video game treat­ment churns out PhII re­sults

Teva Pharmaceuticals is paying the state of Louisiana $15 million in cash over the next 18 years, in exchange for being released from lawsuits over the state’s opioid claims.

As part of the agreement, Teva will also donate $3 million in opioid addiction recovery drugs — contingent upon being released from all Louisiana lawsuits by Nov. 2.

As the US-based subsidiary for Israel’s Teva Pharmaceutical Industries, Teva has been facing legal proceedings in a number of US states, including New York and California, amid claims that the company engaged in misleading marketing of opioids and downplayed the risks of opioid addiction.